Alunbrig Dosage/Direction for Use

Treatment with Alunbrig should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
ALK-positive NSCLC status should be known prior to initiation of Alunbrig therapy. A validated ALK assay is necessary for the selection of ALK-positive NSCLC patients (see Pharmacology: Pharmacodynamics under Actions). Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Posology: The recommended starting dose of Alunbrig is 90 mg once daily for the first 7 days, then 180 mg once daily.
If Alunbrig is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.
If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time.
Treatment should continue as long as clinical benefit is observed.
Dose adjustments: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Alunbrig dose reduction levels are summarised in Table 5. (See Table 5.)

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Alunbrig should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.
Recommendations for dose modifications of Alunbrig for the management of adverse reactions are summarised in Table 6. (See Table 6.)

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Special populations: Elderly patients: The limited data on the safety and efficacy of Alunbrig in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients (see Adverse Reactions). There are no available data on patients over 85 years of age.
Hepatic impairment: No dose adjustment of Alunbrig is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B). A reduced starting dose of 60 mg once daily for the first 7 days, then 120 mg once daily is recommended for patients with severe hepatic impairment (Child-Pugh class C) (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of Alunbrig is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min). A reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended for patients with severe renal impairment (eGFR < 30 mL/min) (see Pharmacology: Pharmacokinetics under Actions).
Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc.) particularly in the first week (see Precautions).
Paediatric population: The safety and efficacy of Alunbrig in patients less than 18 years of age have not been established. No data are available.
Method of Administration: Alunbrig is for oral use. The tablets should be swallowed whole and with water. Alunbrig may be taken with or without food.
Grapefruit or grapefruit juice may increase plasma concentrations of Alunbrig and should be avoided (see Interactions).