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Pemazyre Generic Name & Formulations
Legal Class
Rx
General Description
Pemigatinib 4.5mg, 9mg, 13.5mg; tabs.
Pharmacological Class
Kinase inhibitor.
How Supplied
Tabs—14
Manufacturer
Generic Availability
NO
Pemazyre Indications
Indications
In adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
Pemazyre Dosage and Administration
Adult
Confirm presence of an FGFR2 fusion or rearrangement prior to initiation. Swallow whole. 13.5mg once daily for 14 consecutive days, followed by 7 days off therapy, in 21-day cycles. Continue until disease progression or unacceptable toxicity. Concomitant strong or moderate CYP3A4 inhibitors (if unavoidable): reduce from 13.5mg to 9mg once daily, or reduce from 9mg to 4.5mg once daily. Severe renal or severe hepatic impairment: 9mg once daily. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Pemazyre Contraindications
Not Applicable
Pemazyre Boxed Warnings
Not Applicable
Pemazyre Warnings/Precautions
Warnings/Precautions
Risk of retinal pigment epithelial detachment. Perform eye exam prior to initiation, every 2 months for the first 6 months, then every 3 months thereafter; if visual symptoms develop, evaluate immediately. Monitor for hyperphosphatemia (can lead to soft tissue mineralization, cutaneous calcification, others). Initiate a low phosphate diet if serum phosphate >5.5mg/dL; if serum phosphate >7mg/dL, initiate phosphate lowering therapy and withhold, reduce dose, or permanently discontinue Pemazyre based on duration and severity. Severe renal impairment (GFR <30mL/min). Severe hepatic impairment (total bilirubin >3×ULN with any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Pemazyre Pharmacokinetics
See Literature
Pemazyre Interactions
Interactions
Potentiated by strong or moderate CYP3A4 inhibitors; avoid concomitant use; if unavoidable, reduce dose (see Adults). Antagonized by strong or moderate CYP3A4 inducers; avoid use.
Pemazyre Adverse Reactions
Adverse Reactions
Hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, dry skin; lab abnormalities, ocular toxicity.
Pemazyre Clinical Trials
See Literature
Pemazyre Note
Not Applicable
Pemazyre Patient Counseling
See Literature
Pemazyre Generic Name & Formulations
Legal Class
Rx
General Description
Pemigatinib 4.5mg, 9mg, 13.5mg; tabs.
Pharmacological Class
Kinase inhibitor.
How Supplied
Tabs—14
Manufacturer
Generic Availability
NO
Pemazyre Indications
Indications
In adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with a fibroblast growth factor receptor 1 (FGFR1) rearrangement.
Pemazyre Dosage and Administration
Adult
Confirm presence of an FGFR1 rearrangement prior to initiation. Swallow whole. 13.5mg once daily on a continuous basis until disease progression or unacceptable toxicity. Concomitant strong or moderate CYP3A4 inhibitors (if unavoidable): reduce from 13.5mg to 9mg once daily, or reduce from 9mg to 4.5mg once daily. Severe renal or severe hepatic impairment: 9mg once daily. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Pemazyre Contraindications
Not Applicable
Pemazyre Boxed Warnings
Not Applicable
Pemazyre Warnings/Precautions
Warnings/Precautions
Risk of retinal pigment epithelial detachment. Perform eye exam prior to initiation, every 2 months for the first 6 months, then every 3 months thereafter; if visual symptoms develop, evaluate immediately. Monitor for hyperphosphatemia (can lead to soft tissue mineralization, cutaneous calcification, others). Initiate a low phosphate diet if serum phosphate >5.5mg/dL; if serum phosphate >7mg/dL, initiate phosphate lowering therapy and withhold, reduce dose, or permanently discontinue Pemazyre based on duration and severity. Severe renal impairment (GFR <30mL/min). Severe hepatic impairment (total bilirubin >3×ULN with any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Pemazyre Pharmacokinetics
See Literature
Pemazyre Interactions
Interactions
Potentiated by strong or moderate CYP3A4 inhibitors; avoid concomitant use; if unavoidable, reduce dose (see Adults). Antagonized by strong or moderate CYP3A4 inducers; avoid use.
Pemazyre Adverse Reactions
Adverse Reactions
Hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, dry skin; lab abnormalities, ocular toxicity.
Pemazyre Clinical Trials
See Literature
Pemazyre Note
Not Applicable
Pemazyre Patient Counseling
See Literature
