Doxorubicin Hydrochloride (Doxorubicin Hydrochloride)

Trade Name : Doxorubicin Hydrochloride

Pfizer Laboratories Div Pfizer Inc

INJECTION, SOLUTION

Strength 2 mg/mL

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Doxorubicin Hydrochloride (Doxorubicin Hydrochloride) which is also known as Doxorubicin Hydrochloride and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 2 mg/mL per ml. Read more

Doxorubicin Hydrochloride (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. Read less

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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% u2013 20% for cumulative doses from 300 mg/m to 500 mg/m when 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. ()

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Doxorubicin Hydrochloride Injection/for Injection is an anthracycline topoisomerase 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 Wilms' 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 Injection/for Injection in patients who develop signs or symptoms of cardiomyopathy ().
Reduce dose in patients with hepatic impairment ().

Injection:

10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL in single-dose vial ()
150 mg/75 mL, and 200 mg/100 mL in multiple-dose vial ()

Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:

Severe myocardial insufficiency ().
Recent myocardial infarction ().
Severe persistent drug-induced myelosuppression ().
Severe hepatic impairment ().
Severe hypersensitivity to doxorubicin hydrochloride ().

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 reactions are alopecia, nausea and vomiting ().
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchn

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 4u20137 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]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxylacetyl)-1-methoxy-, hydrochloride (8S-s)-. The chemical structure of doxorubicin hydrochloride is:
Doxorubicin Hydrochloride Injection, for intravenous use is a clear red, sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL doxorubicin hydrochloride (equivalent to 9.37 mg of doxorubicin free base), 20 mg/10 mL doxorubicin hydrochloride (equivalent to 18.74 mg of doxorubicin free base), 50 mg/25 mL doxorubicin hydrochloride (equivalent to 46.86 mg of doxorubicin free base), 150 mg/75 mL doxorubicin hydrochloride (140.58 mg of doxorubicin free base), or 200 mg/100 mL doxorubicin hydrochloride (equivalent to 187.4 mg of doxorubicin free base). The drug product has demonstrated inherent antimicrobial activity suitable for a multiple dose presentation. Each milliliter of solution contains 2 mg of doxorubicin hydrochloride and 9 mg of sodium chloride. The pH of the solution is adjusted to 3.0 with hydrochloric acid, USP.

No data

Doxorubicin hydrochloride treatment can increase the risk of secondary malignancies based on postmarketing reports . Doxorubicin hydrochloride was mutagenic in the in vitro 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 7523 patients) and doxorubicin hydrochloride-containing regimens with CMF as an active control (6 trials including 3510 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 3510 women (2157 received doxorubicin hydrochloride-containing regimens and 1353 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, 1745 first recurrences and 1348 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.

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No data

Advise the patient to read the FDA-approved patient labeling (Patient Information).

This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.
LAB-0073-16.0

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NDC 0069-3030-20
Rx only
Single-DoseDiscard unused portion
DOXOrubicinHCl Injection, USP
10 mg/5 mL
For Intravenous Use Only
Caution: Cytotoxic Agent

NDC 0069-3030-20n n
SINGLE-DOSE: DISCARD UNUSED PORTION
DOXOrubicinHCl Injection,USP
10 mg/5 mL
For Intravenous Use Only
Cytosafe Vial
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3031-20
Rx only
Single-DoseDiscard unused portion
DOXOrubicinHCl Injection, USP
20 mg/10 mL
For Intravenous Use Only
Caution: Cytotoxic Agent

NDC 0069-3031-20n n
SINGLE-DOSE: DISCARD UNUSED PORTION
DOXOrubicinHCl Injection,USP
20 mg/10 mL
For Intravenous Use Only
Cytosafe Vial
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3032-20
Rx only
Single-DoseDiscard unused portion
DOXOrubicinHCl Injection, USP
50 mg/25 mL
For Intravenous Use Only
Caution: Cytotoxic Agent

NDC 0069-3032-20 n n
SINGLE-DOSE: DISCARD UNUSED PORTION
DOXOrubicin HCl Injection, USP
50 mg/25 mL
For Intravenous Use Only
Cytosafe Vial
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3033-20
Multiple Dose Vialn n
DOXOrubicinHCl Injection, USP
150 mg/75 mL
For Intravenous Use Only
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3033-20 n n
Multiple Dose Vial
DOXOrubicin HCl Injection, USP
150 mg/75 mL
For Intravenous Use Only
Cytosafe Vial
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3034-20
Multiple Dose Vialn n
DOXOrubicinHCl Injection, USP
200 mg/100 mL
For Intravenous Use Only
Caution: Cytotoxic Agent
Pfizer Injectables

NDC 0069-3034-20n n
Multiple Dose Vial
DOXOrubicin HCl Injection, USP
200 mg/100 mL
For Intravenous Use Only
Cytosafe Vial
Caution: Cytotoxic Agent
Pfizer Injectables

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Doxorubicin Hydrochloride (Doxorubicin Hydrochloride)

Trade Name : Doxorubicin Hydrochloride

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Doxorubicin Hydrochloride (Doxorubicin Hydrochloride)

Trade Name : Doxorubicin Hydrochloride

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

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Canadian DIN

Swiss Drugs

NZ Drugs

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