PEMAZYRE TABLETS 13.5 MG [SIN17044P]

Product Info

PEMAZYRE TABLETS 13.5 MG

[SIN17044P]

4.1 THERAPEUTIC INDICATIONS

Pemigatinib is indicated for the 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. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR).

4.2 DOSE AND METHOD OF ADMINISTRATION

Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer.

FGFR2 fusion positivity status must be known prior to initiation of PEMAZYRE therapy. Assessment for FGFR2 fusion positivity in tumour specimen should be performed with an appropriate diagnostic test.

Dosage

The recommended dose is 13.5 mg PEMAZYRE taken once daily for 14 days followed by 7 days off therapy.

If a dose of PEMAZYRE is missed by 4 or more hours or vomiting occurs after taking a dose, an additional dose should not be administered and dosing should be resumed with the next scheduled dose.

Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.

Method of administration

PEMAZYRE is for oral use. The 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.

In all patients, a low-phosphate diet should be initiated when serum phosphate level is > 5.5 mg/dL and adding a phosphate-lowering therapy should be considered when level is > 7 mg/dL. The dose of phosphate-lowering therapy should be adjusted until serum phosphate level returns to < 7 mg/dL. Prolonged hyperphosphataemia can cause precipitation of calcium-phosphate crystals that can lead to hypocalcaemia, soft tissue mineralisation, muscle cramps, seizure activity, QT interval prolongation, and arrhythmias (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Discontinuing phosphate-lowering therapy and diet should be considered during PEMAZYRE treatment breaks or if serum phosphate level falls below normal range. Severe hypophosphataemia may present with confusion, seizures, focal neurologic findings, heart failure, respiratory failure, muscle weakness, rhabdomyolysis, and haemolytic anaemia (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose adjustment due to drug interaction

Concomitant use of PEMAZYRE with strong or moderate CYP3A4 inhibitors
If co-administration with a strong or moderate CYP3A4 inhibitor is necessary, the dose of patients who are taking 13.5 mg PEMAZYRE once daily should be reduced to 9 mg once daily and the dose of patients who are taking 9 mg PEMAZYRE once daily should be reduced to 4.5 mg once daily. Grapefruit juice should be avoided during treatment with pemigatinib. Refer Sections 4.4 Special warnings and precautions for use and 4.5 Interactions with other medicines and other forms of interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Management of toxicities

Dose modifications or interruption of dosing should be considered for the management of toxicities.

PEMAZYRE dose reductions levels are summarised in Table 1.

Treatment should be permanently discontinued if patient is unable to tolerate 4.5 mg PEMAZYRE once daily.

Dose modifications for hyperphosphataemia are provided in Table 2.

Dose modifications for serous retinal detachment are provided in Table 3.

Special populations

Elderly patients
The dose of PEMAZYRE is the same in elderly patients as younger adult patients (see Section 5.1 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
Dose adjustment is not required for patients with mild, moderate renal impairment or End Stage Renal Disease (ESRD) on haemodialysis. For patients with severe renal impairment, the dose of patients who are taking 13.5 mg PEMAZYRE once daily should be reduced to 9 mg once daily and the dose of patients who are taking 9 mg PEMAZYRE once daily should be reduced to 4.5 mg once daily (see Section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
Dose adjustment is not required for patients with mild or moderate hepatic impairment. For patients with severe hepatic impairment, the dose of patients who are taking 13.5 mg PEMAZYRE once daily should be reduced to 9 mg once daily and the dose of patients who are taking 9 mg PEMAZYRE once daily should be reduced to 4.5 mg once daily (see Section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of PEMAZYRE in patients less than 18 years of age have not been established. No data are available.

4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Concomitant use with St John’s wort (see Section 4.5 Interactions with other medicines and other forms of interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).