Doxybenz 50 Capsules

Doxybenz 10/50

Generic Name – Doxorubicin hydrochloride
Drug Class – Antineoplastic agent

Doxorubicin is an anthracycline antibiotic, commonly used in the treatment of solid tumors in adult and pediatric patients. It acts by intercalating between DNA base pairs, thereby preventing DNA replication and inhibiting protein synthesis. It also inhibits topoisomerase II, resulting in increased and stabilized cleavable-DNA linked complex during DNA replication. It also produces cytotoxic effects secondary to peroxidation of membrane lipids by forming free radicals.
Dosage and Administration

  • Recommended dose, when used as a single agent: 60 to 75 mg/m2 as a single intravenous injection admin­istered at 21-day intervals. Dose should be reduced in patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration
  • Recommended dose, when used in combination with other chemotherapy drugs: 60 mg/m2 given as a single intravenous injection every 21 to 28 days

Dosage Form and Strength

  • Supplied as a single use vial containing lyophilized injection for intravenous infusion
  • Available as 10 mg and 50mg for injection

 

Category:

Description

Doxybenz 10/50 (Doxorubicin hydrochloride for injection) is the lyophilized concentrate of drug, available in single use glass vial.

Indications & Usage

Doxorubicin hydrochloride is indicated:

  • For treatment of disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histological type is the most responsive compared to other cell types
  • As a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer

Limitations of use

  • Doxorubicin is unresponsive to three tumor categories that are least sensitive to chemotherapy. It includes large bowel adenocarcinoma, renal cancer and malignant melanoma

Clinical Efficacy

  • Produces tumor regression in children with osteosarcoma, neuroblastoma, Wilms tumor, reticulum cell (histolytic) lymphoma, and hepatoblastoma
  • Improves response rate and survival outcomes in various cancers including mesothelioma, lung cancer,  neuroblastoma,nephroblastoma, testicular tumors, stomach carcinoma, sarcomas of bone and soft tissue
  • Shows higher efficacy in treatment of both early and late stage breast cancer

Safety Information

Adverse reactions

  • The most common adverse reactions which may occur after doxorubicin administration include fever, cough, nausea, vomiting, stomach pain, diarrhea, oral sores, lack of appetite, fatigue, thrombocytopenia, neutropenia, weight loss, eye problems, alopecia, malaise/asthenia, amenorrhea and allergic problems
  • Other severe adverse events include cardiac toxicity, bone marrow suppression, increased risk of secondary malignancy diagnoses and severe tissue ulceration and necrosis, if extravasations occurs during administration

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to doxorubicin, any of its excipients, or other anthracyclines or anthracenediones
  • It is not recommended for use in patients with following conditions: baseline neutrophil count < 1500 cells/mm3 severe hepatic impairment, recent myocardial infarction, severe myocardial insufficiency, severe arrhythmias, and previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, or other anthracyclines

Special Precautions

  • Patients should be regularly monitored for cardiac toxicity and possible clinical complications of myelosuppression during the therapy
  • Dose should be reduced in patients with hepatic impairment
  • Blood uric acid levels, potassium, calcium, phosphate, and creatinine levels should be carefully evaluated after initial treatment to reduce risk of hyperuricemia
  • Severe necrosis may occur due to extravasations of doxorubicin, so if signs of extravasations occurs, immediately terminate the injection or infusion
  • Increased toxicity can occur in patients who receive doxorubicin after radiation therapy
  • Patients should use effective contraception during and for 6 months after treatment, as doxorubicin may induce chromosomal damage in sperm, leading to loss of fertility and offspring with birth defects
  • Women with child bearing potential are advised to use effective contraceptives to avoid any chance of pregnancy while receiving doxorubicin
  • It is not recommended for use in pregnant and breast feeding mothers, as it may cause harm to fetus

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