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Midostaurin Side Effects

For the Consumer

Applies to midostaurin: oral capsule

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of skin infection like oozing, heat, swelling, redness, or pain.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Flushing.
  • Chest pain.
  • Pinpoint red spots on the skin.
  • Sweating a lot.
  • Swelling.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Not able to focus.
  • Shakiness.
  • Feeling very tired or weak.
  • Very bad and sometimes deadly lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Mouth irritation or mouth sores.
  • Headache.
  • Muscle or joint pain.
  • Bone pain.
  • Nosebleed.
  • Signs of a common cold.
  • Not able to sleep.
  • Dry skin.
  • Weight gain.
  • Hard stools (constipation).
  • Feeling tired or weak.
  • Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Some side effects of midostaurin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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