What were the most common side effects of taking MIMRYLO™ (rusfertide)?

Certain side effects were seen in people taking MIMRYLO. Make sure to tell your doctor or care team right away if you experience any side effects.

MIMRYLO has a favorable safety profile

The safety of MIMRYLO was evaluated in 285 adults with polycythemia vera (PV) in the 7-month VERIFY study. The most common side effects observed were injection site reactions and low red blood cell counts (anemia). Serious side effects included new or worsening increased blood platelets (thrombocytosis) and injection site reactions.

Injection site reactions

Since MIMRYLO is a subcutaneous injection (just under the skin), you may have reactions at the injection site, such as:

Redness
Itching
Pain
Swelling
Bruising
Hardening
Irritation

Anemia

16% of people receiving MIMRYLO experienced anemia.

In the VERIFY study, serious side effects were rare. Anemia was the only one, occurring in less than 1% (0.4%) of people taking MIMRYLO. A small number of people stopped treatment due to side effects like injection site reactions (0.7%), increased platelets (0.7%), or anemia (0.4%).

Additional safety findings with MIMRYLO

The findings below provide additional information about the safety profile of MIMRYLO from the VERIFY study.

94% remained on therapy

into the long-term portion of the study.

Injection site reactions became less common over time

Among people taking MIMRYLO who experienced injection site reactions, these reactions were reported less often later in treatment than earlier in treatment.

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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.