• Patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
• Adjuvant treatment following tumor resection of ALK-positive NSCLC (tumors 4 cm or node positive).

Contraindicated in:

• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Severe renal impairment or end-stage renal disease
• Severe hepatic impairment (↓ dose)
• Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: bradycardia, edema.

Derm: photosensitivity, rash.

EENT: blurred vision, diplopia.

Endo: hyperglycemia.

F and E: hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia.

GI: constipation, diarrhea, hepatotoxicity, hyperbilirubinemia, nausea, vomiting.

GU: renal impairment.

Hemat: anemia, lymphopenia, BLEEDING, hemolytic anemia.

Metab: ↑weight.

MS: ↑creatine kinase, back pain, myalgia.

Neuro: fatigue, headache.

Resp: cough, dyspnea, INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS, PULMONARY EMBOLISM.

Drug-Drug:

• None reported.

• Capsules: 150 mg;

Metastatic Non-Small Cell Lung Cancer

• PO (Adults): 600 mg twice daily; continue until disease progression or unacceptable toxicity.

Adjuvant Treatment of Resected Non-Small Cell Lung Cancer

• PO (Adults): 600 mg twice daily; continue for a total of 2 yr or until disease recurrence or unacceptable toxicity.

Alecensa

• Inhibits tyrosine kinase receptors targeting ALK and RET.

• Decreased spread of NSCLC and improved disease-free survival.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: kinase inhibitors

Absorption: 37% absorbed following oral administration; high-fat, high-calorie meals ↑ absorption.

Distribution: Extensively distributed to tissues.

Protein Binding: 99%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme to its active metabolite, M4 (also metabolized by CYP3A4). 84% excreted in feces unchanged; minimal excretion in urine.

Half-life: Alectinib: 33 hr; M4 active metabolite: 31 hr.

Alecensaro

(plasma concentrations)

• Instruct patient to take alectinib as directed. If a dose is missed or vomiting occurs after taking, omit dose and take next dose at scheduled time. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Advise patient to use sunscreen and lip balm (SPF 50) and to wear protective clothing to prevent photosensitivity reaction.
• Advise patient to notify health care professional if signs and symptoms of liver problems (feeling tired, itchy skin, feeling less hungry than usual, nausea or vomiting, yellowing of skin or whites of eyes, pain on right side of stomach, dark urine, bleeding or bruising more easily than normal), respiratory problems (trouble breathing, shortness of breath, cough, fever), bradycardia (dizziness, light-headedness, syncope), or myalgia (unexplained muscle pain, tenderness, or weakness) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 1 wk following therapy. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose.

al-EKti-nib