Respiratory and thoracic cancers:

Indications for GAVRETO:

Treatment of patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

Adult:

Confirm presence of a RET gene fusion. Take on an empty stomach. 400mg once daily. Continue until disease progression or until unacceptable toxicity. Concomitant use with combined P-gp and strong CYP3A inhibitors (if unavoidable): reduce to 200mg once daily if current dose is 300mg or 400mg once daily; reduce dose to 100mg once daily if current dose is 200mg once daily. Concomitant use with strong CYP3A inducers (if unavoidable): increase initial dose to double the current Gavreto dosage starting on Day 7 of concomitant use. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Warnings/Precautions:

Monitor for pulmonary symptoms indicative of ILD/pneumonitis; withhold therapy and evaluate if occurs. Uncontrolled hypertension: do not initiate. Optimize BP prior to initiation; monitor after 1 week, then at least monthly thereafter and as clinically indicated. Hepatotoxicity. Monitor AST/ALT prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Permanently discontinue if severe or life-threatening hemorrhagic events occur. Risk of impaired wound healing: withhold for ≥5 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Moderate (total bilirubin >1.5–3.0×ULN and any AST) or severe (total bilirubin >3.0×ULN and any AST) hepatic impairment. Embryo-fetal toxicity. Advise to use effective non-hormonal contraception during and for 2 weeks (females of reproductive potential) or 1 week (males w. female partners) 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:

See Adult dose. Potentiated by strong CYP3A inhibitors. Avoid concomitant combined P-gp and strong CYP3A inhibitors; if unavoidable, reduce Gavreto dose. Antagonized by strong CYP3A inducers; avoid concomitant use; if unavoidable, increase Gavreto dose. May antagonist hormonal contraceptives.

Adverse Reactions:

Fatigue, constipation, musculoskeletal pain, hypertension; laboratory abnormalities (decreased lymphocytes, decreased neutrophils, decreased phosphate, decreased hemoglobin, decreased sodium, decreased calcium [corrected], increased ALT), pneumonia, pneumonitis, sepsis, UTI, pyrexia.

Generic Availability:

NO

How Supplied:

Caps—60, 90

Pricing for GAVRETO

100mg capsule (Qty: 30)
Appx. price $4917
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