Intended for licensed healthcare professionals located in the United Kingdom only.

Dosing and administration

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

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

21-day treatment cycle

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

How to take PEMAZYRE

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PEMAZYRE is for oral use

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

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

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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 PEMAZYRE

PEMAZYRE is available in 3 strengths:

  • 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).


Figure 1. Recommended PEMAZYRE dose reduction levels

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.

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.
  • Dose adjustment is required when administering PEMAZYRE to patients with severe renal impairment or to patients with severe hepatic impairment.
    • 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.
    • 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.

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.
  • 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.
  • 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.
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Further information on dose adjustments for patients in special populations and drug-to-drug interactions may be found in the SmPC.

Reference:
PEMAZYRE® (pemigatinib). Summary of Product Characteristics. 2021.

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