Kalbitor (Ecallantide Injection)
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Kalbitor (Ecallantide Injection)

KALBITOR
(ecallantide) Injection, for Subcutaneous Use

WARNING

Anaphylaxis

Anaphylaxis has been reported after administration of KALBITOR (ecallantide injection) . Because of the risk of anaphylaxis, KALBITOR (ecallantide injection) should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR (ecallantide injection) to patients with known clinical hypersensitivity t o KALBITOR. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS]

DRUG DESCRIPTION

KALBITOR (ecallantide) is a human plasma kallikrein inhibitor for injection for subcutaneous use.

KALBITOR (ecallantide injection) is a clear and colorless, sterile, and nonpyrogenic solution. Each vial contains 10 mg ecallantide as the active ingredient, and the following inactive ingredients: 0.76 mg disodium hydrogen orthophosphate (dihydrate), 0.2 mg monopotassium phosphate, 0.2 mg potassium chloride, and 8 mg sodium chloride in water for injection, USP. KALBITOR (ecallantide injection) is preservative free, with a pH of approximately 7.0. A 30 mg dose is supplied as 3 vials each containing 1 mL of 10 mg/mL KALBITOR (ecallantide injection) . Each vial contains a slight overfill. Vials are intended for single use. Ecallantide is a 60-amino-acid protein produced in Pichia pastor is yeast cells by recombinant DNA technology.

What are the possible side effects of ecallantide (Kalbitor)?

Tell your caregivers right away if you have any of these signs of an allergic reaction within 1 hour after receiving ecallantide:

  • chest pain or discomfort, fast or weak heartbeat;
  • flushing (warmth, redness, or tingly feeling);
  • feeling like you might pass out;
  • itching, rash, or hives;
  • runny nose, sneezing, stuffy nose;
  • wheezing, cough, throat irritation, trouble breathing; or
  • swelling of your face, lips, tongue, or throat.

An allergic reaction to ecallantide can cause symptoms that are very similar to the signs of...

Read All Potential Side Effects and See Pictures of Kalbitor »

What are the precautions when taking ecallantide injection (Kalbitor)?

Before using ecallantide, 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Kalbitor »

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of KALBITOR (ecallantide injection) is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

Administration Instructions

KALBITOR (ecallantide injection) should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.

KALBITOR (ecallantide injection) should be refrigerated and protected from the light. KALBITOR (ecallantide injection) is a clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.

Using aseptic technique, withdraw 1 mL (10 mg) of KALBITOR (ecallantide injection) from the vial using a large bore needle. Change the needle on the syringe to a needle suitable for subcutaneous injection. The recommended needle size is 27 gauge. Inject KALBITOR (ecallantide injection) into the skin of the abdomen, thigh, or upper arm. Repeat the procedure for each of the 3 vials comprising the KALBITOR (ecallantide injection) dose. The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm). There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.

The same instructions apply to an additional dose administered within 24 hours. Different injection sites or the same anatomical location (as used for the first administration) may be used.

HOW SUPPLIED

Dosage forms and Strengths

KALBITOR (ecallantide injection) is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

Storage And Handling

KALBITOR (ecallantide) is supplied as three 10 mg/mL single-use vials packaged in a carton. Each vial contains 10 mg of ecallantide. Each vial contains a slight overfill.

NDC (47783-101-01): 3 single-use vials in 1 carton

KALBITOR (ecallantide injection) should be kept refrigerated (2°C to 8°C/36°F to 46°F). Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use.

Protect vials from light until use.

Do not use beyond the expiration date.

Manufactured for: Dyax Corp., 300 Technology Square, Cambridge, MA 02139. November 27, 2009.

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under 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.

The safety data described below reflect exposure to KALBITOR (ecallantide injection) in 255 patients with HAE treated with either intravenous or subcutaneous KALBITOR (ecallantide injection) . Of the 255 patients, 66% of patients were female and 86% were Caucasian. Patients treated with KALBITOR (ecallantide injection) were between the ages of 10 and 78 years.

Overall, the most common adverse reactions in 255 patients with HAE were headache (16.1%), nausea (12.9%), fatigue (11.8%), diarrhea (10.6%), upper respiratory tract infection (8.2%), injection site reactions (7.4%), nasopharyngitis (5.9%), vomiting (5.5%), pruritus (5.1%), upper abdominal pain (5.1%), and pyrexia (4.7%). Anaphylaxis was reported in 3.9% of patients with HAE. Injection site reactions were characterized by local pruritus, erythema, pain, irritation, urticaria, and/or bruising.

The incidence of adverse reactions below is based upon 2 placebo-controlled, clinical trials (EDEMA3® and EDEMA4®) in a total of 143 unique patients with HAE. Patients were treated with KALBITOR (ecallantide injection) 30 mg subcutaneous or placebo. Patients were permitted to participate sequentially in both placebo-controlled trials; safety data collected during exposure to KALBITOR (ecallantide injection) was attributed to treatment with KALBITOR (ecallantide injection) , and safety data collected during exposure to placebo was attributed to treatment with placebo. Table 1 shows adverse reactions occurring in > 3% of KALBITOR (ecallantide injection) -treated patients that also occurred at a higher rate than in the placebo-treated patients in the two controlled trials (EDEMA3 and EDEMA4) of the 30 mg subcutaneous dose.

Table 1: Adverse Reactions Occurring at ≥ 3% and Higher than Placebo in 2 Placebo Controlled Clinical Trials in Patients with HAE Treated with KALBITOR (ecallantide injection)

Adverse Reactions KALBITOR (ecallantide injection)
N=100
n (%)a
Placebo
N=81
n (%)a
Headache 8 (8%) 6 (7%)
Nausea 5 (5%) 1 (1%)
Diarrhea 4 (4%) 3 (4%)
Pyrexia 4 (4%) 0
Injection site reactions 3 (3%) 1 (1%)
Nasopharyngitis 3 (3%) 0
a Patient s experiencing more than 1 event with the same preferred term are counted only once for that preferred term.

Some patients in EDEMA3 and EDEMA4 received a second, open-label 30 mg subcutaneous dose of KALBITOR (ecallantide injection) within 24 hours following the initial dose. Adverse reactions reported by these patients who received the additional 30 mg subcutaneous dose of KALBITOR (ecallantide injection) were consistent with those reported in the patients receiving a single dose.

Immunogenicity

In the KALBITOR (ecallantide injection) HAE program, patients developed antibodies to KALBITOR (ecallantide injection) . Rates of seroconversion increased with exposure to KALBITOR (ecallantide injection) over time. Overall, 7.4% of patients seroconverted to anti-ecallantide antibodies. Neutralizing antibodies to ecallantide were determined in vitro to be present in 4.7% of patients.

Anti-ecallantide and anti-P. pastoris IgE antibodies were also detected. Patients who seroconvert may be at a higher risk of a hypersensitivity reaction. The long-term effects of antibodies to KALBITOR are not known.

The test results for the ecallantide program were determined using one of two assay formats: ELISA and bridging electrochemiluminescence (ECL). As with all therapeutic proteins, there is a potential for immunogenicity with the use of KALBITOR (ecallantide injection) . The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to KALBITOR (ecallantide injection) with the incidence of antibodies to other products may be misleading.

Read the Kalbitor (ecallantide injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No formal drug interactions studies were performed. No in vitro metabolism studies were performed.

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions, Including Anaphylaxis

Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR (ecallantide injection) . In 255 HAE patients treated with intravenous or subcutaneous KALBITOR (ecallantide injection) in clinical studies, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR (ecallantide injection) , 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing.

Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5.1 %), rash (3.1 %), and urticaria (2.0%).

Patients should be observed for an appropriate period of time after administration of KALBITOR (ecallantide injection) , taking into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.

KALBITOR (ecallantide injection) should not be administered to any patients with known clinical hypersensitivity to KALBITOR [see CONTRAINDICATIONS].

Patient Counseling Information

  • Patients should be advised that KALBITOR (ecallantide injection) may cause anaphylaxis and other hypersensitivity reactions. Patients should be advised that KALBITOR (ecallantide injection) should be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Patients who have known clinical hypersensitivity to KALBITOR (ecallantide injection) should be instructed not to receive additional doses of KALBITOR. [see BOXED WARNING, CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS]
  • Patients should be advised to consult the Medication Guide for additional information regarding the risk of anaphylaxis and other hypersensitivity reactions.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no animal or human studies to assess the carcinogenic or mutagenic potential of KALBITOR (ecallantide).

KALBITOR (ecallantide injection) had no effects on fertility and reproductive performance in rats at subcutaneous doses up to 25 mg/kg/day (approximately 21 times the MRHD on a mg/kg basis).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled trials of KALBITOR (ecallantide injection) in pregnant women. KALBITOR (ecallantide injection) has been shown to cause developmental toxicity in rats, but not rabbits. Because animal reproductive studies are not always predictive of human response, KALBITOR (ecallantide injection) should be used during pregnancy only if clearly needed.

In rats, intravenous KALBITOR (ecallantide injection) at an intravenous dose approximately 13 times the maximum recommended human dose (MRHD) on a mg/kg basis caused increased numbers of early resorptions and percentages of resorbed conceptuses per litter in the presence of mild maternal toxicity. No development toxicity was observed in rats that received an intravenous dose approximately 8 times the MRHD on a mg/kg basis. There were no adverse effects of KALBITOR (ecallantide injection) on embryofetal development in rats that received subcutaneous doses up to approximately 2.4 times the MRHD on an AUC basis, and in rabbits that received intravenous doses up to approximately 6 times the MRHD on an AUC basis.

Labor and Delivery

No information is available on the effects of KALBITOR (ecallantide injection) during labor and delivery.

Nursing Mothers

It is not known whether ecallantide is excreted in human milk. Caution should be exercised when ecallantide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of KALBITOR (ecallantide injection) in patients below 16 years of age have not been established.

Geriatric Use

Clinical trials of KALBITOR (ecallantide injection) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There have been no reports of overdose with KALBITOR (ecallantide injection) . HAE patients have received single doses up to 90 mg intravenously without evidence of dose-related toxicity. No deaths occurred in monkeys that received intravenous or subcutaneous doses up to 25 mg/kg (approximately 22 times the MRHD on an AUC basis).

CONTRAINDICATIONS

Do not administer KALBITOR (ecallantide injection) to a patient who has known clinical hypersensitivity to KALBITOR. [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to Cl-esterase-inhibitor (Cl-INH) located on Chromosome 1 lq and inherited as an autosomal dominant trait. HAE is characterized by low levels of Cl-INH activity and low levels of C4. Cl-INH functions to regulate the activation of the complement and intrinsic coagulation (contact system pathway) and is a major endogenous inhibitor of plasma kallikrein. The kallikrein-kinin system is a complex proteolytic cascade involved n i the initiation of both inflammatory and coagulation pathways. One critical aspect of this pathway is the conversion of High Molecular Weight (HMW) kininogen to bradykinin by the protease plasma kallikrein. In HAE, normal regulation of plasma kallikrein activity and the classical complement cascade is therefore not present. During attacks, unregulated activity of plasma kallikrein results in excessive bradykinin generation. Bradykinin is a vasodilator which is thought by some to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain.

KALBITOR (ecallantide injection) is a potent (Ki = 25 pM), selective, reversible inhibitor of plasma kallikrein. KALBITOR (ecallantide injection) binds to plasma kallikrein and blocks its binding site, inhibiting the conversion of HMW kininogen to bradykinin. By directly inhibiting plasma kallikrein, KALBITOR (ecallantide injection) reduces the conversion of HMW kininogen to bradykinin and thereby treats symptoms of the disease during acute episodic attacks of HAE.

Pharmacodynamics

No exposure-response relationships for KALBITOR (ecallantide injection) to components of the complement or kallikrein-kinin pathways have been established.

The effect of KALBITOR (ecallantide injection) on activated partial thromboplastin time (aPTT) was measured because of potential effect on the intrinsic coagulation pathway. Prolongation of aPTT has been observed following intravenous dosing of KALBITOR (ecallantide injection) at doses ≥ 20 mg/m². At 80 mg administered intravenously in healthy subjects, aPTT values were prolonged approximately two-fold over baseline values and returned to normal by 4 hours post-dose.

For patients taking KALBITOR (ecallantide injection) , no significant QT prolongation has been seen. In a randomized, placebo-controlled trial (EDEMA4) studying the 30 mg subcutaneous dose versus placebo, 12-lead ECGs were obtained at baseline, 2 hours and 4 hours post-dose (covering the time of expected Cmax), and at follow-up (day 7). ECGs were evaluated for PR interval, QRS complex, and QTc interval. KALBITOR (ecallantide injection) had no significant effect on the QTc interval, heart rate, or any other components of the ECG.

Pharmacokinetics

Following the administration of a single 30 mg subcutaneous dose of KALBITOR (ecallantide injection) to healthy subjects, a mean (± standard deviation) maximum plasma concentration of 586 ± 106 ng/mL was observed approximately 2 to 3 hours post-dose. The mean area under the concentration-time curve was 3017 ± 402 ng*hr/mL. Following administration, plasma concentration declined with a mean elimination half-life of 2.0 ± 0.5 hours. Plasma clearance was 153 ± 20 mL/min and the volume of distribution was 26.4 ± 7.8 L. Based on a population pharmacokinetic analysis, body weight, age, and gender were not found to affect KALBITOR exposure significantly. Ecallantide is a small protein (7054 Da) and renal elimination in the urine of treated subjects has been demonstrated.

No pharmacokinetic data are available in patients or subjects with hepatic or renal impairment.

Animal Toxicology

Reproductive Toxicology Studies

KALBITOR (ecallantide injection) has been shown to cause developmental toxicity in rats, but not rabbits. Treatment of rats with an intravenous dose of 15 mg/kg/day (approximately 13 times the MRHD on a mg/kg basis) caused increased numbers of early resorptions and percentages of resorbed conceptuses per litter in the presence of mild maternal toxicity. However, no development toxicity was observed in rats that received an intravenous dose of 10 mg/kg/day (approximately 8 times the MRHD on a mg/kg basis). KALBITOR (ecallantide injection) was not teratogenic in rats at subcutaneous doses up to 20 mg/kg/day (approximately 2.4 times the MRHD on an AUC basis) and rabbits that received intravenous doses up to 5 mg/kg/day (approximately 6 times the MRHD on an AUC basis).

Clinical Studies

The safety and efficacy of KALBITOR (ecallantide injection) was evaluated in 2 randomized, double-blind, placebo-controlled trials (EDEMA4 and EDEMA3) in 168 patients with HAE. Patients having an attack of hereditary angioedema, at any anatomic location, with at least 1 moderate or severe symptom, were treated with 30 mg subcutaneous KALBITOR (ecallantide injection) or placebo. Because patients could participate in both trials, a total of 143 unique patients participated. Of the 143 patients, 94 were female, 123 were Caucasian, and the mean age was 36 years. There were 64 patients with abdominal attacks, 55 with peripheral attacks, and 24 with laryngeal attacks.

In both trials, the effects of KALBITOR (ecallantide injection) were evaluated using the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS). These measures evaluated the severity of attack symptoms at all anatomical locations (MSCS score) and response to therapy (TOS).

MSCS score is a point-in-time measure of symptom severity. At baseline, 4 hours, and 24 hours, patients rated the severity on a categorical scale (0 = normal, 1 = mild, 2 = moderate, 3 = severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms.

TOS is a measure of symptom response to treatment. At 4 hours and 24 hours, patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement [100], improvement [50], same [0], worsening [-50], significant worsening [-100]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. A TOS value > 0 reflected an improvement in symptoms from baseline.

EDEMA4

EDEMA4 was a randomized, double-blind, placebo-controlled trial in which 96 patients were randomized 1:1 to receive KALBITOR (ecallantide injection) 30 mg subcutaneous or placebo for acute attacks of HAE. The primary endpoint was the change from baseline in MSCS score at 4 hours, and the TOS at 4 hours was a key secondary endpoint. Patients treated with KALBITOR (ecallantide injection) demonstrated a greater decrease from baseline in the MSCS than placebo and a greater TOS than patients with placebo and the results were statistically significant (Table 2). At 24 hours, patients treated with KALBITOR (ecallantide injection) also demonstrated a greater decrease from baseline in the MSCS than placebo (-1.5 vs. -1.1; p = 0.04) and a greater TOS (89 vs. 55, p = 0.03).

Table 2: Change in MSCS Score and TOS at 4 Hours

  EDEMA4 EDEMA3
KALBITOR
(N=48)
Placebo
(N=48)
KALBITOR
(N=36)
Placebo
(N=36)
Change in MSCS Score at 4 Hours
  n 47 42 34 35
  Mean -0.8 -0.4 -1.1 -0.6
  95% CI -1.0,-0.6 -0.6,-0.1 -1.4,-0.8, -0.8, -0.4
  P-value 0.010   0.041  
TOS at 4 Hours
  n 47 42 34 35
  Mean 53 8 63 36
  95% CI 39,68 -12, 28 49,76 17,54
  P-value 0.003   0.045  
MSCS: Mean Symptom Complex Severity
TOS: Treatment Outcome Score
CI: confidence interval

More patients in the placebo group (24/48, 50%) required medical intervention to treat unresolved symptoms within 24 hours compared to the KALBITOR (ecallantide injection) -treated group (16/48,33%).

Some patients reported improvement following a second 30 mg subcutaneous dose of KALBITOR (ecallantide injection) , administered within 24 hours following the initial dose for symptom persistence or relapse, but efficacy was not systematically assessed for the second dose.

EDEMA3

EDEMA3 was a randomized, double-blind, placebo-controlled trial in which 72 patients were randomized 1:1 to receive KALBITOR (ecallantide injection) or placebo for acute attacks of HAE. EDEMA3 was similar in design to EDEMA4 with the exception of the order of the prespecified efficacy endpoints. In EDEMA3, the primary endpoint was the TOS at 4 hours, and the key secondary efficacy endpoint was the change from baseline in MSCS at 4 hours. As in EDEMA4, patients treated with KALBITOR (ecallantide injection) demonstrated a greater decrease from baseline in the MSCS than placebo and a greater TOS than patients treated with placebo and the results were statistically significant (Table 2).

In addition, more patients in the placebo group (13/36, 36%) required medical intervention to treat unresolved symptoms within 24 hours compared to the KALBITOR (ecallantide injection) -treated group (5/36, 14%).

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

KALBITOR®
(KAL-bi-tor)
(ecallantide)

Read this Medication Guide before you start receiving KALBITOR (ecallantide injection) and before each treatment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information that I should know about KALBITOR (ecallantide injection) ?

Serious allergic reactions may happen in some people who receive KALBITOR (ecallantide injection) . These allergic reactions can be life-threatening and usually happen within 1 hour after receiving KALBITOR (ecallantide injection) .

  • KALBITOR (ecallantide injection) should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated.
  • Symptoms of a serious allergic reaction to KALBITOR (ecallantide injection) can be similar to the symptoms of HAE, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR (ecallantide injection) .
  • Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with KALBITOR (ecallantide injection) :

What is KALBITOR (ecallantide injection) ?

KALBITOR (ecallantide injection) is a prescription medicine used to treat sudden attacks of hereditary angioedema (HAE).

KALBITOR (ecallantide injection) is not a cure for HAE.

It is not known if KALBITOR (ecallantide injection) is safe and effective in children under 16 years of age.

Who should not receive KALBITOR (ecallantide injection) ?

Do not receive KALBITOR (ecallantide injection) if you are allergic to KALBITOR (ecallantide injection) .

What should I tell my doctor before I receive KALBITOR (ecallantide injection) ?

Before receiving KALBITOR (ecallantide injection) , tell your doctor if you:

  • have ever had an allergic reaction to KALBITOR (ecallantide injection) . See “Who should not take KALBITOR (ecallantide injection) ?“
  • are pregnant or plan to become pregnant. It is not known if KALBITOR (ecallantide injection) will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if KALBITOR (ecallantide injection) passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How will I receive KALBITOR (ecallantide injection) ?

For each dose, you will receive 3 injections just under the skin (subcutaneous or SC injections) of your abdomen, thigh, or upper arm.

What are the possible side effects?

KALBITOR (ecallantide injection) can cause serious allergic reactions. See “What is the most important information I should know about KALBITOR (ecallantide injection) ?“).

Common side effects of KALBITOR (ecallantide injection) include:

  • headache
  • nausea
  • diarrhea
  • fever
  • injection site reactions, such as redness, rash, swelling, itching, or bruising
  • stuffy nose

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

General information about KALBITOR (ecallantide injection)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide gives you the most important information about KALBITOR (ecallantide injection) . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about KALBITOR (ecallantide injection) that is written for health professionals.

What are the ingredients of KALBITOR?

Active Ingredient: ecallantide
Inactive ingredients: disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration. U.S.

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Medication Guide

KALBITOR®
(KAL-bi-tor)
(ecallantide)

Read this Medication Guide before you start receiving KALBITOR (ecallantide injection) and before each treatment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information that I should know about KALBITOR (ecallantide injection) ?

Serious allergic reactions may happen in some people who receive KALBITOR (ecallantide injection) . These allergic reactions can be life-threatening and usually happen within 1 hour after receiving KALBITOR (ecallantide injection) .

  • KALBITOR (ecallantide injection) should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated.
  • Symptoms of a serious allergic reaction to KALBITOR (ecallantide injection) can be similar to the symptoms of HAE, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR (ecallantide injection) .
  • Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with KALBITOR (ecallantide injection) :

What is KALBITOR (ecallantide injection) ?

KALBITOR (ecallantide injection) is a prescription medicine used to treat sudden attacks of hereditary angioedema (HAE).

KALBITOR (ecallantide injection) is not a cure for HAE.

It is not known if KALBITOR (ecallantide injection) is safe and effective in children under 16 years of age.

Who should not receive KALBITOR (ecallantide injection) ?

Do not receive KALBITOR (ecallantide injection) if you are allergic to KALBITOR (ecallantide injection) .

What should I tell my doctor before I receive KALBITOR (ecallantide injection) ?

Before receiving KALBITOR (ecallantide injection) , tell your doctor if you:

  • have ever had an allergic reaction to KALBITOR (ecallantide injection) . See “Who should not take KALBITOR (ecallantide injection) ?“
  • are pregnant or plan to become pregnant. It is not known if KALBITOR (ecallantide injection) will harm your unborn baby.
  • are breast-feeding or plan to breast-feed. It is not known if KALBITOR (ecallantide injection) passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How will I receive KALBITOR (ecallantide injection) ?

For each dose, you will receive 3 injections just under the skin (subcutaneous or SC injections) of your abdomen, thigh, or upper arm.

What are the possible side effects?

KALBITOR (ecallantide injection) can cause serious allergic reactions. See “What is the most important information I should know about KALBITOR (ecallantide injection) ?“).

Common side effects of KALBITOR (ecallantide injection) include:

  • headache
  • nausea
  • diarrhea
  • fever
  • injection site reactions, such as redness, rash, swelling, itching, or bruising
  • stuffy nose

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

General information about KALBITOR (ecallantide injection)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide gives you the most important information about KALBITOR (ecallantide injection) . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about KALBITOR (ecallantide injection) that is written for health professionals.

What are the ingredients of KALBITOR?

Active Ingredient: ecallantide
Inactive ingredients: disodium hydrogen orthophosphate (dihydrate), monopotassium phosphate, potassium chloride, sodium chloride in water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration. U.S.

Last reviewed on RxList: 12/14/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Kalbitor 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.

ECALLANTIDE - INJECTION

(e-KAL-lan-tide)

COMMON BRAND NAME(S): Kalbitor

WARNING: Ecallantide may infrequently cause serious (rarely fatal) allergic reactions. Patients who experience a severe allergic reaction with this drug must never use it again. Because the symptoms can be the same for an allergic reaction and the condition which this medication treats, you will be monitored closely by your healthcare providers as you receive this medication in a clinic or hospital. Immediate medical attention should be provided if you develop any signs of an allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain.

USES: This medication is used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). Ecallantide blocks a natural substance produced by the body (kallikrein) which acts to increase amounts of another natural substance (bradykinin) thought to cause the symptoms seen during an acute attack of HAE. This medication does not cure HAE. Ecallantide may lessen the symptoms during an acute attack of HAE such as rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat. When attacks involve the intestines, symptoms may include abdominal pain/cramps, diarrhea or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people.

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

Your healthcare provider will inject this medication under your skin either in the abdomen, thigh, or upper arms as directed by your doctor. You will receive three separate shots which should be separated by at least 2 inches (5 centimeters). An additional three shots may be given in a 24-hour period if the HAE attack continues.

Do not receive an injection into skin that is tender, red, or hard.

Dosage is based on your medical condition and response to treatment.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Kalbitor Consumer (continued)

SIDE EFFECTS: See also Warning section.

Bruising, itching, redness, swelling of the skin at the injection site may occur. Nausea, fever, or stuffy nose may also 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 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 Kalbitor (ecallantide injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using ecallantide, 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Kalbitor Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If overdose is suspected, contact a 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: Not applicable.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. 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 and will not be stored at home.

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

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Kalbitor Patient Information Including Side Effects

Brand Names: Kalbitor

Generic Name: ecallantide (Pronunciation: e KAL an tide)

What is ecallantide (Kalbitor)?

Ecallantide is used to treat attacks of hereditary angioedema (an immune system disorder). This medication is used in people who are at least 16 years old.

Ecallantide is not a cure for hereditary angioedema.

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

What are the possible side effects of ecallantide (Kalbitor)?

Tell your caregivers right away if you have any of these signs of an allergic reaction within 1 hour after receiving ecallantide:

  • chest pain or discomfort, fast or weak heartbeat;
  • flushing (warmth, redness, or tingly feeling);
  • feeling like you might pass out;
  • itching, rash, or hives;
  • runny nose, sneezing, stuffy nose;
  • wheezing, cough, throat irritation, trouble breathing; or
  • swelling of your face, lips, tongue, or throat.

An allergic reaction to ecallantide can cause symptoms that are very similar to the signs of hereditary angioedema. Your caregivers will watch you closely while you are receiving ecallantide to make sure you are not having an allergic reaction.

Less serious side effects may include:

  • headache;
  • stomach pain, nausea, vomiting, diarrhea;
  • fever;
  • tired feeling;
  • sore throat; or
  • pain, bruising, itching, redness, rash, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Kalbitor (ecallantide injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ecallantide (Kalbitor)?

You should not receive ecallantide if you are allergic to it.

Before you receive ecallantide, tell your doctor if you have a history of any type of allergy.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast-feeding. Make sure any doctor caring for you afterward knows that you have received this medication.

Side Effects Centers

Kalbitor Patient Information including How Should I Take

What should I discuss with my health care provider before receiving ecallantide (Kalbitor)?

You should not receive ecallantide if you are allergic to it.

Before you receive ecallantide, tell your doctor if you have a history of any type of allergy.

FDA pregnancy category C. It is not known whether ecallantide will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ecallantide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated with ecallantide to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

How is ecallantide given (Kalbitor)?

Ecallantide is injected under the skin. You will receive this injection in a clinic or hospital setting where you can be monitored in case the medication causes serious side effects.

Ecallantide is usually given in 3 separate injections. If you still have symptoms of the angioedema attack, more injections may be given within 24 hours.

Side Effects Centers

Kalbitor Patient Information including If I Miss a Dose

What happens if I miss a dose (Kalbitor)?

Since ecallantide is given by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose (Kalbitor)?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving ecallantide (Kalbitor)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect ecallantide (Kalbitor)?

There may be other drugs that can interact with ecallantide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. 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 ecallantide.


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: 1.02. 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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