Idamycin PFS (Idarubicin Hydrochloride Injection)
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Idamycin PFS (Idarubicin Hydrochloride Injection)

Idamycin PFS®
(idarubicin hydrochloride) Injection

WARNINGS

  1. IDAMYCIN PFS (idarubicin hydrochloride injection) Injection should be given slowly into a freely flowing intravenous infusion. It must never be given intramuscularly or subcutaneously. Severe local tissue necrosis can occur if there is extravasation during administration.
  2. As is the case with other anthracyclines the use of IDAMYCIN PFS (idarubicin hydrochloride injection) can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have preexisting cardiac disease.
  3. As is usual with antileukemic agents, severe myelosuppression occurs when IDAMYCIN PFS (idarubicin hydrochloride injection) is used at effective therapeutic doses.
  4. It is recommended that IDAMYCIN PFS (idarubicin hydrochloride injection) be administered only under the supervision of a physician who is experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
  5. Dosage should be reduced in patients with impaired hepatic or renal function. (See DOSAGE AND ADMINISTRATION.)

DRUG DESCRIPTION

IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is 5, 12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxyhydrochloride, (7S-cis). The structural formula is as follows:

Idamycin PFS®  (idarubicin hydrochloride) Structural Formula Illustration

C26H27NO9•Hcl           M.W 533.96

IDAMYCIN PFS (idarubicin hydrochloride injection) is a sterile, red-orange, isotonic parenteral preservative-free solution, available in 5 mL (5 mg), 10 mL (10 mg) and 20 mL (20 mg) single-use-only vials.

Each mL contains Idarubicin HCL, USP 1 mg and the following inactive ingredients: Glycerin, USP 25 mg and Water for Injection, USP q.s. Hydrochloric Acid, NF is used to adjust the pH to a target of 3.5.

What are the possible side effects of idarubicin (Idamycin PFS)?

If you experience any of the following serious side effects from idarubicin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • congestive heart failure (difficulty breathing, fluid retention, chest pain);
  • irregular heartbeats;
  • tissue or vein reactions near the site of...

Read All Potential Side Effects and See Pictures of Idamycin PFS »

What are the precautions when taking idarubicin hydrochloride injection (Idamycin PFS)?

Before using idarubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); 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/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu...

Read All Potential Precautions of Idamycin PFS »

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

IDAMYCIN PFS (idarubicin hydrochloride injection) Injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American-British (FAB) classifications M1 through M7.

DOSAGE AND ADMINISTRATION

(See WARNINGS)

For induction therapy in adult patients with AML the following dose schedule is recommended:

IDAMYCIN PFS (idarubicin hydrochloride injection) Injection 12 mg/m² daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m² daily by continuous infusion for 7 days or as cytarabine 25 mg/m² intravenous bolus followed by cytarabine 200 mg/m² daily for 5 days continuous infusion. In patients with unequivocal evidence of leukemia after the first induction course, a second course may be administered. Administration of the second course should be delayed in patients who experience severe mucositis, until recovery from this toxicity has occurred, and a dose reduction of 25% is recommended. In patients with hepatic and/or renal impairment, a dose reduction of IDAMYCIN PFS (idarubicin hydrochloride injection) should be considered. IDAMYCIN PFS (idarubicin hydrochloride injection) should not be administered if the bilirubin level exceeds 5 mg%. (See WARNINGS.)

The benefit of consolidation in prolonging the duration of remissions and survival is not proven. There is no consensus regarding optional regimens to be used for consolidation. (See Clinical Studies for doses used in U.S. Clinical studies.)

Preparation and Administration Precautions

Caution in handling the solution must be exercised as skin reactions associated with IDAMYCIN PFS (idarubicin hydrochloride injection) may occur. Skin accidentally exposed to IDAMYCIN PFS (idarubicin hydrochloride injection) should be washed thoroughly with soap and water and if the eyes are involved, standard irrigation techniques should be used immediately. The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug.

Care in the administration of IDAMYCIN PFS (idarubicin hydrochloride injection) will reduce the chance of perivenous infiltration. It may also decrease the chance of local reactions such as urticaria and erythematous streaking. During intravenous administration of IDAMYCIN PFS (idarubicin hydrochloride injection) extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If it is known or suspected that subcutaneous extravasation has occurred, it is recommended that intermittent ice packs (1/2 hour immediately, then 1/2 hour 4 times per day for 3 days) be placed over the area of extravasation and that the affected extremity be elevated. Because of the progressive nature of extravasation reactions, the area of injection should be frequently examined and plastic surgery consultation obtained early if there is any sign of a local reaction such as pain, erythema, edema or vesication. If ulceration begins or there is severe persistent pain at the site of extravasation, early wide excision of the involved area should be considered.

IDAMYCIN PFS (idarubicin hydrochloride injection) should be administered slowly (over 10 to 15 minutes) into the tubing of a freely running intravenous infusion of Sodium Chloride Injection, USP (0.9%) or 5% Dextrose Injection, USP. The tubing should be attached to a Butterfly needle or other suitable device and inserted preferably into a large vein.

Incompatibility

Unless specific compatibility data are available, IDAMYCIN PFS (idarubicin hydrochloride injection) should not be mixed with other drugs. Precipitation occurs with heparin. Prolonged contact with any solution of an alkaline pH will result in degradation of the drug.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and containers permit.

Handling and Disposal - Procedures for handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED

IDAMYCIN PFS Injection (idarubicin hydrochloride injection)

Single Dose Glass Vials: Sterile single use only, contains no preservative.

NDC 0013-2200-01 5 mg/5 mL vial (1 mg/mL), single vials.
NDC 0013-2201-01 10 mg/10 mL vial (1 mg/mL), single vials.
NDC 0013-2202-01 20 mg/20 mL vial (1 mg/mL), single vials.

Single Dose Cytosafe™ Vials: Sterile single use only, contains no preservative.

NDC 0013-2576-91 5 mg/5 mL vial (1 mg/mL), single vials.
NDC 0013-2586-91 10 mg/10 mL vial (1 mg/mL), single vials.
NDC 0013-2596-91 20 mg/20 mL vial (1 mg/mL), single vials.

Store under refrigeration 2° to 8°C (36° to 46°F), and protect from light. Retain in carton until time of use.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society. 1999: 32–41.

2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC; Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Department of Health and Human Services, Public Health Service Publication NIH 92–2621.

3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA. 1985; 253:1590–1591.

4. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

5. Clinical Oncological Society of Australia: Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426–428.

6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA Cancer J Clin.1983; 33: 258–263.

7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033–1049.

8. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm. 1996; 53: 1669–1685.

Distributed by: Pharmacia & Upjohn Co., A Division of Pfizer Inc., NY, NY 10017. Revised January 2006. FDA revision date: 5/1/2003

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Approximately 550 patients with AML have received idarubicin in combination with cytarabine in controlled clinical trials worldwide. In addition, over 550 patients with acute leukemia have been treated in uncontrolled trials utilizing idarubicin as a single agent or in combination. The table below lists the adverse experiences reported in U.S.

Study 2 (see Clinical Studies) and is representative of the experiences in other studies. These adverse experiences constitute all reported or observed experiences, including those not considered to be drug related. Patients undergoing induction therapy for AML are seriously ill due to their disease, are receiving multiple transfusions, and concomitant medications including potentially toxic antibiotics and antifungal agents. The contribution of the study drug to the adverse experience profile is difficult to establish.

Induction Phase
Adverse Experiences
Percentage of Patients
IDR
(N=110)
DNR
(N=118)
Infection 95% 97%
Nausea & Vomiting 82% 80%
Hair Loss 77% 72%
Abdominal Cramps/Diarrhea 73% 68%
Hemorrhage 63% 65%
Mucositis 50% 55%
Dermatologic 46% 40%
Mental Status 41% 34%
Pulmonary-Clinical 39% 39%
Fever (not elsewhere classified) 26% 28%
Headache 20% 24%
Cardiac-Clinical 16% 24%
Neurologic-Peripheral Nerves 7% 9%
Pulmonary Allergy 2% 4%
Seizure 4% 5%
Cerebellar 4% 4%

The duration of aplasia and incidence of mucositis were greater on the IDR arm than the DNR arm, especially during consolidation in some U.S. controlled trials (see Clinical Studies).

The following information reflects experience based on U.S. controlled clinical trials.

Myelosuppression

Severe myelosuppression is the major toxicity associated with idarubicin therapy, but this effect of the drug is required in order to eradicate the leukemic clone. During the period of myelosuppression, patients are at risk of developing infection and bleeding which may be life-threatening or fatal.

Gastrointestinal

Nausea and/or vomiting, mucositis, abdominal pain and diarrhea were reported frequently, but were severe (equivalent to WHO Grade 4) in less than 5% of patients. Severe enterocolitis with perforation has been reported rarely. The risk of perforation may be increased by instrumental intervention. The possibility of perforation should be considered in patients who develop severe abdominal pain and appropriate steps for diagnosis and management should be taken.

Dermatologic

Alopecia was reported frequently and dermatologic reactions including generalized rash, urticaria and a bullous erythrodermatous rash of the palms and soles have occurred. The dermatologic reactions were usually attributed to concomitant antibiotic therapy. Local reactions including hives at the injection site have been reported. Recall of skin reaction due to prior radiotherapy has occurred with idarubicin administration.

Hepatic and Renal

Changes in hepatic and renal function tests have been observed. These changes were usually transient and occurred in the setting of sepsis and while patients were receiving potentially hepatotoxic and nephrotoxic antibiotics and antifungal agents. Severe changes in renal function (equivalent to WHO Grade 4) occurred in no more than 1% of patients, while severe changes in hepatic function (equivalent to WHO Grade 4) occurred in less than 5% of patients.

Cardiac

Congestive heart failure (frequently attributed to fluid overload), serious arrhythmias including atrial fibrillation, chest pain, myocardial infarction and asymptomatic declines in LVEF have been reported in patients undergoing induction therapy for AML. Myocardial insufficiency and arrhythmias were usually reversible and occurred in the setting of sepsis, anemia and aggressive intravenous fluid administration. The events were reported more frequently in patients over age 60 years and in those with pre-existing cardiac disease.

Read the Idamycin PFS (idarubicin hydrochloride injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Idarubicin is intended for administration under the supervision of a physician who is experienced in leukemia chemotherapy.

Idarubicin is a potent bone marrow suppressant. Idarubicin should not be given to patients with pre-existing bone marrow suppression induced by previous drug therapy or radiotherapy unless the benefit warrants the risk.

Severe myelosuppression will occur in all patients given a therapeutic dose of this agent for induction, consolidation or maintenance. Careful hematologic monitoring is required. Deaths due to infection and/or bleeding have been reported during the period of severe myelosuppression. Facilities with laboratory and supportive resources adequate to monitor drug tolerability and protect and maintain a patient compromised by drug toxicity should be available. It must be possible to treat rapidly and completely a severe hemorrhagic condition and/or a severe infection.

Pre-existing heart disease and previous therapy with anthracyclines at high cumulative doses or other potentially cardiotoxic agents are co-factors for increased risk of idarubicin-induced cardiac toxicity and the benefit to risk ratio of idarubicin therapy in such patients should be weighed before starting treatment with idarubicin.

Myocardial toxicity as manifested by potentially fatal congestive heart failure, acute life-threatening arrhythmias or other cardiomyopathies may occur following therapy with idarubicin. Appropriate therapeutic measures for the management of congestive heart failure and/or arrhythmias are indicated.

Cardiac function should be carefully monitored during treatment in order to minimize the risk of cardiac toxicity of the type described for other anthracycline compounds. The risk of such myocardial toxicity may be higher following concomitant or previous radiation to the mediastinal-pericardial area or in patients with anemia, bone marrow depression, infections, leukemic pericarditis and/or myocarditis. While there are no reliable means for predicting congestive heart failure, cardiomyopathy induced by anthracyclines is usually associated with a decrease of the left ventricular ejection fraction (LVEF) from pretreatment baseline values.

Since hepatic and/or renal function impairment can affect the disposition of idarubicin, liver and kidney function should be evaluated with conventional clinical laboratory tests (using serum bilirubin and serum creatinine as indicators) prior to and during treatment. In a number of Phase III clinical trials, treatment was not given if bilirubin and/or creatinine serum levels exceeded 2 mg%. However, in one Phase III trial, patients with bilirubin levels between 2.6 and 5 mg% received the anthracycline with a 50% reduction in dose. Dose reduction of idarubicin should be considered if the bilirubin and/or creatinine levels are above the normal range. (See DOSAGE AND ADMINISTRATION.)

Pregnancy Category D - Idarubicin was embryotoxic and teratogenic in the rat at a dose of 1.2 mg/m²/day or one tenth the human dose, which was nontoxic to dams. Idarubicin was embryotoxic but not teratogenic in the rabbit even at a dose of 2.4 mg/m²/day or two tenths the human dose, which was toxic to dams. There is no conclusive information about idarubicin adversely affecting human fertility or causing teratogenesis. There has been one report of a fetal fatality after maternal exposure to idarubicin during the second trimester.

There are no adequate and well-controlled studies in pregnant women. If idarubicin is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid pregnancy.

PRECAUTIONS

General

Therapy with idarubicin requires close observation of the patient and careful laboratory monitoring. Hyperuricemia secondary to rapid lysis of leukemic cells may be induced. Appropriate measures must be taken to prevent hyperuricemia and to control any systemic infection before beginning therapy.

Extravasation of idarubicin can cause severe local tissue necrosis. Extravasation may occur with or without an accompanying stinging or burning sensation even if blood returns well on aspiration of the infusion needle. If signs or symptoms of extravasation occur the injection or infusion should be terminated immediately and restarted in another vein. (See DOSAGE AND ADMINISTRATION.)

Laboratory Tests

Frequent complete blood counts and monitoring of hepatic and renal function tests are recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Formal long-term carcinogenicity studies have not been conducted with idarubicin. Idarubicin and related compounds have been shown to have mutagenic and carcinogenic properties when tested in experimental models (including bacterial systems, mammalian cells in culture and female Sprague-Dawley rats).

In male dogs given 1.8 mg/m²/day 3 times/week (about one seventh the weekly human dose on a mg/m² basis) for 13 weeks, or 3 times the human dose, testicular atrophy was observed with inhibition of spermatogenesis and sperm maturation with few or no mature sperm. These effects were not readily reversed after a recovery of 8 weeks.

Pregnancy Category D

(See WARNINGS.)

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from idarubicin, mothers should discontinue nursing prior to taking this drug.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Patients over 60 years of age who were undergoing induction therapy experienced congestive heart failure, serious arrhythmias, chest pain, myocardial infarction, and asymptomatic declines in LVEF more frequently than younger patients (see ADVERSE REACTIONS).

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is no known antidote to idarubicin. Two cases of fatal overdosage in patients receiving therapy for AML have been reported. The doses were 135 mg/m² over 3 days and 45 mg/m² of idarubicin and 90 mg/m² of daunorubicin over a three day period.

It is anticipated that overdosage with idarubicin will result in severe and prolonged myelosuppression and possibly in increased severity of gastrointestinal toxicity. Adequate supportive care including platelet transfusions, antibiotics and symptomatic treatment of mucositis is required. The effect of acute overdose on cardiac function is not fully known, but severe arrhythmia occurred in 1 of the 2 patients exposed. It is anticipated that very high doses of idarubicin may cause acute cardiac toxicity and may be associated with a higher incidence of delayed cardiac failure.

Disposition studies with idarubicin in patients undergoing dialysis have not been carried out. The profound multicompartment behavior, extensive extravascular distribution and tissue binding, coupled with the low unbound fraction available in the plasma pool make it unlikely that therapeutic efficacy or toxicity would be altered by conventional peritoneal or hemodialysis.

CONTRAINDICATIONS

No information provided.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Idarubicin hydrochloride is a DNA-intercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase II. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake compared with other anthracyclines.

Pharmacokinetics

General Pharmacokinetics: Pharmacokinetic studies have been performed in adult leukemia patients with normal renal and hepatic function following intravenous administration of 10 to 12 mg/m² of idarubicin daily for 3 to 4 days as a single agent or combined with cytarabine. The plasma concentrations of idarubicin are best described by a two or three compartment open model. The elimination rate of idarubicin from plasma is slow with an estimated mean terminal half-life of 22 hours (range, 4 to 48 hours) when used as a single agent and 20 hours (range, 7 to 38 hours) when used in combination with cytarabine. The elimination of the primary active metabolite, idarubicinol, is considerably slower than that of the parent drug with an estimated mean terminal half-life that exceeds 45 hours; hence, its plasma levels are sustained for a period greater than 8 days.

Distribution: The disposition profile shows a rapid distributive phase with a very high volume of distribution presumably reflecting extensive tissue binding. Studies of cellular (nucleated blood and bone marrow cells) drug concentrations in leukemia patients have shown that peak cellular idarubicin concentrations are reached a few minutes after injection. Concentrations of idarubicin and idarubicinol in nucleated blood and bone marrow cells are more than a hundred times the plasma concentrations. Idarubicin disappearance rates in plasma and cells were comparable with a terminal half-life of about 15 hours. The terminal half-life of idarubicinol in cells was about 72 hours. The extent of drug and metabolite accumulation predicted in leukemia patients for Days 2 and 3 of dosing, based on the mean plasma levels and half-life obtained after the first dose, is 1.7- and 2.3-fold, respectively, and suggests no change in kinetics following a daily x 3 regimen. The percentages of idarubicin and idarubicinol bound to human plasma proteins averaged 97% and 94%, respectively, at concentrations similar to maximum plasma levels obtained in the pharmacokinetic studies. The binding is concentration independent. The plasma clearance is twice the expected hepatic plasma flow indicating extensive extrahepatic metabolism.

Metabolism: The primary active metabolite formed is idarubicinol. As idarubicinol has cytotoxic activity, it presumably contributes to the effects of idarubicin.

Elimination: The drug is eliminated predominately by biliary and to a lesser extent by renal excretion, mostly in the form of idarubicinol.

Pharmacokinetics in Special Populations

Pediatric Patients: Idarubicin studies in pediatric leukemia patients, at doses of 4.2 to 13.3 mg/m²/day x 3, suggest dose independent kinetics. There is no difference between the half-lives of the drug following daily x 3 or weekly x 3 administration. Cerebrospinal fluid (CSF) levels of idarubicin and idarubicinol were measured in pediatric leukemia patients treated intravenously. Idarubicin was detected in 2 of 21 CSF samples (0.14 and 1.57 ng/mL), while idarubicinol was detected in 20 of these 21 CSF samples obtained 18 to 30 hours after dosing (mean = 0.51 ng/mL; range, 0.22 to 1.05 ng/mL). The clinical relevance of these findings is unknown.

Hepatic and Renal Impairment: The pharmacokinetics of idarubicin have not been evaluated in leukemia patients with hepatic impairment. It is expected that in patients with moderate or severe hepatic dysfunction, the metabolism of idarubicin may be impaired and lead to higher systemic drug levels. The disposition of idarubicin may be also affected by renal impairment. Therefore, a dose reduction should be considered in patients with hepatic and/or renal impairment (see DOSAGE AND ADMINISTRATION).

Drug-Drug Interactions

No formal drug interaction studies have been performed.

Clinical Studies

Four prospective randomized studies, three U.S. and one Italian, have been conducted to compare the efficacy and safety of idarubicin (IDR) to that of daunorubicin (DNR), each in combination with cytarabine as induction therapy in previously untreated adult patients with acute myeloid leukemia (AML). These data are summarized in the following table and demonstrate significantly greater complete remission rates for the IDR regimen in two of the three U.S. studies and significantly longer overall survival for the IDR regimen in two of the three U.S. studies.

  Inductiona
Regimen Dose in
mg/m²-
Daily x 3 Days
Complete Remission
Rate, All Pts
Randomized
Median Survival
(Days) All Pts
Randomized
IDR DNR IDR DNR IDR DNR
U.S. (IND Studies)
1. MSKCC*
(Age ≤ 60 years)
12b 50b 51/65+(78%) 38/65(58%) 508+ 435
2. SEG**
(Age ≥ 15 years)
12c 45c 76/111+(69%) 65/119(55%) 328 277
3. U.S. Multicenter
(Age ≥ 18 years)
13c 45c 68/101(67%) 66/113(58%) 393+ 281
Foreign (non-IND study)
GIMEMA***
(Age ≥ 55 years)
12c 45c 49/124(40%) 49/125(39%) 87 169
*Memorial Sloan Kettering Cancer Center
**Southeastern Cancer Study Group
***Gruppo Italiano Malattie Ematologiche Maligne dell' Adulto
+ Overall p < 0.05, unadjusted for prognostic factors or multiple endpoints
a Patients who had persistent leukemia after the first induction course received a second course
b Cytarabine 25 mg/m² bolus IV followed by 200 mg/m² daily x 5 days by continuous infusion
c Cytarabine 100 mg/m² daily x 7 days by continuous infusion

There is no consensus regarding optional regimens to be used for consolidation; however, the following consolidation regimens were used in U.S. controlled trials. Patients received the same anthracycline for consolidation as was used for induction.

Studies 1 and 3 utilized 2 courses of consolidation therapy consisting of idarubicin 12 or 13 mg/m² daily for 2 days, respectively (or DNR 50 or 45 mg/m² daily for 2 days), and cytarabine, either 25 mg/m² by IV bolus followed by 200 mg/m² daily by continuous infusion for 4 days (Study 1), or 100 mg/m² daily for 5 days by continuous infusion (Study 3). A rest period of 4 to 6 weeks is recommended prior to initiation of consolidation and between the courses. Hematologic recovery is mandatory prior to initiation of each consolidation course.

Study 2 utilized 3 consolidation courses, administered at intervals of 21 days or upon hematologic recovery. Each course consisted of idarubicin 15 mg/m² IV for 1 dose (or DNR 50 mg/m² IV for 1 dose), cytarabine 100 mg/m² every 12 hours for 10 doses and 6-thioguanine 100 mg/m² orally for 10 doses. If severe myelosuppression occurred, subsequent courses were given with 25% reduction in the doses of all drugs. In addition, this study included 4 courses of maintenance therapy (2 days of the same anthracycline as was used in induction and 5 days of cytarabine).

Toxicities and duration of aplasia were similar during induction on the 2 arms in the U.S. studies except for an increase in mucositis on the IDR arm in one study. During consolidation, duration of aplasia on the IDR arm was longer in all three studies and mucositis was more frequent in two studies. During consolidation, transfusion requirements were higher on the IDR arm in the two studies in which they were tabulated, and patients on the IDR arm in Study 3 spent more days on IV antibiotics (Study 3 used a higher dose of idarubicin).

The benefit of consolidation and maintenance therapy in prolonging the duration of remission and survival is not proven.

Intensive maintenance with idarubicin is not recommended in view of the considerable toxicity (including deaths in remission) experienced by patients during the maintenance phase of Study 2.

A higher induction death rate was noted in patients on the IDR arm in the Italian trial. Since this was not noted in patients of similar age in the U.S. trials, one may speculate that it was due to a difference in the level of supportive care.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Idamycin PFS 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.

IDARUBICIN - INJECTION

(eye-duh-REWB-eh-sin)

COMMON BRAND NAME(S): Idamycin

WARNING: Idarubicin must be given only by injection slowly into a vein. Do not give by injection into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor immediately if you notice redness, pain, or swelling at or near the injection site.

This medication may infrequently result in serious (rarely fatal) heart problems (including heart failure). This may occur both during treatment or after treatment is completed. The risk of heart problems is affected by your dose, medical history (including heart disease, radiation treatment to the chest area, current infections, anemia), and previous use of this and other drugs (including doxorubicin). Tell your doctor immediately if you notice symptoms such as irregular heartbeat, shortness of breath, or swelling ankles/feet.

Idarubicin may cause certain severe blood and bone marrow disorders (low red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection. Tell your doctor immediately if you develop easy bleeding/bruising or signs of infection (e.g., fever, chills, persistent sore throat).

Very rarely, people with cancer who are treated with this type of medication have developed other cancers (e.g., secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs or radiation treatment. Consult your doctor for more details.

Before starting treatment with this medication, tell your doctor if you have liver or kidney problems. Your dose may need to be adjusted.

USES: Idarubicin is used to treat a certain type of cancer (leukemia). It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.

HOW TO USE: This medication is given by injection into a vein by a health care professional, as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.

If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelids and flush with water for 15 minutes, then seek immediate medical attention.

Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (e.g., increased uric acid).

Disclaimer

Idamycin PFS Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, abdominal cramps, diarrhea, and headache may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss is a common side effect. Normal hair growth should return after treatment has ended.

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.

Tell your doctor right away if you have any serious side effects, including: severe abdominal pain, mental/mood changes (e.g., confusion), numbness/tingling of arms/legs, rash/blisters on palms of hands/soles of feet, unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds).

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Get medical help right away if this rare but very serious side effect occurs: seizure.

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

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 Idamycin PFS (idarubicin hydrochloride injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using idarubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); 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/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

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

Caution is advised when using this medication in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the heart.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Disclaimer

Idamycin PFS 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.

Some products that may interact with this drug include: other anti-cancer drugs (especially anthracyclines such as doxorubicin).

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. Symptoms of overdose may include: irregular heartbeat, severe nausea/vomiting.

NOTES: Laboratory and/or medical tests (e.g., kidney/liver function tests, complete blood count, certain heart function tests such as LVEF) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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 to establish a new dosing schedule. Do not double the dose to catch up.

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 (USA) or 1-800-668-1507 (Canada).

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

Idamycin PFS Patient Information Including Side Effects

Brand Names: Idamycin PFS

Generic Name: idarubicin (Pronunciation: EYE da ROO bi sin)

What is idarubicin (Idamycin PFS)?

Idarubicin is a cancer (antineoplastic) medication. Idarubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Idarubicin is used to treat a type of blood cancer (acute myeloid leukemia -AML) in adults .

Idarubicin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of idarubicin (Idamycin PFS)?

If you experience any of the following serious side effects from idarubicin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
  • congestive heart failure (difficulty breathing, fluid retention, chest pain);
  • irregular heartbeats;
  • tissue or vein reactions near the site of administration;
  • liver damage (abdominal pain, yellowing of the skin or eyes);
  • severe nausea, vomiting, diarrhea, and loss of appetite;
  • inflamation and sores inside the mouth, throat, or intestines;
  • fever, chills, or other signs of infection;
  • numbness, tingling, or difficult movement of a body part;
  • seizures; or
  • increased levels of uric acid in the body (joint pain and stiffness).

Other, less serious side effects may be more likely to occur. Continue taking idarubicin and talk to your doctor if you experience:

  • facial flushing during administration;
  • eye irritation or tearing;
  • darkening of the nail beds and skin folds;
  • temporary hair loss; or
  • red colored urine for 1 or 2 days following a dose.

Some breast cancer patients developed a second cancer (leukemia) after treatment with idarubicin. Idarubicin may cause premature menopause.

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 Idamycin PFS (idarubicin hydrochloride injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about idarubicin (Idamycin PFS)?

Idarubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of idarubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others.Talk to your doctor about the possible side effects from treatment with idarubicin.

Side Effects Centers

Idamycin PFS Patient Information including How Should I Take

What should I discuss with my healthcare provider before using idarubicin (Idamycin PFS)?

Do not use idarubicin without first talking to your doctor if you have

  • kidney disease;
  • liver disease;
  • heart disease;
  • poor bone marrow function;
  • received radiation therapy that encompassed the heart; or
  • previously received treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone).

The use of idarubicin may be dangerous if you have any of the conditions listed above.

Idarubicin is in the FDA pregnancy category D. This means that idarubicin is known to be harmful to an unborn baby. Do not use idarubicin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with idarubicin if necessary.

Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with idarubicin.

The safety and effectiveness of idarubicin in children has not been established.

How should I use idarubicin (Idamycin PFS)?

Idarubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Your doctor will determine the correct amount and frequency of treatment with idarubicin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with idarubicin to monitor progress and side effects.

Skin accidentally exposed to idarubicin should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store idarubicin as directed by the manufacturer. If you are storing idarubicin at home, follow the directions provided by your healthcare provider.

Side Effects Centers

Idamycin PFS Patient Information including If I Miss a Dose

What happens if I miss a dose (Idamycin PFS)?

Contact your doctor if you miss a dose of idarubicin.

What happens if I overdose (Idamycin PFS)?

If for any reason an overdose of idarubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a idarubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using idarubicin (Idamycin PFS)?

Skin accidentally exposed to idarubicin should be rinsed thoroughly with soap and warm water.

Do not receive "live" vaccines during treatment with idarubicin. Administration of a live vaccine may be dangerous during treatment with idarubicin.

What other drugs will affect idarubicin (Idamycin PFS)?

Do not use idarubicin without first talking to your doctor if you have had previous treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone). Because there is a maximum amount of these medications that should be administered to an individual, you may not be able to use idarubicin.

Before using idarubicin, tell your doctor if you are taking any of the following medicines.

  • paclitaxel (Taxol);
  • cimetidine (Tagamet, Tagamet HB, others);
  • progesterone (Prometrium);
  • verapamil (Calan, Calan SR, Covera-HS, Isoptin, Isoptin SR, Verelan, Verelan PM, others)
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • cyclophosphamide (Cytoxan, Cytoxan Lyophilized, Neosar);
  • phenobarbital;
  • phenytoin (Dilantin); or
  • streptozocin (Zanosar).

You may not be able to take idarubicin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Do not receive "live" vaccines during treatment with idarubicin. Administration of a live vaccine may be dangerous during treatment with idarubicin.

Drugs other than those listed here may also interact with idarubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with idarubicin.

Where can I get more information?

Your pharmacist can provide more information about idarubicin.


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: 1.07. 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.

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