Rusfertide

Rusfertide is used to treat a high red blood cell count in adults with polycythemia vera.

Rusfertide may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes change your dose. Use the medicine exactly as directed.

Rusfertide is available in different strengths. To avoid medication errors, use it exactly as your healthcare provider instructs.

Do not change your dose or stop using this medication without your doctor's advice.

Rusfertide is injected under the skin. A healthcare provider may give you this injection or may teach you or your caregiver how to properly use this medicine. Your doctor will decide your dose and injection schedule based on how you respond to treatment.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand how to use an injection.

Inject rusfertide under the skin in your stomach area at least 2 inches away from your navel (belly button), upper arm, or in the front of your thigh. The upper arm may be used only if a caregiver gives the injection. Your healthcare provider will show you where to inject rusfertide. Do not inject into the same spot two times in a row.

Do not give an injection into skin that is red, bruised, tender, hard, or broken.

Make sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it according to state or local laws. Keep out of the reach of children and pets.

You may be given other medicines to help treat certain side effects. Keep taking these medicines for as long as your doctor has prescribed.

You may need frequent blood tests when you start and during treatment with this medicine.

Store this medicine in the original carton at room temperature away from moisture, heat, and light. Do not freeze. After mixing, use it within 4 hours and throw away any unused mixed medicine.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or ever had health problems or use other medications.

May harm an unborn baby. You may need to take a pregnancy test before starting this treatment. Use effective birth control while using rusfertide and for at least 30 days after your last dose. Stop using the medicine and tell your doctor right away if you become pregnant or think you may be pregnant.

Do not breastfeed while using rusfertide, and for at least 30 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Rusfertide may cause serious side effects. Call your doctor immediately if you have:

• redness, itching, pain, bruising, swelling, irritation, or hardening of your skin where the medicine was injected; or
• increased blood platelets count--unusual bruising or bleeding, chest pain, shortness of breath, leg pain or swelling, or a sudden severe headache.

Your healthcare provider may change your dose, delay treatment, or permanently stop rusfertide if you have certain side effects.

Common side effects of rusfertide may include:

• a reaction where the medicine was injected; or
• low red blood cells (anemia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you use rusfertide once a week: If you are 1 to 4 days late, take the missed dose as soon as you remember and then go back to your regular schedule. If you are more than 4 days late, take the missed dose as soon as you remember, take your next dose 3 days later, and then return to your regular schedule.

If you use rusfertide twice a week: If you are 1 to 2 days late, take the missed dose as soon as you remember, take your next dose 3 days later, and then return to your regular schedule. If you are more than 2 days late, skip the missed dose and continue your regular schedule.

Do not use two doses at one time.

Call your doctor for instructions if you are not sure what to do if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect rusfertide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.