For the treatment of adult patients with newly diagnosed FLT3+ AML eligible for intensive chemotherapy
Important note: Before prescribing, consult full prescribing information of RYDAPT.
Presentation: Soft capsules containing 25 mg of midostaurin.
Indications: Rydapt® is indicated
Dosage and administration:
AML Adults: Recommended dose is 50 mg orally twice daily. Rydapt is dosed on days 8 to 21 of induction and consolidation chemotherapy, and then for patients in complete response twice daily as a single agent maintenance until relapse for 12 cycles of 28 days each.
Advanced SM Adults: Recommended dose is 100 mg twice daily.
Dose modifications: Management of adverse drug reactions (ADRs) may require treatment interruption, dose reduction or treatment discontinuation.
Contraindications: Patients with hypersensitivity to midostaurin or to any of the excipients. Concomitant administration of potent CYP3A4 inducers.
Warnings and precautions:
Pregnancy, lactation, females of reproductive potential:
Pregnancy: Rydapt can cause fetal harm. Pregnant women should be advised of the potential risk. Rydapt is not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation: Breast-feeding should be discontinued during treatment with Rydapt and for at least 4 months after stopping treatment.
Females of reproductive potential:
Infertility: May impair fertility.
Adverse drug reactions:
Very common (≥10%): Device related infections, febrile neutropenia, petechiae, lymphopenia, hypersensitivity, insomnia, headache, hypotension, epistaxis, laryngeal pain, dyspnoea, nausea, vomiting, stomatitis, abdominal pain upper, haemorrhoids, hyperhidrosis, exfoliative dermatitis, back pain, arthralgia, pyrexia, hyperglycaemia, activated partial thromboplastin time prolonged, absolute neutrophils decreased, haemoglobin decreased, aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, hypokalaemia, hypernatraemia.
Common (1 to 10%): Upper respiratory tract infection, hyperuricaemia, syncope, tremor, eyelid oedema, hypertension, sinus tachycardia, pericardial effusion, nasopharyngitis, pleural effusion, acute respiratory distress syndrome, anorectal discomfort, abdominal discomfort, dry skin, keratitis, neck pain, bone pain, pain in extremities, catheter-related thrombosis, weight increased, hypercalcaemia.
Uncommon (0.1 to 1%): Neutropenic sepsis.
Very common (≥10%): Nausea, vomiting, diarrhea, constipation, peripheral edema, fatigue, pyrexia, urinary tract infection, upper respiratory tract infection, headache, dizziness, dyspnea, cough, pleural effusion, epistaxis, glucose increased, absolute neutrophils decreased, absolute lymphocyte decreased, lipase increased, aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, total bilirubin increased, amylase increased.
Common (1 to 10%): Hypersensitivity, febrile neutropenia, dyspepsia, gastrointestinal hemorrhage, asthenia, chills, edema, pneumonia, sepsis, bronchitis, oral herpes, cystitis, sinusitis, erysipelas, herpes zoster, contusion, fall, weight increased, disturbance in attention, tremor, vertigo, oropharyngeal pain, hypotension, hematoma.
Uncommon (0.1 to 1%): Anaphylactic shock.
Packs and prices: Country-specific.
Legal classification: Country-specific.
This is an international site for RYDAPT® (midostaurin) and is intended for Healthcare Professionals outside the United States.
The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country. Please contact your local representative for local prescribing information via www.novartisoncology.com/about-novartis-oncology/contact-us.
IMPORTANT : The information on this website is based on the European Summary of Product Characteristics.
Below is a list of the countries that host a RYDAPT website based on local label and in local language. They are intended for Healthcare Professionals (HCPs) only. If you are an HCP from one of the countries listed below, click on your country link to be redirected to your country RYDAPT website.