Product image of Mylotarg (Gemtuzumab Ozogamicin) supplied by GNH India

Mylotarg

Active Ingredient:
Gemtuzumab Ozogamicin
Origin:
EU

Mylotarg (Gemtuzumab Ozogamicin)

Gemtuzumab ozogamicin, the active ingredient in Mylotarg, is a antibody‑drug conjugate presented as a lyophilized powder for solution for infusion for intravenous use. It treats CD33‑positive acute myeloid leukemia in combination with chemotherapy.

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

Manufacturer / TM Owner

Pfizer Europe Ma Eeig

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

Mylotarg is an antibody‑drug conjugate indicated for CD33‑positive acute myeloid leukemia, acting as part of combination chemotherapy regimens.

  • Acute Myeloid Leukemia (CD33‑positive): Used with chemotherapy to improve remission rates.
  • Newly diagnosed AML (CD33‑positive): Added to standard induction therapy to increase overall survival.
  • Relapsed or refractory AML (CD33‑positive): Provides an additional option when standard therapies have failed.

How It Works

  • Gemtuzumab ozogamicin binds specifically to the CD33 antigen expressed on myeloid leukemia cells. After binding, the complex is internalized, releasing a calicheamicin derivative that creates DNA double‑strand breaks, leading to apoptosis of the targeted cancer cells.

Side Effects

Mylotarg may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset occurring during or after infusion.
  • Fever and chills: transient pyrexia often related to infusion reactions.
  • Fatigue: generalized tiredness reported by many patients.
  • Infusion‑related reactions: flushing, rash, or mild hypotension during administration.

Serious or Rare Side Effects

  • Veno‑occlusive disease of the liver: potentially life‑threatening hepatic toxicity.
  • Severe infections: increased susceptibility due to myelosuppression.
  • Hemorrhage: bleeding events linked to thrombocytopenia or coagulopathy.

Precautions & Warnings

Before initiating therapy with Mylotarg, clinicians should consider several safety measures.

  • Monitor liver function: baseline and periodic tests are required due to risk of hepatotoxicity.
  • Assess for veno‑occlusive disease: watch for abdominal pain, weight gain, and jaundice.
  • Avoid concomitant hepatotoxic drugs: reduce the potential for liver injury.
  • Pregnancy: use is not recommended; safety data are lacking.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Mylotarg can interact with other medicines, necessitating careful management.

Major Interactions (Avoid)

  • Concomitant hepatotoxic agents: may amplify liver toxicity.
  • Strong CYP3A4 inducers: could lower the effectiveness of the calicheamicin payload.
  • Other CD33‑targeted therapies: overlapping toxicities increase risk.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: heightened bleeding risk.
  • Live vaccines: immunosuppression may reduce vaccine efficacy.
  • Additional myelosuppressive chemotherapy: may exacerbate cytopenias.

Frequently Asked Questions

Mylotarg is indicated for the treatment of CD33‑positive acute myeloid leukemia (AML). It is administered in combination with standard chemotherapy regimens to improve remission rates in newly diagnosed, relapsed, or refractory AML patients.

Gemtuzumab ozogamicin is an antibody‑drug conjugate that binds to the CD33 antigen on myeloid leukemia cells. After binding, the complex is internalized, releasing a calicheamicin derivative that creates DNA double‑strand breaks, leading to programmed cell death of the malignant cells.

The dose of Mylotarg is individualized by the prescribing physician based on the patient’s disease status, body surface area, and treatment protocol. Specific dosing regimens are determined by clinical guidelines and the treating oncologist.

Safety data for Mylotarg in pregnancy and lactation are limited. It is generally advised to avoid use in pregnant or breastfeeding women unless the potential benefit justifies the potential risk to the fetus or infant.

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

Standard chemotherapy for AML relies on cytotoxic agents that affect rapidly dividing cells. Mylotarg adds a targeted approach by delivering a cytotoxic payload directly to CD33‑expressing leukemia cells, potentially enhancing efficacy while allowing lower doses of conventional chemotherapy.

Mylotarg should be stored at 2‑8 °C in a refrigerator, protected from light. The lyophilized powder must not be frozen or shaken. Before use, reconstitute according to the product label and keep the solution refrigerated if not administered immediately.

Mylotarg is supplied as a lyophilized powder that is reconstituted with a suitable diluent to form an infusion solution. It is administered intravenously over a specified period under medical supervision, typically as part of a combination chemotherapy schedule.

The most serious risks include veno‑occlusive disease of the liver, severe infections due to myelosuppression, and significant bleeding events. Patients should be closely monitored for hepatic dysfunction, signs of infection, and abnormal coagulation parameters throughout treatment.

Mylotarg should not be used in patients with known hypersensitivity to gemtuzumab ozogamicin or any of its excipients, in individuals with active uncontrolled infections, or in pregnant women unless the benefits outweigh the risks. Caution is also advised for patients with pre‑existing liver disease.

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.