Romiplostim

Generic name: Romiplostim
Brand names: Nplate
Dosage form: subcutaneous injection
Drug class: Platelet-stimulating agents

Usage of Romiplostim

Romiplostim belongs to a class of drugs called TPO (thrombopoietin) peptide mimetics. These drugs help your body to make more platelets, which are cells that help your blood to clot.

Romiplostim works by mimicking the action of your own natural TPO, which is a hormone produced by your liver and kidneys that regulates how many platelets you produce. Romiplostim binds to and activates the same receptors that your own endogenous TPO uses to increase platelet production. It is a TPO receptor agonist.

Romiplostim is a peptibody, which is a peptide fused to an antibody. It was the first fully engineered peptibody designed to stimulate platelet production and was approved by the US Food and Drug Administration (FDA) in 2008.

Romiplostim side effects

Romiplostim may cause serious side effects.

See “Important information” above.

The most common side effects of romiplostim in adults include:

headache

tingling or numbness in hands and feet

joint pain

bronchitis

dizziness

inflammation of the sinuses (sinusitis)

trouble sleeping

vomiting

muscle tenderness or weakness

pain in the arms and legs

stomach (abdomen) pain

shoulder pain

indigestion

diarrhea

upper respiratory tract infection

cough

nausea

pain in mouth and throat (oropharyngeal pain)

The most common side effects of romiplostim in children 1 year of age and older include:

bruising

upper respiratory tract infection

pain in mouth and throat (oropharyngeal pain)

People who take romiplostim may have an increased risk of developing new or worsening changes in the bone marrow called “increased reticulin”. These changes may improve if you stop taking romiplostim. Your healthcare provider may need to check your bone marrow for this problem during treatment with romiplostim.

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).

Before taking Romiplostim

Tell your doctor if you are pregnant or plan to become pregnant. Romiplostim may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with romiplostim.

Tell your doctor if you are breastfeeding or plan to breastfeed. Romiplostim may pass into your breast milk and harm your baby. Do not breastfeed during treatment with romiplostim.

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How to use Romiplostim

In patients with ITP the recommended initial dose of romiplostim is 1 mcg/kg once weekly as a suBCutaneous injection. The dose should be adjusted based on platelet response.

In patients acutely exposed to myelosuppressive doses of radiation the recommended dose of romiplostim is 10 mcg/kg administered once as a subcutaneous injection. The dose should be administered as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation.

See Full Prescribing Information for instructions on reconstitution, preparation, and administration.

Warnings

Romiplostim can cause serious side effects, including:

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 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.

If you have a chronic liver disease, you may get blood clots in the veins of your liver. This may affect your liver function.

Injection of too much romiplostim may cause a dangerous increase in your blood platelet count and serious side effects. Your healthcare provider may change your dose or stop romiplostim depending upon the change in your blood platelet count. You must have blood platelet counts done before you start, during, and after romiplostim therapy is stopped (see “How should I receive romiplostim?” below).

See “What are the side effects of romiplostim?” below for other side effects of romiplostim.

What other drugs will affect Romiplostim

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

Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a new medicine.

Disclaimer

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