Class Name(s):

• 10:00 Antineoplastic Agents

Brand Name(s):

• Mimrylo^®

WHY is this medicine prescribed?

Rusfertide injection is used to decrease the number of red blood cells in patients with polycythemia vera (PV; condition in which the body makes too many red blood cells). Rusfertide injection is in a class of medications called hepcidin mimetics. It works by decreasing the amount of iron available in the body needed to make red blood cells.

HOW should this medicine be used?

Rusfertide injection comes as a powder to be mixed with a liquid to be given subcutaneously (under the skin). It is given once weekly. Higher doses may be given twice weekly. Give rusfertide on the same day(s) of the week.

Use rusfertide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully. Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

You or a caregiver may inject rusfertide in abdomen (at least 2 inches from bellybutton area), front of thigh or outer area of upper arm. Do not inject in area where skin is tender, bruised, red, raised hard, broken or irritated. Rotate injection sits each injection.

Once you have mixed the powder with the liquid following the instructions for use provided, you must use within 4 hours. If you have not given your injection within that 4 hours, you must throw away the mixed medicine.

Your doctor will probably start you on a low dose of rusfertide and gradually increase your dose, not more than once every 2 weeks.

Your doctor may have to lower your dose based on your lab results. Make sure you attend all scheduled laboratory visits.

Rusfertide injection controls PV but does not cure it. Continue to use rusfertide injection even if you feel well. Do not stop using rusfertide injection without talking to your doctor.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving rusfertide injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking rusfertide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking rusfertide injection. You may have to take a pregnancy test before starting treatment. You should use effective birth control to prevent pregnancy during your treatment and for 30 days after your final dose. Talk to your doctor about the best birth control method for you. If you become pregnant while taking rusfertide injection, call your doctor immediately. Rusfertide injection may harm the fetus.
• do not breastfeed during treatment and for 30 days after your final dose of rusfertide.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rusfertide injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you inject rusfertide once a week and miss a dose:

• if it has been less than 4 days since your scheduled dose, inject the missed dose immediately and resume regular dosing schedule.
• if it has been more than 4 days since your schedule dose, inject the missed dose immediately and then give the next dose 3 days later and then resume the regular dosing schedule.

If you inject rusfertide twice a week and miss a dose:

• if it has been 1 to 2 days since your scheduled dose, inject the missed dose immediately and then give the next dose 3 days later and then resume the regular dosing schedule
• if it has been more than 2 days since your schedule dose, skip the missed dose and resume the regular dosing schedule.

What SIDE EFFECTS can this medicine cause?

Rusfertide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, itching, pain and swelling at site of injection
• shortness of breath

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• confusion; changes in speech; headache; seizures; pain, stiffness, or numbness in one or both arms, back, neck, jaw or abdomen; shortness of breath; nausea; weakness; chest pain
• nosebleeds; unusual bruising; bleeding from mouth or gums; blood in the stool
• shortness of breath; pale skin; weakness; tiredness; headache; dizziness; fainting

Rusfertide injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to rusfertide injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking rusfertide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2026.