Pemigatinib Dosage

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Usual Adult Dose for Cholangiocarcinoma of biliary tract

13.5 mg orally once a day for 14 consecutive days followed by 7 days off therapy, in 21-day cycles

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Comments:

• Patients should be selected for the treatment of locally advanced or metastatic cholangiocarcinoma with this drug based on the presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an approved test.
• FGFR2 fusion positivity status must be known prior to initiation of therapy.
• This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval may depend on verification and description of clinical benefit in confirmatory trials.

Use: For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by a US FDA-approved test

Usual Adult Dose for Malignant Myeloid/Lymphoid Neoplasm

13.5 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity occurs

Comments:

• Patients should be selected for treatment of relapsed or refractory myeloid/lymphoid neoplasms (MLNs) based on the presence of an FGFR1 rearrangement.
• A US FDA-approved test for detection of FGFR1 rearrangement in these patients is not available.

Use: For the treatment of adults with relapsed or refractory MLNs with FGFR1 rearrangement

Renal Dose Adjustments

Mild or moderate renal dysfunction (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73 m2): No adjustment recommended.
Severe renal dysfunction (eGFR 15 to 29 mL/min/1.73 m2):

• Cholangiocarcinoma: 9 mg orally once a day for 14 consecutive days followed by 7 days off therapy, in 21-day cycles
• MLNs: 9 mg orally once a day

Comments:

• Estimated by Modification of Diet in Renal Disease

Liver Dose Adjustments

Mild (total bilirubin greater than the upper limit of normal [ULN] to 1.5 times ULN [1.5 x ULN] or AST greater than ULN) or moderate (total bilirubin greater than 1.5 to 3 × ULN with any AST) liver dysfunction: No adjustment recommended
Severe liver dysfunction (total bilirubin greater than 3 x ULN with any AST):

• Cholangiocarcinoma: 9 mg orally once a day for 14 consecutive days followed by 7 days off therapy, in 21-day cycles
• MLNs: 9 mg orally once a day

Dose Adjustments

GENERAL RECOMMENDED DOSE MODIFICATION SCHEDULE FOR ADVERSE REACTIONS:
Cholangiocarcinoma with FGFR2 Fusion or Rearrangement:

• First dose reduction: 9 mg orally once a day for first 14 days of each 21-day cycle
• Second dose reduction: 4.5 mg orally once a day for first 14 days of each 21-day cycle
• Discontinue this drug if unable to tolerate 4.5 mg orally once a day.

MLNs with FGFR1 Rearrangement:

• First dose reduction: 9 mg orally once a day
• Second dose reduction: 4.5 mg orally once a day
• Third dose reduction: 4.5 mg orally once a day for first 14 days of each 21-day cycle
• Permanently discontinue this drug if unable to tolerate 4.5 mg orally once a day for 14 days of each 21-day cycle.

RECOMMENDED DOSE MODIFICATION FOR SPECIFIC ADVERSE REACTIONS:
Retinal Pigment Epithelial Detachment:

• If asymptomatic and stable on serial examination, continue this drug.
• If symptomatic or worsening on serial examination, withhold this drug.
• If asymptomatic and improved on subsequent examination, resume this drug at a lower dose.
• If symptoms persist or examination does not improve, consider permanent discontinuation of therapy, based on clinical status.

Hyperphosphatemia:

• Serum phosphate greater than 7 to 10 mg/dL: Initiate phosphate-lowering therapy and monitor serum phosphate weekly.
• Withhold this drug if levels are not less than 7 mg/dL within 2 weeks of starting phosphate-lowering therapy.
• Resume this drug at the same dose when phosphate levels are less than 7 mg/dL for first occurrence. Resume at a lower dose level for subsequent recurrences.
• Serum phosphate greater than 10 mg/dL: Initiate phosphate-lowering therapy and monitor serum phosphate weekly.
• Withhold therapy if levels are not 10 mg/dL or less within 1 week after starting phosphate-lowering therapy.
• Resume therapy at the next lower dose level when phosphate levels are less than 7 mg/dL.
• Permanently discontinue therapy for recurrence of serum phosphate more than 10 mg/dL following 2 dose reductions.

Other Adverse Reactions:

• Grade 3: Withhold therapy until resolves to grade 1 or baseline.
• Resume therapy at next lower dose if resolves within 2 weeks.
• Permanently discontinue therapy if does not resolve within 2 weeks.
• Permanently discontinue therapy for recurrent grade 3 after 2 dose reductions.
• Grade 4: Permanently discontinue therapy.

RECOMMENDED DOSE MODIFICATION FOR CONCOMITANT USE WITH STRONG OR MODERATE CYP450 3A INHIBITORS:
Avoid concomitant use of strong and moderate CYP450 3A inhibitors with this drug. If concomitant use with a strong or moderate CYP450 3A inhibitor cannot be avoided:

• Reduce dose from 13.5 mg to 9 mg.
• Reduce dose from 9 mg to 4.5 mg.
• If concomitant use of a strong or moderate CYP450 3A inhibitor is discontinued, increase this drug dose (after 3 plasma half-lives of the CYP450 3A inhibitor) to the dose that was used before starting the strong inhibitor.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

ESRD (eGFR less than 15 mL/min/1.73 m2) receiving intermittent hemodialysis: No adjustment recommended

Other Comments

Administration advice:

• Take this drug with or without food at the same time every day.
• Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.
• If the patient misses a dose by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.

Storage requirements:

• Store at room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

General:

• Information on US FDA-approved test(s) for the detection of an FGFR2 fusion or rearrangement in cholangiocarcinoma is available at http://www.fda.gov/companiondiagnostics.

Monitoring:

• Metabolic: Hyperphosphatemia; serum phosphate levels
• Ocular: Ophthalmological including optical coherence tomography (before starting, every 2 months for first 6 months, and every 3 months thereafter during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Immediately inform your health care provider if any visual changes occur; use artificial tears/substitutes or hydrating/lubricating eye gels to prevent or treat dry eyes.
• Immediately inform your health care provider of any symptoms related to acute change in phosphate levels (e.g., muscle cramps, numbness, tingling around the mouth).
• Patients of childbearing potential: Inform your health care provider if you are/become pregnant; use effective contraception during therapy and for 1 week after the last dose.
• Male patients with partners of childbearing potential or who are pregnant: Use effective contraception during therapy and for 1 week after the last dose.
• Do not breastfeed during therapy and for 1 week after the last dose.
• Avoid grapefruit products during therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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