Doxorubicin Hydrochloride (Adriamycin)

Trade Name : Adriamycin

West-Ward Pharmaceuticals Corp

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 2 mg/mL

Storage and handling for Adriamycin

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

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

Doxorubicin Hydrochloride (Adriamycin) 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.

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Doxorubicin 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 u00a0.
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 u00a0.

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Single agent: 60 to 75 mg/m given intravenously every 21 days u00a0.
In combination therapy: 40 to 75 mg/m given intravenously every 21 to 28 days u00a0.
Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy u00a0.
Reduce dose in patients with hepatic impairment u00a0.

Adriamycin (DOXOrubicin HCl) for Injection, USP: Vials contain 10 mg and 50 mg doxorubicin hydrochloride as a red-orange lyophilized powder.

Adriamycin (DOXOrubicin HCl) for Injection, USP: Vials contain 10 mg and 50 mg as a lyophilized powder u00a0

Doxorubicin is contraindicated in patients with:

u2022Severe myocardial insufficiency (4)
u2022Recent myocardial infarction (4)
u2022Severe persistent drug-induced myelosuppression (4)
u2022Severe hepatic impairment (4)
u2022Hypersensitivity to doxorubicin HCl (4)

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Radiation-induced toxicity can be increased by the administration of doxorubicin. Radiation recall can occur in patients who receive doxorubicin after prior radiation therapy u00a0.
Embryofetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetusu00a0u00a0.

The following adverse reactions are discussed in more detail in other sections of the labeling.
The most common (>10%) adverse drug reactions are alopecia, nausea and vomiting (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or n

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Avoid concurrent use of doxorubicin with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp u00a0.
Do not administer doxorubicin in combination with trastuzumab due to increased risk of cardiac dysfunctionu00a0, u00a0.

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Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother ).
Pediatric Use: Recommend long-term follow-up cardiac evaluations due to risk of delayed cardiotoxicityu00a0.
Females and Males of Reproductive Potential: May impair fertility. Counsel female and male patients on pregnancy planning and prevention u00a0.

Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin (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 daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4-7 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 is a cytotoxic anthracycline antibiotic isolated from cultures of var.. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine. Chemically, doxorubicin hydrochloride is (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-a-L-lyxo-hexopyranosyl)-oxy]-8-glycoloyl-7,8,9,10-tetrahydro-
6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride. The structural formula is as follows:
Doxorubicin binds to nucleic acids, presumably by specific intercalation of the planar anthracycline nucleus with the DNA double helix. The anthracycline ring is lipophilic, but the saturated end of the ring system contains abundant hydroxyl groups adjacent to the amino sugar, producing a hydrophilic center. The molecule is amphoteric, containing acidic functions in the ring phenolic groups and a basic function in the sugar amino group. It binds to cell membranes as well as plasma proteins.
It is supplied in the hydrochloride form as a sterile red-orange lyophilized powder containing lactose and as a sterile parenteral, isotonic solution with sodium chloride for intravenous use only.
Adriamycin (DOXOrubicin HCl) for Injection, USP:
Each 10 mg lyophilized vial contains 10 mg of Doxorubicin Hydrochloride, USP and 50 mg of Lactose Monohydrate, NF.
Each 50 mg lyophilized vial contains 50 mg of Doxorubicin Hydrochloride, USP and 250 mg of Lactose Monohydrate, NF.

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Doxorubicin treatment results in an increased risk of secondary malignancies based on postmarketing reports . Doxorubicin was mutagenic in the Ames assay, and clastogenic in multiple assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the mouse micronucleus assay.
Doxorubicin 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 (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 induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice.

The clinical efficacy of doxorubicin HCl-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 5-fluorouracil (CMF) to no chemotherapy (19 trials including 7523 patients) and doxorubicin HCl-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 HCl-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 HCl-containing regimens retained at least 75% of the historical CMF adjuvant effect on DFS with a hazard ratio (HR) of 0.91 (95% CI, 0.8 to 1.01 ) and on OS with a HR of 0.91 (95% CI, 0.8 to 1.03 ). Results of these analyses for both DFS and OS are provided in Table 2 and Figures 1 and 2.
Table 2. Summary of Randomized Trials Comparing Doxorubicin Containing Regimens Versus CMF in Meta-Analysis
Abbreviations:
* Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF. ** a hazard ratio of less than 1 indicates that the treatment with doxorubicin HCl-containing regimens is associated with lower risk of disease recurrences or death compared to the treatment with CMF.
u2020 Patients received alternating cycles of AVb and CMF.

1. u201cHazardous Drugsu201d. . n

Adriamycin (DOXOrubicin HCI) for Injection, USP is supplied as a sterile red-orange lyophilized powder in single dose flip-top vials in the following package strengths:
NDC 0143-9275-01
NDC 0143-9277-01
Store all vials at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Retain in carton until time of use. Discard unused portion.
Reconstituted Solution Stability
After adding the diluent, the vial should be shaken and the contents allowed to dissolve. The reconstituted solution is stable for 7 days at room temperature and under normal room light (100 foot-candles) and 15 days under refrigeration (2u00b0 to 8u00b0C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials.
Handling and Disposal
Handle and dispose of Adriamycin (DOXOrubicin HCl) for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.n

See FDA-Approved Patient Labeling (Patient Information). Inform patients of the following:
Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
Distributed by
West-Ward Pharmaceuticalsu00a0
Eatontown, NJ 07724 USA
Revised January 2018
127.207.029/01

Patient Information
DOXORUBICINu00a0n- uhn- roon- uhn- HYDROCHLORIDE for Injection, for intravenous use
What is the most important information I should know about Doxorubicin?u00a0
Doxorubicin may cause serious side effects including:
What is Doxorubicin?
Doxorubicin is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines.
Who should not receive Doxorubicin?
Do not receive Doxorubicin if:
What should I tell my doctor before receiving Doxorubicin?
Before you receive Doxorubicin, tell your doctor if you:
Tell your doctor about all the medicines you take,u00a0
Know the medicines you take. Keep a list to show your doctor and pharmacist each time you get a new medicine.
How will I receive Doxorubicin?
What are the possible side effects of Doxorubicin?
Doxorubicin may cause serious side effects, including:
Doxorubicin may cause lower sperm counts and sperm problems in men.
This could affect your ability to father a child and cause birth defects. Talk to your healthcare provider if this is a concern for you. Talk to your healthcare provider about family planning options that might be right for you.
Irreversible amenorrhea or early menopause.u00a0
The most common side effects of Doxorubicin include:
Other side effects:
Tell your doctor or nurse if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Doxorubicin.
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.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
You can ask your pharmacist or doctor for information about Doxorubicin that is written for health professionals.
For more information, call 1-877-845-0689.
What are the ingredients of Doxorubicin?
Active ingredient:
Inactive ingredients for Doxorubicin Hydrochloride for Injection:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured by
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
Distributed by
West-Ward Pharmaceuticals
Eatontown, NJ 07724 USA
Revised January 2018u00a0
127.207.029/01

NDC 0143-9275-01 Rx onlyn n
10 mg/vial
LYOPHILIZED

NDC 0143-9277-01 Rx onlyn n
50 mg/vial
LYOPHILIZED

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