Mogamulizumab-kpkc Injection
Mogamulizumab-kpkc Injection (Poteligeo) is an intravenous antibody medicine used for adults with certain T-cell skin lymphomas, mycosis fungoides and Sézary syndrome, that have come back or not responded to earlier treatment.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Poteligeo (mogamulizumab) is a specialist IV antibody for adults whose mycosis fungoides or Sézary syndrome (skin T-cell lymphomas) has come back or stopped responding after earlier body-wide treatment; it latches onto a protein called CCR4 on the cancer cells and flags them for immune destruction, and has been available in the U.S. since about 2018. Many people handle it reasonably well, though rash is common, as are tiredness, diarrhea and infusion reactions like chills or flushing. Report a new or worsening rash right away, especially with blistering, peeling skin or mouth sores, because fatal skin reactions have occurred. Fever or cough deserves a quick call too, since serious infections occur.
Clinical pearls
- Make sure any transplant team knows you received Poteligeo, because severe graft-versus-host disease has occurred after later donor stem cell transplants.
- The first infusion usually comes after diphenhydramine (Benadryl) and acetaminophen, so expect drowsiness and arrange a ride home.
- Because CCR4 also sits on regulatory T-cells (the immune system’s brakes), mention any autoimmune condition before starting.
- Women who can become pregnant need a pregnancy check first and effective contraception during treatment and for 3 months after.
Patient information guide A plain-language walkthrough of Mogamulizumab-kpkc Injection, written from its FDA label.
What Mogamulizumab-kpkc Injection is used for
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Mogamulizumab-kpkc Injection is used for a specific type of T-cell lymphoma.
- Poteligeo (intravenous) treats adults with relapsed or refractory mycosis fungoides after at least one prior systemic therapy.
- Poteligeo (intravenous) treats adults with relapsed or refractory Sézary syndrome after at least one prior systemic therapy.
How Mogamulizumab-kpkc Injection works
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Mogamulizumab-kpkc is a monoclonal antibody that binds to CCR4, a protein found on the surface of some T-cell cancers. Binding marks these cells for destruction by the immune system, a process called antibody-dependent cellular cytotoxicity. CCR4 is also found on regulatory T-cells and a subset of Th2 T-cells.
Mogamulizumab-kpkc Injection dosage
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Poteligeo is an IV infusion given by a healthcare professional over at least 60 minutes. Doses are based on your weight.
- Given weekly for the first 28-day cycle, then every two weeks in later cycles.
- Continues until the disease progresses or side effects become unacceptable.
- Not given under the skin or by rapid IV push.
- Premedication with diphenhydramine and acetaminophen is given for the first infusion.
- If a dose is missed, the next dose is given as soon as possible and the schedule resumed.
Dosing details from the FDA-approved label
From the Mogamulizumab-kpkc Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (POTELIGEO, mogamulizumab-kpkc)
- 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, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity
- Administer within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume dosing schedule; premedicate with diphenhydramine and acetaminophen for the first infusion
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 ). 2.1 Recommended Dosage 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. 2.2 Dose Modifications for Toxicity 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. 2.3 Preparation and Administration Preparation Visually inspect drug product solution for particulate matter and discoloration prior to administration. POTELIGEO is a clear to slightly opalescent colorless solution.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mogamulizumab-kpkc Injection side effects
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The most common side effects in clinical trials were:
Common side effects
- Rash
- Infusion-related reactions
- Fatigue
- Diarrhea
- Musculoskeletal pain
- Upper respiratory tract infection
- Skin infection
- Fever
When to get medical help
- Call your care team about a new or worsening rash, especially with blistering, peeling skin or mouth sores. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred and can be fatal.
- Tell your team right away if you have chills, fever, flushing, or trouble breathing during or after an infusion.
- Report signs of infection promptly, such as fever, cough, or skin redness or warmth. Serious infections like pneumonia and sepsis have occurred.
- Report symptoms that could point to autoimmune complications, so your team can pause or stop treatment if needed.
- If you have had or may have a donor stem cell transplant (allogeneic HSCT), tell your team. Severe graft-versus-host disease and transplant-related death have occurred after Poteligeo.
Other common effects included skin infection, fever, nausea, swelling, low platelets, headache, constipation, mouth sores, anemia, cough and high blood pressure. Serious reactions include severe skin reactions, infusion reactions, serious infections and autoimmune problems. Report these promptly.
Mogamulizumab-kpkc Injection warnings and precautions
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- Dermatologic toxicity: Fatal and life-threatening skin reactions, including SJS and TEN, have occurred. Treatment is paused for moderate or severe rash and stopped for life-threatening rash.
- Infusion reactions: The infusion is paused and symptoms are treated. It is restarted at a slower rate once symptoms resolve. Life-threatening reactions mean permanent discontinuation.
- Infections: Your team will monitor you and treat infections promptly.
- Autoimmune complications: Treatment may be interrupted or permanently stopped.
- Stem cell transplant: Severe graft-versus-host disease and transplant-related death have occurred when a donor transplant follows Poteligeo.
Before taking Mogamulizumab-kpkc Injection
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- There are no listed contraindications.
- Not recommended during pregnancy or in women of childbearing potential not using contraception. Pregnancy status should be checked before starting.
- Use effective contraception during treatment and for 3 months after the last dose.
- Discuss breastfeeding with your doctor.
- Safety and effectiveness have not been established in children.
- Adults 65 and older were studied and no overall differences in effectiveness were seen.
What Mogamulizumab-kpkc Injection does in the body
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The relationship between mogamulizumab-kpkc exposure and its effects, and the time course of those effects, are unknown. In laboratory studies, the drug causes depletion of cells that carry CCR4.
How your body processes Mogamulizumab-kpkc Injection
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Blood levels of mogamulizumab-kpkc rise in proportion to the dose. With repeated dosing, steady levels are reached after 8 doses (about 12 weeks). The terminal half-life is about 17 days. Age, sex, and ethnicity did not cause clinically significant changes in how the body handles the drug.
How to store Mogamulizumab-kpkc Injection
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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.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Mogamulizumab-kpkc Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mogamulizumab-kpkc Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Poteligeo used for?
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How will I receive it?
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What side effects should I expect?
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When should I call my care team right away?
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Can I use it if I'm pregnant or breastfeeding?
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Do I need to tell my doctor about a stem cell transplant?
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Is Mogamulizumab-kpkc Injection available over the counter?
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When was Mogamulizumab-kpkc Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Mogamulizumab-kpkc Injection on HelloPharmacist
Mogamulizumab-kpkc Injection forms and strengths (how it comes)
Mogamulizumab-kpkc Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Mogamulizumab-kpkc Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Poteligeo is used for adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.
- Poteligeo is given as an intravenous infusion over at least 60 minutes.
- Poteligeo must not be given under the skin or by rapid intravenous administration.
- Poteligeo is diluted before use and given through an IV line with an in-line filter, without other drugs in the same line.
- Poteligeo's first infusion is preceded by diphenhydramine and acetaminophen.
Mogamulizumab-kpkc Injection on the U.S. market: products, makers and brands
How Mogamulizumab-kpkc Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Mogamulizumab-kpkc Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2018. Brand names on the directory include Poteligeo; the rest are generics.
How widely Mogamulizumab-kpkc Injection is used (Medicaid data)
A general measure of how commonly Mogamulizumab-kpkc Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Mogamulizumab-kpkc Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Mogamulizumab-kpkc Injection prescribed? Of the 1,601 medications we measure, Mogamulizumab-kpkc Injection ranks #1,440 by Medicaid prescriptions — more than 10% of them.
Utilization by Mogamulizumab-kpkc Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
5 ML mogamulizumab-kpkc 4 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2054081
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mogamulizumab-kpkc Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Mogamulizumab-kpkc Injection NDCs with Medicaid activity.
Compare Mogamulizumab-kpkc Injection products
A representative set of FDA-listed product records for Mogamulizumab-kpkc Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 4 mg/mL | Intravenous | Kyowa Kirin, Inc. | BLA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Mogamulizumab-kpkc Injection NDCs →
Mogamulizumab-kpkc Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mogamulizumab-kpkc Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mogamulizumab-kpkc Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Mogamulizumab-kpkc Injection FDA approval history
How Mogamulizumab-kpkc Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Mogamulizumab-kpkc Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Mogamulizumab-kpkc recalls since July 2021.
✅No Mogamulizumab-kpkc recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2054068 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2054080In current FDA listingsClinical drug / strength (SCD) 5 ML mogamulizumab-kpkc 4 MG/MLRxCUI 2054081
Look up RxCUI 2054068 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Mogamulizumab-kpkc Injection supply and shortage status
Whether Mogamulizumab-kpkc Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Mogamulizumab-kpkc Injection brand names
Mogamulizumab-kpkc Injection is sold under one brand name in the FDA directory — Poteligeo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mogamulizumab-kpkc Injection: manufacturers and labelers
One company lists Mogamulizumab-kpkc Injection products with the FDA. By number of product records, the largest are Kyowa Kirin, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Mogamulizumab-kpkc Injection drug class (RxNorm)
Mogamulizumab-kpkc Injection belongs to the Monoclonal Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Mogamulizumab-kpkc Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Kyowa Kirin, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →