alectinib hydrochloride: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
alectinib hydrochloride: clinical details
Prescribing considerations
- Initiation and supervision should be by a clinician experienced with anticancer treatment.
- Confirm ALK-positive status using a validated assay before treatment.
- Review hepatic function, pregnancy potential, contraception and interacting medicines.
- Assess gastrointestinal-perforation risk, including diverticulitis, gastrointestinal metastases and relevant concomitant medicines.
- Advise about photosensitivity and the potential effects of bradycardia or visual disturbance on driving.
Contraindications and cautions
- Hypersensitivity to alectinib or any capsule excipient.
- The capsules contain lactose and should not be used in specified rare hereditary disorders of galactose metabolism or absorption.
- Exercise caution for pneumonitis, hepatic injury, symptomatic bradycardia, muscle toxicity, haemolytic anaemia, hypertriglyceridaemia or pancreatitis risk, and gastrointestinal-perforation risk.
Monitoring
- Confirm baseline liver function, then monitor ALT, AST and bilirubin every two weeks for the first three months and periodically thereafter; test more frequently if abnormalities occur.
- Measure creatine phosphokinase every two weeks for the first month and when muscle symptoms occur.
- Monitor heart rate and blood pressure as clinically indicated.
- Check triglycerides before treatment and periodically thereafter, with symptom surveillance for pancreatitis.
- Monitor for pulmonary symptoms, haemolysis and clinically significant renal-function changes.
Clinical pharmacology
Alectinib selectively inhibits ALK and RET tyrosine kinases. CYP3A4 contributes substantially to formation of the active metabolite M4. Alectinib and M4 are highly protein-bound, distribute extensively into tissues, and are eliminated predominantly in faeces; renal elimination is minimal. Food substantially increases exposure.
Formulation and product differences
- The selected UK product is a hard-capsule formulation that must be swallowed whole with food and must not be opened or dissolved.
- The capsule contains lactose and sodium.
- Blisters and bottles should remain in their original packaging to protect the capsules from moisture; bottles should be kept tightly closed.
alectinib hydrochloride preparations and strengths
Capsule
Route: Oral
Strengths: 150 mg
alectinib hydrochloride interactions
Provide the oncology team with a complete list of medicines, supplements and herbal products. Important examples include:
Strong CYP3A inducers, including rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital and St John’s wort
These can alter alectinib and active-metabolite exposure; appropriate monitoring is recommended.
Strong CYP3A inhibitors, including ritonavir, azole antifungals, grapefruit and Seville oranges
These can alter alectinib and active-metabolite exposure; appropriate monitoring is recommended.
Oral contraceptives
Alectinib may reduce contraceptive effectiveness; discuss a highly effective method with the specialist team.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.