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Note: This document contains side effect information about midostaurin. Some of the dosage forms listed on this page may not apply to the brand name Rydapt.
Applies to midostaurin: oral capsule liquid filled
Along with its needed effects, midostaurin (the active ingredient contained in Rydapt) 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 immediately if any of the following side effects occur while taking midostaurin:
Incidence not known
Some side effects of midostaurin 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:
Applies to midostaurin: oral capsule
Acute Myeloid Leukemia (AML):
-The most common laboratory abnormalities (incidence 10% or more and 2% or more frequent than placebo) were hypocalcemia, increased ALT, and hypernatremia.
-The most frequent adverse reactions (incidence 20% or greater) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, and upper respiratory tract infections.
Systemic Mastocytosis/Mantle Cell Leukemia:
-The most common laboratory abnormalities (incidence 49% or more) were hyperglycemia, lymphopenia, leukopenia, anemia, thrombocytopenia, and neutropenia.
-The most frequent adverse reactions (incidence 20% or greater) were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea.
Very common (10% or more): Nausea (83%), vomiting (68%), mucositis/stomatitis (66%), diarrhea/gastroenteritis/colitis (54%), increased lipase (37%), abdominal pain (34%), constipation (29%), increased amylase (20%), hemorrhoids (15%), gastrointestinal/hemorrhoidal/duodenal ulcer hemorrhage (14%)
Common (1% to 10%): Dyspepsia, gastritis
Very common (10% or more): Febrile neutropenia (83%), lymphopenia (66%), leukopenia (61%), anemia (60%), thrombocytopenia (50%), neutropenia (49%), prolonged activated partial thromboplastin time (13%)
Very common (10% or more): Hyperglycemia (80%)
Very common (10% or more): Hypocalcemia (74%), hypernatremia (34%), hypoalbuminemia (27%), hypokalemia (25%), hyperkalemia (23%), hypophosphatemia (22%), hypomagnesemia (20%)
Common (1% to 10%): Increased weight, hypercalcemia
Very common (10% or more): Increased ALT (71%), increased alkaline phosphate (39%), increased GGT (35%), increased AST (32%), hyperbilirubinemia (29%)
Very common (10% or more): Headache (46%), dizziness (13%)
Common (1% to 10%): Tremor, vertigo
Very common (10% or more): Edema/peripheral edema (40%), fatigue/asthenia (34%), pyrexia (27%), device-related infection (24%)
Common (1% to 10%): Chills, sepsis (staphylococcal/enterobacter/escherichia), fungal infection (bronchopulmonary aspergillosis, pneumonia fungal, splenic fungal, hepatic candidiasis)
Very common (10% or more): Hyperuricemia (37%), urinary tract infection/cystitis (16%)
Very common (10% or more): Petechiae (36%), rash/maculo-papular rash/erythema multiforme (14%), hyperhidrosis (14%)
Common (1% to 10%): Cellulitis or erysipelas, dry skin, contusion
Very common (10% or more): Musculoskeletal/back/bone/extremity pain (35%), arthralgia (19%)
Very common (10% or more): Upper respiratory tract infection/nasopharyngitis/sinusitis (30%), epistaxis (28%), dyspnea/bronchospasm/respiratory failure (23%), cough (18%), pleural effusion (13%), pneumonia/lung infection (10%)
Common (1% to 10%): Bronchitis, oropharyngeal pain, interstitial lung disease or pneumonitis, pulmonary edema/congestion
Very common (10% or more): Increased creatinine (25%), renal insufficiency/failure (12%)
Very common (10% or more): Insomnia (12%)
Common (1% to 10%): Disturbance in attention, mental status changes
Very common (10% or more): Prolonged QT (11%)
Common (1% to 10%): Hypertension, hypotension, pericardial effusion, thrombosis, hematoma, cardiac failure, myocardial infarction or ischemia, angina pectoris
Very common (10% or more): Herpes virus infection (10%)
Common (1% to 10%): Hypersensitivity reaction, anaphylactic shock
Common (1% to 10%): Eyelid edema