Mylotarg TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: gemtuzumab ozogamicin
Pack: Mylotarg 5 mg powder for injection, 1 vial
Brand name
(ARTG)
: MYLOTARG gemtuzumab ozogamicin 5 mg powder for injection vialDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
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).
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Injection, powder for
- Intravenous
- White to off-white powder cake
Storage conditions
(ARTG)
- 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
- Shelf lifetime is 5 Years.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 1 vial pack
Is this medicine subsidised ?
(PBS)
This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on December, 1 2024. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.
Pregnant or planning a pregnancy ?
(AHT)
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.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
