Medically reviewed by Drugs.com. Last updated on Jun 16, 2021.
Generic name: PEMIGATINIB 4.5mg
Dosage form: tablet
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 dosage from 13.5 mg to 9 mg.
- Reduce PEMAZYRE dosage from 9 mg to 4.5 mg.
If concomitant use of a strong or moderate CYP3A inhibitor is discontinued, increase the PEMAZYRE dosage (after 3 plasma half-lives of the CYP3A inhibitor) to the dosage that was used before starting the strong or moderate inhibitor [see Clinical Pharmacology (12.3)].
Recommended Dosage for Severe Renal Impairment
The recommended dosage of PEMAZYRE for patients with severe renal impairment (eGFR estimated by MDRD 15 to 29 mL/min/1.73 m2) is 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles [see Renal Impairment (8.6) and Clinical Pharmacology (12.3)].
Recommended Dosage for Severe Hepatic Impairment
The recommended dosage of PEMAZYRE for patients with severe hepatic impairment (total bilirubin > 3 × ULN with any AST) is 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles [see Hepatic Impairment (8.7) and Clinical Pharmacology (12.3)].
More about Pemazyre (pemigatinib)
- Side Effects
- During Pregnancy
- Imprints, Shape & Color Data
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: multikinase inhibitors
- FDA Approval History
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