Romiplostim

Romiplostim is a prescription medication used to treat low blood platelet counts in patients with chronic immune thrombocytopenia (ITP). Romiplostim belongs to a group of drugs called thrombopoietin receptor agonists, which work by causing bone marrow to increase platelet production.

This medication comes in an injectable form to be given just under the skin by a healthcare provider. It is usually given once a week.

Common side effects of romiplostim include headache, joint pain, and dizziness.

Romiplostim is a prescription medication used to increase the number of blood platelets in adults with chronic immune thrombocytopenia (ITP), a long-term condition of abnormally low blood platelet counts that may cause bruising or bleeding.

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

Romiplostim may be found in some form under the following brand names:

• Nplate

Romiplostim may cause serious side effects. See "Romiplostim Precautions".

The most common side effects of romiplostim are:

• Headache
• Joint pain
• Dizziness
• Trouble sleeping
• Muscle tenderness or weakness
• Pain in arms and legs
• Abdominal pain
• Shoulder pain
• Indigestion
• Tingling or numbness in hands and feet

These are not all the possible side effects of romiplostim. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436).

No romiplostim drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Romiplostim can cause serious side effects:

• Worsening of a precancerous blood condition to a blood cancer (leukemia). Romiplostim is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS) or for any condition other than chronic (lasting a long time) immune thrombocytopenia (ITP). If you have MDS and receive romiplostim, your MDS condition may worsen and become an acute leukemia. If MDS worsens to become acute leukemia you may die sooner from the acute leukemia.

• Higher risk for blood clots.
  • You may have a higher risk of getting a blood clot if your platelet count becomes high during treatment with romiplostim. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts and change your dose or stop romiplostim if your platelet counts get high.
  • If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.
• Bone marrow changes (increased reticulin and possible bone marrow fibrosis). Romiplostim may cause changes in your bone marrow, but these changes may improve if you stop taking romiplostim. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin." It is not known if this may progress to a more severe form called "fibrosis." The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking romiplostim.

• Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping romiplostim. When you stop receiving romiplostim, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving romiplostim. These effects are most likely to happen shortly after stopping romiplostim and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking romiplostim. Call your healthcare provider right away to report any bruising or bleeding.

When you are being treated with romiplostim, your healthcare provider will closely monitor your romiplostim dose and blood tests, including platelet counts.

• Injection of too much romiplostim may cause a dangerous increase in your blood platelet count and serious side effects.

• During romiplostim therapy, your healthcare provider may change your romiplostim dose, depending upon the change in your blood platelet count. You must have blood platelet counts done before you start romiplostim, during romiplostim therapy, and after romiplostim therapy is stopped.
• Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of romiplostim. You should arrange for your next dose as soon as possible and call your healthcare provider.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of romiplostim there are no specific foods that you must exclude from your diet when receiving romiplostim.

Tell your healthcare provider about all your medical conditions, including if you:

• Have had surgery to remove your spleen (splenectomy).
• Have a bone marrow problem, including a blood cancer or MDS.
• Have or had a blood clot.
• Have chronic liver disease.
• Have bleeding problems.
• Have any other medical condition.
• Are pregnant, or plan to become pregnant. It is not known if romiplostim will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if romiplostim passes into your breast milk. You and your healthcare provider should decide whether you will take romiplostim or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products.

Tell your healthcare provider if you are pregnant, or plan to become pregnant. It is not known if romiplostim will harm your unborn baby.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with romiplostim. If you become pregnant, consider this registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the registry for you. You or your healthcare provider can get information and enroll in the registry by calling 1-800-77-AMGEN (1-800-772-6436).

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if romiplostim passes into your breast milk. You and your healthcare provider should decide whether you will take romiplostim or breastfeed. You should not do both.

Romiplostim is given as a subcutaneous (SC) injection under the skin one time each week. You may not give romiplostim injections to yourself.

Your healthcare provider will check your platelet count every week and change your dose of romiplostim as needed. This will continue until your healthcare provider decides that your dose of romiplostim can stay the same. After that, you will need to have blood tests every month. When you stop receiving romiplostim, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.

Tell your healthcare provider about any bruising or bleeding that occurs while you are receiving romiplostim.

If you miss a scheduled dose of romiplostim, call your healthcare provider to arrange for your next dose as soon as possible.

Avoid situations that may increase your risk of bleeding, such as missing a scheduled dose of romiplostim. You should arrange for your next dose as soon as possible and call your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Starting dose is 1 mcg/kg once weekly as a subcutaneous (under the skin) injection.

Your dose may be adjusted on a weekly basis to achieve optimal dosing.

The maximum weekly dose is 10 mcg/kg.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments.