Intended for licensed healthcare professionals located in the United Kingdom and Republic of Ireland only
Frequently Asked Questions
Special warnings and precautions for use
Special warnings and precautions for use with PEMAZYRE include:1
- Hyperphosphataemia
- Hypophosphataemia
- Serous retinal detachment
- Dry eye
- Embryo-foetal toxicity
- Blood creatinine increase
- Combination with proton pump inhibitors
- Combination with strong CYP3A4 inhibitors
- Combination with strong or moderate CYP3A4 inducers
- Central nervous system metastasis
- Contraception
- Pregnancy
Consult the Summary of Product Characteristics for full details of the special warnings and precautions for use.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Concurrent use of PEMAZYRE with strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir) should be avoided. Concomitant use of PEMAZYRE with strong (eg, carbamazepine, phenytoin, phenobarbital, rifampicin) or moderate CYP3A4 inducers is not recommended. Concomitant use of PEMAZYRE with St John’s wort is contraindicated. If needed, other enzyme inducers (eg, efavirenz) should be used under close surveillance. Concomitant use of PEMAZYRE with proton pump inhibitors should be avoided.1
Consult the Summary of Product Characteristics for full details of drug interactions.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Co-administration of PEMAZYRE with CYP2B6 substrates (eg, cyclophosphamide, ifosfamide, methadone, efavirenz) may decrease their exposure. Close clinical surveillance is recommended when PEMAZYRE is administered with these medicinal products. Co-administration of PEMAZYRE with P-gp substrates (eg, digoxin, dabigatran, colchicine) may increase their exposure and thus their toxicity. PEMAZYRE administration should be separated by at least 6 hours before or after administration of P-gp substrates with a narrow therapeutic index.1
Consult the Summary of Product Characteristics for full details of drug interactions.
Summary of Product Characteristics (SmPC) – United Kingdom
Summary of Product Characteristics (SmPC) – Republic of Ireland
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Patients should be advised to avoid eating grapefruit or drinking grapefruit juice while taking PEMAZYRE. 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.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
PEMAZYRE has a moderate influence on the ability to drive and use machines. Adverse reactions such as fatigue and visual disturbances have been associated with PEMAZYRE. Therefore, caution should be recommended when driving or operating machines.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
Fibroblast growth factor receptor 2 (FGFR2) fusion positivity status must be known prior to initiation of PEMAZYRE therapy. Assessment for FGFR2 fusion positivity in tumour specimens should be performed with an appropriate diagnostic test. A pregnancy test should be performed before treatment initiation to exclude pregnancy.1
- Reference
- PEMAZYRE® (pemigatinib) Summary of Product Characteristics.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.
