Description

Altretamine Capsules

Healthy Inc is a specialized global supplier and exporter of advanced antineoplastic and gynecological oncology therapeutics. We provide high-purity Altretamine Capsules (50 mg), manufactured in WHO–GMP certified, dedicated cytotoxic oral solid dosage facilities. This “Oral Alkylating Agent” is a highly specialized, high-value export to comprehensive cancer centers, gynecological oncology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical palliative intervention for persistent or recurrent ovarian cancer.

Product Overview

This formulation contains Altretamine (formerly known as hexamethylmelamine or HMM), a synthetic s-triazine derivative with potent antineoplastic properties.

The “Gynecological Salvage Therapy” Specialist:

• Mechanism (Hepatic Activation & DNA Cross-linking): Unlike direct-acting alkylating agents, Altretamine requires extensive hepatic metabolism (via CYP450 enzymes) to become active. It undergoes sequential demethylation, releasing highly reactive intermediates, including formaldehyde and reactive iminium ions. These metabolites covalently bind to DNA and RNA, causing catastrophic cross-linking that halts DNA synthesis and forces the rapidly dividing ovarian cancer cells into apoptosis.
• The Ovarian Cancer Niche: Altretamine is uniquely positioned for patients with advanced adenocarcinoma of the ovary who have experienced disease progression or recurrence despite prior aggressive treatment with platinum-based (e.g., Cisplatin) and standard alkylating agent-based combination therapies.
• Oral Chemotherapy Convenience: As an orally administered capsule, it allows patients in the palliative care phase to receive potent antineoplastic therapy without the need for constant, invasive intravenous infusions, significantly improving quality of life.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-Alu blisters or specialized child-resistant glass/HDPE bottles designed for safe cytotoxic dispensing.

*Pack Sizes: 10×10 Alu-Alu Blisters or 100-count Amber Glass/HDPE Bottles (Standard for multi-week oncology cycles).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Oncology Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Dedicated Cytotoxic Isolation: Altretamine is highly potent and toxic. It is manufactured in a 100% isolated, negative-pressure cytotoxic manufacturing block utilizing advanced barrier isolators. This protects operators from aerosolized exposure and guarantees absolute zero cross-contamination with non-oncology pharmaceutical lines.
• API Uniformity for BSA Dosing: Because the daily dose is strictly calculated based on the patient’s Body Surface Area (BSA), our manufacturing process utilizes advanced high-shear blending to guarantee absolute content uniformity across every 50 mg capsule, preventing severe hematological toxicity caused by accidental over-dosing.

Therapeutic Indications (Human Use)

Indicated for the palliative treatment of specific gynecological malignancies:

• Recurrent Ovarian Cancer: Used as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecological Oncologist):

• Administration (CRITICAL FOOD RULE): To minimize severe gastrointestinal toxicity (nausea/vomiting), the total daily dose should be divided into four oral doses and taken after meals and at bedtime.
• BSA Dosing: The standard dose is calculated as 260 mg/m² per day.
• Cycle Protocol: Administered for either 14 or 21 consecutive days of a 28-day cycle, dictated by the patient’s hematological and neurological tolerance.
• Strict Cytotoxic Handling: Capsules must be swallowed whole. They must never be opened, crushed, or chewed.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Neurologic Toxicity): Altretamine causes severe, sometimes irreversible, peripheral neuropathy and central nervous system symptoms (mood disorders, ataxia, dizziness, vertigo). Continuous neurological examinations are mandatory during therapy.
• BLACK BOX WARNING (Myelosuppression): Causes dose-related bone marrow depression (leukopenia and thrombocytopenia). Frequent complete blood counts (CBCs) must be performed before the initiation of each course of therapy and routinely during treatment.
• MAOI Interaction (Fatal Orthostatic Hypotension): Concurrent use with Monoamine Oxidase Inhibitors (MAOIs) is strictly contraindicated. Co-administration can cause severe, potentially fatal orthostatic hypotension.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Antineoplastic and Oncology Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.