Select therapeutic use:

Pancreatic, thyroid, and other endocrine cancers:

Indications for RETEVMO:

Treatment of patients ≥12yrs with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy. Treatment of patients ≥12yrs with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Adult:

Confirm presence of a RET gene fusion or specific RET gene mutation in tumor specimens or plasma. Swallow whole. ≥12yrs (<50kg): 120mg twice daily (approx. every 12hrs); (≥50kg): 160mg twice daily (approx. every 12hrs). Continue until disease progression or unacceptable toxicity. Concomitant with acid-reducing agents (if unavoidable): take Retevmo with food when used with PPI; take 2hrs before or 10hrs after H2-receptor antagonist; take 2hrs before or 2hrs after locally-acting antacid. Concomitant with moderate CYP3A inhibitors (if unavoidable): 80mg twice daily if current dose is 240mg/day; 120mg twice daily if current dose is 320mg/day. Concomitant with strong CYP3A inhibitors (if unavoidable): 40mg twice daily if current dose is 240mg/day; 80mg twice daily if current dose is 320mg/day. Severe hepatic impairment: 80mg twice daily. Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established.

Warnings/Precautions:

Risk of hepatotoxicity. Monitor ALT/AST prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Uncontrolled hypertension: do not initiate. Optimize BP prior to initiation, monitor after 1 week, then at least monthly thereafter and as clinically indicated. Monitor patients with significant risk of QTc prolongation (including known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled HF). Assess QT interval, electrolytes, TSH at baseline and periodically during treatment. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiation and during therapy. Withhold if hypersensitivity occurs and begin corticosteroids. Permanently discontinue if recurrent hypersensitivity, severe or life-threatening hemorrhage occurs. Impaired wound healing: withhold for ≥7 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Clinically significant active cardiovascular disease, recent MI: not studied. Severe renal impairment (CrCl <30mL/min) or ESRD. Severe hepatic impairment (total bilirubin >3–10×ULN and any AST): reduce dose (see Adults). 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 or moderate CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults), and monitor QT interval frequently. Antagonized by strong or moderate CYP3A inducers; avoid. Antagonized by acid-reducing agents (eg, PPIs, H2-receptor antagonists, locally-acting antacids); avoid; if unavoidable (see Adults). Potentiates CYP2C8 and CYP3A substrates; avoid; if unavoidable, follow recommendations for substrates (see respective product labeling). Concomitant with drugs known to prolong QT interval; obtain ECGs more frequently.

Adverse Reactions:

Increased AST/ALT, increased glucose, decreased leukocytes, decreased albumin, decreased calcium, dry mouth, diarrhea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, edema, decreased platelets, increased total cholesterol, rash, decreased sodium, constipation; hemorrhagic events.

Generic Availability:

NO

How Supplied:

Caps 40mg—60; 80mg—60, 120

Pricing for RETEVMO

80mg capsule (Qty: 30)
Appx. price $5263
GoodRx

Respiratory and thoracic cancers:

Indications for RETEVMO:

Treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

Adult:

Confirm presence of a RET gene fusion in tumor specimens or plasma. Swallow whole. <50kg: 120mg twice daily (approx. every 12hrs). ≥50kg: 160mg twice daily (approx. every 12hrs). Continue until disease progression or unacceptable toxicity. Concomitant with acid-reducing agents (if unavoidable): take Retevmo with food when used with PPI; take 2hrs before or 10hrs after H2-receptor antagonist; take 2hrs before or 2hrs after locally-acting antacid. Concomitant with moderate CYP3A inhibitors (if unavoidable): 80mg twice daily if current dose is 240mg/day; 120mg twice daily if current dose is 320mg/day. Concomitant with strong CYP3A inhibitors (if unavoidable): 40mg twice daily if current dose is 240mg/day; 80mg twice daily if current dose is 320mg/day. Severe hepatic impairment: 80mg twice daily. Dose modifications for adverse reactions: see full labeling.

Children:

Not established.

Warnings/Precautions:

Risk of hepatotoxicity. Monitor ALT/AST prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Uncontrolled hypertension: do not initiate. Optimize BP prior to initiation, monitor after 1 week, then at least monthly thereafter and as clinically indicated. Monitor patients with significant risk of QTc prolongation (including known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled HF). Assess QT interval, electrolytes, TSH at baseline and periodically during treatment. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiation and during therapy. Withhold if hypersensitivity occurs and begin corticosteroids. Permanently discontinue if recurrent hypersensitivity, severe or life-threatening hemorrhage occurs. Impaired wound healing: withhold for ≥7 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Clinically significant active cardiovascular disease, recent MI: not studied. Severe renal impairment (CrCl <30mL/min) or ESRD. Severe hepatic impairment (total bilirubin >3–10×ULN and any AST): reduce dose (see Adults). 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 or moderate CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults), and monitor QT interval frequently. Antagonized by strong or moderate CYP3A inducers; avoid. Antagonized by acid-reducing agents (eg, PPIs, H2-receptor antagonists, locally-acting antacids); avoid; if unavoidable (see Adults). Potentiates CYP2C8 and CYP3A substrates; avoid; if unavoidable, follow recommendations for substrates (see respective product labeling). Concomitant with drugs known to prolong QT interval; obtain ECGs more frequently.

Adverse Reactions:

Increased AST/ALT, increased glucose, decreased leukocytes, decreased albumin, decreased calcium, dry mouth, diarrhea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, edema, decreased platelets, increased total cholesterol, rash, decreased sodium, constipation; hemorrhagic events.

Generic Availability:

NO

How Supplied:

Caps 40mg—60; 80mg—60, 120

Pricing for RETEVMO

80mg capsule (Qty: 30)
Appx. price $5263
GoodRx