Select therapeutic use:

Leukemias, lymphomas, and other hematologic cancers:

Indications for XALKORI:

Relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive in pediatric patients aged ≥1yr and young adults.

Limitations of Use:

Safety and efficacy have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Adult Dosage:

Not established.

Children Dosage:

<1yr or (BSA <0.60m2): not established. Swallow whole. Assess ability to swallow intact capsules before prescribing. Usual dose: 280mg/m2 twice daily until disease progression or unacceptable toxicity. Based dose on BSA; if needed, may combine different strengths. ≥1yr (0.60–0.80m2): 200mg twice daily; (0.81–1.16m2): 250mg twice daily; (1.17–1.51m2): 400mg twice daily; (1.52–1.69m2): 450mg twice daily; (≥1.70m2): 500mg twice daily. Provide antiemetic and antidiarrheal agents for GI toxicities; consider IV or oral hydration for patients at risk of dehydration. Dose modifications for concomitant strong CYP3A inhibitors, moderate/severe hepatic impairment, severe renal impairment, hematologic and non-hematologic toxicities: see full labeling.

XALKORI Warnings/Precautions:

Monitor ALT, AST and total bilirubin every 2 weeks during first 2 months, then monthly, and more frequently for elevated transaminases; temporarily suspend, reduce dose, or permanently discontinue as clinically indicated. Monitor CBCs with differential monthly and more frequently if Grade 3 or 4 abnormalities, fever or infection occurs. Risk of severe interstitial lung disease (ILD)/pneumonitis: monitor for pulmonary symptoms; permanently discontinue if occurs. Congenital long QT syndrome; avoid. History of or predisposition for QTc prolongation (eg, CHF, bradyarrhythmias, electrolyte abnormalities, or those who are taking drugs known to prolong the QT interval): consider monitoring ECG, electrolytes periodically. Torsade de pointes, ventricular tachycardia, serious arrhythmia: permanently discontinue if QTc >500ms or ≥60ms change from baseline. Monitor HR and BP regularly; discontinue if life-threatening bradycardia occurs. Discontinue if onset of severe visual loss; perform eye evaluation. For ALCL: obtain eye exam prior to and within 1 month of initiation (include retinal exam), every 3 months, and then as clinically indicated; permanently discontinue if Grade 3 or 4 ocular disorders occur (unless another cause is identified). Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Use effective contraception during and for at least 45 days (females) or 90 days (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 45 days after the last dose).

XALKORI Classification:

Tyrosine kinase inhibitor.

XALKORI Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, itraconazole, ketoconazole, grapefruit, or grapefruit juice). Avoid concomitant strong CYP3A inducers (eg, rifampin). Avoid concomitant CYP3A substrates with narrow therapeutic indices (eg, oral midazolam); if needed, reduce doses. Avoid concomitant agents known to cause bradycardia (eg, beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, digoxin); adjust dose or discontinue. Avoid drugs known to prolong QT interval. Caution with moderate CYP3A inhibitors.

Adverse Reactions:

Vision disorders, nausea, diarrhea, vomiting, decreased appetite, fatigue; NSCLC: also edema, constipation, elevated transaminases, upper RTI, dizziness, neuropathy; ALCL: also headache, musculoskeletal pain, stomatitis, pyrexia, abdominal pain, cough, pruritus, Grade 3 or 4 lab abnormalities (neutropenia, lymphopenia, thrombocytopenia); hepatotoxicity (may be fatal), bradycardia.

Generic Drug Availability:

NO

How Supplied:

Caps—60

Pricing for XALKORI

250mg capsule (Qty: 60)
Appx. price $17518
GoodRx

Respiratory and thoracic cancers:

Indications for XALKORI:

Metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.

Adult Dosage:

Confirm ALK or ROS1-positive NSCLC with an FDA-approved test before treating. Swallow whole. 250mg twice daily until disease progression or intolerance. Concomitant strong CYP3A inhibitors (if unavoidable): reduce to 250mg once daily. Moderate hepatic impairment (AST and total bilirubin >1.5–≤3×ULN): 200mg twice daily; severe (AST and total bilirubin >3×ULN): 250mg once daily. Severe renal impairment (CrCl <30mL/min) not requiring dialysis: 250mg once daily. Dose modifications for hematologic and non-hematologic toxicities: see full labeling.

Children Dosage:

Not established.

XALKORI Warnings/Precautions:

Monitor ALT, AST and total bilirubin every 2 weeks during first 2 months, then monthly, and more frequently for elevated transaminases; temporarily suspend, reduce dose, or permanently discontinue as clinically indicated. Monitor CBCs with differential monthly and more frequently if Grade 3 or 4 abnormalities, fever or infection occurs. Risk of severe interstitial lung disease (ILD)/pneumonitis: monitor for pulmonary symptoms; permanently discontinue if occurs. Congenital long QT syndrome; avoid. History of or predisposition for QTc prolongation (eg, CHF, bradyarrhythmias, electrolyte abnormalities, or those who are taking drugs known to prolong the QT interval): consider monitoring ECG, electrolytes periodically. Torsade de pointes, ventricular tachycardia, serious arrhythmia: permanently discontinue if QTc >500ms or ≥60ms change from baseline. Monitor HR and BP regularly; discontinue if life-threatening bradycardia occurs. Discontinue if onset of severe visual loss; perform eye evaluation. For ALCL: obtain eye exam prior to and within 1 month of initiation (include retinal exam), every 3 months, and then as clinically indicated; permanently discontinue if Grade 3 or 4 ocular disorders occur (unless another cause is identified). Hepatic impairment. Severe renal impairment. Embryo-fetal toxicity. Use effective contraception during and for at least 45 days (females) or 90 days (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 45 days after the last dose).

XALKORI Classification:

Tyrosine kinase inhibitor.

XALKORI Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, itraconazole, ketoconazole, grapefruit, or grapefruit juice). Avoid concomitant strong CYP3A inducers (eg, rifampin). Avoid concomitant CYP3A substrates with narrow therapeutic indices (eg, oral midazolam); if needed, reduce doses. Avoid concomitant agents known to cause bradycardia (eg, beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, digoxin); adjust dose or discontinue. Avoid drugs known to prolong QT interval. Caution with moderate CYP3A inhibitors.

Adverse Reactions:

Vision disorders, nausea, diarrhea, vomiting, decreased appetite, fatigue; NSCLC: also edema, constipation, elevated transaminases, upper RTI, dizziness, neuropathy; ALCL: also headache, musculoskeletal pain, stomatitis, pyrexia, abdominal pain, cough, pruritus, Grade 3 or 4 lab abnormalities (neutropenia, lymphopenia, thrombocytopenia); hepatotoxicity (may be fatal), bradycardia.

Generic Drug Availability:

NO

How Supplied:

Caps—60

Pricing for XALKORI

250mg capsule (Qty: 60)
Appx. price $17518
GoodRx