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Rydapt Side Effects

Generic Name: midostaurin

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.

For the Consumer

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:

More common

  • Black, tarry stools
  • bloody urine
  • body aches or pain
  • chest pain
  • cough
  • decreased frequency or amount of urine
  • dizziness
  • ear congestion
  • fever or chills
  • headache
  • increased thirst
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • painful or difficult urination
  • pale skin
  • runny nose
  • sneezing
  • sore throat
  • swelling of the face, fingers, or lower legs
  • tightness in the chest
  • troubled breathing
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Incidence not known

  • Chills
  • general feeling of discomfort or illness
  • thickening of bronchial secretions

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:

More common

  • Abdominal or stomach pain
  • bloody nose
  • blurred vision
  • cracked lips
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • difficulty with swallowing
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urination
  • joint or muscle pain
  • muscle stiffness
  • small red or purple spots on the skin
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • sweating
  • trouble sleeping
  • unexplained weight loss

For Healthcare Professionals

Applies to midostaurin: oral capsule

General

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.[Ref]

Gastrointestinal

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[Ref]

Hematologic

Very common (10% or more): Febrile neutropenia (83%), lymphopenia (66%), leukopenia (61%), anemia (60%), thrombocytopenia (50%), neutropenia (49%), prolonged activated partial thromboplastin time (13%)[Ref]

Endocrine

Very common (10% or more): Hyperglycemia (80%)[Ref]

Metabolic

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[Ref]

Hepatic

Very common (10% or more): Increased ALT (71%), increased alkaline phosphate (39%), increased GGT (35%), increased AST (32%), hyperbilirubinemia (29%)[Ref]

Nervous system

Very common (10% or more): Headache (46%), dizziness (13%)
Common (1% to 10%): Tremor, vertigo[Ref]

Other

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)[Ref]

Genitourinary

Very common (10% or more): Hyperuricemia (37%), urinary tract infection/cystitis (16%)[Ref]

Dermatologic

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[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal/back/bone/extremity pain (35%), arthralgia (19%)[Ref]

Respiratory

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[Ref]

Renal

Very common (10% or more): Increased creatinine (25%), renal insufficiency/failure (12%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (12%)
Common (1% to 10%): Disturbance in attention, mental status changes[Ref]

Cardiovascular

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[Ref]

Immunologic

Very common (10% or more): Herpes virus infection (10%)[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction, anaphylactic shock[Ref]

Ocular

Common (1% to 10%): Eyelid edema[Ref]

References

1. "Product Information. Rydapt (midostaurin)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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