Romiplostim Side Effects

Some side effects of romiplostim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to romiplostim: subcutaneous powder for injection

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

Less serious side effects of romiplostim may include:

• headache;

• dizziness;

• joint or muscle pain;

• pain in your arms, legs, or shoulder;

• numbness or tingly feeling;

• sleep problems (insomnia); or

• stomach pain or upset.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to romiplostim: subcutaneous powder for injection

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.

Hypersensitivity

Hypersensitivity postmarketing reports have included hypersensitivity and angioedema.

Cardiovascular

Cardiovascular postmarketing reports have included erythromelalgia.

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