Dosing and administration

PEMAZYRE^® (pemigatinib) is a once-daily oral therapy¹

Please refer to the SmPC for full dosing and administration information 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 cycle

14 days of once-daily therapy

7 days of no therapy

Continue treatment until disease progression or unacceptable toxicity occurs

Figure created by Incyte, based on reference 1.

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

PEMAZYRE is for oral use¹

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

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

PEMAZYRE may be taken with or without food¹

Dose adjustments and modifications

Download the PEMAZYRE adverse event management and dosing guide

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 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

Figure created by Incyte, based on reference 1.

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

Special populations

The dose of PEMAZYRE is the same in elderly patients as in 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, including grapefruit juice, should be avoided. Patients should be advised to avoid eating grapefruit or drinking grapefruit juice while taking PEMAZYRE.¹
- Concomitant use of PEMAZYRE with strong CYP3A4 inhibitors requires dose adjustment.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

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

Reference:
1. PEMAZYRE^® (pemigatinib). Summary of Product Characteristics: Sections 3, 4.2, 4.4 and 4.5 on www.fass.se.

Learn more about PEMAZYRE^® (pemigatinib):

Discover about FGFR2 fusions in patients with CCA

FGFR2 fusion testing

Understand the mechanism of action of PEMAZYRE

About PEMAZYRE

Learn about the efficacy of PEMAZYRE

Efficacy

Review the safety data of PEMAZYRE

Safety

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A self-directed learning material on PEMAZYRE to complete in your own time. With the PEMAZYRE learning module, you can learn about the unmet needs in CCA, discuss the need for molecular profiling for early patient identification and learn more about PEMAZYRE.

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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: Section 4.2 on www.fass.se.

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: Section 4.2 on www.fass.se.

^▼Detta läkemedel är föremål för utökad övervakning. Detta kommer att göra det möjligt att snabbt identifiera ny säkerhetsinformation. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning. Se avsnitt 4.8 om hur man rapporterar biverkningar.

Prescribing InformationPemazyre (pemigatinib), 4,5, mg, 9 mg, 13,5 mg, tabletter. Rx. EF.
ATC-kod: LO1E N02, antineoplastiska medel, proteinkinashämmare. Indikation: Pemazyre som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerat eller metastaserat kolangiokarcinom, med fusion eller rearrangemang av fibroblasttillväxtfaktorreceptor 2 (FGFR2) som har progredieratefter minst en tidigare linjes systemisk behandling. Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne som anges i avsnitt 6.1 i produktresumén. Samtidig användning med johannesört. Varningar och försiktighet: Permigatinib kan orsaka hyperfosfatemi, svår hypofosfatemi, exudativa näthinneavlossningsreaktioner, torra ögon och ökad serumkreatinin genom att minska renal tubulär sekretion av kreatinin. Samtidig användning av pemigatinib och protonpumpshämmare ska undvikas. Samtidig användning av pemigatinib och starka CYP3A4-hämmare kräver dosjustering. Patienterna ska rådas att undvika att äta grapefrukt och att dricka grapefruktjuice vid behandling med pemigatinib. Samtidig användning av pemigatinib och starka eller måttliga CYP3A4-inducerare rekommenderas inte. Baserat på fynd i en djurstudie och dess verkningsmekanism kan Pemazyre orsaka fosterskador när det ges till en gravid kvinna. Gravida kvinnor ska även informeras om den potentiella risken för fostret. Fertila kvinnor som behandlas med Pemazyre ska avrådas från att bli gravida och män som behandlas med Pemazyre ska avrådas från att göra en kvinna gravid under behandlingen. En effektiv preventivmedelsmetod ska användas hos fertila kvinnor och hos män med fertila kvinnliga partners under behandling med Pemazyre och under en vecka efter avslutad behandling. Effekter på förmågan att framföra fordon och använda maskiner: Pemigatinib har måttlig effekt på förmågan att framföra fordon och använda maskiner. Biverkningar som trötthet och synstörningar har förknippats med pemigatinib. Försiktighet ska därför iakttas vid framförande av fordon eller användning av maskiner.
MAH: Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederländerna. För mer information se www.fass.se. Senaste datum för översyn av produktresumén: 2023-07-26.

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Marketing authorisation holder:
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to their local authority or to Incyte (by e-mail: eumedinfo@incyte.com).

Local representative: John Eriksson, Key Account Manager | Email: jeriksson@incyte.com | Phone: +46 73 440 88 12

Dosing and administration

PEMAZYRE® (pemigatinib) is a once-daily oral therapy1

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

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