PEMAZYRE

What it is

PEMAZYRE (pemigatinib) is available as tablets in three strengths: 4.5 mg, 9 mg, and 13.5 mg. The tablets are immediate release and uncoated. Pemigatinib is a small molecule kinase inhibitor of FGFR1, 2 and 3.

Approved indications

— Treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.

Dosing overview

The recommended dose is 13.5 mg PEMAZYRE taken once daily for 14 days followed by 7 days off therapy. FGFR2 fusion positivity status must be known prior to initiation of PEMAZYRE therapy, and assessment for FGFR2 fusion positivity in tumour specimen should be performed with an appropriate diagnostic test. Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity. PEMAZYRE is for oral use and tablets should be taken at approximately the same time every day. Patients should not crush, chew, split or dissolve the tablets. PEMAZYRE may be taken with or without food.

Key safety warnings

Hyperphosphataemia is a pharmacodynamic effect expected with PEMAZYRE administration. Prolonged hyperphosphataemia can cause precipitation of calcium-phosphate crystals that can lead to hypocalcaemia, soft tissue mineralisation, anaemia, secondary hyperparathyroidism, muscle cramps, seizure activity, QT interval prolongation, and arrhythmias. In all patients, a low-phosphate diet should be initiated when serum phosphate level is greater than 5.5 mg/dL and adding a phosphate-lowering therapy should be considered when level is greater than 7 mg/dL. PEMAZYRE can cause serous retinal detachment reactions, which may present with symptoms such as blurred vision, visual floaters, or photopsia. This can moderately influence the ability to drive and use machines. Ophthalmological examination, including optical coherence tomography (OCT), should be performed prior to initiation of therapy and every 2 months for the first 6 months of treatment, every 3 months afterwards, and urgently at any time for visual symptoms. PEMAZYRE can cause dry eye. Patients should use ocular demulcents in order to prevent or treat dry eye, as needed. Based on the mechanism of action and findings in an animal reproduction study, PEMAZYRE can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment with pemigatinib and for 1 week after the last dose.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Concomitant use with St John's wort is contraindicated.

Regulatory history

PEMAZYRE pemigatinib 4.5 mg, 9 mg, and 13.5 mg tablet blister packs were first listed on the ARTG on 14 September 2022. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate and duration of response. Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).