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Drugs & Devices

MYLOTARG

gemtuzumab ozogamicin

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Primary source: US · Source publication:
Source checked:

MYLOTARG · US package-label artwork; supplied packaging may differ.
US package-label artwork; supplied packaging may differ.
PRINCIPAL DISPLAY PANEL - 4.5 mg Vial Carton

Clinical source excerpts are in English. Review the original label with your clinician.

What is it used for?

MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.

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This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

Product details

Active ingredient
gemtuzumab ozogamicin
Form and strength
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · 5 mg / 5 mL
Manufacturer / applicant
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.

For injection: 4.5 mg as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution and further dilution.

Safety and clinical review

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs …

  • Hepatotoxicity, Including Veno-occlusive Liver Disease (VOD)
  • Infusion-Related Reactions (Including Anaphylaxis)
  • Hemorrhage
  • QT Interval Prolongation
  • Use in AML with Adverse-Risk Cytogenetics
  • Embryo-Fetal Toxicity

Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.

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Prepare your enquiry

Include the brand or generic name, strength, dosage form, requested quantity and country where care is needed. You can attach a prescription when you continue.

Questions patients ask

What is MYLOTARG used for?

MYLOTARG is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. MYLOTARG is indicated for the treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older.

This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

Which formulation of MYLOTARG should I ask about?

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · 5 mg / 5 mL

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What determines the price of MYLOTARG?

A current quote depends on the exact presentation, quantity, provider and access arrangements. A catalogue entry is not a stock or delivery promise. Medical charges are paid to the provider, separately from coordination fees.

What should I check before using MYLOTARG?

Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.

Sources and review scope

FDA prescribing information

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MYLOTARG (GEMTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]

Primary source: US · Source publication:
Source checked:

This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.

More catalogue entries

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