Penpulimab
Penpulimab is an immunotherapy (PD-1 blocking antibody) used to treat recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) in adults, either as a first-line combination treatment or as a single agent after prior chemotherapy.
🧬 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 →
📖 Penpulimab: Patient Information Guide
A plain-language walkthrough of Penpulimab — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Penpulimab is an immunotherapy approved for adults with a specific type of head and neck cancer called non-keratinizing nasopharyngeal carcinoma (NPC).
- First-line combination therapy: Penpulimab injection, given together with cisplatin or carboplatin and gemcitabine (chemotherapy), is approved for adults whose non-keratinizing NPC has recurred (come back) or spread (metastatic) and who have not yet received treatment for advanced disease.
- Single-agent therapy: Penpulimab injection, used alone, is approved for adults with metastatic non-keratinizing NPC whose cancer has grown or spread during or after platinum-based chemotherapy and at least one other prior line of treatment.
⚙️How it works▾
Cancer cells can evade your immune system by activating a checkpoint called the PD-1 pathway. This pathway normally prevents the immune system from overreacting, but tumors exploit it to hide from immune cells called T cells. Penpulimab is a monoclonal antibody — a lab-made protein — that attaches to PD-1 receptors on T cells and blocks two proteins (PD-L1 and PD-L2) from switching off those T cells. By releasing this brake, Penpulimab restores the immune system's ability to recognize and attack the cancer.
💊How it's taken▾
Penpulimab is given only as an intravenous (IV) infusion — directly into a vein — by a trained healthcare professional in a clinic or infusion center. It is never taken by mouth.
- When combined with chemotherapy (cisplatin or carboplatin and gemcitabine): infused every 3 weeks, for up to 24 months.
- When used as a single agent: infused every 2 weeks, for up to 24 months.
- Each infusion takes 60 minutes. Treatment continues until the cancer progresses or side effects become unacceptable.
Follow your oncology team's schedule exactly. If a dose needs to be delayed due to side effects, your team will guide you on next steps.
🤒Side effects — in detail▾
The most commonly reported side effects depend on whether Penpulimab is used with chemotherapy or alone.
- With chemotherapy: nausea, vomiting, constipation, underactive thyroid (hypothyroidism), decreased appetite, weight loss, cough, COVID-19 infection, fatigue, rash, and fever
- As a single agent: anemia (low red blood cells) and hypothyroidism (underactive thyroid)
- Lab abnormalities such as low blood cell counts and changes in liver enzymes, kidney function, and electrolytes are also common
Serious immune-related reactions can affect the lungs, liver, bowel, kidneys, skin, or hormone glands — report any new or worsening symptoms to your doctor right away, as early treatment is critical.
⚠️Warnings & precautions▾
- Immune-mediated reactions: Penpulimab can trigger the immune system to attack healthy tissues in virtually any organ — including the lungs (pneumonitis), liver (hepatitis), bowel (colitis), kidneys (nephritis), skin (including rare severe reactions like Stevens-Johnson Syndrome), and hormone glands. These can be severe or fatal. Monitoring with regular blood tests is essential throughout treatment.
- Infusion reactions: Reactions during the IV infusion can occur, ranging from mild (flushing, chills) to life-threatening. Your infusion may be slowed, paused, or stopped permanently depending on severity.
- Stem cell transplant complications: Serious and potentially fatal complications can occur in patients who receive an allogeneic (donor) bone marrow or stem cell transplant before or after Penpulimab treatment.
- Embryo-fetal toxicity: Penpulimab can harm or kill a developing fetus. Women who could become pregnant must use effective contraception during treatment and for 4 months after the last dose.
- Immune-related reactions can occur at any time — even after treatment ends. Report any new or unusual symptoms promptly.
🔀What it interacts with▾
The FDA label for Penpulimab does not identify specific drug, food, or supplement interactions. Always tell your entire care team about every medication, supplement, and herbal product you take so they can watch for any potential concerns.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Penpulimab can cause fetal harm, including miscarriage or stillbirth. A pregnancy test is required before starting treatment. Effective contraception must be used during treatment and for 4 months after the last dose.
- Breastfeeding: Do not breastfeed during treatment or for 4 months after the last dose — potential risks to the infant are unknown.
- Children: Safety and effectiveness in patients under 18 have not been established; Penpulimab is not approved for pediatric use.
- Older adults (65+): No overall differences in safety or effectiveness were observed in older patients, though clinical studies included limited numbers of patients in this age group.
- Autoimmune conditions: Tell your doctor if you have any condition where your immune system attacks your own body — Penpulimab may worsen these.
- Prior organ or stem cell transplant: Serious and fatal complications have been reported; discuss your transplant history with your doctor before starting treatment.
- Liver or kidney impairment: Mild to moderate impairment does not appear to meaningfully affect how the body handles Penpulimab, but the effect of severe impairment is not fully known. Inform your doctor of any liver or kidney problems.
📡Pharmacodynamics — effects in the body▾
The full relationship between Penpulimab blood levels and its effects on the body — and the precise time course of those effects — have not been completely characterized based on currently available data.
🔬Pharmacokinetics — how your body processes it▾
Penpulimab reaches stable blood levels (steady state) by around Week 15 of treatment. It has a relatively long half-life of about 32 days, meaning it stays in the body for an extended period after each dose. The drug is distributed in a small volume (mainly the bloodstream and tissues), is cleared slowly, and is broken down into small peptides (protein fragments) through normal metabolic processes — not through the liver enzymes that process most traditional medications. Body weight, age, sex, race, and mild to moderate kidney or liver impairment do not meaningfully change how the body handles Penpulimab.
📦How to store it▾
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.
📄 Written from Penpulimab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Penpulimab — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Penpulimab and why has my doctor prescribed it? ▾
How is Penpulimab given, and how often will I need to come in? ▾
What side effects should I actually expect, and which ones do I need to call about right away? ▾
Can I get pregnant or breastfeed while on this treatment? ▾
Will Penpulimab affect my thyroid, and what does that mean for me? ▾
What happens if I need a stem cell or bone marrow transplant — does that affect my treatment with Penpulimab? ▾
Is Penpulimab available over the counter? ▾
When was Penpulimab first available? ▾
💬 Answers drafted from Penpulimab’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Penpulimab comes
Penpulimab 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.
Injection
How this form is used
- Penpulimab injection is used with cisplatin or carboplatin and gemcitabine as first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC)
- Penpulimab injection is used as a single agent to treat adults with metastatic non-keratinizing NPC after prior platinum-based chemotherapy and at least one other treatment
- Penpulimab injection is diluted and administered as an intravenous infusion over 60 minutes by a healthcare professional
- Penpulimab injection is given every 3 weeks when used with chemotherapy, or every 2 weeks when used as a single agent
- Penpulimab injection must be diluted before administration and should not be shaken; do not mix with other medications in the same IV line
- Penpulimab injection is given for up to a maximum of 24 months, or until disease progression or unacceptable side effects occur
📊 Penpulimab across the U.S. market
How Penpulimab 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.
🔍 Compare Penpulimab products
A representative set of FDA-listed product records for Penpulimab — 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 | ||||
| 100 mg/10 mL | Intravenous | Akeso Biopharma, Co., Ltd × 2 listings | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Penpulimab NDCs →
📈 What people report — real-world data (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 Penpulimab — 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 Penpulimab 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.
🏛️ The road to your pharmacy
How Penpulimab went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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 2712542 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 2712649In current FDA listingsClinical drug / strength (SCD) 10 ML penpulimab-kcqx 10 MG/MLRxCUI 2712652
Look up RxCUI 2712542 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.
📦 Supply & shortage status
Whether Penpulimab 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Akeso Biopharma, Co., Ltd is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.