Medication Guide App

Romiplostim Side Effects

It is possible that some side effects of romiplostim may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to romiplostim: subcutaneous powder for solution

As well as its needed effects, romiplostim may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking romiplostim, check with your doctor or nurse immediately:

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 romiplostim side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • difficulty with moving
  • dizziness
  • headache
  • heartburn
  • indigestion
  • 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

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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