Pemazyre Tablet
FDA Label NDC 50881-028

PEMAZYRE is indicated for the treatment of 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 [see Dosage and Administration (2.1)].

This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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.

The recommended dose reductions for adverse reactions are provided in Table 1.

The recommended dosage modifications for adverse reactions are provided in Table 2.

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)].

Tablets:

• 4.5 mg: round, white to off-white tablet debossed on one side with "I" and "4.5" on the other side.
• 9 mg: oval, white to off-white tablet debossed on one side with "I" and "9" on the other side.
• 13.5 mg: round, white to off-white tablet debossed on one side with "I" and "13.5" on the other side.

None.

Retinal Pigment Epithelial Detachment (RPED)

PEMAZYRE can cause RPED, which may cause symptoms such as blurred vision, visual floaters, or photopsia. Clinical trials of PEMAZYRE did not conduct routine monitoring including optical coherence tomography (OCT) to detect asymptomatic RPED; therefore, the incidence of asymptomatic RPED with PEMAZYRE is unknown.

Among 466 patients who received PEMAZYRE across clinical trials, RPED occurred in 6% of patients, including Grade 3-4 RPED in 0.6%. The median time to first onset of RPED was 62 days. RPED led to dose interruption of PEMAZYRE in 1.7% of patients, and dose reduction and permanent discontinuation in 0.4% and in 0.4% of patients, respectively. RPED resolved or improved to Grade 1 levels in 87.5% of patients who required dosage modification of PEMAZYRE for RPED.

Perform a comprehensive ophthalmological examination including OCT prior to initiation of PEMAZYRE and every 2 months for the first 6 months and every 3 months thereafter during treatment. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of PEMAZYRE.

Modify the dose or permanently discontinue PEMAZYRE as recommended [see Dosage and Administration (2.3)].

Dry Eye

Among 466 patients who received PEMAZYRE across clinical trials, dry eye occurred in 27% of patients, including Grade 3-4 in 0.6% of patients. Treat patients with ocular demulcents as needed.

Increases in phosphate levels are a pharmacodynamic effect of PEMAZYRE [see Clinical Pharmacology (12.2)]. Among 466 patients who received PEMAZYRE across clinical trials, hyperphosphatemia was reported in 92% of patients based on laboratory values above the upper limit of normal. The median time to onset of hyperphosphatemia was 8 days (range 1-169). Phosphate lowering therapy was required in 29% of patients receiving PEMAZYRE.

Monitor for hyperphosphatemia and initiate a low phosphate diet when serum phosphate level is > 5.5 mg/dL. For serum phosphate levels > 7 mg/dL, initiate phosphate lowering therapy and withhold, reduce the dose, or permanently discontinue PEMAZYRE based on duration and severity of hyperphosphatemia [see Dosage and Administration (2.3)].

Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm when administered to a pregnant woman. Oral administration of pemigatinib to pregnant rats during the period of organogenesis caused fetal malformations, fetal growth retardation, and embryo-fetal death at maternal exposures lower than the human exposure based on area under the curve (AUC) at the clinical dose of 13.5 mg.

Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose [see Use in Special Population (8.1, 8.3)].

The following adverse reactions are discussed elsewhere in the labeling:

• Ocular Toxicity [see Warnings and Precautions (5.1)]
• Hyperphosphatemia [see Warnings and Precautions (5.2)]

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 (14.1)]. 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 abnormalitiesin FIGHT-202.

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]).

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 (12.3)].

Strong and Moderate CYP3A Inducers

Concomitant use of PEMAZYRE with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations, [see Clinical Pharmacology (12.3)] which may reduce the efficacy of PEMAZYRE. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE.

Strong and Moderate CYP3A Inhibitors

Concomitant use of a strong or moderate CYP3A inhibitor with PEMAZYRE increases pemigatinib plasma concentrations, [see Clinical Pharmacology (12.3)] which may increase the incidence and severity of adverse reactions. Reduce PEMAZYRE dose if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided [see Dosage and Administration (2.2)].

Risk Summary

Based on findings in an animal study and its mechanism of action, PEMAZYRE can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of PEMAZYRE in pregnant women. Oral administration of pemigatinib to pregnant rats during the period of organogenesis at maternal plasma exposures below the human exposure at the clinical dose of 13.5 mg resulted in fetal malformations, fetal growth retardation, and embryo-fetal death (see Data). Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Once daily oral administration of pemigatinib to pregnant rats during the period of organogenesis resulted in 100% embryofetal mortality due to post-implantation loss at doses ≥ 0.3 mg/kg (approximately 0.6 times the human exposure based on AUC at the clinical dose of 13.5 mg). Fetal survival was unaffected at 0.1 mg/kg per day; however, once daily oral administration of pemigatinib at the 0.1 mg/kg dose level (approximately 0.2 times the human exposure based on AUC at the clinical dose of 13.5 mg) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification.

Risk Summary

There are no data on the presence of pemigatinib 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, advise women not to breastfeed during treatment and for 1 week after the final dose.

Pregnancy Testing

Verify pregnancy status of females of reproductive potential prior to initiating PEMAZYRE [see Use in Specific Populations (8.1)].

Contraception

PEMAZYRE can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)].

Females

Advise females of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose.

Males

Advise males with female partners of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose.

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

Animal Toxicity Data

In 4- or 13-week repeat-dose toxicology studies in rats and non-human primates, animals displayed toxicities in bone and teeth at pemigatinib exposures lower than the human exposure at the clinical dose of 13.5 mg. Physeal and cartilage dysplasia were present in multiple bones in both species, and tooth (incisor) abnormalities (complete loss of ameloblasts with associated secondary changes) occurred in rats. Six weeks after cessation of dosing, these findings did not show complete evidence of recovery, and additional tooth-related findings (mal-aligned, whitened, broken, and trimmed/thinned incisors) developed in the 13-week study.

In FIGHT-202, 32% of patients were 65 years and older, and 8% of patients were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients.

No dose adjustment is recommended for patients with mild or moderate renal impairment (glomerular filtration rate (GFR) ≥ 30 to <90 mL/min estimated by Modification of Diet in Renal Disease (MDRD) equation). The recommended dose of PEMAZYRE has not been established for patients with severe renal impairment (GFR <30 mL/min) [see Clinical Pharmacology (12.3)].

No dose adjustment is recommended for patients with mild (total bilirubin > upper limit of normal (ULN) to 1.5 × ULN or AST > ULN) or moderate hepatic impairment (total bilirubin >1.5–3 × ULN with any AST). The recommended dose of PEMAZYRE has not been established for patients with severe hepatic impairment (total bilirubin >3 × ULN with any AST) [see Clinical Pharmacology (12.3)].

Pemigatinib is a kinase inhibitor with the chemical name 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2H-pyrrolo[3',2':5,6]pyrido[4,3-d]pyrimidin-2-one. Pemigatinib has a molecular formula of C₂₄H₂₇F₂N₅O₄ and molecular mass of 487.5 g/mole. Pemigatinib has the following chemical structure:

Chemical Structure (Pemazyre 1)

Pemigatinib is a white to off-white solid that is not hygroscopic. The solubility of pemigatinib is pH dependent with decreasing solubility observed with increasing pH. PEMAZYRE tablets are uncoated and for oral administration. Tablets are available containing 4.5 mg, 9 mg, or 13.5 mg of pemigatinib active ingredient. The inactive ingredients include magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Pemigatinib is a small molecule kinase inhibitor that targets FGFR1, 2 and 3 with IC₅₀ values of less than 2 nM. Pemigatinib also inhibited FGFR4 in vitro at a concentration approximately 100 times higher than those that inhibit FGFR1, 2, and 3. Pemigatinib inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling. Constitutive FGFR signaling can support the proliferation and survival of malignant cells. Pemigatinib exhibited anti-tumor activity in mouse xenograft models of human tumors with FGFR1, FGFR2, or FGFR3 alterations resulting in constitutive FGFR activation including a patient-derived xenograft model of cholangiocarcinoma that expressed an oncogenic FGFR2-Transformer-2 beta homolog (TRA2b) fusion protein.

Cardiac Electrophysiology

At a dose 1.5 times the maximum recommended dose, PEMAZYRE does not result in a large mean increase (i.e. >20 ms) of the QTc interval.

Serum Phosphate

Pemigatinib increased serum phosphate levels as a consequence of FGFR inhibition. In patients, the increase in serum phosphate observed after treatment with pemigatinib was exposure-dependent across the dose range of 1 to 20 mg once daily (0.07 to 1.5 times the recommended dose), with increased risk of hyperphosphatemia with higher pemigatinib exposure.

The geometric mean steady-state pemigatinib AUC_0-24h was 2620 nM·h (54% CV) and C_max was 236 nM (56% CV) for 13.5 mg orally once daily. Steady state pemigatinib concentrations increased proportionally over the dose range of 1 to 20 mg (0.07 to 1.5 times the recommended dose). Steady-state was achieved within 4 days following repeated once daily dosing. With repeated once daily dosing, pemigatinib accumulated with a median accumulation ratio of 1.63 (range 0.63 to 3.28).

Absorption

The median time to achieve peak pemigatinib plasma concentration (T_max) was 1.13 (0.50‑6.00) hours.

Effect of Food

Administration of PEMAZYRE with a high-fat and high-calorie meal (approximately 1000 calories with 150 calories from protein, 250 calories from carbohydrate, and 500‑600 calories from fat) had no clinically meaningful effect on pemigatinib pharmacokinetics.

Distribution

The estimated apparent volume of distribution was 235 L (60.8%) following a 13.5 mg oral dose. In vitro, pemigatinib was 90.6% bound to human plasma proteins at concentrations ranging from 1 to 10 µM.

Elimination

The geometric mean elimination half-life (t_½) of pemigatinib was 15.4 (51.6% CV) hours and the geometric mean apparent clearance (CL/F) was 10.6 L/h (54% CV).

Metabolism

Pemigatinib is predominantly metabolized by CYP3A4 in vitro. The major drug-related moiety in plasma was unchanged pemigatinib in a human [¹⁴C] mass balance study.

Excretion

Following a single oral 11 mg dose of radiolabeled pemigatinib, 82.4% of the dose was recovered in feces (1.4% as unchanged) and 12.6% in urine (1% as unchanged).

Specific Populations

No clinically meaningful differences in the systemic exposure of pemigatinib were observed based on age (21 ‑ 79 years), sex, race/ethnicity, body weight (39.8 ‑ 156 kg), mild to moderate renal impairment, or mild to moderate hepatic impairment. The effect of severe renal impairment, renal dialysis in end-stage renal disease, or severe hepatic impairment on pemigatinib exposure is unknown.

Drug Interaction Studies

Clinical Studies and Model-Based Approaches

Effect of CYP3A Inhibitors on Pemigatinib: Itraconazole, a strong CYP3A inhibitor, increased C_max by 17% and increased AUC by 88% following a single oral PEMAZYRE dose of 4.5 mg [see Drug Interactions (7.1)].

Concomitant use of moderate CYP3A inhibitors is predicted to increase pemigatinib exposure by approximately 50-80% [see Drug Interactions (7.1)].

Effect of CYP3A Inducers on Pemigatinib: Rifampin, a strong CYP3A inducer, decreased pemigatinib C_max by 62% and AUC by 85% following a single oral PEMAZYRE dose of 13.5 mg [see Drug Interactions (7.1)]. Concomitant use of a moderate CYP3A inducer is predicted to decrease pemigatinib exposure by more than 50% [see Drug Interactions (7.1)].

Effect of Acid-Lowering Agents on Pemigatinib: Esomeprazole, a proton pump inhibitor, decreased pemigatinib C_max by 35% and AUC by 8% following a single oral PEMAZYRE dose of 13.5 mg; these differences are not expected to be clinically meaningful. Ranitidine, a histamine-2 antagonist, did not affect pemigatinib exposure.

Other Drugs: No clinically significant differences in glucose levels were observed when metformin (OCT2/MATE1 substrate) was co-administered with pemigatinib.

In Vitro Studies

Effect of Pemigatinib on CYP Enzymes: Pemigatinib is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 or an inducer of CYP1A2, CYP2B6, or CYP3A4.

Pemigatinib as a Substrate for Transporters: Pemigatinib is a substrate of both P-gp and BCRP. P-gp or BCRP inhibitors are not expected to affect pemigatinib exposure at clinically relevant concentrations.

Effect of Pemigatinib on Transporters: Pemigatinib is an inhibitor of P-gp, OCT2, and MATE1. Pemigatinib may increase serum creatinine by decreasing renal tubular secretion of creatinine; this may occur due to inhibition of renal transporters OCT2 and MATE1 and may not affect glomerular function [see Adverse Reactions (6.1)].

Carcinogenicity studies have not been conducted with pemigatinib.

Pemigatinib was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay and was not clastogenic in either an in vitro chromosome aberration assay or an in vivo micronucleus assay in rats.

Dedicated fertility studies with pemigatinib have not been conducted. Oral administration of pemigatinib did not result in any dose-related findings likely to result in impaired fertility in male and female reproductive organs.

FIGHT-202 (NCT02924376), a multicenter open-label single-arm trial, evaluated the efficacy of PEMAZYRE in 107 patients with locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after at least 1 prior therapy and who had an FGFR2 gene fusion or non-fusion rearrangement, as determined by a clinical trial assay performed at a central laboratory. Qualifying in-frame fusions and other rearrangements were predicted to have a breakpoint within intron 17/exon 18 of the FGFR2 gene leaving the FGFR2 kinase domain intact.

Patients received PEMAZYRE in 21-day cycles at a dosage of 13.5 mg orally once daily for 14 consecutive days, followed by 7 days off therapy. PEMAZYRE was administered until disease progression or unacceptable toxicity. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR) as determined by an independent review committee (IRC) according to RECIST v1.1.

The median age was 56 years (range: 26 to 77 years), 61% were female, 74% were White, and 95% had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (42%) or 1 (53%). Ninety-eight percent of patients had intrahepatic cholangiocarcinoma. Eighty-six percent of patients had in-frame FGFR2 gene fusions and the most commonly identified FGFR2 fusion was FGFR2-BICC1 (34%). Fourteen percent of patients had other FGFR2 rearrangements that could not be confidently predicted to be in-frame fusions, including rearrangements without an identifiable partner gene. All patients had received at least 1 prior line of systemic therapy, 27% had 2 prior lines of therapy, and 12% had 3 or more prior lines of therapy. Ninety-six percent of patients had received prior platinum-based therapy including 76% with prior gemcitabine/cisplatin.

Efficacy results are summarized in Table 5.

The median time to response was 2.7 months (range 0.7 – 6.9 months).

PEMAZYRE tablets are available as follows:

• 4.5 mg: Round, white to off-white debossed on one side with “I” and “4.5” on the other side in bottles of 14 with child-resistant closure, NDC 50881-026-01
• 9 mg: Oval, white to off-white debossed on one side with “I” and “9” on the other side in bottles of 14 with child-resistant closure, NDC 50881-027-01
• 13.5 mg: Round, white to off-white debossed on one side with “I” and “13.5” on the other side in bottles of 14 with child-resistant closure, NDC 50881-028-01

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

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Ocular Toxicity

Advise patients that PEMAZYRE may cause ocular toxicity including RPED and to immediately inform their healthcare provider if they experience any visual changes. Also advise patients that they should use artificial tear or substitutes, hydrating or lubricating eye gels in order to prevent or treat dry eyes [see Warnings and Precautions (5.1)].

Hyperphosphatemia

Inform patients that they may experience increase in phosphate levels and of the need to monitor serum phosphate levels. They should immediately inform their healthcare provider of any symptoms related to acute change in phosphate levels such as muscle cramps, numbness, or tingling around the mouth [see Warnings and Precautions 5.2)].

Nail Disorders

Advise patients that PEMAZYRE may cause nail disorders [see Adverse Reactions (6.1)].

Embryo-Fetal Toxicity

• Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of pregnancy[see Warnings and Precautions (5.3) and Use in Specific Populations (8.1)].
• Advise females of reproductive potential to use effective contraception during treatment with PEMAZYRE and for 1 week after the final dose [see Use in Specific Populations(8.3)].
• Advise males with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 1 week after receiving the final dose of PEMAZYRE[see Use in Specific Populations (8.3)].
  

Lactation

• Advise patients not to breastfeed during treatment with PEMAZYRE and for 1 week after the final dose [see Use in Specific Populations (8.2)].

Administration

• Instruct patients do not crush, chew, split or dissolve tablets.
• Instruct patients if they miss a dose by 4 or more hours or if they vomit after taking a dose, resume dosing with the next scheduled dose. Extra tablets should not be taken to make up for the missed dose [see Dosage and Administration (2.2)].

Drug Interactions

Advise patients to inform their healthcare providers of all concomitant medications, herbal and dietary supplements. Advise patients to avoid grapefruit products during treatment with PEMAZYRE [see Drug Interactions (7.1)].

Manufactured for:
Incyte Corporation
Wilmington, DE 19803

PEMAZYRE is a trademark of Incyte Corporation.
U.S. Patent Nos. 9,611,267 and 10,131,667
© 2020 Incyte Corporation. All rights reserved.

Rx only

NDC 50881-026-01

Pemazyre^TM (pemigatinib) tablets

4.5 mg

14 tablets

Pemazyre (pemigatinib) 4.5mg Tablets (14 Tablet Bottle Label)

Rx only

NDC 50881-027-01

Pemazyre^TM (pemigatinib) tablets

9 mg

14 tablets

Pemazyre (pemigatinib) 9mg Tablets (14 Tablet Bottle Label)

Rx only

NDC 50881-028-01

Pemazyre^TM (pemigatinib) tablets

13.5 mg

14 tablets

Pemazyre (pemigatinib) 13.5mg Tablets (14 Tablet Bottle Label)