Mylotarg™

Read the CMI leaflet (Opens in new tab) for facts you need to know before, during and after taking your medicine.

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MYLOTARG is indicated for combination therapy with standard anthracycline and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see Section 4.4 Special warnings and precautions for use, and Section 5.1 Pharmacodynamic properties).

Source: ARTG

• Shelf lifetime is 5 Years
• Store at 2 to 8 degrees Celsius
• Protect from Light; Do not Freeze; Refrigerate; Store in Original Container; See Product information for shelf life; Reconstituted Solution see label for shelf life

Source: ARTG

Non-composite pack

This medicine contains one component only.

Component

• Injection, powder for
• Intravenous
• White to off-white powder cake

Source: ARTG

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4: Prescription Only Medicine.?What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’. You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

• 1 vial

Source: ARTG

This medicine was verified as available on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2026, under the following PBS item codes:

• 12878T (Opens in new tab)
• 12844B (Opens in new tab)
• 12904E (Opens in new tab)
• 12861X (Opens in new tab)

Ask your pharmacist or doctor about your eligibility

Source: PBS

For the active ingredient: gemtuzumab ozogamicin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Source: AHT

Healthdirect medicines information is not intended for use in an emergency. If you are suffering an acute illness, overdose, or emergency condition, call triple zero (000) and ask for an ambulance.

Reasonable care has been taken to provide accurate information at the time of creation. This information is not intended to substitute medical advice, diagnosis or treatment and should not be exclusively relied on to manage or diagnose a medical condition. Please refer to our terms and conditions (Opens in new tab).