RYDAPT (midostaurin)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Congenital long QT syndrome
Interstitial lung disease
Pregnancy

There are 0 moderate contraindications.

There are 27 severe adverse reactions.

More Frequent

Less Frequent

Anemia Hypocalcemia Infection Neutropenic disorder Thrombocytopenic disorder

Acute myocardial infarction Fungal infection Gastritis Gastrointestinal hemorrhage Herpes zoster Hypersensitivity drug reaction Hypertension Hypotension Interstitial lung disease Interstitial pneumonitis Kidney disease with reduction in glomerular filtration rate (GFr) Opportunistic fungal infection Pericardial effusion Pleural effusions Prolonged QT interval Pulmonary edema Sepsis Thrombotic disorder Tumor lysis syndrome

Rare/Very Rare
Anaphylaxis Pulmonary congestion Sweet's syndrome

There are 36 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Constipation Diarrhea Dyspnea Edema Elevated serum lipase Epistaxis Fatigue Fever Headache disorder Hyperglycemia Lymphopenia Musculoskeletal pain Nausea Petechiae Stomatitis Upper respiratory infection Vomiting	Arthralgia Cellulitis Chills Disturbance of attention Dry skin Dyspepsia Eyelid edema Heart failure Hematoma Hemorrhoids Herpes simplex infection Hypercalcemia Hyperhidrosis Insomnia Pain in oropharynx Tremor Vertigo Weight gain

Rare/Very Rare
None.

Midostaurin may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. Females who may have been exposed to midostaurin during pregnancy directly or through a male partner while receiving midostaurin should report the exposure to Novartis' pregnancy exposure registry at 1-888-669-6682. Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating treatment.

Midostaurin and its metabolites are distributed into milk in rats; it is not known whether the drug or its metabolites are distributed into milk in humans. Because of the potential for serious adverse reactions to midostaurin in nursing infants, women should be advised to discontinue nursing during midostaurin therapy. Women may begin nursing 4 months after discontinuance of therapy. The effects of the drug on nursing infants or on milk production are unknown.

The manufacturer makes no special population dosage recommendations at this time. In phase 3 clinical trials evaluating midostaurin in patients with advanced systemic mastocytosis, 45% of patients were 65 years of age or older, while 11% were 75 years of age or older. No overall differences in safety and efficacy were observed between geriatric patients and younger adults, but greater sensitivity in some older patients cannot be ruled out.

Clinical studies evaluating midostaurin in patients with AML did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults. The manufacturer states that midostaurin should be used with caution in geriatric patients, considering the patient's eligibility for concomitant chemotherapy and the greater frequency of concomitant disease and drug therapy observed in this age group.