Capmaxen Tablet
Capmatinib
200 mg
Everest Pharmaceuticals Ltd.
| Pack size | 28's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1,500.00 AED |
Indications
Capmaxen Tablet is used for:
Non-Small Cell Lung Cancer
Adult Dose
Oral
Non-Small Cell Lung Cancer
Indicated for metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping
400 mg PO BID
Continue until disease progression or unacceptable toxicity
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary
Severe (CrCl 15 to <30 mL/min): Not studied
Administration
May take with or without food
Swallow tablets whole; do not break, crush, or chew
Contra Indications
Precautions
Hepatotoxicity occurred; monitor liver function tests (including ALT, AST, and total bilirubin) before initiation, every 2 weeks during the first 3 months of treatment, and then once monthly or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin
ILD/pneumonitis, which can be fatal, occurred during clinical trials; monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis
Elevations in amylase and lipase levels occurred in patients receiving therapy; monitor amylase and lipase at baseline and regularly during treatment; based on severity of adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue therapy
Serious hypersensitivity reactions reported with use; signs and symptoms of hypersensitivity included pyrexia, chills, pruritus, rash, decreased blood pressure, nausea, and vomiting; based on severity of adverse reaction, temporarily withhold or permanently discontinue therapy
May cause photosensitivity reactions; advise patients to limit direct ultraviolet exposure; limit direct ultraviolet exposure by using sunscreen or protective clothing during treatment
Fetal harm may occur
Pregnancy-Lactation
Pregnancy
Based on animal studies and its mechanism of action, fetal harm may occur when administered to pregnant females
No available data on use in pregnant females
Verify pregnancy status for females of reproductive potential before starting treatment
Contraception
Females of reproductive potential: Use effective contraception during treatment and for 1 week after final dose
Males with female partners of reproductive potential: Use effective contraception during treatment and for 1 week after final dose
Animal data
Oral administration to pregnant rats and rabbits during organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg BID clinical dose
Lactation
No data available on the presence of capmatinib or its metabolites in either human or animal milk or its effects on breastfeeding, or on milk production
Advise females not to breastfeed during treatment and for 1 week after final dose
Interactions
Capmatinib is a CYP3A4 substrate and inhibits CYP1A2, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), MATE 1, and MATE2K
Strong CYP3A Inhibitors
Coadministration with a strong CYP3A inhibitor increased capmatinib exposure, which may increase the incidence and severity of adverse reactions of capmatinib
Closely monitor for adverse reactions
Strong and moderate CYP3A inducers
Avoid coadministration
Concomitant use with capmatinib a strong or moderate CYP3A inducer decreased capmatinib exposure and efficacy
Substrates of CYP1A2, P-gp, BCRP, MATE1 or MATE2K
Coadministration with CYP1A2, P-gp, BCRP, MATE1 or MATE2K substrates increased the exposure and adverse reactions of these substrates
If coadministration unavoidable, reduce dose of CYP1A2, P-gp, BCRP, MATE1 or MATE2K substrate in accordance with the approved prescribing information
Contraindicated (0)
Serious (21)
amobarbital
apalutamide
bosentan
carbamazepine
conivaptan
dabrafenib
efavirenz
enzalutamide
etrasimod
fosphenytoin
lorlatinib
mifepristone
mitotane
nafcillin
phenobarbital
phenytoin
primidone
rifabutin
rifampin
rifapentine
ritonavir
Adverse Effects
Side effects of Capmatinib :
>10%
All grades
Decreased albumin (68%)
Increased creatinine (62%)
Peripheral edema (52%)
Nausea (44%)
Decreased lymphocytes (44%)
Increased ALT (37%)
Increased alkaline phosphatase (32%)
Fatigue (32%)
Increased amylase (31%)
Increased gamma-glutamyltransferase (GGT) (29%)
Vomiting (28%)
Increased lipase (26%)
Increased AST (25%)
Dyspnea (24%)
Decreased hemoglobin (24%)
Decreased sodium (23%)
Decreased phosphate (23%)
Increased potassium (23%)
Decreased leukocytes (23%)
Decreased glucose (21%)
Decreased appetite (21%)
Constipation (18%)
Diarrhea (18%)
Cough (16%)
Noncardiac chest pain (15%)
Back pain (14%)
Pyrexia (14%)
Grade 3 to 4
Decreased lymphocytes (14%)
1-10%
All grades
Decreased weight (10%)
<10%
Pruritus (allergic and generalized)
ILD/pneumonitis
Cellulitis
Acute kidney injury (including renal failure)
Urticaria
Acute pancreatitis
Grade 3 to 4
Peripheral edema (9%)
Fatigue (8%)
Increased ALT (8%)
Increased GGT (7%)
Increased lipase (7%)
Dyspnea (7%)
Decreased sodium (6%)
Increased AST (4.9%)
Increased amylase (4.4%)
Increased potassium (3.1%)
Decreased hemoglobin (2.8%)
Nausea (2.7%)
Vomiting (2.4%)
Noncardiac chest pain (2.1%)
Decreased albumin (1.8%)
<1%
Grade 3 to 4
Back pain (0.9%)
Constipation (0.9%)
Decreased appetite (0.9%)
Decreased leukocytes (0.9%)
Pyrexia (0.6%)
Decreased weight (0.6%)
Cough (0.6%)
Diarrhea (0.3%)
Decreased glucose (0.3%)
Increased alkaline phosphatase (0.3%)
Increased creatinine (0.3%)
Mechanism of Action
MET tyrosine kinase stimulates cell scattering, invasion, protection from apoptosis, and angiogenesis; a variety of cancers (eg, lung, gastric) are associated when MET becomes dysregulated owing to MET amplifications and exon 14 skipping mutations
Note
Capmaxen 200 mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Capmatinib. Capmaxen is availble in Bangladesh.
Farmaco BD drug index information on Capmaxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.