Romiplostim (Nplate)
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Romiplostim (Nplate)

Nplate®
(romiplostim) for Injection

DRUG DESCRIPTION

Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli (E coli).

Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Each single-use 250 mcg vial of Nplate contains the following: 375 mcg romiplostim, 30 mg mannitol, 15 mg sucrose, 1.2 mg L-histidine, 0.03 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0. Each single-use 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 50 mg mannitol, 25 mg sucrose, 1.9 mg L-histidine, 0.05 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0 [see DOSAGE AND ADMINISTRATION].

What are the possible side effects of romiplostim (Nplate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;
  • dizziness;
  • joint or muscle pain;
  • pain in your arms, legs, or shoulder;
  • numbness or tingly feeling;
  • sleep problems (insomnia); or
  • stomach pain or upset.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side...

Read All Potential Side Effects and See Pictures of Nplate »

What are the precautions when taking romiplostim (Nplate)?

Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Nplate »

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Nplate is indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Limitations of use
  • Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP [see WARNINGS AND PRECAUTIONS].
  • Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding [see WARNINGS AND PRECAUTIONS].
  • Nplate should not be used in an attempt to normalize platelet counts [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommended Dosage Regimen

Use the lowest dose of Nplate to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding. Administer Nplate as a weekly subcutaneous injection with dose adjustments based upon the platelet count response.

The prescribed Nplate dose may consist of a very small volume (eg, 0.15 mL). Administer Nplate only with a syringe that contains 0.01 mL graduations.

Initial Dose

The initial dose for Nplate is 1 mcg/kg based on actual body weight.

Dose Adjustments

Use the actual body weight at initiation of therapy, then adjust the weekly dose of Nplate by increments of 1 mcg/kg until the patient achieves a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg. In clinical studies, most patients who responded to Nplate achieved and maintained platelet counts ≥ 50 x 109/L with a median dose of 2 mcg/kg.

During Nplate therapy, assess CBCs, including platelet counts, weekly until a stable platelet count ( ≥ 50 x 109/L for at least 4 weeks without dose adjustment) has been achieved. Obtain CBCs, including platelet counts, monthly thereafter.

Adjust the dose as follows

  • If the platelet count is < 50 x 109/L, increase the dose by 1 mcg/kg.
  • If platelet count is > 200 x 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg.
  • If platelet count is > 400 x 109/L, do not dose. Continue to assess the platelet count weekly. After the platelet count has fallen to < 200 x 109/L, resume Nplate at a dose reduced by 1 mcg/kg.
Discontinuation

Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of Nplate therapy at the maximum weekly dose of 10 mcg/kg [see WARNINGS AND PRECAUTIONS]. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate [see WARNINGS AND PRECAUTIONS].

Administration Precautions

Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection. Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].

Preparation and Administration

Nplate is supplied in single-use vials as a sterile, preservative-free, white lyophilized powder that must be reconstituted as outlined in Table 1 and administered using a syringe with 0.01 mL graduations. Using aseptic technique, reconstitute Nplate with preservative-free Sterile Water for Injection, USP as described in Table 1. Do not use bacteriostatic water for injection.

Table 1: Reconstitution of Nplate Single-Use Vials

Nplate Single-Use Vial Total Vial Content of Romiplostim   Sterile Water for Injection*   Deliverable Product and Volume Final Concentration
250 mcg 375 mcg add 0.72 mL = 250 mcg in 0.5 mL 500 mcg/mL
500 mcg 625 mcg add 1.2 mL = 500 mcg in 1 mL 500 mcg/mL
* Use preservative-free Sterile Water for Injection.

Gently swirl and invert the vial to reconstitute. Avoid excess or vigorous agitation: DO NOT SHAKE. Generally, dissolution of Nplate takes less than 2 minutes. The reconstituted Nplate solution should be clear and colorless. Visually inspect the reconstituted solution for particulate matter and/or discoloration. Do not administer Nplate if particulate matter and/or discoloration is observed.

Reconstituted Nplate can be kept at room temperature (25°C/77°F) or refrigerated at 2° to 8°C (36° to 46°F) for up to 24 hours prior to administration. Protect the reconstituted product from light.

To determine the injection volume to be administered, first identify the patient's total dose in micrograms (mcg) using the dosing information in Section 2.1. For example, a 75 kg patient initiating therapy at 1 mcg/kg will begin with a dose of 75 mcg. Next, calculate the volume of Nplate solution that is given to the patient by dividing the microgram dose by the concentration of the reconstituted Nplate solution (500 mcg/mL). For this patient example, the 75 mcg dose is divided by 500 mcg/mL, resulting in an injection volume of 0.15 mL.

As the injection volume may be very small, use a syringe with graduations to 0.01 mL.

Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than one dose from a vial.

Use of Nplate With Concomitant Medical ITP Therapies

Nplate may be used with other medical ITP therapies, such as corticosteroids, danazol, azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. If the patient's platelet count is ≥ 50 x 109/L, medical ITP therapies may be reduced or discontinued [see Clinical Studies].

HOW SUPPLIED

Dosage Forms And Strengths

Single-use vials contain 250 or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder.

Storage And Handling

Nplate is supplied in single-use vials containing 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) deliverable romiplostim.

Store Nplate vials in their carton to protect from light until time of use. Keep Nplate vials refrigerated at 2° to 8°C (36° to 46°F). Do not freeze.

Nplate® (romiplostim), Manufactured by: Amgen Inc., One Amgen Center Drive Thousand Oaks, California 91320-1799. Revised 11/2012

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Trials Experience

Serious adverse reactions associated with Nplate in ITP clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation [see WARNINGS AND PRECAUTIONS].

The data described below reflect Nplate exposure to 271 patients with chronic ITP, aged 18 to 88, of whom 62% were female. Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated nonsplenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP. Data are also reported from an open-label, single-arm study in which patients received Nplate over an extended period of time. Overall, Nplate was administered to 114 patients for at least 52 weeks and 53 patients for at least 96 weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity. Table 2 presents adverse drug reactions from Studies 1 and 2 with a ≥ 5% higher patient incidence in Nplate versus placebo. The majority of these adverse drug reactions were mild to moderate in severity.

Table 2: Adverse Drug Reactions Identified in Two Placebo-Controlled Studies

Preferred Term Nplate
(n = 84)
Placebo
(n = 41)
Arthralgia 26% 20%
Dizziness 17% 0%
Insomnia 16% 7%
Myalgia 14% 2%
Pain in Extremity 13% 5%
Abdominal Pain 11% 0%
Shoulder Pain 8% 0%
Dyspepsia 7% 0%
Paresthesia 6% 0%

Among 142 patients with chronic ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Nplate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immunogenicity

As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein. Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay. This assay is capable of detecting both high- and low-affinity binding antibodies that bind to romiplostim and cross-react with TPO. The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay.

In clinical studies, the incidence of preexisting antibodies to romiplostim was 8% (43/537) and the incidence of binding antibody development during Nplate treatment was 6% (31/537). The incidence of preexisting antibodies to endogenous TPO was 5% (29/537) and the incidence of binding antibody development to endogenous TPO during Nplate treatment was 4% (21/537). Of the patients with positive binding antibodies that developed to romiplostim or to TPO, two (0.4%) patients had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No correlation was observed between antibody activity and clinical effectiveness or safety.

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to romiplostim with the incidence of antibodies to other products may be misleading.

Read the Nplate (romiplostim) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No formal drug interaction studies of Nplate have been performed.

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia

Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in clinical trials with Nplate. A randomized, double-blind, placebo-controlled trial enrolling patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate treatment arm. At the time of an interim analysis, among 219 MDS patients randomized 2:1 to treatment with Nplate or placebo (147 Nplate: 72 placebo), 11 patients showed progression to AML, including nine on the Nplate arm versus two on the placebo arm. In addition, in peripheral blood counts, the percentage of circulating myeloblasts increased to greater than 10% in 28 patients, 25 of whom were in the romiplostim treatment arm. Of the 28 patients who had an increase in circulating myeloblasts to greater than 10%, eight of these patients were diagnosed to have AML and 20 patients had not progressed to AML. In four patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate. In a single-arm trial of Nplate given to 72 patients with thrombocytopenia related to MDS, eight (11%) patients were reported as having possible disease progression, and three patients had confirmation of AML during follow-up. In addition, in three patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate.

Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.

Thrombotic/Thromboembolic Complications

Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. Nplate should be used with caution in patients with ITP and chronic liver disease.

To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L [see DOSAGE AND ADMINISTRATION].

Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis

Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy. Clinical trials are in progress to assess the risk of bone marrow fibrosis and clinical consequences with cytopenias.

If new or worsening morphological abnormalities or cytopenia(s) occur, consider a bone marrow biopsy to include staining for fibrosis [see ADVERSE REACTIONS].

Worsened Thrombocytopenia after Cessation of Nplate

In clinical studies of patients with chronic ITP who had Nplate discontinued, four of 57 patients developed thrombocytopenia of greater severity than was present prior to Nplate therapy. This worsened thrombocytopenia resolved within 14 days. Following discontinuation of Nplate, obtain weekly CBCs, including platelet counts, for at least 2 weeks and consider alternative treatments for worsening thrombocytopenia, according to current treatment guidelines [see ADVERSE REACTIONS].

Lack or Loss of Response to Nplate

Hyporesponsiveness or failure to maintain a platelet response with Nplate should prompt a search for causative factors, including neutralizing antibodies to Nplate [see ADVERSE REACTIONS]. To detect antibody formation, submit blood samples to Amgen (1-800-772-6436). Amgen will assay these samples for antibodies to Nplate and thrombopoietin (TPO). Discontinue Nplate if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.

Laboratory Monitoring

Obtain CBCs, including platelet counts, weekly during the dose-adjustment phase of Nplate therapy and then monthly following establishment of a stable Nplate dose. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of Nplate [see DOSAGE AND ADMINISTRATION].

Medication Errors

Medication errors including overdose and underdose have been reported in patients receiving Nplate. Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations. Underdose may result in lower than expected platelet counts and potential for bleeding. Platelet counts should be monitored in patients receiving Nplate [see DOSAGE AND ADMINISTRATION and OVERDOSAGE].

Patient Counseling Information

See FDA-Approved Medication Guide.

Information for Patients

Prior to treatment, patients should fully understand the risks and benefits of Nplate. Inform patients that the risks associated with long-term administration of Nplate are unknown.

Inform patients of the following risks and considerations for Nplate:

  • Nplate therapy is administered to achieve and maintain a platelet count ≥ 50 x 109/L as necessary to reduce the risk for bleeding; Nplate is not used to normalize platelet counts.
  • Following discontinuation of Nplate, thrombocytopenia and risk of bleeding may develop that is worse than that experienced prior to the Nplate therapy.
  • Nplate therapy may increase the risk of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation. Detection of peripheral blood cell abnormalities may necessitate a bone marrow examination.
  • Too much Nplate may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications.
  • Nplate stimulates certain bone marrow cells to make platelets and increases the risk of progression to acute myelogenous leukemia in patients with myelodysplastic syndromes.
  • Platelet counts and CBCs must be performed weekly until a stable Nplate dose has been achieved; thereafter, platelet counts and CBCs must be performed monthly while taking Nplate.
  • Patients must be closely monitored with weekly platelet counts and CBCs for at least 2 weeks following Nplate discontinuation.
  • Even with Nplate therapy, patients should continue to avoid situations or medications that may increase the risk for bleeding.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of romiplostim has not been evaluated. The mutagenic potential of romiplostim has not been evaluated. Romiplostim had no effect on the fertility of rats at doses up to 37 times the MHD based on systemic exposure.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Nplate use in pregnant women. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality. Nplate should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Pregnancy Registry

A pregnancy registry has been established to collect information about the effects of Nplate use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the Nplate pregnancy registry by calling 1-800-77-AMGEN (1-800-772-6436).

In rat and rabbit developmental toxicity studies, no evidence of fetal harm was observed at romiplostim doses up to 11 times (rats) and 82 times (rabbits) the maximum human dose (MHD) based on systemic exposure. In mice at doses 5 times the MHD, reductions in maternal body weight and increased postimplantation loss occurred. In a prenatal and postnatal development study in rats, at doses 11 times the MHD, there was an increase in perinatal pup mortality. Romiplostim crossed the placental barrier in rats and increased fetal platelet counts at clinically equivalent and higher doses.

Nursing Mothers

It is not known whether Nplate is excreted in human milk; however, human IgG is excreted in human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Nplate, a decision should be made whether to discontinue nursing or to discontinue Nplate, taking into account the importance of Nplate to the mother and the known benefits of nursing.

Pediatric Use

The safety and effectiveness in pediatric patients ( < 18 years) have not been established.

Geriatric Use

Of the 271 patients who received Nplate in ITP clinical studies, 55 (20%) were age 65 and over, and 27 (10%) were 75 and over. No overall differences in safety or efficacy have been observed between older and younger patients in the placebo-controlled studies, but greater sensitivity of some older individuals cannot be ruled out. In general, dose adjustment for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

No clinical studies were conducted in patients with renal impairment. Use Nplate with caution in this population.

Hepatic Impairment

No clinical studies were conducted in patients with hepatic impairment. Use Nplate with caution in this population.

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In this case, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

CONTRAINDICATIONS

None

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Nplate increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.

Pharmacodynamics

In clinical studies, treatment with Nplate resulted in dose-dependent increases in platelet counts. After a single subcutaneous dose of 1 to 10 mcg/kg Nplate in patients with chronic ITP, the peak platelet count was 1.3 to 14.9 times greater than the baseline platelet count over a 2- to 3-week period. The platelet counts were above 50 x 109/L for seven out of eight patients with chronic ITP who received six weekly doses of Nplate at 1 mcg/kg.

Pharmacokinetics

In the long-term extension study in patients with ITP receiving weekly treatment of Nplate subcutaneously, the pharmacokinetics of romiplostim over the dose range of 3 to 15 mcg/kg indicated that peak serum concentrations of romiplostim were observed about 7 to 50 hours post dose (median: 14 hours) with half-life values ranging from 1 to 34 days (median: 3.5 days). The serum concentrations varied among patients and did not correlate with the dose administered. The elimination of serum romiplostim is in part dependent on the TPO receptor on platelets. As a result, for a given dose, patients with high platelet counts are associated with low serum concentrations and vice versa. In another ITP clinical study, no accumulation in serum concentrations was observed (n = 4) after six weekly doses of Nplate (3 mcg/kg). The accumulation at higher doses of romiplostim is unknown.

Animal Toxicology and/or Pharmacology

In a 4-week repeat-dose toxicity study in which rats were dosed subcutaneously three times per week, romiplostim caused extramedullary hematopoiesis, bone hyperostosis, and marrow fibrosis at clinically equivalent and higher doses. In this study, these findings were not observed in animals after a 4-week post treatment recovery period. Studies of long-term treatment with romiplostim in rats have not been conducted; therefore, it is not known if the fibrosis of the bone marrow is reversible in rats after long-term treatment.

Clinical Studies

Chronic ITP

The safety and efficacy of Nplate were assessed in two double-blind, placebo-controlled clinical studies and in an open-label extension study.

Studies 1 and 2

In Studies 1 and 2, patients with chronic ITP who had completed at least one prior treatment and had a platelet count of ≤ 30 x 109/L prior to study entry were randomized (2:1) to 24 weeks of Nplate (1 mcg/kg subcutaneous [SC]) or placebo. Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. Patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the studies. Rescue therapies (ie, corticosteroids, IVIG, platelet transfusions, and anti-D immunoglobulin) were permitted for bleeding, wet purpura, or if the patient was at immediate risk for hemorrhage. Patients received single weekly SC injections of Nplate, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L).

Study 1 evaluated patients who had not undergone a splenectomy. The patients had been diagnosed with ITP for approximately 2 years and had received a median of three prior ITP treatments. Overall, the median platelet count was 19 x 109/L at study entry. During the study, the median weekly Nplate dose was 2 mcg/kg (25th–75th percentile: 1–3 mcg/kg).

Study 2 evaluated patients who had undergone a splenectomy. The patients had been diagnosed with ITP for approximately 8 years and had received a median of six prior ITP treatments. Overall, the median platelet count was 14 x 109/L at study entry. During the study, the median weekly Nplate dose was 3 mcg/kg (25th–75th percentile: 2–7 mcg/kg).

Study 1 and 2 outcomes are shown in Table 3. A durable platelet response was the achievement of a weekly platelet count ≥ 50 x 109/L for any 6 of the last 8 weeks of the 24-week treatment period in the absence of rescue medication at any time. A transient platelet response was the achievement of any weekly platelet counts ≥ 50 x 109/L for any 4 weeks during the treatment period without a durable platelet response. An overall platelet response was the achievement of either a durable or a transient platelet response. Platelet responses were excluded for 8 weeks after receiving rescue medications.

Table 3: Results From Placebo-Controlled Studiesa

Outcomes Study 1 Nonsplenectomized Patients Study 2 Splenectomized Patients
Nplate
(n = 41)
Placebo
(n = 21)
Nplate
(n = 42)
Placebo
(n = 21)
Platelet Responses and Rescue Therapy
Durable Platelet Response, n (%) 25 (61%) 1 (5%) 16 (38%) 0 (0%)
Overall Platelet Response, n (%) 36 (88%) 3 (14%) 33 (79%) 0 (0%)
Number of Weeks With Platelet Counts ≥ 50 x 109/L, average 15 1 12 0
Requiring Rescue Therapy, n (%) 8 (20%) 13 (62%) 11 (26%) 12 (57%)
Reduction/Discontinuation of Baseline Concurrent ITP Medical Therapy
Receiving Therapy at Baseline (n = 11) (n = 10) (n = 12) (n = 6)
Patients Who Had > 25% Dose Reduction in Concurrent Therapy, n (%) 4/11 (36%) 2/10 (20%) 4/12 (33%) 1/6 (17%)
Patients Who Discontinued Baseline 4/11 3/10 8/12 0/6
Therapy, n (%)b (36%) (30%) (67%) (0%)
a All p values < 0.05 for platelet response and rescue therapy comparisons between Nplate and placebo.
b For multiple concomitant baseline therapies, all therapies were discontinued.

In Studies 1 and 2, nine patients reported a serious bleeding event [five (6%) Nplate, four (10%) placebo]. Bleeding events that were grade 2 severity or higher occurred in 15% of patients treated with Nplate and 34% of patients treated with placebo.

Extension Study

Patients who had participated in either Study 1 or Study 2 were withdrawn from study medications. If platelet counts subsequently decreased to ≤ 50 x 109/L, the patients were allowed to receive Nplate in an open-label extension study with weekly dosing based on platelet counts. Following Nplate discontinuation in Studies 1 and 2, seven patients maintained platelet counts of ≥ 50 x 109/L. Among 100 patients who subsequently entered the extension study, platelet counts were increased and sustained regardless of whether they had received Nplate or placebo in the prior placebo-controlled studies. The majority of patients reached a median platelet count of 50 x 109/L after receiving one to three doses of Nplate, and these platelet counts were maintained throughout the remainder of the study with a median duration of Nplate treatment of 60 weeks and a maximum duration of 96 weeks.

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

MEDICATION GUIDE

Nplate®
(N-plat)
(romiplostim) for Injection

Read this Medication Guide before you start Nplate and before each Nplate injection. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Nplate?

Nplate can cause serious side effects:

  • Worsening of a precancerous blood condition to a blood cancer (leukemia). Nplate is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS) or for any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP). If you have MDS and receive Nplate, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia.
  • Higher risk for blood clots.
    • You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts and change your dose or stop Nplate if your platelet counts get high.
    • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.
  • Bone marrow changes (increased reticulin and possible bone marrow fibrosis). Nplate may cause changes in your bone marrow, but these changes may improve if you stop taking Nplate. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called “increased reticulin.” It is not known if this may progress to a more severe form called “fibrosis.” The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
  • Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping Nplate. When you stop receiving Nplate, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving Nplate. These effects are most likely to happen shortly after stopping Nplate and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking Nplate. Call your healthcare provider right away to report any bruising or bleeding.

When you are being treated with Nplate, your healthcare provider will closely monitor your Nplate dose and blood tests, including platelet counts.

  • Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects.
  • During Nplate therapy, your healthcare provider may change your Nplate dose, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start Nplate, during Nplate therapy, and after Nplate therapy is stopped.

See “What are the possible side effects of Nplate?” for other side effects of Nplate.

What is Nplate?

Nplate is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP), when certain other medicines, or surgery to remove your spleen, have not worked well enough.

Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS) or low platelet count caused by any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP).

Nplate is only used if your low platelet count and medical condition increase your risk of bleeding.

Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Nplate is not used to make your platelet count normal.

It is not known if Nplate works or if it is safe in people under the age of 18.

What should I tell my healthcare provider before taking Nplate?

Tell your healthcare provider about all your medical conditions, including if you:

  • Have had surgery to remove your spleen (splenectomy).
  • Have a bone marrow problem, including a blood cancer or MDS.
  • Have or had a blood clot.
  • Have chronic liver disease.
  • Have bleeding problems.
  • Have any other medical condition.
  • Are pregnant, or plan to become pregnant. It is not known if Nplate will harm your unborn baby.
    Pregnancy Registry: There is a registry for women who become pregnant during treatment with Nplate. If you become pregnant, consider this registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll in the registry by calling 1-800-77-AMGEN (1-800-772-6436).
  • Are breast-feeding or plan to breast-feed. It is not known if Nplate passes into your breast milk. You and your healthcare provider should decide whether you will take Nplate or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines you take,

including prescription and nonprescription medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Nplate?

Before you receive Nplate you should first talk with your healthcare provider and understand the benefits and risks of Nplate.

  • Nplate is given as a subcutaneous (SC) injection under the skin one time each week. You may not give Nplate injections to yourself.

Your healthcare provider will check your platelet count every week and change your dose of Nplate as needed. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. After that, you will need to have blood tests every month. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.

Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving Nplate.

If you miss a scheduled dose of Nplate, call your healthcare provider to arrange for your next dose as soon as possible.

What should I avoid while receiving Nplate?

Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate. You should arrange for your next dose as soon as possible and call your healthcare provider.

What are the possible side effects of Nplate?

Nplate may cause serious side effects. See “What is the most important information I should know about Nplate?

The most common side effects of Nplate are:

  • Headache
  • Joint pain
  • Dizziness
  • Trouble sleeping
  • Muscle tenderness or weakness
  • Pain in arms and legs
  • Abdominal pain
  • Shoulder pain
  • Indigestion
  • Tingling or numbness in hands and feet

These are not all the possible side effects of Nplate. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).

General information about the safe and effective use of Nplate.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Nplate. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Nplate that is written for health professionals.

What are the ingredients in Nplate?

Active ingredient: romiplostim

Inactive ingredients: L-histidine, sucrose, mannitol, polysorbate 20, and hydrochloric acid

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

MEDICATION GUIDE

Nplate®
(N-plat)
(romiplostim) for Injection

Read this Medication Guide before you start Nplate and before each Nplate injection. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Nplate?

Nplate can cause serious side effects:

  • Worsening of a precancerous blood condition to a blood cancer (leukemia). Nplate is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS) or for any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP). If you have MDS and receive Nplate, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia.
  • Higher risk for blood clots.
    • You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with Nplate. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts and change your dose or stop Nplate if your platelet counts get high.
    • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.
  • Bone marrow changes (increased reticulin and possible bone marrow fibrosis). Nplate may cause changes in your bone marrow, but these changes may improve if you stop taking Nplate. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called “increased reticulin.” It is not known if this may progress to a more severe form called “fibrosis.” The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate.
  • Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping Nplate. When you stop receiving Nplate, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving Nplate. These effects are most likely to happen shortly after stopping Nplate and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking Nplate. Call your healthcare provider right away to report any bruising or bleeding.

When you are being treated with Nplate, your healthcare provider will closely monitor your Nplate dose and blood tests, including platelet counts.

  • Injection of too much Nplate may cause a dangerous increase in your blood platelet count and serious side effects.
  • During Nplate therapy, your healthcare provider may change your Nplate dose, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start Nplate, during Nplate therapy, and after Nplate therapy is stopped.

See “What are the possible side effects of Nplate?” for other side effects of Nplate.

What is Nplate?

Nplate is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP), when certain other medicines, or surgery to remove your spleen, have not worked well enough.

Nplate is not for use in people with a precancerous condition called myelodysplastic syndrome (MDS) or low platelet count caused by any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP).

Nplate is only used if your low platelet count and medical condition increase your risk of bleeding.

Nplate is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Nplate is not used to make your platelet count normal.

It is not known if Nplate works or if it is safe in people under the age of 18.

What should I tell my healthcare provider before taking Nplate?

Tell your healthcare provider about all your medical conditions, including if you:

  • Have had surgery to remove your spleen (splenectomy).
  • Have a bone marrow problem, including a blood cancer or MDS.
  • Have or had a blood clot.
  • Have chronic liver disease.
  • Have bleeding problems.
  • Have any other medical condition.
  • Are pregnant, or plan to become pregnant. It is not known if Nplate will harm your unborn baby.
    Pregnancy Registry: There is a registry for women who become pregnant during treatment with Nplate. If you become pregnant, consider this registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll in the registry by calling 1-800-77-AMGEN (1-800-772-6436).
  • Are breast-feeding or plan to breast-feed. It is not known if Nplate passes into your breast milk. You and your healthcare provider should decide whether you will take Nplate or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines you take,

including prescription and nonprescription medicines, vitamins, and herbal products. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Nplate?

Before you receive Nplate you should first talk with your healthcare provider and understand the benefits and risks of Nplate.

  • Nplate is given as a subcutaneous (SC) injection under the skin one time each week. You may not give Nplate injections to yourself.

Your healthcare provider will check your platelet count every week and change your dose of Nplate as needed. This will continue until your healthcare provider decides that your dose of Nplate can stay the same. After that, you will need to have blood tests every month. When you stop receiving Nplate, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.

Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving Nplate.

If you miss a scheduled dose of Nplate, call your healthcare provider to arrange for your next dose as soon as possible.

What should I avoid while receiving Nplate?

Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of Nplate. You should arrange for your next dose as soon as possible and call your healthcare provider.

What are the possible side effects of Nplate?

Nplate may cause serious side effects. See “What is the most important information I should know about Nplate?

The most common side effects of Nplate are:

  • Headache
  • Joint pain
  • Dizziness
  • Trouble sleeping
  • Muscle tenderness or weakness
  • Pain in arms and legs
  • Abdominal pain
  • Shoulder pain
  • Indigestion
  • Tingling or numbness in hands and feet

These are not all the possible side effects of Nplate. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).

General information about the safe and effective use of Nplate.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Nplate. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Nplate that is written for health professionals.

What are the ingredients in Nplate?

Active ingredient: romiplostim

Inactive ingredients: L-histidine, sucrose, mannitol, polysorbate 20, and hydrochloric acid

Last reviewed on RxList: 12/5/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Nplate Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ROMIPLOSTIM - INJECTION

COMMON BRAND NAME(S): Nplate

USES: This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which the blood does not clot properly due to a lack of platelets. Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Romiplostim decreases your risk of bleeding by increasing the number of platelets. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using romiplostim and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Only patients enrolled in the NEXUS program may obtain and use romiplostim. After talking with your doctor about the risks and benefits of treatment, you will need to sign an enrollment form at your doctor's office before receiving your first injection. Consult your doctor or pharmacist for more details about the NEXUS program and for more information about the risks and benefits of using this medication.

This medication is injected under the skin by a health care professional, usually once a week.

Dosage is based on your medical condition, weight, and response to treatment. Your doctor will order blood tests (platelet counts) to find the right dose for you. Be sure to keep all medical/lab appointments.

Your risk of bleeding may increase when you stop using romiplostim. Your doctor should order weekly blood tests for at least 2 weeks after your last dose. Tell your doctor immediately if you develop any bleeding/bruising.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition (bleeding/bruising) persists or worsens.

Disclaimer

Nplate Consumer (continued)

SIDE EFFECTS: Headache, joint/muscle pain, dizziness, heartburn, abdominal pain, tingling/numbness in hands/feet, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious problems from blood clots to the heart, brain or lung (such as pulmonary embolism, stroke, heart attack), especially if your platelet counts are too high. Keep all medical/lab test appointments. Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, weakness on one side of the body, vision problems/changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Nplate (romiplostim) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome).

Before having surgery, tell your doctor or dentist that you are using this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Nplate Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: This medication must be used under close medical supervision so your blood counts can be monitored. Laboratory and/or medical tests (such as blood and platelet counts) should be performed before you start treatment, weekly when first starting, and then monthly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2010. Copyright(c) 2010 First Databank, Inc.

Nplate Patient Information Including Side Effects

Brand Names: Nplate

Generic Name: romiplostim (Pronunciation: ROM i PLOS tim)

What is romiplostim (Nplate)?

Romiplostim is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Romiplostim is usually given after other medications have been tried without successful treatment of symptoms.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Romiplostim may also be used for other purposes not listed in this medication guide.

What are the possible side effects of romiplostim (Nplate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;
  • dizziness;
  • joint or muscle pain;
  • pain in your arms, legs, or shoulder;
  • numbness or tingly feeling;
  • sleep problems (insomnia); or
  • stomach pain or upset.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nplate (romiplostim) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about romiplostim (Nplate)?

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Before you use romiplostim, tell your doctor if you have kidney or liver disease.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

Side Effects Centers

Nplate Patient Information including How Should I Take

What should I discuss with my health care provider before receiving romiplostim (Nplate)?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use romiplostim, tell your doctor if you have kidney or liver disease.

FDA pregnancy category C. It is not known whether romiplostim is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while receiving romiplostim. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether romiplostim had any effect on the baby

It is not known whether romiplostim passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Using romiplostim may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any scheduled visits to your doctor.

How is romiplostim given (Nplate)?

Romiplostim is available only under a special program called Nplate NEXUS. You must be enrolled in this program and sign all required agreements in order to receive the medication. Read all program brochures and agreements carefully.

Romiplostim is given as an injection under the skin, usually once per week. Your doctor, nurse, or other healthcare provider will give you this injection.

It may take up to 4 weeks of using this medicine before it is completely effective in preventing bleeding episodes. For best results, keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

Side Effects Centers

Nplate Patient Information including If I Miss a Dose

What happens if I miss a dose (Nplate)?

Call your doctor for instructions if you miss an appointment for your romiplostim injection.

What happens if I overdose (Nplate)?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose can cause signs of a blood clot, including sudden numbness or weakness, sudden headache or confusion, problems with vision or speech, loss of balance, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, and pain or swelling in one or both legs.

What should I avoid while receiving romiplostim (Nplate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using romiplostim.

What other drugs will affect romiplostim (Nplate)?

There may be other drugs that can interact with romiplostim. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about romiplostim.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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