VARENICLINE

What it is

Varenicline Lupin contains varenicline as varenicline tartrate in tablet strengths of 0.5 mg or 1 mg. The medicine is supplied as film-coated tablets for oral administration, with the 0.5 mg strength being white to off-white and the 1 mg strength being yellow.

Approved indications

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

Dosing overview

The recommended dose of Varenicline Lupin is 1 mg twice daily following a one-week titration: Days 1–3 consist of 0.5 mg once daily, Days 4–7 consist of 0.5 mg twice daily, and Day 8 onwards consists of 1 mg twice daily. Patients should set a date to stop smoking, and dosing should start 1–2 weeks before this date. Alternatively, patients can begin varenicline dosing and then quit smoking between days 8 and 35 of treatment. Patients should be treated with Varenicline Lupin for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with Varenicline Lupin at 1 mg twice daily is recommended to further increase the likelihood of long-term abstinence. No dosage adjustment is necessary for patients with mild to moderate renal impairment; for patients with severe renal impairment, the recommended dose is 1 mg once daily, starting with 0.5 mg once daily for the first 3 days then increasing to 1 mg once daily. No dosage adjustment is necessary for patients with hepatic impairment.

Key safety warnings

Serious neuropsychiatric symptoms have occurred in patients being treated with varenicline, and patients and their families should be advised to stop taking Varenicline Lupin 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 Varenicline Lupin. There have been post-marketing reports of traffic accidents, near-miss incidents in traffic, and other accidental injuries in patients taking varenicline, with some cases involving somnolence, dizziness, loss of consciousness 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 Varenicline Lupin 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, and patients should be advised to discontinue varenicline and immediately contact a healthcare provider if they experience a seizure while on treatment. There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline, with clinical signs including swelling of the face, mouth, neck and extremities, and rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise; patients experiencing these symptoms should discontinue treatment with Varenicline Lupin and contact a healthcare provider immediately. There have been post-marketing reports of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline; patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.

Contraindications

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

Regulatory history

Varenicline Lupin was first listed on the ARTG on 14 March 2025 in strengths of 0.5 mg and 1 mg as blister packs and composite packs.