Product Dossier

ADVAGRAF XL

Product Dossier for ADVAGRAF XL (tacrolimus, Astellas Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

ADVAGRAF XL is a prolonged-release capsule formulation of tacrolimus available in strengths of 0.5 mg, 1 mg, 3 mg and 5 mg.

Approved indications

— Prevention of transplant rejection

Dosing overview

ADVAGRAF XL is administered as a once daily prolonged-release formulation.

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. Exposure of the skin to sunlight should be minimised and the use of ultraviolet light from a solarium, therapy with UVB or UVA in combination with psoralens should be avoided during use of tacrolimus.

Contraindications

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

PBS listing

ADVAGRAF XL is listed on the PBS in four strengths: 0.5 mg, 1 mg, 3 mg and 5 mg capsules. The 0.5 mg capsule has an ex-manufacturer price of A$37.52 with mixed restriction types; the 1 mg capsule has an ex-manufacturer price of A$61.78 with mixed restriction types; the 3 mg capsule has an ex-manufacturer price of A$329.10 with mixed restriction types; and the 5 mg capsule has an ex-manufacturer price of A$375.22 with mixed restriction types. In November 2019, the PBAC recommended an unrestricted benefit listing for the 3 mg capsule and a streamlined authority required listing under Section 100 (Highly Specialised Drugs Program).

Regulatory history

ADVAGRAF XL 0.5 mg, 1 mg and 5 mg prolonged-release capsules were first listed on the Australian Register of Therapeutic Goods on 23 May 2016. The 3 mg prolonged-release capsule was first listed on 19 July 2019. In November 2019, the PBAC recommended listing for prevention of transplant rejection.