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 solution
Along with its needed effects, romiplostim may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking romiplostim:Rare
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty with breathing
- pain in the chest, groin, or legs, especially the calves
- pinpoint red spots on the skin
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- unusual bleeding or bruising
- vision changes
Some side effects of romiplostim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- difficulty with moving
- muscle aching or cramping
- muscle pains or stiffness
- pain in the arms or legs
- pain in the joints
- pain in the shoulder
- stomach discomfort, upset, or pain
- swollen joints
- trouble sleeping
- unable to sleep
For Healthcare Professionals
Applies to romiplostim: subcutaneous powder for injection
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 side effects including arthralgia (26%) and myalgia (14%) have been reported.
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.
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 postmarketing reports have included hypersensitivity and angioedema.
Cardiovascular postmarketing reports have included erythromelalgia.
More romiplostim resources
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