Idarubicin Hydrochloride 1 mg/mL
Idarubicin Hydrochloride · INJECTION, SOLUTION · Hikma Pharmaceuticals USA Inc.
Idarubicin Hydrochloride is a chemotherapy medication given by injection into a vein that is used to treat certain types of leukemia and other blood cancers. It works by interfering with cancer cell growth and is typically administered as part of a combination treatment plan by a healthcare provider.
Key Facts
- Brand Name
- Idarubicin Hydrochloride
- Generic Name
- Idarubicin Hydrochloride
- NDC Code (Product)
0143-9217- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 1 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA065275
- Marketing Start
- 01/30/2017
Recall History
Teva Pharmaceuticals USA Inc
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Idarubicin Hydrochloride injection, USP 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 & Administration
DOSAGE AND ADMINISTRATION ( 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 CLINICA…
Warnings
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 sho…
Adverse Reactions
ADVERSE REACTIONS 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 cl…
Frequently Asked Questions
What is Idarubicin Hydrochloride used for?
Idarubicin Hydrochloride is a chemotherapy medication given by injection into a vein that is used to treat certain types of leukemia and other blood cancers. It works by interfering with cancer cell growth and is typically administered as part of a combination treatment plan by a healthcare provider.
Is Idarubicin Hydrochloride a controlled substance?
Idarubicin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Idarubicin Hydrochloride?
The generic name for Idarubicin Hydrochloride is Idarubicin Hydrochloride. There are 3 other brand versions of Idarubicin Hydrochloride.
What is the NDC code for Idarubicin Hydrochloride 1 mg/mL?
The NDC (National Drug Code) for Idarubicin Hydrochloride 1 mg/mL is 0143-9217, listed by Hikma Pharmaceuticals USA Inc..
Other Idarubicin Hydrochloride Dosages
- Idarubicin Hydrochloride1 mg/mL0143-9307
- Idarubicin Hydrochloride1 mg/mL0143-9219
- Idarubicin Hydrochloride1 mg/mL71288-185
- Idarubicin Hydrochloride1 mg/mL71288-186
- Idarubicin Hydrochloride1 mg/mL0143-9308
- Idarubicin Hydrochloride1 mg/mL0143-9218
- Idarubicin Hydrochloride1 mg/mL0143-9306
- Idarubicin Hydrochloride1 mg/mL71288-184
Other Idarubicin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)