Romiplostim Side Effects

Brand Names: Nplate

Please note - some side effects for Romiplostim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Romiplostim - for the Consumer

Romiplostim

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Romiplostim:

Dizziness; headache; indigestion; joint pain; muscle tenderness or weakness; shoulder pain; stomach pain or upset; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blurred vision; chest pain; leg or arm pain; numbness or tingling of the hands and feet; one-sided weakness; severe or persistent dizziness or headache; unusual bruising or bleeding; unusual weakness or tiredness; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Headaches were usually of mild or moderate severity.

Nervous system side effects including headaches (35%), dizziness (17%), insomnia (16%), and paresthesia (6%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (26%) and myalgia (14%) have been reported.

Other

Other side effects have been extremity pain (13%), abdominal pain (11%), and shoulder pain (8%). Bone marrow reticulin deposition and worsening thrombocytopenia have been reported after romiplostim discontinuation.

Immunologic

In clinical studies, the incidence of preexisting antibodies to romiplostim was 8% and the incidence of binding antibody development during romiplostim treatment was 10%. The incidence of preexisting antibodies to endogenous TPO was 5% and the incidence of binding antibody development to endogenous TPO during romiplostim treatment was 5%. Of the patients with positive antibodies to romiplostim or to TPO, (0.4%) had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No correlation was observed between antibody activity and clinical effectiveness or safety.

Immunologic side effects for all therapeutic proteins include the development of antibodies to the therapeutic protein.

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