Product image of Mitomycine Substipharm (Mitomycin) supplied by GNH India

Mitomycine Substipharm

Active Ingredient:
Mitomycin
Origin:
EU

Mitomycine Substipharm (Mitomycin)

Mitomycin, the active ingredient in Mitomycine Substipharm, is an alkylating agent presented as a solution for intravesical use. It is employed to treat non‑muscle invasive bladder cancer in patients whose disease is confined to the bladder lining.

GNH India supplies Mitomycine Substipharm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Substipharm

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Mitomycin is an alkylating antineoplastic agent used in the management of bladder cancer that is limited to the mucosal layer.

  • Non‑muscle invasive bladder cancer: reduces tumour recurrence after transurethral resection.
  • Carcinoma in situ of the bladder: eradicates residual malignant cells.
  • Superficial bladder tumors: provides intravesical chemotherapy to delay progression.

How It Works

  • Mitomycin undergoes enzymatic reduction within tumor cells to generate reactive intermediates that form covalent cross‑links between DNA strands. These cross‑links inhibit DNA replication and transcription, ultimately triggering apoptosis and cell death in rapidly dividing cancer cells.

Side Effects

Mitomycine Substipharm may cause a range of adverse reactions following intravesical administration.

Common Side Effects

  • Bladder irritation: dysuria, urgency, and frequency.
  • Hematuria: visible blood in urine.
  • Mild nausea or fatigue.

Serious or Rare Side Effects

  • Systemic absorption leading to bone‑marrow suppression and pancytopenia.
  • Severe infection secondary to neutropenia.
  • Pulmonary toxicity, including interstitial pneumonitis.
  • Allergic reactions such as rash or anaphylaxis.
  • Renal toxicity manifested by elevated creatinine.

Precautions & Warnings

Prior to using Mitomycine Substipharm, several safety considerations should be observed.

  • Renal function: assess creatinine clearance before instillation.
  • Hematologic status: obtain baseline blood counts and monitor regularly.
  • Pregnancy: avoid unless potential benefit justifies risk.
  • Concomitant chemotherapy: evaluate for additive myelosuppression.
  • Bladder integrity: ensure no perforation before administration.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Mitomycin can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Other alkylating agents: heightened myelosuppression.
  • Pelvic radiation therapy: increased bladder toxicity.
  • Nephrotoxic drugs (e.g., cisplatin): risk of renal impairment.

Moderate Interactions (Monitor Closely)

  • Aminoglycoside antibiotics: monitor renal function.
  • Non‑steroidal anti‑inflammatory drugs: may exacerbate renal stress.
  • Warfarin or other anticoagulants: observe coagulation parameters.

Frequently Asked Questions

Mitomycine Substipharm is an intravesical formulation of mitomycin used primarily to treat non‑muscle invasive bladder cancer. It is administered directly into the bladder after tumor resection to reduce the risk of recurrence and to eradicate residual malignant cells.

Mitomycin is a bioreductive alkylating agent. Inside cancer cells it is reduced to a reactive form that creates covalent cross‑links between DNA strands, blocking DNA synthesis and transcription. This interference triggers programmed cell death, especially in rapidly dividing tumor cells.

The exact dose and schedule are determined by the prescribing oncologist based on the patient’s clinical condition, bladder size, and prior treatments. Intravesical regimens typically involve a single‑dose instillation repeated weekly for several weeks, but the prescriber sets the precise regimen.

Mitomycin is classified as potentially harmful to a developing fetus and is generally avoided during pregnancy unless the therapeutic benefit outweighs the risk. Limited data exist for breastfeeding, and because systemic absorption can occur, use while nursing is not recommended without specialist advice.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

The principal alternative for non‑muscle invasive bladder cancer is intravesical Bacillus Calmette‑Guérin (BCG) immunotherapy. Mitomycin provides a chemotherapeutic approach that directly damages DNA, while BCG stimulates an immune response. Choice depends on tumour characteristics, prior treatment response, and patient tolerance to side‑effects.

The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to use, allow the solution to reach room temperature if required, and handle it in a sterile environment to maintain aseptic conditions.

Mitomycine Substipharm is given by intravesical instillation. After transurethral resection of bladder tumours, the solution is introduced into the bladder through a catheter and retained for a prescribed dwell time, usually 1–2 hours, before being drained.

Serious risks include systemic absorption leading to bone‑marrow suppression (pancytopenia), severe infections due to neutropenia, pulmonary toxicity such as interstitial pneumonitis, and renal impairment. Prompt monitoring of blood counts and renal function is essential to detect these complications early.

Patients with known hypersensitivity to mitomycin, active urinary tract infection, bladder perforation, severe renal impairment, or uncontrolled systemic infection should avoid this therapy. Additionally, pregnant women should not receive it unless the potential benefit justifies the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.