OTEZLA

What it is

Otezla is a medicine containing apremilast . Otezla is available as film-coated tablets in three strengths: 10 mg (pink, diamond shaped), 20 mg (brown, diamond shaped), and 30 mg (beige, diamond shaped) . Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators .

Approved indications

— The treatment of signs and symptoms of active psoriatic arthritis in adult patients. — The treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. — The treatment of adult patients with oral ulcers associated with Behçet's Disease who are candidates for systemic therapy.

Dosing overview

The recommended dose of Otezla is 30 mg twice daily taken orally approximately 12 hours apart . An initial titration schedule is required over 6 days, starting with 10 mg once daily on day 1 and increasing progressively to reach the 30 mg twice daily maintenance dose by day 6 . Otezla tablets should be swallowed whole, either with or without food, and should not be crushed, split or chewed . In patients with severe renal impairment (creatinine clearance less than 30 mL per minute), Otezla should be dose reduced to 30 mg once daily, using only the morning doses during the initial titration schedule .

Key safety warnings

Treatment with Otezla has been associated with weight decrease in some patients, and patients treated with Otezla should have their weight monitored regularly . Treatment with Otezla is associated with an increase in occurrences of depression; prescribers should carefully weigh the risks and benefits in patients with a history of depression and/or suicidal thoughts or behaviour, and patients, their caregivers and families should be advised to be alert for emergence or worsening of depression, suicidal thoughts or other mood changes . There have been post-marketing reports of severe diarrhoea, nausea and vomiting associated with the use of Otezla, with most events occurring within the first few weeks of treatment, and in some cases patients were hospitalised . Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at higher risk of complications . Otezla dose reduction or suspension should be considered if patients develop severe diarrhoea, nausea or vomiting .

Contraindications

Otezla is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients . Otezla is contraindicated during pregnancy and in nursing women . Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Otezla .

PBS listing

Otezla 30 mg tablets are listed on the PBS with streamlined restriction status at an ex-manufacturer price of A$543.36 . A titration pack containing 4 tablets of 10 mg, 4 tablets of 20 mg and 19 tablets of 30 mg is also listed with streamlined restriction status at an ex-manufacturer price of A$223.16 .

Regulatory history

Otezla was first registered on the ARTG on 19 March 2015 . The TGA approved the registration of Otezla for the treatment of signs and symptoms of active psoriatic arthritis in adult patients and for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy . In November 2014, the PBAC did not recommend apremilast for psoriatic arthritis due to uncertain clinical benefit and unacceptable cost-effectiveness . In November 2017, the PBAC recommended apremilast for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or are intolerant to at least one conventional synthetic disease-modifying anti-rheumatic drug . In July 2020, the PBAC recommended apremilast for severe chronic plaque psoriasis in patients who have failed treatment with or who are contraindicated or intolerant to methotrexate . In November 2023, the PBAC recommended changes to treatment criteria for chronic plaque psoriasis to allow rheumatologists and general physicians to initiate treatment, and rheumatology registrars to initiate treatment in consultation with these practitioners .