Ciclosporin

What it is and how it works

Mechanism class: Calcineurin Inhibitors · Cytochrome P450 3A4 Inhibitors · P-Glycoprotein Inhibitors

Indications

INDICATIONS AND USAGE Kidney, Liver, and Heart Transplantation Cyclosporine capsules, USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP MODIFIED have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP MODIFIED are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules, USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclosporine capsules, USP MODIFIED are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Cyclosporine capsules, USP MODIFIED, soft gelatin capsules, has increased bioavailability in comparison to Sandimmune (cyclosporine capsules, USP). Cyclosporine capsules, USP MODIFIED and Sandimmune (cyclosporine capsules, USP) are not bioequivalent and cannot be used interchangeably without physician supervision. The daily dose of cyclosporine capsules, USP MODIFIED should always be given in two divided doses (BID). It is recommended that cyclosporine capsules, USP MODIFIED be administered on a consistent schedule with regard to time of day and relation to meals.

Contraindications

CONTRAINDICATIONS General Cyclosporine capsules, USP MODIFIED are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid Arthritis Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive cyclosporine capsules, USP MODIFIED.

Warnings and precautions

WARNINGS (See also BOXED WARNING ) All Patients Cyclosporine, the active ingredient of cyclosporine capsules, USP MODIFIED, can cause nephrotoxicity and hepatotoxicity. The risk increases with increasing doses of cyclosporine. Renal dysfunction including structural kidney damage is a potential consequence of cyclosporine capsules, USP MODIFIED and therefore renal function must be monitored during therapy. Care should be taken in using cyclosporine with nephrotoxic drugs (see PRECAUTIONS ).

Storage and supply

HOW SUPPLIED Cyclosporine capsules, USP MODIFIED are available as follows: 25 mg: yellow soft gelatin (oval 5) capsules, filled with yellowish to yellow-brown oily liquid, printed “Ivax hourglass logo” and “25 mg”, containing 25 mg cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol USP, packaged in unit-dose cartons of 30 c…

Source: Cyclosporine (Cyclosporine Modified) — US FDA prescribing information, 2024-04-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.