IMPORTANT SAFETY INFORMATION
Before using MIMRYLO, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. MIMRYLO may harm your unborn baby.
Females who are able to become pregnant:- Your healthcare provider may do a pregnancy test before you start treatment with MIMRYLO.
- Use effective birth control (contraception) during treatment and for at least 30 days after the final dose of MIMRYLO.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MIMRYLO.
- Stop taking MIMRYLO if you become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if MIMRYLO passes into your breast milk. Do not breastfeed during treatment with MIMRYLO and for 30 days after the final dose of MIMRYLO. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of MIMRYLO?
MIMRYLO may cause serious side effects, including:
- New or worsening increased blood platelets (thrombocytosis). MIMRYLO may increase blood platelet counts. Your healthcare provider will do blood tests when you start and during treatment with MIMRYLO to check your platelet counts.
- Injection site reactions. MIMRYLO may cause injection-site reactions such as redness, itching, pain, swelling, bruising, hardening at the injection site, and irritation. If you get an injection site reaction, apply ice packs, steroid cream, or take medicines as needed to treat injection site pain and swelling.
Your healthcare provider may change your dose or stop treatment with MIMRYLO if you have side effects.
The most common side effects of MIMRYLO are:
- injection site reactions
- low red blood cell count (anemia)
These are not all of the possible side effects of MIMRYLO. Call your doctor for medical advice about side effects. You may report side effects to Takeda at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Patient Information in the MIMRYLO (rusfertide) full Prescribing Information.
What is MIMRYLO (rusfertide)?
MIMRYLO is a prescription medicine that is used to treat erythrocytosis (high red blood cell count) in adults with polycythemia vera.
It is not known if MIMRYLO is safe and effective in children.