romiplostim

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is romiplostim?

Romiplostim is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

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 usually given after other medications have been tried without successful treatment of symptoms.

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

What should I discuss with my health care 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.

To make sure romiplostim is safe for you, tell your doctor if you have:

• blood or bone marrow cancer such as leukemia, or myelodysplastic syndrome;
• liver disease; or
• a history of bleeding problems or a blood clot.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any 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.

While using romiplostim, you will need frequent blood tests.

Using romiplostim long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders. To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often.

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

What happens if I miss a dose?

What happens if I overdose?

Overdose can cause signs of a blood clot, including sudden numbness or weakness, problems with vision or speech, chest pain, or pain and swelling in one or both legs.

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?

• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• 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 --pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• headache;
• dizziness;
• muscle or joint pain;
• pain in your arms, legs, or shoulder;
• numbness or tingly feeling;
• sleep problems (insomnia); or
• stomach pain or indigestion.

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 interact with romiplostim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about romiplostim.