PROGRAF

What it is

PROGRAF contains tacrolimus . The medicine is available in multiple pharmaceutical forms registered on the Australian Register of Therapeutic Goods.

Approved indications

PROGRAF capsule formulations are registered on the ARTG for systemic use in immunosuppression in transplant recipients. PROGRAF tacrolimus capsules (0.5 mg, 1 mg and 5 mg) and injection have been registered since 1997 or later .

Key safety warnings

In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies . Tacrolimus is able to cross the placenta . Tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies potential risk to the foetus . Tacrolimus is excreted into breast milk. It is therefore recommended that mothers should not breast-feed while receiving tacrolimus .

Contraindications

Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1 .

PBS listing

PROGRAF capsule 5 mg is listed on the PBS with four items at varying restrictions, with an ex-manufacturer price of A$257.28. PROGRAF capsule 1 mg is listed with four items at varying restrictions, with an ex-manufacturer price of A$102.96. PROGRAF capsule 0.5 mg is listed with four items at varying restrictions, with an ex-manufacturer price of A$51.48 .

Regulatory history

PROGRAF tacrolimus capsules (1 mg and 5 mg) and injection were first listed on the ARTG on 25 August 1997. PROGRAF tacrolimus 0.5 mg capsule was first listed on 27 February 2001. PROGRAF XL tacrolimus 3 mg prolonged-release capsule was first listed on 19 July 2019 .