Zuellig Pharma
Concise Prescribing Info
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 positive. Advanced systemic mastocytosis (advanced SM) in adult patients.
Dosage/Direction for Use
AML 50 mg bid (approx 12-hr intervals) on days 8-21 of induction & consolidation chemotherapy cycles & then bid as single agent maintenance for 12 mth. Patients w/ Grade 4 neutropenia (ANC <0.5 x 109/L) Interrupt treatment until ANC ≥1 x 109/L, then resume Rydapt at 50 mg bid. Advanced SM Initially 100 mg bid. Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. Patients w/ ANC <1 x 109/L who did not have severe neutropenia at baseline Interrupt Rydapt until ANC ≥1.5 x 109/L, then resume at 50 mg bid, & if tolerated, gradually increase to 100 mg bid. Patients w/ Grade 3/4 nausea &/or vomiting despite optimal anti-emetic therapy Interrupt treatment for 3 days (6 doses), then resume Rydapt at 50 mg bid & if tolerated gradually increase to 100 mg bid.
Should be taken with food: Swallow whole w/ a glass of water, do not open/chew/crush.
Special Precautions
Risk of neutropenia; monitor WBCs at initiation of treatment & regularly thereafter; for signs & symptoms of infection; patients at risk of cardiac dysfunction; pulmonary symptoms indicative of interstitial lung disease. Severe hepatic & renal impairment. Females of reproductive potential should use effective contraception & discontinue breastfeeding during treatment & for at least 4 mth after stopping treatment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Device-related infection; febrile neutropenia, petechiae, lymphopenia; hypersensitivity; insomnia; headache; hypotension; epistaxis; laryngeal pain; dyspnoea; nausea; vomiting; stomatitis; upper abdominal pain; haemorrhoids; dermatitis exfoliative; hyperhidrosis; back pain; arthralgia; pyrexia; hyperglycaemia; prolonged activated partial thromboplastin time; decreased absolute neutrophils, Hb, AST & ALT; hypokalemia, hypernatraemia; UTI, upper resp tract infection; dizziness; cough, pleural effusion; diarrhoea, constipation; peripheral oedema, fatigue; increased glucose, AST & ALT, total bilirubin, amylase, lipase; decreased lymphocyte.
Drug Interactions
Decreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine, rifampin, St. John's wort). Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, clarithromycin & nefazodone). Drugs w/ narrow therapeutic range that are substrates of CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or OATP1B1.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX10 - midostaurin ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Rydapt softcap 25 mg
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