APO-CICLOSPORIN

What it is

APO-CICLOSPORIN is available as soft gelatin capsules in strengths of 10 mg, 25 mg, 50 mg and 100 mg. An oral solution formulation containing 100 mg/mL of ciclosporin is also available. The capsules and oral solution contain ethanol (11.8% v/v in capsules and 12% v/v in oral solution).

Approved indications

— Prevention of graft rejection following kidney, liver and heart allogeneic transplantation. — Induction and/or maintenance of remission in nephrotic syndrome. — Treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. — Treatment of severe psoriasis in patients in whom conventional therapy is ineffective or inappropriate and the disease has caused significant interference with quality of life. — Treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

Dosing overview APO-CICLOSPORIN should always be given in two divided doses.

Key safety warnings

Ciclosporin increases the risk of developing lymphomas and other malignancies, particularly of the skin, with the increased risk related to the degree and duration of immunosuppression. Patients taking APO-CICLOSPORIN should be strongly advised to avoid excessive unprotected exposure to ultraviolet light or the sun. APO-CICLOSPORIN predisposes patients to bacterial, fungal, parasitic and viral infections, often with opportunistic pathogens, and activation of latent Polyomavirus infections that may lead to Polyomavirus-associated nephropathy or JC virus-associated progressive multifocal leukoencephalopathy have been observed. Hypertension induced by ciclosporin has been reported in up to 50% of post-transplant patients and 8.5% of patients being treated for non-transplant indications. Regular monitoring of blood pressure is required during APO-CICLOSPORIN therapy. Hyperkalaemia, which may become life-threatening, can occur with ciclosporin treatment, especially in patients with renal dysfunction. Patients receiving APO-CICLOSPORIN should avoid high dietary potassium intake and not be given potassium-containing medication or potassium-sparing diuretics. An increase in serum creatinine and urea may occur during the first few weeks of ciclosporin therapy; these functional changes are dose-dependent and reversible, usually responding to dose reduction. During long-term treatment, some patients may develop structural changes in the kidney such as arteriolar hyalinosis, tubular atrophy and interstitial fibrosis.

Contraindications

Known hypersensitivity to ciclosporin and/or any excipients of APO-CICLOSPORIN. For non-transplant indications: uncontrolled hypertension, uncontrolled infection, and primary or secondary immunodeficiency excluding autoimmune diseases and selective IgA deficiency. For nephrotic syndrome: ciclosporin is contraindicated in patients with impaired baseline renal function (serum creatinine >200 micromol/L in adults and >140 micromol/L in children). In other non-transplant indications, ciclosporin is contraindicated in patients with impaired renal function of any degree of severity.

Regulatory history

APO-CICLOSPORIN was first listed on the Australian Register of Therapeutic Goods on 9 February 2021, with three strengths registered: 25 mg, 50 mg and 100 mg soft capsules.