Note: This document contains side effect information about romiplostim. Some dosage forms listed on this page may not apply to the brand name Nplate.
Summary
Common side effects of Nplate include: abdominal pain, dizziness, insomnia, limb pain, and myalgia. Other side effects include: dyspepsia, paresthesia, and shoulder pain. Continue reading for a comprehensive list of adverse effects.
Applies to romiplostim: parenteral powder for injection.
Side effects include:
Most common adverse reactions in adults receiving romiplostim (the active ingredient contained in Nplate) in clinical studies (≥5% higher patient incidence than placebo) were arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia.
Most common adverse reactions in pediatric patients receiving romiplostim in clinical studies (≥25%) were contusion, upper respiratory tract infection, and oropharyngeal pain.
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
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]
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]
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): Upper respiratory tract infection (up to 31%), nasopharyngitis (up to 26.2%), oropharyngeal pain (up to 25%), epistaxis (22.6%), cough (up to 17.3%)
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): Contusion (up to 41%), pyrexia (up to 24%), fatigue (up to 23.3%)
Common (1% to 10%): Influenza-like illness, pain, asthenia, chills, injection site reaction, chest pain, peripheral swelling
Uncommon (0.1% to 1%): Injection site hemorrhage, malaise, feeling hot, feeling jittery, body temperature increased[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (up to 20%), nausea (up to 19.4%), upper abdominal pain (14%), 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 15%)
Common (1% to 10%): Angioedema, pruritus, ecchymosis, purpura, urticaria
Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction, acne, dermatitis contact, dry skin, eczema, erythema, exfoliative rash, hair growth abnormal, prurigo, rash papular, rash pruritic, skin nodule, skin odor abnormal, 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
Very common (10% or more): Antibodies to this drug (up to 16%)
Common (1% to 10%): Preexisting antibodies to this drug, influenza, ear infection
Uncommon (0.1% to 1%): Localized infection, neutralizing antibodies
Frequency not reported: Hypersensitivity reactions including angioedema and anaphylaxis (postmarketing reports)[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]
