Trade Name: Doxorubicin Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/mL

Storage and handling

DOXORUBICIN HYDROCHLORIDE Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
  • See full prescribing information for complete boxed warning.
  • Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1% to 20% for cumulative doses from 300 mg/mto 500 mg/mwhen doxorubicin hydrochloride is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride. ()
  • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride. ()
  • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. ()
  • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ()u00a0
  • Warnings and Precautions, Embryo-Fetal Toxicity ()u00a012/2019
  • Warnings and Precautions, Embryo-Fetal Toxicity (5.8)u00a0u00a0u00a0u00a0u00a0 12/2019
  • Doxorubicin hydrochloride for injection is an anthracycline topoisomerase II inhibitor indicated:
  • as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ().
  • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilmsu2019 tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ().
  • No data
  • Single agent
  • In combination:
  • Discontinue doxorubicin hydrochloride for injection in patients who develop signs or symptoms of cardiomyopathy ().
  • Reduce dose in patients with hepatic impairment ().
  • Doxorubicin Hydrochloride for Injection:
  • 20 mg/vial and 50 mg/vial as a lyophilized powder ().
  • Doxorubicin hydrochloride for injection is contraindicated in patients with:
  • Severe myocardial insufficiency ().
  • Recent myocardial infarction ().
  • Severe persistent drug-induced myelosuppression ().
  • Severe hepatic impairment ().
  • Severe hypersensitivity to doxorubicin hydrochloride ().n
  • No data
  • Radiation-Induced Toxicity:
  • Embryo-Fetal Toxicity:
  • The following clinically significant adverse reactions are described elsewhere in the labeling.
  • The most common (>10%) adverse drug reactions are alopecia, nausea and vomiting ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp ().
  • Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction (, ).
  • No data
  • Lactation:
  • Females and Males of Reproductive Potential:
  • Few cases of overdose have been described.
  • A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose.
  • A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin hydrochloride daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4 to 7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.
  • Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of var. The chemical name of doxorubicin hydrochloride is 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-u03b1-L-o-hexopyranosyl)oxy]-7,8,9,10tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-s)-. The chemical structure of doxorubicin hydrochloride is:n
  • Doxorubicin Hydrochloride for Injection, USP, for intravenous use is a sterile red to orange red lyophilized cake or powder, provided in vials containing 20 mg or 50 mg doxorubicin hydrochloride, USP.
  • Each 20 mg lyophilized vial contains 20 mg of doxorubicin hydrochloride, USP and 100 mg of lactose monohydrate.
  • Each 50 mg lyophilized vial contains 50 mg of doxorubicin hydrochloride, USP and 250 mg of lactose monohydrate, NF.
  • No data
  • Doxorubicin hydrochloride treatment can increase the risk of secondary malignancies based on postmarketing reports . Doxorubicin hydrochloride was mutagenic in the Ames assay, and clastogenic in multiple in vitro assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the in vivo mouse micronucleus assay.
  • Doxorubicin hydrochloride decreased fertility in female rats at the doses of 0.05 and 0.2 mg/kg/day (approximately 0.005 and 0.02 times the recommended human dose, based on body surface area).
  • A single intravenous dose of 0.1 mg/kg doxorubicin hydrochloride (approximately 0.01 times the recommended human dose based on body surface area) was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and oligospermia/hypospermia in rats. Doxorubicin hydrochloride induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice.
  • The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically resected breast cancer was evaluated in a meta-analysis conducted by the Early Breast Cancer Trialists Collaborative Group (EBCTCG). The EBCTCG meta-analyses compared cyclophosphamide, methotrexate, and fluorouracil (CMF) to no chemotherapy (19 trials including 7,523 patients) and doxorubicin hydrochloride-containing regimens with CMF as an active control (6 trials including 3,510 patients). Data from the meta-analysis of trials comparing CMF to no therapy were used to establish the historical treatment effect size for CMF regimens. The major efficacy outcome measures were disease-free survival (DFS) and overall survival (OS).
  • Of the 3,510 women (2,157 received doxorubicin hydrochloride-containing regimens and 1,353 received CMF treatment) with early breast cancer involving axillary lymph nodes included in the six trials from the meta-analyses, approximately 70% were premenopausal and 30% were postmenopausal.
  • At the time of the meta-analysis, 1,745 first recurrences and 1,348 deaths had occurred. The analyses demonstrated that doxorubicin hydrochloride-containing regimens retained at least 75% of the historical CMF adjuvant effect on DFS with a hazard ratio (HR) of 0.91 (95% CI: 0.82, 1.01) and on OS with a HR of 0.91 (95% CI: 0.81, 1.03). Efficacy results are provided in Table 3 and Figures 1 and 2.
  • Table 3. Summary of Randomized Trials Comparing Doxorubicin Hydrochloride-Containing Regimens Versus CMF in Meta-Analysis
  • Figure 1. Meta-analysis of Disease-Free Survival
  • Figure 2. Meta-analysis of Overall Survival
  • 1. u201cHazardous Drugsu201d. . http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • Doxorubicin Hydrochloride for Injection, USP is supplied as a sterile red to orange red lyophilized cake or powder, available in single-dose vial packs or 10 vial packs as:
  • Arrayn- :
  • Single-Dose Vial in mono-cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1218-1
  • 10 mono-cartons in Outer Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1218-7
  • Arrayn- 50 mg/vial:
  • Single-Dose Vial in a Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1219-1
  • Store all vials at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Discard unused portion.
  • Handling and Disposal
  • Doxorubicin Hydrochloride for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.n
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Cardiomyopathy
  • Advise patients that doxorubicin hydrochloride for injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment .
  • Secondary Malignancy
  • Advise patients of the increased risk of treatment-related leukemia .
  • Myelosuppression
  • Advise patients that doxorubicin hydrochloride for injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection .
  • Embryo-Fetal Toxicity
  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy .
  • Advise females of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 6 months after treatment .
  • Advise patients that doxorubicin hydrochloride for injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with doxorubicin hydrochloride for injection and for 3 months after treatment .
  • Advise males with pregnant partners to use condoms during treatment with doxorubicin hydrochloride for injection and for at least 10 days after the final dose .
  • Lactation
  • Advise females not to breastfeed during treatment with doxorubicin hydrochloride for injection and for 10 days after the final dose .
  • Infertility
  • Advise females and males of the potential loss of fertility from doxorubicin hydrochloride for injection .
  • Gastrointestinal and Dermatologic Adverse Reactions
  • Advise patients that doxorubicin hydrochloride for injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking . Advise patients that doxorubicin hydrochloride for Injection can cause alopecia .
  • Administration
  • Advise patients that doxorubicin hydrochloride for injection can cause their urine to appear red for 1 to 2 days after administration.
  • This productu2019s label may have been updated. For full prescribing information, please visit www.amneal.com.
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 02-2020-01
  • DOXORUBICIN n- HYDROCHLORIDE for injection, for intravenous use
  • What is the most important information I should know about doxorubicinn- hydrochloride for injection?
  • Doxorubicin hydrochloride for injection may cause serious side effects including:
  • Tell your healthcare provider if you get any of these symptoms of heart failure during or after treatment with doxorubicin hydrochloride for injection:
  • Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with doxorubicin hydrochloride for injection.
  • What is doxorubicin n- hydrochloride for injection?
  • Doxorubicin hydrochloride for injection is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines.
  • Do not receive doxorubicin n- hydrochloride for injection if:
  • Before you receive doxorubicin n- hydrochloride for injection, tell your healthcare provider about all of your medical conditions, including if you:
  • Females who are able to become pregnant
  • Males
  • Tell your healthcare provider about all the medicines you take,
  • How will I receive doxorubicinn- hydrochloride for injection?
  • What are the possible side effects of doxorubicinn- hydrochloride for injection?
  • Doxorubicin hydrochloride for injection may cause serious side effects, including:
  • Other side effects:
  • Doxorubicin hydrochloride for injection may cause fertility problems in males.
  • Doxorubicin hydrochloride for injection may cause fertility problems in females.
  • These are not all of the possible side effects of doxorubicin hydrochloride for injection.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of doxorubicin n- hydrochloride for injection.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
  • You can ask your pharmacist or healthcare provider for information about doxorubicin that is written for health professionals.
  • What are the ingredients in doxorubicin n- hydrochloride for injection?
  • Active ingredient:
  • Inactive ingredients for Doxorubicin Hydrochloride for Injection:
  • For more information, call 1-877-835-5472 or visit www.amneal.com
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:n Telangana 509301, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 02-2020-01
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Doxorubicin (Doxorubicin Hydrochloride) which is also known as Doxorubicin Hydrochloride and Manufactured by Amneal Biosciences. It is available in strength of 2 mg/mL.

Doxorubicin (Doxorubicin Hydrochloride) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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