Rydapt Capsules (Soft Gelatin)
Midostaurin
25mg
Novartis Pharma AG
| Pack size | 56's [28’s (7’s x 4 Blister) x 2] |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 37133.50 AED |
Available as:
Indications
Rydapt Capsules (Soft Gelatin) is used for:
Acute Myeloid Leukemia (AML),
Adult Dose
Child Dose
Renal Dose
Administration
Take with food twice daily at ~12-hr intervals
Administer prophylactic antiemetics before treatment to reduce the risk of nausea and vomiting
Contra Indications
Hypersensitivity; reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema (eg, swelling of the airways or tongue, with or without respiratory impairment)
Precautions
Cases of interstitial lung disease and pneumonitis, some fatal, reported with monotherapy or in combination with chemotherapy; monitor for pulmonary symptoms; discontinue if signs or symptoms of interstitial lung disease or pneumonitis occur without an infectious etiology
Based on its mechanism of action and findings from animal reproduction studies, midostaurin may cause fetal harm when administered to pregnant women
Pregnancy-Lactation
Pregnancy
Based on mechanism of action and findings in animal reproduction studies, may cause fetal harm when administered to pregnant women
Administration to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicities, including late embryo-fetal death and reduced fetal birth weight, with delays in fetal growth at doses lower than the recommended human dose
Pregnancy testing: Recommended for females of reproductive potential within 7 days before initiating midostaurin
Infertility: Based on findings in animals, midostaurin may impair fertility in females and males of reproductive potential
Contraception
Females: Drug may cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose
Males: Males with female sexual partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose
Lactation
Unknown if distributed in human breast milk
Orally administered midostaurin and its active metabolites pass into the milk of lactating rats within 1 hr of a 30-mg/kg/day dose, with approximately 5 times more in the milk of lactating rats compared with plasma
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for at least 4 months after the last dose
Interactions
Adverse Effects
Side effects of Midostaurin :
>10% (AML)
Nausea (83%)
Febrile neutropenia (83%)
Hypocalcemia (74%)
Increased ALT, all grades (71%)
Mucositis (66%)
Vomiting (61%)
Headache (46%)
Petechiae (36%)
Musculoskeletal pain (33%)
Epistaxis (28%)
Device-related infection (24%)
Hypernatremia (21%)
Upper respiratory tract infection (20%)
Hyperglycemia (20%)
Increased ALT, grades 3 and 4 (20%)
Hemorrhoids (15%)
Arthralgia (14%)
Hyperhidrosis (14%)
Prolonged aPTT (13%)
Renal insufficiency (12%)
Insomnia (12%)
>10% (SM)
Nausea (82%)
Hyperglycemia (80%)
Vomiting (68%)
Lymphopenia (66%)
Leukopenia (61%)
Anemia (60%)
Diarrhea (54%)
Thrombocytopenia (50%)
Neutropenia (49%)
Edema (40%)
Increased alkaline phosphatase (39%)
Hypocalcemia (39%)
Lipase increased (37%)
Hyperuricemia (37%)
Increased GGT (35%)
Musculoskeletal pain (35%)
Hyponatremia (34%)
Increased AST (32%)
Increased ALT (31%)
Fatigue (34%)
Abdominal pain (34%)
Upper respiratory tract infection (30%)
Hyperbilirubinemia (29%)
Hypoalbuminemia (27%)
Pyrexia (27%)
Constipation (29%)
Headache (26%)
Hypokalemia (25%)
Increased creatinine (25%)
Hyperkalemia (23%)
Dyspnea (23%)
Hypophosphatemia (22%)
Increased amylase (20%)
Hypomagnesemia (20%)
Arthralgia (19%)
Cough (18%)
Urinary tract infection (16%)
GI hemorrhage (14%)
Rash (14%)
Dizziness (13%)
Pleural effusion (13%)
Epistaxis (12%)
QT prolonged (11%)
Insomnia (11%)
Renal insufficiency (11%)
1-10% (AML)
Hyperuricemia (8%)
Hypertension (8%)
Cellulitis (7%)
Fungal infection (7%)
Dry skin (7%)
Weight increased (7%)
Pleural effusion (6%)
Thrombosis (5%)
Tremor (4%)
Pericardial effusion (4%)
Hypercalcemia (3%)
Eyelid edema (3%)
1-10% (SM)
Pneumonia (10%)
Herpes virus infection (10%)
Sepsis (9%)
Hypotension (9%)
Febrile neutropenia (8%)
Disturbance in attention (7%)
Tremor (6%)
Hematoma (6%)
Cardiac failure (6%)
Bronchitis (6%)
Dyspepsia (6%)
Weight increased (6%)
Contusion (6%)
Cellulitis or erysipelas (5%)
Vertigo (5%)
Chills (5%)
Oropharyngeal pain (4%)
Myocardial infarction or ischemia (4%)
Hypersensitivity (4%)
Mental status changes (4%)
Pulmonary edema (3%)
Gastritis (3%)
Interstitial lung disease or pneumonitis (2%)
Mechanism of Action
Inhibits multiple receptor tyrosine kinases
In vitro biochemical or cellular assays have shown that midostaurin or its major human active metabolites CGP62221 and CGP52421 inhibit the activity of wild type FLT3, FLT3 mutant kinases (ITD and TKD), KIT (wild type and D816V mutant), PDGFR-alpha/beta, VEGFR2, and members of the serine/threonine kinase PKC (protein kinase C) family
Midostaurin demonstrated the ability to inhibit FLT3 receptor signaling and cell proliferation, and it induced apoptosis in leukemic cells expressing ITD and TKD mutant FLT3 receptors or overexpressing wild type FLT3 and PDGF receptors
Midostaurin also demonstrated the ability to inhibit KIT signaling, cell proliferation, and histamine release and induce apoptosis in mast cells
Note
Rydapt 25mg Capsules (Soft Gelatin) manufactured by Novartis Pharma AG. Its generic name is Midostaurin. Rydapt is availble in United Arab Emirates.
Farmaco UAE drug index information on Rydapt Capsules (Soft Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.