Romiplostim, Injection

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KEY POINTS

• This medicine is given by injection to treat thrombocytopenia in people with chronic immune (idiopathic) thrombocytopenic purpura.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause blood clotting problems or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: thrombopoietin receptor agonist; colony stimulating factor

Generic and brand names: romiplostim, injection; Nplate

What is this medicine used for?

This medicine is given by injection (shots) to treat thrombocytopenia (too few platelets in your blood) in people with chronic immune (idiopathic) thrombocytopenic purpura (ITP). This medicine is usually given when other medicines have not worked well enough.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A stroke or transient ischemic attack (TIA)
• Blood clots or bleeding problems
• Bone marrow problems, including myelodysplastic syndrome (MDS) or blood cancer
• Kidney or liver problems
• Surgery to remove your spleen

Tell your healthcare provider all prescription and nonprescription medicines you take. Tell your healthcare provider if you take medicine to prevent or treat blood clots such as warfarin (Coumadin) or clopidogrel (Plavix).

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that when you start this medicine and each time you get an injection.

This medicine is given by a healthcare provider once a week as an injection (shot) just under the skin. Your healthcare provider will adjust the dose of this medicine based upon your blood platelet count.

What if I miss a dose?

If you miss a dose, contact your healthcare provider as soon as possible.

What should I watch out for?

You will need blood tests while you receive the medicine and for at least 2 weeks after you stop receiving this medicine. Keep all appointments for these tests.

You may have blood clotting problems while taking this medicine, or after you stop taking it. Contact your healthcare provider right away if you have:

• Any unusual bruising or bleeding (bleeding gum, nosebleed, blood in urine or bowel movements)
• Shortness of breath and chest pain
• Swelling, pain, or tenderness in your leg

This medicine may worsen blood cancer or cause changes in your bone marrow. Talk with your provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Shortness of breath that gets worse; chest pain; pain, warmth, or swelling in your leg; confusion, blurred vision or eye pain; unusual bruising or bleeding, blood in the urine, or bloody bowel movements; unusual tiredness.

Other: Joint or muscle pain, headache, tingling or numbness in hands or feet, dizziness, trouble sleeping, heartburn, stomach pain, itching or swelling at injection site.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.