Pemazyre

Last updated on RxList: 3/3/2021
Pemazyre Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Pemazyre?

Pemazyre (pemigatinib) is a kinase inhibitor used to treat 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.

What Are Side Effects of Pemazyre?

Side effects of Pemazyre include:

Dosage for Pemazyre

The recommended dose 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.

Pemazyre In Children

The safety and effectiveness of Pemazyre have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Pemazyre?

Pemazyre may interact with other medicines such as:

  • strong and moderate CYP3A inhibitors and inducers

Tell your doctor all medications and supplements you use.

Pemazyre During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Pemazyre; it may harm a fetus or result in loss of pregnancy. Females of reproductive potential and males with female partners of reproductive potential are advised to use effective contraception during treatment with Pemazyre and for 1 week after the final dose. There are no data on the presence of Pemazyre or its metabolites in human milk or their effects on either the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children from Pemazyre, breastfeeding is not recommended during treatment and for 1 week after the final dose.

Additional Information

Our Pemazyre (pemigatinib) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

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Pemazyre Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • eye problems--eye pain or redness, dry or puffy eyes, watery eyes, your eyes may be more sensitive to light;
  • vision changes--blurred vision, seeing black spots or "floaters," or seeing flashes of light; or
  • high phosphate levels in your blood--muscle cramps, numbness, tingly feeling around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • high or low phosphate levels in your blood;
  • dry eyes;
  • stomach pain, nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • mouth sores, dry mouth;
  • joint pain, back pain;
  • feeling tired;
  • problems with your fingernails or toenails;
  • dry skin, hair loss; or
  • changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pemazyre (Pemigatinib Tablets)

Pemazyre Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

  • Ocular Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hyperphosphatemia and Soft Tissue Mineralization [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PEMAZYRE was evaluated in FIGHT-202, which included 146 patients with previously treated, locally advanced or metastatic cholangiocarcinoma [see Clinical Studies]. Patients were treated orally with PEMAZYRE 13.5 mg once daily for 14 days on followed by 7 days off therapy until disease progression or unacceptable toxicity. The median duration of treatment was 181 days (range: 7 to 730 days).

The median age of PEMAZYRE-treated patients was 59 years (range 26-78), 58% were females, and 71% were White.

Serious adverse reactions occurred in 45% of patients receiving PEMAZYRE. Serious adverse reactions in ≥ 2% of patients who received PEMAZYRE included abdominal pain, pyrexia, cholangitis, pleural effusion, acute kidney injury, cholangitis infective, failure to thrive, hypercalcemia, hyponatremia, small intestinal obstruction, and urinary tract infection. Fatal adverse reactions occurred in 4.1% of patients, including failure to thrive, bile duct obstruction, cholangitis, sepsis, and pleural effusion.

Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received PEMAZYRE. Adverse reactions requiring permanent discontinuation in ≥ 1% of patients included intestinal obstruction and acute kidney injury.

Dosage interruptions due to an adverse reaction occurred in 43% of patients who received PEMAZYRE. Adverse reactions requiring dosage interruption in ≥ 1% of patients included stomatitis, palmar-plantar erythrodysesthesia syndrome, arthralgia, fatigue, abdominal pain, AST increased, asthenia, pyrexia, ALT increased, cholangitis, small intestinal obstruction, alkaline phosphatase increased, diarrhea, hyperbilirubinemia, electrocardiogram QT prolonged, decreased appetite, dehydration, hypercalcemia, hyperphosphatemia, hypophosphatemia, back pain, pain in extremity, syncope, acute kidney injury, onychomadesis, and hypotension.

Dose reductions due to an adverse reaction occurred in 14% of patients who received PEMAZYRE. Adverse reactions requiring dosage reductions in ≥ 1% of patients who received PEMAZYRE included stomatitis, arthralgia, palmar-plantar erythrodysesthesia syndrome, asthenia, and onychomadesis.

Table 3 summarizes the adverse reactions in FIGHT-202. Table 4 summarizes laboratory abnormalities in FIGHT-202.

Table 3 Adverse Reactions (≥ 15%) in Patients Receiving PEMAZYRE in FIGHT-202

Adverse ReactionPEMAZYRE
N=146
All Gradesa
(%)
Grades ≥ 3*
(%)
Metabolism and nutrition disorders
Hyperphosphatemiab600
Decreased appetite331.4
Hypophosphatemiac2312
Dehydration153.4
Skin and subcutaneous tissue disorders
Alopecia490
Nail toxicityd432.1
Dry skin200.7
Palmar-plantar erythrodysesthesia syndrome154.1
Gastrointestinal disorders
Diarrhea472.7
Nausea402.1
Constipation350.7
Stomatitis355
Dry mouth340
Vomiting271.4
Abdominal pain234.8
General disorders
Fatigue424.8
Edema peripheral180.7
Nervous system disorders
Dysgeusia400
Headache160
Eye disorders
Dry eyee350.7
Musculoskeletal and connective tissue disorders
Arthralgia256
Back pain202.7
Pain in extremity192.1
Infections and infestations
Urinary tract infection162.7
Investigations
Weight loss162.1
*Only Grades 3 – 4 were identified.
a Graded per NCI CTCAE 4.03.
b Includes hyperphosphatemia and blood phosphorous increased; graded based on clinical severity and medical interventions taken according to the "investigations-other, specify" category in NCI CTCAE v4.03.
c Includes hypophosphatemia and blood phosphorous decreased.
d Includes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail ridging, nail infection, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.
e Includes dry eye, keratitis, lacrimation increased, pinguecula, and punctate keratitis.

Clinically relevant adverse reactions occurring in ≤ 10% of patients included fractures (2.1%). In all patients treated with pemigatinib, 1.3% experienced pathologic fractures (which included patients with and without cholangiocarcinoma [N=466]). Soft tissue mineralization, including cutaneous calcification, calcinosis, and non-uremic calciphylaxis associated with hyperphosphatemia were observed with PEMAZYRE treatment.

Table 4: Select Laboratory Abnormalities (≥ 10%) Worsening from Baseline in Patients Receiving PEMAZYRE in FIGHT-202

Laboratory AbnormalityPEMAZYREa
N=146
All Gradesb (%)Grades ≥ 3 (%)
Hematology
Decreased hemoglobin436
Decreased lymphocytes368
Decreased platelets283.4
Increased leukocytes270.7
Decreased leukocytes181.4
Chemistry
Increased phosphatec940
Decreased phosphate6838
Increased alanine aminotransferase434.1
Increased aspartate aminotransferase436
Increased calcium434.1
Increased alkaline phosphatase4111
Increased creatinined411.4
Decreased sodium3912
Increased glucose360.7
Decreased albumin340
Increased urate3010
Increased bilirubin266
Decreased potassium265
Decreased calcium172.7
Increased potassium122.1
Decreased glucose111.4
aThe denominator used to calculate the rate varied from 142-146 based on the number of patients with a baseline value and at least one post-treatment value.
bGraded per NCI CTCAE 4.03.
cBased on CTCAE 5.0 grading.
dGraded based on comparison to upper limit of normal.

Increased Creatinine

Within the first 21-day cycle of PEMAZYRE dosing, serum creatinine increased (mean increase of 0.2 mg/dL) and reached steady state by Day 8, and then decreased during the 7 days off therapy. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Pemazyre (Pemigatinib Tablets)

© Pemazyre Patient Information is supplied by Cerner Multum, Inc. and Pemazyre Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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