Rydapt Side Effects

Generic name: midostaurin

Medically reviewed by Drugs.com. Last updated on May 13, 2024.

Note: This document provides detailed information about Rydapt.

Applies to midostaurin: oral capsule liquid filled Side Effects associated with midostaurin. Some dosage forms listed on this page may not apply specifically to the brand name Rydapt.

Applies to midostaurin: oral capsule liquid filled.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant within 7 days before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for 4 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor if you have chest pain, chills, cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing. These may be symptoms of a serious lung problem.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Rydapt

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:

Other side effects of Rydapt

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:

For healthcare professionals

Applies to midostaurin: oral capsule.

General adverse events

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%), pneumonitis (11%)
• Common (1% to 10%): Bronchitis, oropharyngeal pain, interstitial lung disease, 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]

See also:

Frequently asked questions

• What is Rydapt used to treat?

Further information

Rydapt side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer