Pronunciation: ROM i PLOS tim

Brand: Nplate

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").

Romiplostim may also increase your risk of a blood clot or stroke. Call your doctor right away if you have signs of a blood clot, such as sudden numbness or weakness on one side of the body, chest pain, problems with speech or balance, warmth or swelling in an arm or leg.

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 not a cure for ITP and it will not make your platelet counts normal if you have this condition.

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?

You should not use romiplostim if you are allergic to it.

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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

You should not breastfeed while using romiplostim.

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.

After you stop using romiplostim, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 2 weeks after you stop using romiplostim. Your blood will need to be tested weekly during this time.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your romiplostim injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • 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.

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