DailyMed Label: POTELIGEO

DailyMed Label: POTELIGEO

2023

DailyMed Prescription

POTELIGEO

mogamulizumab-kpkc

Kyowa Kirin, Inc.

NDC: 42747-761

NDC: 42747-761

Mogamulizumab-kpkc is a recombinant humanized monoclonal antibody that targets CC chemokine receptor 4 (CCR4)-expressing cells. Mogamulizumab-kpkc is an IgG1 kappa immunoglobulin that has a calculated molecular mass of approximately 149 kDa. Mogamulizumab-kpkc is produced by recombinant DNA technology in Chinese hamster ovary cells. POTELIGEO (mogamulizumab-kpkc) injection is a sterile, ready-to-use, preservative-free, clear to slightly opalescent colorless solution in a single-dose vial for dilution prior to intravenous infusion. Each vial contains 20 mg of mogamulizumab-kpkc in 5 mL of solution. Each mL of solution contains 4 mg of mogamulizumab-kpkc and is formulated in: citric acid monohydrate (0.44 mg), glycine (22.5 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP. May contain hydrochloric acid/sodium hydroxide to adjust pH to 5.5.

POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. POTELIGEO is a CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy ( 1 ).

1 mg/kg as an intravenous infusion over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle ( 2 ). The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity. Administer POTELIGEO within 2 days of the scheduled dose. If a dose is missed, administer the next dose as soon as possible and resume dosing schedule. Do not administer POTELIGEO subcutaneously or by rapid intravenous administration. Recommended Premedications Administer premedication with diphenhydramine and acetaminophen for the first POTELIGEO infusion. Dermatologic Toxicity Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) [ see Warnings and Precautions (5.1) ]. If SJS or TEN is suspected, stop POTELIGEO and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less. If moderate or severe (Grades 2 or 3) rash occurs, interrupt POTELIGEO and administer at least 2 weeks of topical corticosteroids. If rash improves to Grade 1 or less, POTELIGEO may be resumed [ see Warnings and Precautions (5.1) ]. If mild (Grade 1) rash occurs, consider topical corticosteroids. Infusion Reactions Permanently discontinue POTELIGEO for a life-threatening (Grade 4) infusion reaction [ see Warnings and Precautions (5.2) ]. Temporarily interrupt the infusion of POTELIGEO for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If reaction recurs and is unmanageable, discontinue infusion. [ see Warnings and Precautions (5.2) ]. If an infusion reaction occurs, administer premedication (such as diphenhydramine and acetaminophen) for subsequent POTELIGEO infusions. Preparation Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution. Discard the vial if cloudiness, discoloration, or particulates are observed. Calculate the dose (mg/kg) and number of vials of POTELIGEO needed to prepare the infusion solution based on patient weight. Aseptically withdraw the required volume of POTELIGEO into the syringe and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP. The final concentration of the diluted solution should be between 0.1 mg/mL to 3.0 mg/mL. Mix diluted solution by gentle inversion. Do not shake. Discard any unused portion left in the vial. The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags. Administration Administer infusion solution over at least 60 minutes through an intravenous line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter. Do not mix POTELIGEO with other drugs. Do not co-administer other drugs through the same intravenous line. Storage of Diluted Solution After preparation, infuse the POTELIGEO solution immediately, or store under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation. Do not freeze. Do not shake.

Injection: 20 mg/5 mL (4 mg/mL) as a clear to slightly opalescent colorless solution in a single-dose vial. Injection: 20 mg/5 mL (4 mg/mL) solution in a single-dose vial ( 3 ).

None. None ( 4 ).

Dermatologic Toxicity : Temporarily interrupt POTELIGEO for moderate or severe skin rashes. Permanently discontinue POTELIGEO for life-threatening rash ( 5.1 ). Infusion Reactions : Temporarily interrupt POTELIGEO for any infusion reaction. Permanently discontinue POTELIGEO for any life-threatening infusion reaction ( 5.2 ). Infections : Monitor and treat promptly ( 5.3 ). Autoimmune Complications : Interrupt or permanently discontinue POTELIGEO as appropriate ( 5.4 ). Complications of Allogeneic HSCT after POTELIGEO : Monitor for severe acute graft-versus-host disease (GVHD) and steroid-refractory GVHD. Transplant-related mortality has occurred ( 5.5 ). Fatal and life-threatening skin adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred in recipients of POTELIGEO. Rash (drug eruption) is one of the most common adverse reactions associated with POTELIGEO. In Trial 1, 25% (80/319) of patients treated with POTELIGEO had an adverse reaction of drug eruption, with 18% of these cases being severe (Grade 3) and 82% of these cases being Grade 1 or 2. Of 528 patients treated with POTELIGEO in clinical trials, Grade 3 skin adverse reactions were reported in 3.6%, Grade 4 skin adverse reactions in <1%, and SJS in <1%. The onset of drug eruption is variable, and the affected areas and appearance vary. In Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. The more common presentations reported included papular or maculopapular rash, lichenoid, spongiotic or granulomatous dermatitis, and morbilliform rash. Other presentations included scaly plaques, pustular eruption, folliculitis, non-specific dermatitis, and psoriasiform dermatitis. Monitor patients for rash throughout the treatment course. Management of dermatologic toxicity includes topical corticosteroids and interruption or permanent cessation of POTELIGEO [ see Dosage and Administration (2.2) ]. Consider skin biopsy to help distinguish drug eruption from disease progression. Discontinue POTELIGEO permanently for SJS or TEN or for any life-threatening (Grade 4) reaction. For possible SJS or TEN, interrupt POTELIGEO and do not restart unless SJS or TEN is ruled out and the cutaneous reaction has resolved to Grade 1 or less. Fatal and life-threatening infusion reactions have been reported in patients treated with POTELIGEO. In Trial 1, infusion reactions occurred in 35% (112/319) of patients treated with POTELIGEO, with 8% of these reactions being severe (Grade 3). Most reactions (approximately 90%) occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. The most commonly reported signs include chills, nausea, fever, tachycardia, rigors, headache, and vomiting. Consider premedication (such as diphenhydramine and acetaminophen) for the first infusion of POTELIGEO in all patients. Whether premedication reduces the risk or severity of these reactions is not established. In Trial 1, infusion reactions occurred in 42% of patients without premedication and 32% of patients with premedication. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly [ see Dosage and Administration (2.2) ]. Fatal and life-threatening infections have occurred in patients treated with POTELIGEO, including sepsis, pneumonia, and skin infection. In Trial 1, 18% (34/184) of patients randomized to POTELIGEO had Grade 3 or higher infection or an infection-related serious adverse reaction. Monitor patients for signs and symptoms of infection and treat promptly. Fatal and life-threatening immune-mediated complications have been reported in recipients of POTELIGEO. Grade 3 or higher immune-mediated or possibly immune-mediated reactions have included myositis, myocarditis, polymyositis, hepatitis, pneumonitis, glomerulonephritis and a variant of Guillain-Barré syndrome. Use of systemic immunosuppressants for immune-mediated reactions was reported in 1.9% (6/319) of recipients of POTELIGEO in Trial 1, including for a case of Grade 2 polymyalgia rheumatica. New-onset hypothyroidism (Grade 1 or 2) was reported in 1.3% of patients and managed with observation or levothyroxine. Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease. Increased risks of transplant complications have been reported in patients who receive allogeneic HSCT after POTELIGEO including severe (Grade 3 or 4) acute graft-versus-host disease (GVHD), steroid-refractory GVHD, and transplant-related death. Among recipients of pre-transplantation POTELIGEO, a higher risk of transplant complications has been reported if POTELIGEO is given within a shorter time frame (approximately 50 days) before HSCT. Follow patients closely for early evidence of transplant-related complications.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Risk Summary There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC ( see Data ). In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data The effects of mogamulizumab-kpkc on embryo-fetal development were evaluated in 12 pregnant cynomolgus monkeys that received mogamulizumab-kpkc once weekly by intravenous administration from the start of organogenesis through delivery at an exposure level 27 times higher than the clinical dose. Mogamulizumab-kpkc administration did not show a potential for embryo-fetal lethality, teratogenicity, or fetal growth retardation and did not result in spontaneous abortion or increased fetal death. In surviving fetuses (10 of 12 compared with 11 of 12 in the control group) of cynomolgus monkeys treated with mogamulizumab-kpkc, a decrease in CCR4-expressing lymphocytes due to the pharmacological activity of mogamulizumab-kpkc was noted; there were no apparent mogamulizumab-kpkc -related external, visceral, or skeletal abnormalities. Risk Summary There is no information regarding the presence of POTELIGEO in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for POTELIGEO and any potential adverse effects on the breastfed child from POTELIGEO or from the underlying maternal condition. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. Pregnancy Testing For females of reproductive potential, verify pregnancy status prior to initiating POTELIGEO. Contraception Advise females of reproductive potential to use effective contraception during treatment with POTELIGEO and for 3 months following the last dose of POTELIGEO. The safety and effectiveness of POTELIGEO in pediatric patients have not been established. Of 319 patients with MF or SS who received POTELIGEO in Trial 1, 162 (51%) were ≥65 years. No overall differences in effectiveness were observed between these patients and younger patients. In patients aged ≥65, Grade 3 or higher adverse reactions were reported in 45% and serious adverse reactions in 36%, whereas in patients aged <65, Grade 3 or higher adverse reactions were reported in 36% and serious adverse reactions in 29%.

POTELIGEO (mogamulizumab-kpkc) injection is a sterile, preservative-free, clear to slightly opalescent colorless solution supplied in a carton containing one 20 mg/5 mL (4 mg/mL), single-dose glass vial (NDC 42747-761-01). Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in original package to protect from light until time of use. Do not freeze. Do not shake.

Mogamulizumab-kpkc is a defucosylated, humanized IgG1 kappa monoclonal antibody that binds to CCR4, a G protein-coupled receptor for CC chemokines that is involved in the trafficking of lymphocytes to various organs. Non-clinical in vitro studies demonstrate mogamulizumab-kpkc binding targets a cell for antibody-dependent cellular cytotoxicity (ADCC) resulting in depletion of the target cells. CCR4 is expressed on the surface of some T-cell malignancies and is expressed on regulatory T-cells (Treg) and a subset of Th2 T-cells. Mogamulizumab-kpkc exposure-response relationships and the time course of pharmacodynamics response are unknown. Mogamulizumab-kpkc pharmacokinetics (PK) was evaluated in patients with T-cell malignancies. Parameters are presented as the geometric mean [% coefficient of variation (%CV)] unless otherwise specified. Mogamulizumab-kpkc concentrations increased proportionally with dose over the dose range of 0.01 to 1.0 mg/kg (0.01 to 1 times the approved recommended dosage). Following repeated dosing of the approved recommended dosage, steady state concentrations were reached after 8 doses (12 weeks), and the systemic accumulation was 1.6-fold. At steady state, the peak concentration (C max,ss ) is 32 (68%) µg/mL, the trough concentration (C min,ss ) is 11 (239%) µg/mL, and AUC ss is 5,577 (125%) µg∙hr/mL. Distribution The central volume of distribution is 3.6 L (20%). Elimination The terminal half-life is 17 days (66%), and the clearance is 12 mL/h (84%). Specific Populations : No clinically significant changes in the PK of mogamulizumab-kpkc were observed based on age (range: 22 to 101 years), sex, ethnicity, renal impairment (creatinine clearance <90 mL/min, estimated by Cockcroft-Gault), mild (total bilirubin ≤ ULN and AST <ULN, or total bilirubin <1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment, disease subtype (MF or SS), degree of CCR4 expression, or ECOG status. The effect of severe hepatic impairment (total bilirubin >3 times ULN and any AST) on mogamulizumab-kpkc PK is unknown. Drug Interaction Studies No drug interaction studies have been conducted with POTELIGEO.

No carcinogenicity or genotoxicity studies have been conducted with POTELIGEO. No specific studies have been conducted to evaluate potential effects of POTELIGEO on fertility. No mogamulizumab-kpkc -related toxic effects in the male and female reproductive organs were observed in sexually mature monkeys in repeat-dose toxicology studies up to 26 weeks in duration.

Trial 1 A randomized, open-label, multicenter trial (Study 0761-010; NCT01728805) evaluated the efficacy of POTELIGEO in adult patients with MF or SS after at least one prior systemic therapy. The trial randomized 372 patients 1:1 to either POTELIGEO (186 patients; 56% with MF, 44% with SS) or vorinostat (186 patients; 53% with MF, 47% with SS). The trial included patients regardless of tumor CCR4 expression status and excluded patients with histologic transformation, prior allogeneic HSCT, autologous HSCT within 90 days, active autoimmune disease, or active infection. The trial required patients to have ANC ≥1,500/µL (≥1,000/µL if bone marrow was involved), platelet count ≥100,000/µL (≥75,000/µL if bone marrow was involved), creatinine clearance >50 mL/min or serum creatinine ≤1.5 mg/dL and hepatic transaminases ≤2.5 times ULN (≤5 times ULN if lymphomatous liver infiltration). The dose of POTELIGEO was 1 mg/kg administered intravenously over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle and on days 1 and 15 of each subsequent cycle. Vorinostat was dosed at 400 mg orally once daily, continuously for 28-day cycles. Treatment continued until disease progression or unacceptable toxicity. Vorinostat-treated patients with disease progression or unacceptable toxicities were permitted to cross over to POTELIGEO. The median age was 64 years (range: 25 to 101), 58% of patients were male, and 70% were white. At study baseline, 38% had stage IB-II disease, 10% stage III, and 52% stage IV. The median number of prior systemic therapies was 3. In the POTELIGEO arm, baseline CCR4 expression status by immunohistochemistry was available in 140 patients (75%), of whom all had CCR4 detected on ≥1% of lymphocytes on skin biopsy, and 134/140 (96%) had CCR4 detected on ≥10% of the lymphocytes. CCR4 expression status was similar in the vorinostat arm. During randomized treatment, the median duration of exposure to POTELIGEO was 5.6 months (range: <1 to 45.3 months), with 48% of patients with at least 6 months of exposure and 23% with at least 12 months of exposure. The median duration of exposure to vorinostat was 2.8 months (range: <1 to 34.8 months), with 22% of patients with at least 6 months of exposure. Efficacy was based on investigator-assessed progression-free survival (PFS), which was defined as the time from the date of randomization until documented progression of disease or death. Other efficacy measures included overall response rate (ORR) based on global composite response criteria that combine measures from each disease compartment (skin, blood, lymph nodes and viscera). Responses required confirmation at two successive disease assessments, which included the modified Severity Weighted Assessment Tool, skin photographs, central flow cytometry, and computed tomography. The trial demonstrated that POTELIGEO significantly prolonged PFS compared to vorinostat (Table 3). The Kaplan-Meier curve for PFS by Investigator is shown in Figure 1. The estimated median follow-up for investigator-assessed PFS was 13 months in the POTELIGEO arm and 10.4 months in the vorinostat arm. By independent review committee assessment, the estimated median PFS was 6.7 months (95% CI, 5.6 to 9.4) in the POTELIGEO arm and 3.8 months (95% CI, 3.0 to 4.7) in the vorinostat arm (hazard ratio 0.64; 95% CI: 0.49, 0.84). Figure 1 Kaplan-Meier Curve for Progression-Free Survival per Investigator Table 3 also summarizes investigator-assessed confirmed response rates, overall and by disease compartment. The trial demonstrated improvement in ORR with POTELIGEO. Table 3 Efficacy of Randomized Treatment (Trial 1) Outcome per Investigator POTELIGEO N=186 Vorinostat N=186 CI=confidence interval; CR=complete response; NE=not estimable; PR=partial response PFS Number of events, n 110 131   Progressive disease 104 128   Death 6 3 Median PFS (95% CI) (months) Kaplan-Meier estimate. 7.6 (5.6, 10.2) 3.1 (2.8, 4.0) Hazard ratio (95% CI) Log rank p-value 0.53 (0.41, 0.69) <.001 Overall response rate (confirmed CR + PR), n (%) Based on Global Composite Response score. , Responses in blood and skin must have persisted for at least 4 weeks to be considered confirmed and were evaluated every 4 weeks for the first year. Responses in lymph nodes, visceral disease and overall were evaluated every 8 weeks for the first year. 52 (28) 9 (5)   95% CI (22, 35) (2, 9)   P-value From Cochran-Mantel-Haenszel test adjusted for disease type, stage, and region. <.001 Duration of overall response (months)   Median (95% CI) 13.9 (9.3, 18.9) 9.0 (4.6, NE) Confirmed best overall response   CR, n (%) 4 (2) 0 (0)     95% CI (1, 5) (0, 2)   PR, n (%) 47 (25) 9 (5)     95% CI (20, 33) (2, 9) Response by compartment (confirmed CR + PR)    Blood n=124 n=125     Response rate, n (%) 83 (67) 23 (18)     95% CI (58, 75) (12, 26)    Skin n=186 n=186     Response rate, n (%) 78 (42) 29 (16)     95% CI (35, 49) (11, 22)    Lymph nodes n=136 n=133     Response rate, n (%) 21 (15) 5 (4)     95% CI (10, 23) (1, 9)    Viscera n=6 n=4     Response rate, n (%) 0 (0) 0 (0)     95% CI (0, 46) (0, 60) Figure 1

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 3/2023 PATIENT INFORMATION POTELIGEO ® ( poe–te–lig'–ee–oh ) (mogamulizumab-kpkc) injection, for intravenous use What is the most important information I should know about POTELIGEO? POTELIGEO may cause serious side effects that can be severe, life-threatening or lead to death. Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse: Skin problems. Signs and symptoms of skin reactions may include: skin pain itching skin blistering or peeling rash painful sores or ulcers in your mouth, nose, throat, or genital area Infusion reactions. Signs and symptoms of infusion reactions may include: chills or shaking redness on your face (flushing) itching or rash shortness of breath, coughing, or wheezing dizziness feeling like passing out tiredness fever Infections. Signs and symptoms of infection may include: fever, sweats, or chills nausea flu-like symptoms sore throat or difficulty swallowing shortness of breath diarrhea or stomach pain cough Autoimmune problems. Some people receiving POTELIGEO develop autoimmune problems (a condition where the immune cells in your body attack other cells or organs in the body). Some people who already have an autoimmune disease may get worse during treatment with POTELIGEO. Complications of stem cell transplantation that uses donor stem cells (allogeneic) after treatment with POTELIGEO. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with POTELIGEO. Your healthcare provider may need to delay or completely stop treatment with POTELIGEO if you have severe side effects. What is POTELIGEO? POTELIGEO is a prescription medicine used to treat mycosis fungoides (MF) or Sézary syndrome (SS) in adults when you have tried at least one prior medicine (taken by mouth or injection) and it did not work or the disease has come back. It is not known if POTELIGEO is safe and effective in children. Before receiving POTELIGEO treatment, tell your healthcare provider about all your medical conditions, including if you: have had a severe skin reaction after receiving POTELIGEO. have had an infusion-related reaction during or after receiving POTELIGEO. have or have had liver problems including hepatitis B (HBV) infection. have a history of autoimmune problems have undergone or plan to have a stem cell transplant, using stem cells from a donor. have lung or breathing problems are pregnant or plan to become pregnant. It is not known if POTELIGEO will harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with POTELIGEO. Females who are able to become pregnant should use an effective method of birth control during treatment with POTELIGEO and for 3 months after the last dose of POTELIGEO. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment with POTELIGEO. are breastfeeding or plan to breastfeed. It is not known if POTELIGEO passes into your breast milk Talk to your healthcare provider about the best way to feed your baby during treatment with POTELIGEO. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive POTELIGEO? Your healthcare provider will give you POTELIGEO into your vein through an intravenous (IV) line over at least 60 minutes. POTELIGEO is usually given on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each 28-day cycle thereafter. Your healthcare provider will decide how many treatments you need based on how well you respond and tolerate the treatment. If you miss any appointments call your healthcare provider as soon as possible. What are the possible side effects of POTELIGEO? POTELIGEO may cause serious side effects including: See " What is the most important information I should know about POTELIGEO? " The most common side effects of POTELIGEO include: rash tiredness diarrhea muscle and bone pain upper respiratory tract infection These are not all the possible side effects of POTELIGEO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of POTELIGEO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about POTELIGEO that is written for healthcare professionals. What are the ingredients in POTELIGEO? Active ingredient: mogamulizumab-kpkc Inactive ingredients: citric acid monohydrate, glycine, polysorbate 80, and Water for Injection, USP. Manufactured by: Kyowa Kirin, Inc., Princeton, NJ 08540 U.S. License No. 2077 POTELIGEO is a registered trademark of Kyowa Kirin, Inc. For more information, call 1-844-768-3544 or go to www.POTELIGEO.com.

Rx only NDC 42747-761-01 POTELIGEO ® (mogamulizumab-kpkc) Injection 20 mg/5 mL (4 mg/mL) For Intravenous Infusion Single-dose vial. Discard unused portion. PRINCIPAL DISPLAY PANEL - 4 mg/mL Vial Carton