Alecnib Capsule contains Alectinib, a highly selective and potent tyrosine kinase inhibitor used in the treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Alecnib represents a major advancement in targeted lung cancer therapy, offering effective disease control, including activity within the central nervous system. It is designed for long-term oral use under specialist oncology supervision.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

Anti-neoplastic preparations, Protein Kinase Inhibitor

Indications

Alecnib as monotherapy is indicated for:

• First-line treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC)

• Treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib

Pharmacology

Alectinib is a highly selective inhibitor of anaplastic lymphoma kinase (ALK) and RET tyrosine kinases. Inhibition of ALK activity blocks downstream signaling pathways, including STAT3 and PI3K/AKT, which are essential for tumor cell proliferation and survival. This leads to apoptosis and tumor regression.

Alectinib has demonstrated activity against multiple ALK mutations, including those associated with resistance to crizotinib. Its active metabolite, M4, shows similar potency and pharmacological activity. Importantly, alectinib is not a substrate of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP), allowing effective penetration and retention in the central nervous system. Nonclinical studies have shown significant antitumor activity in both systemic and intracranial tumor models, with prolonged survival outcomes.

Dosage & Administration

• Recommended dose: 600 mg twice daily (four 150 mg capsules per dose), taken with food

• Total daily dose: 1200 mg

• Patients with severe hepatic impairment (Child-Pugh C): 450 mg twice daily

• Treatment should continue until disease progression or unacceptable toxicity

• If a dose is missed, it may be taken unless the next dose is due within 6 hours

• Do not take two doses at the same time

• If vomiting occurs after dosing, take the next dose at the scheduled time

• Dose reduction may be required in steps of 150 mg twice daily based on tolerability

• Permanently discontinue if unable to tolerate 300 mg twice daily

• Capsules must be swallowed whole and not opened or dissolved

Drug Interactions

• Metabolized primarily by CYP3A4

• Strong CYP3A inducers (e.g., rifampicin) reduce alectinib exposure, but no dose adjustment is generally required; monitoring is advised

• Strong CYP3A inhibitors increase exposure modestly; no dose adjustment required with appropriate monitoring

• Proton pump inhibitors, H2 blockers, and antacids do not have a clinically relevant effect

• Alectinib inhibits P-gp; however, co-administration with P-gp inhibitors is not expected to significantly affect exposure

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Contraindications

Alecnib is contraindicated in patients with known hypersensitivity to alectinib or any of its excipients.

Side Effects

Common adverse reactions include:

• Constipation

• Edema (peripheral, generalized, eyelid, periorbital)

• Myalgia and musculoskeletal pain

• Nausea

• Increased bilirubin levels

• Anemia

• Rash and related skin reactions

Pregnancy & Lactation

• Alectinib may cause fetal harm when administered during pregnancy

• Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose

• Breastfeeding is not recommended during treatment due to potential risk to the infant

• No fertility impairment observed in nonclinical toxicology studies

Precautions & Warnings

• Interstitial lung disease (ILD) and pneumonitis have been reported; discontinue if confirmed

• Hepatotoxicity may occur; monitor liver function regularly, especially during the first 3 months

• Symptomatic bradycardia has been observed; monitor heart rate and blood pressure

• Photosensitivity reactions may occur; advise sun protection during treatment and for at least 7 days after discontinuation

• Contains lactose and sodium; caution in patients with relevant metabolic or dietary restrictions

Use in Special Populations

• Hepatic impairment: Dose adjustment required only in severe impairment

• Renal impairment: No dose adjustment required

• Elderly patients: No clinically relevant safety differences observed

• Pediatric patients: Safety and efficacy not established

• Extreme body weight: Limited data available

Overdose

There is no specific antidote for alectinib overdose. Patients should receive close monitoring and supportive care as required.

Storage Conditions

Store below 30°C.
Protect from light and moisture.
Keep out of the reach of children.