VARENIX

What it is

VARENIX contains varenicline tartrate, available as 0.5 mg or 1 mg film-coated tablets. The tablets are supplied for oral administration in two strengths: white to off-white capsule-shaped tablets of 0.5 mg, and light blue capsule-shaped tablets of 1 mg.

Approved indications

— Aid to smoking cessation in adults over the age of 18 years.

Dosing overview

The recommended dose of VARENIX is 1 mg twice daily following a one-week titration: days 1–3 at 0.5 mg once daily, days 4–7 at 0.5 mg twice daily, and day 8 onwards at 1 mg twice daily. VARENIX dosing should start one to two weeks before the target date to stop smoking. Patients should be treated with VARENIX for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with VARENIX at 1 mg twice daily is recommended to further increase the likelihood of long-term abstinence. VARENIX tablets should be swallowed whole with water and can be taken with or without food.

Key safety warnings

Serious neuropsychiatric symptoms have occurred in patients being treated with varenicline. Patients and their families, friends or carers should be advised that the patient should stop taking VARENIX and contact a healthcare professional immediately if changes in behaviour or thinking, agitation or depressed mood that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behaviour. Patients should be advised that alcohol intake may increase the risk of experiencing neuropsychiatric events during treatment with VARENIX. There have been post-marketing reports of traffic accidents, near-miss incidents in traffic, and other accidental injuries in patients taking varenicline. In some cases, the patients reported somnolence, dizziness, loss of consciousness (blackouts), seizures or difficulty concentrating. Therefore, patients should be advised not to engage in potentially hazardous activities, such as driving or operating complex machinery, until they know how VARENIX may affect them. In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with varenicline. Varenicline should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline. Clinical signs included swelling of the face, mouth (tongue, lips and gums), neck (throat and larynx) and extremities. There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise. There have been post-marketing reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline. As these skin reactions can be life-threatening, patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.

Contraindications

VARENIX is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

Prescription information for VARENIX is not provided in the source documents.

Regulatory history

VARENIX was first listed on the ARTG on 17 August 2023, with four registered variants: 0.5 mg and 1 mg film-coated tablet composite blister pack, 1 mg film-coated tablet bottle, 1 mg film-coated tablet blister pack, and 0.5 mg film-coated tablet bottle.