Generic name: PEMIGATINIB 4.5mg
Dosage form: tablet
Medically reviewed by Drugs.com. Last updated on April 17, 2020.
Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with PEMAZYRE based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved test [see Clinical Studies (14.1)].
Information on FDA-approved test(s) for the detection of an FGFR2 fusion or rearrangement in cholangiocarcinoma is available at http://www.fda.gov/CompanionDiagnostics.
The recommended dosage of PEMAZYRE is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.
Take PEMAZYRE with or without food at approximately the same time every day [see Clinical Pharmacology (12.3)].
Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.
If the patient misses a dose of PEMAZYRE by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.
Dosage Modification for Adverse Reactions
The recommended dose reductions for adverse reactions are provided in Table 1.
|Dose Reduction||Recommended Dosage|
|First||9 mg once daily for first 14 days of each 21-day cycle|
|Second*||4.5 mg once daily for first 14 days of each 21-day cycle|
The recommended dosage modifications for adverse reactions are provided in Table 2.
|Adverse Reaction||Severity*||PEMAZYRE Dosage Modification|
|Retinal Pigment Epithelial Detachment (RPED) [see Warnings and Precautions (5.1)]||RPED||
[see Warnings and Precautions (5.2)]
> 7 mg/dL- ≤10 mg/dL
|Serum phosphate >10 mg/dL
|Other Adverse Reactions||Grade 3||
Dosage Modification for Concomitant Use with Strong or Moderate CYP3A Inhibitors
Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. If concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided:
- Reduce PEMAZYRE dose from 13.5 mg to 9 mg.
- Reduce PEMAZYRE dose from 9 mg to 4.5 mg.
If concomitant use of a strong or moderate CYP3A inhibitor is discontinued, increase the PEMAZYRE dose (after 3 plasma half-lives of the CYP3A inhibitor) to the dose that was used before starting the strong inhibitor [see Clinical Pharmacology (12.3)].
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Imprints, Shape & Color Data
- Drug Interactions
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- En Español
- Drug class: multikinase inhibitors
- FDA Approval History