Tabrecta Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Capmatinib HCl

Indications/Uses

Metastatic non-small cell lung cancer in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping.

Click to view Tabrecta detailed prescribing information

Dosage/Direction for Use

Recommended dose: 400 mg bd.

Click to view Tabrecta detailed prescribing information

Administration

May be taken with or without food: Swallow whole, do not break/crush/chew.

Special Precautions

Risk of interstitial lung disease/pneumonitis; monitor for new or worsening pulmonary symptoms (eg, dyspnea, cough, fever). Risk of hepatotoxicity; monitor liver function tests (including ALT, AST, & total bilirubin) prior to initiation, every 2 wk during the 1st 3 mth of treatment, then once a mth or as clinically indicated. Risk of photosensitivity reactions; limit direct UV exposure during treatment. Patients w/ severe renal impairment (CrCl 15-29 mL/min). Females of reproductive potential & male patients w/ female partners of reproductive potential should use effective contraception during treatment & for 1 wk after the last dose. Pregnancy testing prior to starting treatment; can cause fetal harm when administered to a pregnant woman. Do not breastfeed during treatment & for 1 wk after the last dose. Ped patients.

Click to view Tabrecta detailed prescribing information

Use In Pregnancy & Lactation

Click to view Tabrecta detailed prescribing information

Adverse Reactions

Peripheral edema, nausea, fatigue, vomiting, dyspnea, & decreased appetite.

Click to view Tabrecta detailed prescribing information

Drug Interactions

Increased exposure w/ strong CYP3A inhibitors. Decreased exposure w/ strong & moderate CYP3A inducers. Increased exposure of CYP1A2, P-gp, BCRP, MATE1 & MATE2K substrates.

Click to view Tabrecta detailed prescribing information

Description

View Tabrecta description for details of the chemical structure and excipients (inactive components).

Action

View Tabrecta mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX17 - capmatinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

P₁S₁S₃

Patient Counseling Information

View Tabrecta patient counselling information

Presentation/Packing

Form

Tabrecta FC tab 150 mg

Packing/Price

60's

Form

Tabrecta FC tab 200 mg

Packing/Price

60's

Tabrecta

capmatinib

Manufacturer:

Novartis

Distributor:

Zuellig