Respiratory and thoracic cancers:

Indications for LORBRENA:

Treatment of ALK (+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on crizotinib and at least 1 other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Adult:

Swallow whole. 100mg once daily until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A inhibitors; if unavoidable, reduce Lorbrena dose to 75mg once daily; or to 50mg once daily (see full labeling); increase dose after inhibitor is discontinued. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Contraindications:

Concomitant strong CYP3A inducers.

Warnings/Precautions:

Risk of severe hepatotoxicity with concomitant strong CYP3A inducers. Withhold and resume (at same or reduced dose) or permanently discontinue based on severity if CNS effects occur. Monitor serum cholesterol and TGs prior to treatment, at Months 1 and 2, and periodically thereafter; withhold and resume (at same or reduced dose) based on severity, if hypercholesterolemia or hypertriglyceridemia occurs. Monitor ECG prior to treatment and periodically thereafter; withhold and resume (at same or reduced dose) if undergoing pacemaker placement; permanently discontinue if AV block recurs in patients without a pacemaker. Withhold if interstitial lung disease (ILD)/pneumonitis is suspected; permanently discontinue for treatment-related ILD/pneumonitis of any severity. Embryo-fetal toxicity. Use effective non-hormonal contraception during and for ≥6 months (females of reproductive potential) or ≥3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

See Contraindications. Antagonized by strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives prior to treatment. Avoid concomitant moderate CYP3A inducers; if unavoidable, monitor AST/ALT and bilirubin 48hrs after treatment initiation and at least 3 times during the first week; discontinue either agent if persistent Grade ≥2 hepatotoxicity occurs. Potentiated by strong CYP3A inhibitors; avoid; if unavoidable, reduce Lorbrena dose (see Adults). Antagonizes CYP3A substrates; avoid; if unavoidable, increase substrate dose as appropriate.

Adverse Reactions:

Edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, diarrhea, lab abnormalities; serious hepatotoxicity, hyperlipidemia, AV block, ILD/pneumonitis.

Generic Availability:

NO

How Supplied:

Tabs—30