romiplostim

What is the most important information I should know about romiplostim?

Using romiplostim may increase your risk of developing blood cancers, especially if you have a myelodysplastic syndrome (sometimes called "preleukemia").

You will need frequent blood tests and your treatment with romiplostim may be delayed or stopped based on the results.

What is romiplostim?

Romiplostim is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Romiplostim is for use in adults and children who are at least 1 year old.

Romiplostim is usually given after other treatments have failed.

Romiplostim may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving romiplostim?

Using romiplostim may increase your risk of developing blood cancers, especially if you have a myelodysplastic syndrome (bone marrow failure disorder, sometimes called "preleukemia"). Talk with your doctor if you have concerns about this risk.

Tell your doctor if you have ever had:

• blood or bone marrow cancer such as leukemia, or myelodysplastic syndrome;
• bleeding problems or a blood clot;
• surgery to remove your spleen; or
• liver disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of romiplostim on the baby.

How is romiplostim given?

Romiplostim is injected under the skin, usually once per week. A healthcare provider will give you this injection.

It may take up to 4 weeks of before romiplostim is completely effective in preventing bleeding episodes. Keep receiving the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. You will need frequent blood tests. Your treatment with romiplostim may be delayed or permanently discontinued based on the results.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving romiplostim?

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What are the possible side effects of romiplostim?

• severe or ongoing diarrhea;
• purple or red spots under your skin;
• signs of an ear infection (more common in children) --fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg --swelling, warmth, or redness in an arm or leg.

Common side effects may include:

• bruising;
• headache;
• dizziness;
• joint pain, muscle weakness or tenderness;
• pain in your arms, legs, or shoulder;
• numbness or tingling in your hands or feet;
• trouble sleeping;
• stomach pain, indigestion, nausea, vomiting, diarrhea;
• cough, wheezing, chest tightness, trouble breathing;
• stuffy nose, sneezing, sinus pain; or
• pain in your mouth and throat.

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.

What other drugs will affect romiplostim?

Other drugs may affect romiplostim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about romiplostim.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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