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Rydapt

Rydapt

midostaurin

Manufacturer:

Novartis

Distributor:

DKSH
/
Four Star
Concise Prescribing Info
Contents
Midostaurin
Indications/Uses
In combination w/ standard daunorubicin & cytarabine induction & high-dose cytarabine consolidation chemotherapy, & for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients w/ newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation +ve. As monotherapy for treatment of adult patients w/ aggressive systemic mastocytosis (ASM), systemic mastocytosis w/ associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
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Dosage/Direction for Use
AML 50 mg bd (approx 12-hr intervals) dosed on days 8-21 of induction & consolidation chemotherapy cycles. For patients in complete response, dosing is every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each. ASM, SM-AHN & MCL 100 mg bd. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
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Overdosage
View Rydapt overdosage for action to be taken in the event of an overdose.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Concomitant use w/ potent CYP3A4 inducers [eg, rifampicin, St. John's Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin].
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Special Precautions
Risk of neutropenia & infections; interstitial lung disease (ILD) & pneumonitis; cardiac dysfunction eg, CHF & transient decreases in left ventricular ejection fraction; increased frequency of QTc prolongation. Regularly monitor WBC especially at treatment initiation. Monitor patients for signs & symptoms of infection. Concomitant use w/ strong CYP3A4 inhibitors eg, antifungals (eg, ketoconazole), certain antivirals (eg, ritonavir), macrolide antibiotics (eg, clarithromycin) & nefazodone. Contains macrogolglycerol hydroxystearate & approx 14 vol % ethanol anhydrous. Minor influence on the ability to drive & use machines. Severe hepatic & severe renal impairment. Females of reproductive potential should use effective contraception during treatment & for at least 4 mth after stopping treatment. Pregnancy & lactation. Childn <18 yr. Not recommended for use in patients w/ acute promyelocytic leukaemia.
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Adverse Reactions
Headache; epistaxis; dyspnoea; nausea, vomiting; pyrexia; decreased ANC, increased ALT & AST, hyperglycaemia. AML: Device-related infection; febrile neutropenia, petechiae, lymphopenia; hypersensitivity; insomnia; hypotension; laryngeal pain; stomatitis, upper abdominal pain, haemorrhoids; exfoliative dermatitis, hyperhidrosis; back pain, arthralgia; decreased Hb, hypokalaemia, hypernatraemia, prolonged activated partial thromboplastin time. ASM, SM-AHN & MCL: UTI, upper resp tract infection; dizziness; cough, pleural effusion; diarrhoea, constipation; peripheral oedema, fatigue; decreased absolute lymphocyte, increased total bilirubin, increased amylase.
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Drug Interactions
Decreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine, rifampicin, enzalutamide, phenytoin, St. John's Wort [Hypericum perforatum]). Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole). Medicinal products w/ narrow therapeutic range that are substrates of CYP1A2 (eg, tizanidine), CYP2D6 (eg, codeine), CYP2C8 (eg, paclitaxel), CYP2C9 (eg, warfarin), CYP2C19 (eg, omeprazole), CYP2E1 (eg, chlorzoxazone), CYP3A4/5 (eg, tacrolimus), CYP2B6 (eg, efavirenz), P-gp (eg, paclitaxel), BCRP (eg, atorvastatin) or OATP1B1 (eg, digoxin) may need dose adjustment to maintain optimal exposure when given concomitantly w/ midostaurin. Increased absroption (AUC) & reduced peak conc (Cmax) w/ standard & high-fat meal.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Rydapt detailed prescribing information
Storage
View Rydapt storage conditions for details to ensure optimal shelf-life.
Description
View Rydapt description for details of the chemical structure and excipients (inactive components).
Action
View Rydapt mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX10 - midostaurin ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Rydapt cap 25 mg
Packing/Price
56's
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