Select therapeutic use:

Pancreatic, thyroid, and other endocrine cancers:

Indications for: RETEVMO

In patients ≥12yrs with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. In patients ≥12yrs with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Adult Dosage:

Confirm presence of a RET gene fusion or specific RET gene mutation in tumor specimens. 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 Dosage:

<12yrs: not established.

RETEVMO Warnings/Precautions:

Risk of serious hepatotoxicity. Monitor ALT/AST prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Risk of severe interstitial lung disease (ILD)/pneumonitis. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold and promptly evaluate for ILD if acute or worsening of respiratory symptoms occur. 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. Tumor lysis syndrome: monitor in those with rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Impaired wound healing: withhold for ≥7 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Monitor thyroid function before and periodically during treatment; treat as clinically indicated. Clinically significant active cardiovascular disease, recent MI: not studied. 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).

RETEVMO Classification:

Kinase inhibitor.

RETEVMO Interactions:

Potentiated by strong or moderate CYP3A inhibitors (eg, itraconazole, diltiazem, fluconazole, verapamil); avoid; if unavoidable, reduce dose (see Adults), and monitor QT interval frequently. Antagonized by strong or moderate CYP3A inducers (eg, rifampin, bosentan, efavirenz); avoid. Antagonized by acid-reducing agents (eg, PPIs, H2-receptor antagonists, locally-acting antacids); avoid; if unavoidable (see Adult). Potentiates CYP2C8, CYP3A, and certain P-gp substrates (eg, repaglinide, midazolam, dabigatran); 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:

Edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache, decreased lymphocytes, increased ALT/AST, decreased sodium, decreased calcium; hypertension, QT interval prolongation, hemorrhagic events, hypothyroidism.

Generic Drug Availability:

NO

How Supplied:

Caps 40mg—60; 80mg—60, 120

Pricing for RETEVMO

80mg capsule (Qty: 60)
Appx. price $10163
GoodRx

Respiratory and thoracic cancers:

Indications for: RETEVMO

In adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, as detected by an FDA-approved test.

Adult Dosage:

Confirm presence of a RET gene fusion in tumor specimens. 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 Dosage:

Not established.

RETEVMO Warnings/Precautions:

Risk of serious hepatotoxicity. Monitor ALT/AST prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Risk of severe interstitial lung disease (ILD)/pneumonitis. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold and promptly evaluate for ILD if acute or worsening of respiratory symptoms occur. 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. Tumor lysis syndrome: monitor in those with rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Impaired wound healing: withhold for ≥7 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Monitor thyroid function before and periodically during treatment; treat as clinically indicated. Clinically significant active cardiovascular disease, recent MI: not studied. 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).

RETEVMO Classification:

Kinase inhibitor.

RETEVMO Interactions:

Potentiated by strong or moderate CYP3A inhibitors (eg, itraconazole, diltiazem, fluconazole, verapamil); avoid; if unavoidable, reduce dose (see Adults), and monitor QT interval frequently. Antagonized by strong or moderate CYP3A inducers (eg, rifampin, bosentan, efavirenz); avoid. Antagonized by acid-reducing agents (eg, PPIs, H2-receptor antagonists, locally-acting antacids); avoid; if unavoidable (see Adult). Potentiates CYP2C8, CYP3A, and certain P-gp substrates (eg, repaglinide, midazolam, dabigatran); 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:

Edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache, decreased lymphocytes, increased ALT/AST, decreased sodium, decreased calcium; hypertension, QT interval prolongation, hemorrhagic events, hypothyroidism.

Generic Drug Availability:

NO

How Supplied:

Caps 40mg—60; 80mg—60, 120

Pricing for RETEVMO

80mg capsule (Qty: 60)
Appx. price $10163
GoodRx

Solid tumors:

Indications for: RETEVMO

In adults with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Adult Dosage:

Confirm presence of a RET gene fusion in tumor specimens. 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 Dosage:

Not established.

RETEVMO Warnings/Precautions:

Risk of serious hepatotoxicity. Monitor ALT/AST prior to initiation, every 2 weeks during 1st 3 months, then monthly thereafter and as clinically indicated. Risk of severe interstitial lung disease (ILD)/pneumonitis. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold and promptly evaluate for ILD if acute or worsening of respiratory symptoms occur. 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. Tumor lysis syndrome: monitor in those with rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Impaired wound healing: withhold for ≥7 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Monitor thyroid function before and periodically during treatment; treat as clinically indicated. Clinically significant active cardiovascular disease, recent MI: not studied. 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).

RETEVMO Classification:

Kinase inhibitor.

RETEVMO Interactions:

Potentiated by strong or moderate CYP3A inhibitors (eg, itraconazole, diltiazem, fluconazole, verapamil); avoid; if unavoidable, reduce dose (see Adults), and monitor QT interval frequently. Antagonized by strong or moderate CYP3A inducers (eg, rifampin, bosentan, efavirenz); avoid. Antagonized by acid-reducing agents (eg, PPIs, H2-receptor antagonists, locally-acting antacids); avoid; if unavoidable (see Adult). Potentiates CYP2C8, CYP3A, and certain P-gp substrates (eg, repaglinide, midazolam, dabigatran); 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:

Edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, headache, decreased lymphocytes, increased ALT/AST, decreased sodium, decreased calcium; hypertension, QT interval prolongation, hemorrhagic events, hypothyroidism.

Generic Drug Availability:

NO

How Supplied:

Caps 40mg—60; 80mg—60, 120

Pricing for RETEVMO

80mg capsule (Qty: 60)
Appx. price $10163
GoodRx