idarubicin hydrochloride
Pharmaranks rates Idarubicin Hydrochloride 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Idarubicin Hydrochloride is an anthracycline topoisomerase inhibitor used to treat Breast Neoplasms, Bcr-Abl Positive Chronic Myelogenous Leukemia, Acute Myeloid Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Anthracycline Topoisomerase Inhibitor · by Hikma
Generic of Idamycin Pfs
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Idarubicin Hydrochloride
- Drug class
- Anthracycline Topoisomerase Inhibitor
- Form
- Injectable
- Strength
- Idarubicin Hydrochloride 10MG/10ML (1MG/ML) · Idarubicin Hydrochloride 20MG/20ML (1MG/ML) · Idarubicin Hydrochloride 5MG/5ML (1MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Hikma
- FDA application
- ANDA065275
- FDA boxed warning
- Yes — see the boxed warning
What is Idarubicin Hydrochloride?
From the FDA label:Idarubicin Hydrochloride Injection, USP contains idarubicin hydrochloride and is a sterile, semi-synthetic, preservative-free solution (PFS) antineoplastic anthracycline for intravenous use. Chemically, idarubicin hydrochloride is (1 S ,3 S )-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L- lyxo -hexopyranoside, hydrochloride. The structural formula is as follows: Structural Formula C 26 H 27 NO 9 •HCl M.W. 533.95 Idarubicin Hydrochloride Injection, USP 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 hydrochloride 1 mg and the following inactive ingredients: glycerin 25 mg and water for injection q.s. Hydrochloric acid is used to adjust the pH to a target of 3.5. Structural Formula
How to use
( See WARNINGS ) For induction therapy in adult patients with AML the following dose schedule is recommended: Idarubicin hydrochloride injection 12 mg/m 2 daily for 3 days by slow (10 to 15 min) intravenous injection in combination with cytarabine. The cytarabine may be given as 100 mg/m 2 daily by continuous infusion for 7 days or as cytarabine 25 mg/m 2 intravenous bolus followed by cytarabine 200 mg/m 2 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 idarubicin hydrochloride should be considered. Idarubicin hydrochloride 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 idarubicin hydrochloride may occur. Skin…
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 Percentage of Patients IDR DNR Adverse Experiences (N=110) (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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Idarubicin Hydrochloride 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 idarubicin Hydrochloride can cause myocardial toxicity leading to congestive heart failure. Cardiac toxicity is more common in patients who have received prior anthracyclines or who have pre-existing cardiac disease. 3. As is usual with antileukemic agents, severe myelosuppression occurs when idarubicin hydrochloride is used at effective therapeutic doses. 4. It is recommended that idarubicin hydrochloride 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 .)
Warnings
Important safety information
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, active or dormant cardiovascular disease, previous therapy with other anthracyclines or anthracenediones, and concomitant use of drugs with the ability to suppress cardiace contractility or cardiotoxic drugs (e.g., trastuzumab, cyclophosphamide and paclitaxel). Do not administer idarubicin with other cardiotoxic agents unless the patient’s cardiac function is monitored frequently. Patients receiving anthracyclines after stopping treatment with other cardiotoxic agents, especially those with long half-lives, may also be at an increased risk of developing cardiotoxicity. Avoid the use of anthracycline-based therapy for at least 5 half-lives after discontinuation of the cardiotoxic agent. If anthracyclines are used before this time, carefully monitor the cardiac function. 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/m 2 /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/m 2 /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.
Overdose — what happens if you take too much
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/m 2 over 3 days and 45 mg/m 2 of idarubicin and 90 mg/m 2 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Anthracyclines - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- breast neoplasms
- bcr-abl positive chronic myelogenous leukemia
- acute myeloid leukemia
- precursor cell lymphoblastic leukemia-lymphoma
See how Idarubicin Hydrochloride ranks — best-rated anthracycline topoisomerase inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Idarubicin Hydrochloride treat?
- Idarubicin Hydrochloride (Idarubicin Hydrochloride) may be used to treat breast neoplasms, bcr-abl positive chronic myelogenous leukemia, acute myeloid leukemia, precursor cell lymphoblastic leukemia-lymphoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Idarubicin Hydrochloride work?
- Idarubicin Hydrochloride is a anthracycline topoisomerase inhibitor. These chemotherapy drugs slip between the strands of a cancer cell's DNA and jam an enzyme called topoisomerase II that the cell needs to copy its DNA. This leaves the DNA broken and unrepairable, so the cancer cell stops dividing and dies.
- How is Idarubicin Hydrochloride rated?
- pharmaranks gives Idarubicin Hydrochloride a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Idarubicin Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Idarubicin Hydrochloride. To pay less, Idarubicin Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Idarubicin Hydrochloride?
- Idarubicin Hydrochloride is marketed by Hikma. You can see Hikma's full profile, rating, and other products on pharmaranks.
- Is Idarubicin Hydrochloride a brand-name or generic drug?
- Idarubicin Hydrochloride is a generic medication; its active ingredient is Idarubicin Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Idarubicin Hydrochloride available over the counter?
- No. Idarubicin Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Idarubicin Hydrochloride come in?
- Idarubicin Hydrochloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Idarubicin Hydrochloride?
- Idarubicin Hydrochloride is classified as anthracycline topoisomerase inhibitor, per the FDA's Established Pharmacologic Class.
- Is Idarubicin Hydrochloride FDA-registered?
- Idarubicin Hydrochloride is on record with the U.S. FDA under application number ANDA065275. You can verify this on its official FDA label.
- Has Idarubicin Hydrochloride been recalled by the FDA?
- Idarubicin Hydrochloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Idarubicin Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Idarubicin Hydrochloride a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Idarubicin Hydrochloride?
- Idarubicin Hydrochloride's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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