Alecensa for ALK-Positive Non-Small Cell Lung Cancer Treatment

Alecensa is an oral medication containing alectinib, approved for treating adults with ALK-positive non-small cell lung cancer (NSCLC). It is used both after tumor surgery as an adjuvant therapy and for treating metastatic disease, helping target cancer cells that express the ALK gene rearrangement.

Alecensa is prescribed for adult patients diagnosed with ALK-positive NSCLC confirmed by an FDA-approved test. Its uses include:

• Adjuvant treatment after surgical removal of NSCLC tumors that are 4 cm or larger or have spread to lymph nodes.
• Treatment of metastatic ALK-positive NSCLC in adults.

alectinib hydrochloride

Alecensa works by inhibiting an abnormal form of the anaplastic lymphoma kinase (ALK) protein found in some lung cancer cells. By blocking this kinase, Alecensa interferes with cancer cell growth and survival, specifically targeting tumors with ALK gene rearrangements.

General Dosing

The recommended dose for adults is 600 mg taken orally twice daily with food. Capsules should be swallowed whole without opening or dissolving the contents.

Adjuvant Therapy

Use Alecensa for up to 2 years or until disease recurrence or unacceptable side effects occur.

Metastatic Disease

Treat until disease progression or unacceptable toxicity.

Hepatic Impairment

For patients with severe liver impairment (Child-Pugh C), reduce the dose to 450 mg twice daily.

Dose Reductions for Adverse Reactions

• First reduction: 450 mg twice daily
• Second reduction: 300 mg twice daily
• Discontinue if 300 mg twice daily is not tolerated

Missed Dose

If a dose is missed or vomiting occurs after taking Alecensa, take the next dose at the regularly scheduled time without doubling doses.

There are no explicit contraindications listed for Alecensa.

Serious Warnings and Precautions

• Hepatotoxicity: Frequent liver function monitoring is required. Severe liver injury can occur, mostly within the first 3 months. Dose modification or discontinuation may be necessary.
• Interstitial Lung Disease (ILD) / Pneumonitis: Monitor for respiratory symptoms. If ILD/pneumonitis is diagnosed, stop Alecensa permanently.
• Renal Impairment: Monitor kidney function. Withhold therapy for severe impairment; dose adjustment or permanent discontinuation may be needed.
• Bradycardia: Regular heart rate and blood pressure checks are necessary. Symptomatic bradycardia requires withholding and possible dose adjustment.
• Severe Myalgia and Elevated CPK: Assess creatine phosphokinase levels, especially if muscle pain occurs. Dose holds or reductions may be required.
• Hemolytic Anemia: Hold Alecensa if suspected; consider dose modification or discontinuation upon confirmation.
• Severe Hypertriglyceridemia and Pancreatitis: Monitor blood triglycerides before and during treatment. Manage elevations with dose interruption, reduction, or discontinuation.
• Embryo-Fetal Toxicity: Alecensa may cause fetal harm. Women of reproductive potential must use effective contraception during treatment and for 5 weeks after.

Common Side Effects

• Muscle pain and elevated creatine phosphokinase (seen in about half of patients)
• Liver enzyme elevations (ALT, AST), sometimes severe
• Bradycardia (slow heart rate)
• Renal impairment

Serious Side Effects

• Drug-induced liver injury
• Interstitial lung disease or pneumonitis
• Severe renal toxicity, including fatal cases
• Hemolytic anemia
• Severe hypertriglyceridemia leading to acute pancreatitis

The label does not provide specific details on drug interactions, but careful evaluation of concomitant medications, particularly those affecting heart rate and liver metabolism, is advised due to risks of bradycardia and hepatotoxicity.

Pregnancy

Alecensa can cause fetal harm. It is contraindicated during pregnancy unless the potential benefit justifies the risk.

Contraception

Women of reproductive potential must use effective contraception during treatment and for 5 weeks after the last dose.

Lactation

Information not provided in the supplied label.

Specific overdose symptoms and management guidelines are not detailed in the label.

Store according to the product packaging instructions. Specific storage conditions are not detailed in the provided label.