Frequently asked questions

Questions about polycythemia vera (PV) or getting started on MIMRYLO™ (rusfertide)?

Explore common questions below:

What is PV?

Polycythemia vera (PV) is a rare, chronic blood cancer that belongs to a group of diseases called myeloproliferative neoplasms (MPNs).

What is MIMRYLO and who is it for?

MIMRYLO is a type of medicine called a hepcidin mimetic for erythrocytosis in adults with PV.

How does MIMRYLO work?

MIMRYLO acts like a natural hormone in your body called hepcidin, which controls how much iron the body absorbs, stores, and uses. By mimicking hepcidin, MIMRYLO helps to reduce red blood cell overproduction and, in turn, lower hematocrit levels.

What is hematocrit?

Hematocrit is the percentage of your blood made up of red blood cells. Increased hematocrit can pose risks to your health, such as blood clots, heart problems, and strokes.

How can I start treatment on MIMRYLO?

You can start by talking with your healthcare provider. Before beginning MIMRYLO, your healthcare provider may review your blood tests and monitor your hematocrit levels.

How is MIMRYLO taken?

MIMRYLO is delivered via subcutaneous injection (meaning that the medication is injected in the fatty tissue layer just under the skin). MIMRYLO can be injected into the abdomen, thigh, or upper arm (injections to the upper arm should only be administered by a caregiver). Choose a different site each time you inject MIMRYLO. For more information about how to take MIMRYLO, download the Dosing and Administration Guide, Step-by-Step Injection Guide, and the Instructions for Use.

What is the starting dose?

The recommended starting dose is 19 mg once a week. Your healthcare provider may adjust your dose based on your hematocrit levels and how you're tolerating MIMRYLO.

How often do I need to take MIMRYLO?

MIMRYLO is usually injected once a week. Your healthcare provider may adjust your dose over time based on your hematocrit levels and how you tolerate it. If you are prescribed a higher dose, you may need two injections to get your full weekly dose.

What should I do if I receive a damaged medication kit?

If you believe you received a damaged product or observe any product issues, do not use the medication. Please contact us at 1-844-817-6468 and we will help process a replacement request. It is important that you keep the original packaging to help with investigating any quality issues.

Will I still require phlebotomies if I start MIMRYLO?

Some people with PV may still require phlebotomies to keep their hematocrit levels under the 45% threshold. Your doctor will tell you if you still require rescue phlebotomies while taking MIMRYLO.

If I am pregnant or breastfeeding, can I still take MIMRYLO?

MIMRYLO may cause fetal harm when taken by a pregnant patient. If you can become pregnant, use effective birth control (contraception) during treatment and for at least 30 days after the final dose. Stop taking MIMRYLO if you become pregnant.

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.

What are the possible side effects of taking MIMRYLO?

The most common side effects are:

Injection site reactions
Low red blood cell counts (anemia)

MIMRYLO may cause serious side effects, including:

New or worsening increased blood platelets (thrombocytosis)
Injection site reactions

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.