ALECINIX (ALECTINIB HCL) 150MG CAPSULES 120`S

ALECINIX contains alectinib, a targeted cancer medicine that works by blocking a faulty protein called ALK (Anaplastic Lymphoma Kinase). In some patients with non-small cell lung cancer (NSCLC), a genetic rearrangement in the ALK gene causes the ALK protein to drive cancer cell growth. By inhibiting ALK, alectinib shuts down this signal and slows or stops cancer growth.

Alectinib 150 mg is indicated for: First-line treatment of adults with ALK-positive, locally advanced or metastatic NSCLC; Treatment of adults with ALK-positive advanced NSCLC previously treated with crizotinib.

Alectinib has excellent CNS (brain) penetration, making it particularly effective for patients with brain metastases. The standard dose is 600 mg (4 × 150 mg capsules) taken twice daily.

The recommended dose is 600 mg (four 150 mg capsules) taken TWICE DAILY with food. Take capsules with a full meal to ensure adequate absorption.

•       Morning dose: 600 mg (4 capsules) with breakfast.

•       Evening dose: 600 mg (4 capsules) with dinner or main evening meal.

•       Swallow capsules whole — do not open, dissolve, or chew.

•       If you vomit after a dose, do not retake it — wait until the next scheduled dose.

•       If you miss a dose, take it as soon as you remember — unless the next dose is within 6 hours. In that case, skip the missed dose.

Dose Reductions

•       Dose reductions in 150 mg steps: 600 mg BD → 450 mg BD → 300 mg BD, based on tolerability.

Common Side Effects

•       Constipation, nausea, vomiting, diarrhoea.

•       Fatigue and muscle pain (myalgia).

•       Oedema (swelling) — especially peripheral oedema.

•       Elevated liver enzymes (AST, ALT, bilirubin) — detected on blood tests.

•       Elevated creatinine (reduced kidney function markers).

•       Anaemia and raised CPK (muscle enzyme).

Serious Side Effects — Report Immediately

•       Interstitial lung disease / pneumonitis — worsening breathlessness, cough, fever. Requires immediate treatment interruption.

•       Severe liver toxicity — yellowing of skin/eyes, dark urine, severe abdominal pain.

•       Bradycardia (slow heartbeat) — dizziness, fainting, chest pain.

•       Severe myopathy — extreme muscle pain, weakness, dark (brown) urine (rhabdomyolysis).

•       Photosensitivity reactions — severe sun sensitivity.

Liver Toxicity

Alectinib can cause elevated liver enzymes. Regular liver function tests are required every 2 weeks for the first 3 months, then monthly. Report any yellowing of skin or eyes, dark urine, or right upper abdominal pain immediately.

Muscle Problems (Myopathy / Rhabdomyolysis)

Rare but serious muscle breakdown can occur. Report severe muscle pain, weakness, or dark urine to your oncologist immediately.

Heart Rate

Alectinib can slow the heart rate (bradycardia). Tell your doctor if you feel dizzy, faint, or have an unusually slow pulse.

Photosensitivity

Alectinib increases skin sensitivity to sunlight. Avoid prolonged sun exposure, use SPF 30+ sunscreen, and wear protective clothing — especially from 10 am to 4 pm.

Pregnancy and Breastfeeding

Women of childbearing potential must use effective contraception during treatment and for 3 months after the last dose. Breastfeeding is not recommended.

•       Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) — may increase alectinib exposure; use with caution.

•       Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St John's Wort) — significantly reduce alectinib levels; avoid.

•       Drugs causing bradycardia (beta-blockers, digoxin, diltiazem) — additive risk of slow heart rate.

•       Store below 30°C in a dry place, away from light and moisture.

•       Keep in the original packaging.

•       Keep out of reach of children.

ALECINIX is a prescription-only specialist medicine (POM) in Kenya. Must only be initiated by an oncologist following molecular testing confirming ALK-positive NSCLC.

•       Confirm ALK-positive NSCLC status by validated test (FISH, IHC, or RT-PCR) before initiating.

•       Monitor: LFTs every 2 weeks for 3 months then monthly; CPK and creatinine periodically; heart rate and ECG in at-risk patients.

•       Hepatic impairment: No adjustment for mild impairment. Moderate: reduce to 450 mg BD. Severe: no data — avoid.

•       Renal impairment: No adjustment for mild-moderate. Severe: caution, limited data.

•       Alectinib penetrates the CNS well and is effective for brain metastases — preferred over crizotinib in this setting.

Do I need a genetic test before starting ALECINIX?

Yes. Your oncologist must confirm ALK rearrangement in your tumour using a validated diagnostic test (FISH, immunohistochemistry, or RT-PCR) before starting treatment.

Why do I take 4 capsules at once?

Each capsule contains 150 mg of alectinib, and the recommended dose is 600 mg (4 × 150 mg) taken twice daily with food. This dosing was established in clinical trials to achieve effective blood levels.

Can alectinib treat cancer that has spread to the brain?

Yes. One of the major advantages of alectinib is its ability to penetrate the blood-brain barrier and treat brain metastases, making it a preferred choice over older ALK inhibitors like crizotinib for patients with CNS involvement.

Why is it important to take ALECINIX with food?

Food significantly increases the absorption of alectinib. Taking it on an empty stomach results in much lower blood levels, reducing its effectiveness.

What should I do about sun sensitivity?

Always apply SPF 30+ broad-spectrum sunscreen to exposed skin, wear protective clothing, and avoid direct sun between 10 am and 4 pm. Phototoxic reactions can be severe with alectinib.