Respiratory and thoracic cancers:

Indications for TABRECTA:

Treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA approved test.

Adult:

Confirm presence of a mutation that leads to MET exon 14 skipping in tumor specimens. Swallow whole. 400mg twice daily. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold immediately if suspected and permanently discontinue if no other causes are identified. Monitor LFTs prior to initiation, every 2 weeks during 1st 3 months, then once monthly or as clinically indicated; test more frequently if increased AST, ALT or bilirubin develops. Potential risk of photosensitivity. Advise patients to limit direct UV exposure. Severe renal impairment (CrCl 15–29mL/min). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A inhibitors; monitor closely. Potentiates CYP1A2, P-gp, or BCRP substrates; if unavoidable, decrease substrate dosage. May potentiate MATE1 or MATE2K substrates; if unavoidable, decrease substrate dosage. Antagonized by strong or possibly moderate CYP3A inducers; avoid.

Adverse Reactions:

Peripheral edema, nausea, fatigue, vomiting, dyspnea, decreased appetite, constipation, diarrhea, cough; lab abnormalities, hepatoxicity.

Metabolism:

CYP3A4 (primarily). Aldehyde oxidase.

Elimination:

Fecal (major), renal. Half-life: 6.5 hours.

Generic Availability:

NO

How Supplied:

Tabs—56

Pricing for TABRECTA

200mg tablet (Qty: 30)
Appx. price $4914
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