Romiplostim Side Effects

In Summary

Commonly reported side effects of romiplostim include: abdominal pain, dizziness, insomnia, limb pain, and myalgia. Other side effects include: dyspepsia, paresthesia, and shoulder pain. See below for a comprehensive list of adverse effects.

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:

• 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:

• 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

General

The most serious adverse reactions were increased bone marrow reticulin, thrombotic/thromboembolic complications, and progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML).^[Ref]

Hematologic

Very common (10% or more): Grade 2 or higher bleeding event (15%)
Common (1% to 10%): Bone marrow reticulin formation increased 2 grades or more, bone marrow collagen fibrosis increased to grade 4, grade 4 bone marrow collagen fibrosis, bone marrow disorder, thrombocytopenia, anemia, thrombocytosis, bone marrow reticulin deposition, anemia, reticulin increased, serious bleeding event
Uncommon (0.1% to 1%): Aplastic anemia, bone marrow failure, leukocytosis, splenomegaly, thrombocythemia, platelet count increased, platelet count abnormal, blood lactate dehydrogenase increased
Frequency not reported: Marrow fibrosis with collagen^[Ref]

Serious bleeding events included any event that was fatal, life-threatening, required hospitalization or prolongation of hospitalization, caused persistent or significant disability/incapacity, congenital anomaly/birth defect, and any other significant hazard.^[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, flushing, hematoma, hypertension, peripheral ischemia, peripheral embolism
Uncommon (0.1% to 1%): Myocardial infarction, heart rate increased, deep vein thrombosis, hypotension, phlebitis, thrombophlebitis superficial, thrombosis, erythromelalgia, blood pressure increased
Frequency not reported: Congestive heart failure^[Ref]

Oncologic

Common (1% to 10%): B-cell lymphoma
Uncommon (0.1% to 1%): Multiple myeloma, myelofibrosis
Frequency not reported: Progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML), blast cell counts transiently increased^[Ref]

Nervous system

Very common (10% or more): Headache (up to 36.2%), dizziness (up to 17%)
Common (1% to 10%): Paresthesia, migraine
Uncommon (0.1% to 1%): Clonus, dysgeusia, hypoesthesia, hypogeusia, neuropathy peripheral, transverse sinus thrombosis, vertigo^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 26.2%), epistaxis (22.6%), upper respiratory tract infection (18.2%), cough (up to 17.3%), oropharyngeal pain (12.2%)
Common (1% to 10%): Pulmonary embolism, sinusitis, bronchitis, dyspnea, nasal congestion, rhinorrhea
Uncommon (0.1% to 1%): Dry throat, painful respiration
Frequency not reported: Upper respiratory tract infection, pneumonia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 26%), back pain (up to 15.8%), pain in extremity (up to 15.6%), myalgia (up to 14%)
Common (1% to 10%): Shoulder pain, muscle spasms, bone pain, musculoskeletal pain
Uncommon (0.1% to 1%): Muscle tightness, muscle weakness, muscle twitching^[Ref]

Other

Very common (10% or more): Fatigue (up to 23.3%), contusion (up to 22.5%), pyrexia (up to 11.8%)
Common (1% to 10%): Influenza-like illness, pain, asthenia, chills, injection site reaction, chest pain
Uncommon (0.1% to 1%): Injection site hemorrhage, malaise, feeling hot, feeling jittery, body temperature increased^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 19.4%), diarrhea (up to 18.7%), abdominal pain (up to 11%), vomiting (up to 10.5%)
Common (1% to 10%): Dyspepsia, gastroenteritis, constipation, gingival bleeding, mouth hemorrhage, upper abdominal pain, toothache
Uncommon (0.1% to 1%): Rectal hemorrhage, breath odor, dysphagia, gastroesophageal reflux disease, hematochezia, stomach discomfort, stomatitis, tooth discoloration^[Ref]

Dermatologic

Very common (10% or more): Petechiae (18.6%), rash (up to 11.3%)
Common (1% to 10%): Angioedema, pruritus, ecchymosis
Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction, acne, dermatitis contact, dry skin, eczema, erythema, exfoliative rash, hair growth abnormal, prurigo, purpura, rash papular, rash pruritic, skin nodule, skin odor abnormal, urticaria, face edema^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 16%)
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Depression, abnormal dreams, irritability^[Ref]

Metabolic

Very common (10% or more): Peripheral edema (up to 12.5%)
Common (1% to 10%): Hypokalemia
Uncommon (0.1% to 1%): Alcohol intolerance, anorexia, appetite decreased, dehydration, gout, weight decreased, weight increased^[Ref]

Immunologic

Common (1% to 10%): Antibodies to this drug, preexisting antibodies to this drug, influenza
Uncommon (0.1% to 1%): Localized infection, neutralizing antibodies
Frequency not reported: Hypersensitivity^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Protein urine present, vaginal hemorrhage^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctival hemorrhage, accommodation disorder, blindness, eye disorder, eye pruritus, lacrimation increased, papilledema, visual disturbances^[Ref]

Hepatic

Uncommon (0.1% to 1%): Portal vein thrombosis, transaminase increased^[Ref]

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.

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