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▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.

Dosing and administration

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PEMAZYRE®▼ (pemigatinib) is a once-daily oral therapy

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Please refer to the SmPC for full dosing and administration before prescribing.

The recommended dose is 13.5 mg PEMAZYRE taken once daily for 14 days, followed by 7 days off therapy.1

21-day treatment cycle1

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14 days of once-daily therapy

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7 days of no therapy

Continue treatment until disease progression or unacceptable toxicity occurs

  • 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.1
  • Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.1

How to take PEMAZYRE

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PEMAZYRE is for oral use1

Clock

The tablets should be taken at approximately the same time every day1

Pill

Patients should not crush, chew, split or dissolve the tablets1

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PEMAZYRE may be taken with or without food.
Patients should be advised to avoid eating grapefruit or drinking grapefruit juice while taking PEMAZYRE1

Dose adjustments and modifications

PEMAZYRE is available in 3 strengths:1

  • PEMAZYRE 4.5 mg tablets
  • PEMAZYRE 9 mg tablets
  • PEMAZYRE 13.5 mg tablets

Dose modifications or interruption of dosing should be considered for the management of toxicities (Figure 1, Table 1, Table 2).1


Figure 1. Recommended PEMAZYRE dose reduction levels1

Recommended dose

13.5 mg taken orally once daily for
14 days on, followed by 7 days off therapy

13.5 mg
once daily

First level

9 mg taken orally once daily for
14 days on, followed by 7 days off therapy

9 mg
once daily

Second level

4.5 mg taken orally once daily for
14 days on, followed by 7 days off therapy

4.5 mg
once daily

Treatment should be permanently discontinued if patient is unable to tolerate 4.5 mg PEMAZYRE once daily.1

Table 1. Dose modifications for hyperphosphataemia

Table 2. Dose modifications for serous retinal detachment

Special populations

  • The dose of PEMAZYRE is the same in elderly patients as younger adult patients. The safety and efficacy of PEMAZYRE in patients less than 18 years of age have not been established. No data are available.1
  • Dose adjustment is required when administering PEMAZYRE to patients with severe renal impairment or to patients with severe hepatic impairment.1
    • 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.1
    • 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.1

Interaction with other medicinal products and other forms of interaction

  • Concurrent use of strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, ritonavir) should be avoided during treatment with PEMAZYRE.1
  • 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.1
  • Concomitant use of PEMAZYRE with proton pump inhibitors should be avoided.1
  • 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.1
  • 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

Reference:
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics.

Learn more about PEMAZYRE (pemigatinib):

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Discover more about FGFR2 fusions in patients with CCA

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ESMO guideline recommendations

Discover more about ESMO guideline recommendations for patients with CCA.

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Table 1. Dose modifications for hyperphosphataemia1

Serum phosphate Dose modification
>5.5–≤7 mg/dL
  • PEMAZYRE should be continued at current dose.
>7–≤10 mg/dL
  • PEMAZYRE should be continued at current dose, phosphate-lowering therapy should be initiated, serum phosphate should be monitored weekly, dose of phosphate-lowering therapy should be adjusted as needed until level returns to <7 mg/dL.
  • PEMAZYRE should be withheld if levels do not return to <7 mg/dL within 2 weeks of starting a phosphate-lowering therapy. PEMAZYRE and phosphate-lowering therapy should be restarted at the same dose when level returns to <7 mg/dL.
  • Upon recurrence of serum phosphate at >7 mg/dL with phosphate-lowering therapy, PEMAZYRE should be reduced 1 dose level.
>10 mg/dL
  • PEMAZYRE should be continued at current dose, phosphate-lowering therapy should be initiated, serum phosphate should be monitored weekly and dose of phosphate-lowering therapy should be adjusted as needed until level returns to <7 mg/dL.
  • PEMAZYRE should be withheld if levels continue >10 mg/dL for 1 week. PEMAZYRE and phosphate-lowering therapy should be restarted 1 dose level lower when serum phosphate is <7 mg/dL.
  • If there is recurrence of serum phosphate >10 mg/dL following 2 dose reductions, PEMAZYRE should be permanently discontinued.

Reference:
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics.

Table 2. Dose modifications for serous retinal detachment1

Adverse reaction Dose modification
Asymptomatic
  • PEMAZYRE should be continued at current dose. Monitoring should be performed as described in section 4.4 of the SmPC.
Moderate decrease in visual acuity (best corrected visual acuity 20/40 or better or ≤3 lines of decreased vision from baseline); limiting instrumental activities of daily living
  • PEMAZYRE should be withheld until resolution. If improved on subsequent examination, PEMAZYRE should be resumed at the next lower dose level.
  • If it recurs, symptoms persist or examination does not improve, permanent discontinuation of PEMAZYRE should be considered based on clinical status.
Marked decrease in visual acuity (best corrected visual acuity worse than 20/40 or >3 lines decreased vision from baseline up to 20/200); limiting activities of daily living
  • PEMAZYRE should be withheld until resolution. If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower.
  • If it recurs, symptoms persist or examination does not improve, permanent discontinuation of PEMAZYRE should be considered, based on clinical status.
Visual acuity worse than 20/200 in affected eye; limiting activities of daily living
  • PEMAZYRE should be withheld until resolution. If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower.
  • If it recurs, symptoms persist or examination does not improve, permanent discontinuation of PEMAZYRE should be considered, based on clinical status

Reference:
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics.

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REPUBLIC OF IRELAND
Adverse events should be reported.Reporting forms and information can be found at HPRA Pharmacovigilance: www.hpra.ie. Adverse events should also be reported to Incyte immediately by phoning the Toll-free phone number 1800‑456‑748.

▼ 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.

IE/PEMA/P/25/0010
Date of preparation: January 2025
Developed and funded by Incyte Biosciences International Sàrl.
© 2025, Incyte. All rights reserved.
PEMAZYRE, the PEMAZYRE logo and the Incyte logo are registered trademarks of Incyte.

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