TM Owner Incyte
Pemazyre 13.5mg Tablet
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Indications & Clinical Uses
- Pemazyre 13.5 mg tablets contain pemigatinib, a fibroblast growth factor receptor (FGFR) 1-3 kinase inhibitor made by Incyte.
- In the US, Pemazyre has accelerated approval for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with an FGFR2 fusion or rearrangement confirmed by an FDA-approved test, in adults who have progressed after at least one prior line of systemic therapy.
- It is also approved for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement.
- Continued approval for the cholangiocarcinoma indication may depend on results of confirmatory trials verifying clinical benefit.
- Pemazyre is taken by mouth once daily, and treatment is guided and monitored by a cancer specialist.
- It is a targeted, precision-oncology therapy used only when genetic testing confirms the relevant FGFR alteration, and is not for the general population of bile-duct or blood cancers.
Side Effects
- Very common side effects of Pemazyre (affecting more than 1 in 10 people) include raised blood phosphate levels, hair loss, diarrhoea, changes to nails (thickening, discolouration or loosening), tiredness, altered taste, nausea, constipation, mouth sores and dry eyes.
- Pemazyre has no boxed warning, but it can cause serious eye problems, including retinal detachment and central serous retinopathy, which may cause blurred vision, flashing lights or vision loss; regular eye examinations are required during treatment.
- Raised phosphate levels are common and are usually managed with a low-phosphate diet or phosphate-lowering medicine.
- Report any new or worsening vision changes to your healthcare provider immediately, and attend all scheduled eye examinations, required every two months for the first six months and every three months thereafter, plus urgently if symptoms occur.
Precautions & Warnings
- Before starting Pemazyre, a comprehensive eye examination, including optical coherence tomography, is required, and this must be repeated regularly during treatment because of the risk of retinal detachment and central serous retinopathy.
- Serum phosphate must be checked regularly; if levels rise above 5.5 mg/dL, a low-phosphate diet is started, and phosphate-lowering treatment is required above 7 mg/dL, with treatment interruption or dose reduction if levels remain high.
- Pemazyre can cause harm to an unborn baby, so effective contraception is required for females and males of reproductive potential during treatment and for one week after the last dose; it should not be used in pregnancy.
- There is no formal contraindication listed on the label.
- Pemazyre is for oral use only and must be swallowed whole; it should not be crushed, chewed or split.
- It is not approved for use in children.
Avoid Interactions
- Pemazyre is broken down by the liver enzyme CYP3A, so strong or moderate CYP3A inhibitors (such as certain antifungal and antibiotic medicines, and grapefruit or grapefruit juice) can raise pemigatinib levels and should be avoided; if unavoidable, the healthcare provider will reduce the Pemazyre dose.
- Strong or moderate CYP3A inducers (such as rifampin, carbamazepine and St John's Wort) can lower pemigatinib levels and reduce its effectiveness, and should also be avoided.
- Because Pemazyre affects phosphate levels, phosphate-containing supplements should be used cautiously and only as directed.
- Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, herbal products and supplements you take, including grapefruit products, before and during treatment, since dose adjustments or closer monitoring may be needed.
References
Frequently Asked Questions
Pemazyre (pemigatinib) treats adults with previously treated bile duct cancer (cholangiocarcinoma) that has a specific FGFR2 gene change, confirmed by testing. It is also used for certain blood cancers with an FGFR1 gene rearrangement. It is a targeted cancer tablet used only when genetic testing confirms the right mutation.
Pemazyre is taken by mouth once daily, with or without food, exactly as your cancer specialist prescribes. Swallow the tablet whole; do not crush, chew or split it. Your dosing schedule may include treatment and rest periods depending on your condition.
The most common effects are raised blood phosphate, hair loss, diarrhoea, nail changes, tiredness, altered taste and dry eyes, each affecting more than 1 in 10 people. Pemazyre can also cause serious eye problems like retinal detachment; report blurred vision or flashing lights straight away.
Avoid grapefruit and grapefruit juice, and strong CYP3A-affecting medicines such as certain antifungals, antibiotics, rifampin, carbamazepine and St John's Wort, as these change pemigatinib levels. Tell your healthcare provider about every medicine and supplement you take before starting Pemazyre.
Yes. Pemazyre requires an eye examination with optical coherence tomography before starting, then every 2 months for 6 months and every 3 months after that, because of retinal detachment risk. Report any vision changes to your healthcare provider immediately for urgent assessment.
No. Pemazyre can harm an unborn baby, so effective contraception is required during treatment and for one week after the last dose, for both women and men. Tell your healthcare provider if you are pregnant, planning pregnancy, or breastfeeding before starting Pemazyre.
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