FDA-filed SPL labeling · retrieved through openFDA

Toripalimab-Tpzi

Toripalimab-tpzi is an immunotherapy drug used to treat nasopharyngeal carcinoma (a type of head and neck cancer), either as a first-line combination treatment or as a single agent after prior chemotherapy.

Brand name Loqtorzi
Drug class Programmed Death Receptor-1 Blocking Antibody
Rx Form 1 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 3, 2026
🧬 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 →

At a glance
Linked label effectiveJul 23, 2026
AvailabilityRx
Earliest approval/marketing year 2023
FDA-listed product records 3
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Toripalimab-Tpzi at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Toripalimab-tpzi (Loqtorzi) is an immunotherapy used to treat nasopharyngeal carcinoma, either alongside chemotherapy at the start of treatment or alone after prior platinum-based chemotherapy. It works by helping the immune system recognize and fight cancer cells, but this same immune activation can cause serious side effects in any organ — so prompt reporting of new symptoms is essential. It is given by IV infusion in a clinical setting and requires regular monitoring of thyroid, liver, and kidney function throughout treatment.

📖 Toripalimab-Tpzi: Patient Information Guide

A plain-language walkthrough of Toripalimab-Tpzi — 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

Toripalimab-tpzi (brand name Loqtorzi) is approved to treat nasopharyngeal carcinoma (NPC) in adults in two distinct settings:

  • Loqtorzi in combination with cisplatin and gemcitabine: First-line (initial) treatment of metastatic or recurrent locally advanced NPC in adults who have not previously received systemic chemotherapy for recurrent or metastatic disease
  • Loqtorzi as a single agent: Treatment of adults with recurrent unresectable or metastatic NPC whose disease has progressed on or after a platinum-containing chemotherapy regimen
⚙️How it works

Toripalimab-tpzi is a humanized monoclonal antibody — a precision-engineered protein — that binds to the PD-1 receptor on T cells (immune cells). Certain tumors exploit this receptor by sending signals (via PD-L1 and PD-L2 proteins) that essentially tell the immune system to stand down, allowing the cancer to grow unchecked. By blocking PD-1, toripalimab-tpzi removes that suppression, freeing the immune system to mount a stronger attack against the tumor.

💊How it's taken

Loqtorzi is always given as an intravenous (IV) infusion by a healthcare professional — never taken by mouth. The schedule differs depending on how it is used:

  • With cisplatin and gemcitabine (first-line NPC): Administered every three weeks, before chemotherapy on days when both are given, for up to 24 months or until disease progression or unacceptable side effects
  • As a single agent (recurrent/metastatic NPC): Administered every two weeks until disease progression or unacceptable toxicity

The first infusion takes at least 60 minutes. If no infusion-related reactions occur, later infusions may be shortened to 30 minutes. No dose reductions are made; your doctor may pause or stop treatment depending on side effects. Always follow your prescriber's specific instructions.

🤒Side effects — in detail

Side effects vary depending on whether Loqtorzi is used with chemotherapy or alone. Common reactions include:

  • Nausea, vomiting, and constipation (especially with combination chemotherapy)
  • Decreased appetite
  • Fatigue and malaise
  • Hypothyroidism (underactive thyroid)
  • Rash or skin reactions
  • Musculoskeletal pain (muscles and joints)
  • Diarrhea
  • Upper respiratory infections
  • Peripheral neuropathy (numbness or tingling in hands or feet, mainly with combination therapy)

Serious immune-related reactions — including lung, liver, kidney, skin, heart, and hormonal problems — can occur and require prompt medical attention. Report any new or unusual symptoms to your care team right away.

⚠️Warnings & precautions

The most critical risk with toripalimab-tpzi is immune-mediated adverse reactions — when the immune system becomes overactive and attacks normal, healthy tissue. These reactions can affect any organ (lungs, liver, colon, kidneys, skin, heart, nerves, hormone glands) and can be severe or fatal. They may happen during treatment or after it has been stopped. Your care team will monitor your blood (liver enzymes, creatinine, thyroid) regularly.

  • Pneumonitis (lung inflammation): Watch for new cough, shortness of breath, or chest pain
  • Colitis (bowel inflammation): Watch for persistent diarrhea or severe abdominal pain
  • Hepatitis (liver inflammation): Watch for jaundice (yellowing), dark urine, or right-sided abdominal pain
  • Endocrinopathies (hormone gland problems): Including thyroid disorders, adrenal insufficiency, and type 1 diabetes — watch for unexplained fatigue, weight changes, headaches, or high blood sugar
  • Nephritis (kidney inflammation): Watch for reduced urination or swelling
  • Myocarditis (heart inflammation): Chest pain or abnormal heart rhythm — requires permanent discontinuation
  • Severe skin reactions: Including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
  • Infusion-related reactions: Your first infusion will be closely monitored
  • Stem cell transplant complications: Serious and fatal complications can occur in patients who undergo allogeneic HSCT before or after treatment with Loqtorzi
  • Embryo-fetal toxicity: Can cause fetal death or harm; not for use during pregnancy
🔀What it interacts with

The FDA label for toripalimab-tpzi does not identify specific drug, food, or supplement interactions. However, always tell your entire care team about every medication, supplement, and herbal product you take before starting Loqtorzi.

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: Loqtorzi can cause fetal harm, including increased risk of miscarriage or stillbirth; do not use if pregnant; a pregnancy test is required before starting treatment
  • Contraception: Women who can become pregnant must use effective birth control during treatment and for 4 months after the last dose
  • Breastfeeding: Do not breastfeed during treatment or for 4 months after the last dose due to risk of serious effects on the infant
  • Children: Safety and effectiveness in pediatric patients have not been established
  • Older adults (65+): May receive Loqtorzi; limited data available for NPC patients over 65; no overall safety differences were observed in broader pooled data
  • Organ transplant history: Risk of serious transplant rejection; tell your doctor if you have had a solid organ transplant
  • Stem cell transplant (HSCT): Fatal complications have been reported in patients who had allogeneic HSCT before or after PD-1 blocking therapy; discuss with your doctor
  • Liver or kidney impairment: Mild impairment does not significantly affect how the drug behaves; effects of moderate to severe impairment have not been fully studied
  • Autoimmune conditions or prior immune-related toxicities: Discuss any history of autoimmune disease with your doctor before starting
📡Pharmacodynamics — effects in the body

The precise relationship between toripalimab-tpzi blood levels and its effects in the body — including how quickly it produces a response and how long that response lasts — has not been fully characterized based on current data.

🔬Pharmacokinetics — how your body processes it

After IV infusion, toripalimab-tpzi distributes into a relatively small volume (about 3.7 liters), consistent with being confined mainly to the bloodstream and tissues, as expected for a large antibody. The drug reaches steady levels in the body by around week 7 of treatment. Its half-life (the time for half the drug to clear from the body) is approximately 10 days after the first dose and extends to about 18 days with continued dosing. Like other antibodies, it is broken down into small peptides through normal metabolic pathways — not through the liver enzymes that process many other drugs. Age, weight, sex, race, and mild kidney or liver impairment do not meaningfully change how the drug behaves in the body.

📦How to store it

Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze.

📄 Written from Toripalimab-Tpzi’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 →

42

Supplements & herbs that interact with Toripalimab-Tpzi

42 supplements and herbal products have documented interactions with Toripalimab-Tpzi in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 37
  • Minor · 1
Every supplement checked against Toripalimab-Tpzi — ranked by severity The full interaction hub: 4 major · 37 moderate · 1 minor · every one linked to its full report. Check Toripalimab-Tpzi against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Toripalimab-Tpzi — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Loqtorzi and how is it different from regular chemotherapy?
Loqtorzi is an immunotherapy, not a traditional chemotherapy. Instead of directly attacking cancer cells the way chemo does, it works by unlocking your immune system — specifically by blocking a 'brake' signal that tumors use to hide from your body's defenses. This allows your own immune system to recognize and fight the cancer. It's given by IV infusion, and it's sometimes combined with chemotherapy for the best effect, especially when starting treatment for the first time.
What side effects should I watch out for and report right away?
Because Loqtorzi revs up your immune system, it can sometimes cause the immune system to attack healthy organs — a group of side effects called immune-mediated reactions. Call your care team right away if you notice new shortness of breath or cough (lungs), severe diarrhea or stomach pain (intestines), yellowing of your skin or eyes (liver), significantly less urination (kidneys), or severe rashes with blistering. These can happen during treatment or even weeks after it stops, so stay alert and don't wait to report anything unusual.
How will I receive this medication and what happens during my infusion appointments?
You'll receive Loqtorzi through an IV at your cancer care clinic — it's not a pill you take at home. Your first infusion will be given slowly over at least an hour so the team can watch for any reactions. If everything goes well, later infusions can be given over about 30 minutes. If you're also receiving cisplatin and gemcitabine, Loqtorzi will always be given first on those days. You'll have regular blood tests throughout treatment to monitor your thyroid, liver, and kidneys.
Will this affect my thyroid? I've heard immunotherapy can cause thyroid problems.
Yes, thyroid changes are one of the more common side effects with Loqtorzi — particularly hypothyroidism (an underactive thyroid). When used with chemotherapy, about 38% of patients in trials experienced it. As a single agent, about 15% to 20% did. Many of these patients needed thyroid hormone replacement therapy. Your care team will check your thyroid function regularly, and if needed, hypothyroidism is very manageable with a daily thyroid hormone pill. Hyperthyroidism (overactive thyroid) can also occur but is less common.
Is it safe to get pregnant or breastfeed while on this treatment?
No — Loqtorzi can cause serious harm to a developing baby, including an increased risk of miscarriage or fetal death. You should not become pregnant during treatment. If you can get pregnant, your doctor will do a pregnancy test before you start, and you must use effective birth control throughout treatment and for 4 months after your last dose. Breastfeeding is also not recommended during treatment and for 4 months after the last dose. If you have any questions about family planning, bring them up with your oncologist before starting.
What happens if I have a bad reaction — will I have to stop treatment forever?
Not necessarily. For many immune-related side effects, your doctor will temporarily pause Loqtorzi, treat the reaction (often with corticosteroid medications), and restart once things settle. However, certain severe reactions — like serious heart inflammation, some neurological problems, or extreme liver toxicity — do require stopping permanently. Your team will always weigh the risks and benefits with you. The key is catching problems early, which is why reporting new symptoms quickly matters so much.
Is Toripalimab-Tpzi available over the counter?
Toripalimab-Tpzi is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Toripalimab-Tpzi first available?
Toripalimab-Tpzi has been available in the United States since at least 2023, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Toripalimab-Tpzi?
Toripalimab-Tpzi is supplied by 2 manufacturers listed in the FDA NDC Directory, including Coherus Oncology, Inc., Coherus BioSciences, Inc..

💬 Answers drafted from Toripalimab-Tpzi’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 Toripalimab-Tpzi comes

Toripalimab-Tpzi 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

Into a vein
Brands Loqtorzi
How this form is used
What it may be used for
  • Loqtorzi is used intravenously in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)
  • Loqtorzi is used intravenously as a single agent for adults with recurrent unresectable or metastatic NPC that has progressed on or after platinum-containing chemotherapy
Important instructions
  • Loqtorzi is administered as an intravenous infusion; the first infusion is given over at least 60 minutes, and subsequent infusions may be given over 30 minutes if no infusion reactions occurred
  • Loqtorzi should be administered before chemotherapy when both are given on the same day
  • Loqtorzi should not be given through the same IV line as other medications
  • Loqtorzi is given every three weeks when used with cisplatin and gemcitabine, or every two weeks when used as a single agent — always follow your care team's schedule
Available strengths 1 strength
3 FDA-listed product records

📊 Toripalimab-Tpzi across the U.S. market

How Toripalimab-Tpzi 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
Dose forms
2
Manufacturers
1
Brand names
3
FDA-listed product records
2023
First marketed
Coherus Oncology, Inc.67%
Coherus BioSciences, Inc.33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Toripalimab-Tpzi is used

A general measure of how commonly Toripalimab-Tpzi 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 Toripalimab-Tpzi 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.

108
Medicaid prescriptions filled (Q1–Q4 2025)
$551,655 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Toripalimab-Tpzi prescribed? Of the 1,596 medications we measure, Toripalimab-Tpzi ranks #1,495 by Medicaid prescriptions — more than 6% of them.

Where Toripalimab-Tpzi ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Toripalimab-Tpzi 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.

6 ML toripalimab-tpzi 40 MG/ML Injection

108 Medicaid prescriptions (Q1–Q4 2025) 100% of Toripalimab-Tpzi prescriptions shown $551,655 gross reimbursement (before rebates) ≈ $5,108 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2669413

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 Toripalimab-Tpzi, 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 Toripalimab-Tpzi NDCs with Medicaid activity.

🔍 Compare Toripalimab-Tpzi products

A representative set of FDA-listed product records for Toripalimab-Tpzi — 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
240 mg/6 mL Intravenous Coherus BioSciences, Inc. BLA View NDC →
240 mg/6 mL Intravenous Coherus Oncology, Inc. × 2 listings BLA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Toripalimab-Tpzi NDCs →

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.

Ingredient (IN) Toripalimab-Tpzi RxCUI 2669406 1 dose form · 1 strength
  1. Dose form (SCDF) Injection RxCUI 2669410 In current FDA listings
    Clinical drug / strength (SCD) 6 ML toripalimab-tpzi 40 MG/ML RxCUI 2669413

Look up RxCUI 2669406 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.

🏷️ Sold under these brand names

Loqtorzi

🏭 Manufacturers & labelers

Coherus Oncology, Inc. 2 Coherus BioSciences, Inc. 1

RxNorm drug class

Toripalimab-Tpzi belongs to the Programmed Death Receptor-1 Blocking Antibody class.

Pharmacologic class Programmed Death Receptor-1 Blocking Antibody
Drug family (ATC) PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
How it works Programmed Death Receptor-1-directed Antibody Interactions

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.

🔬 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 23, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Toripalimab-Tpzi.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Toripalimab-Tpzi after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
3
Distinct labelers/manufacturers represented
2
Linked representative label
Coherus Oncology, Inc.
Linked label effective
Jul 23, 2026
Composite sections available
20
Linked SPL Set ID
82e7921a-1e84-4988-9799-0ad7d19b2a75
Linked SPL Document ID
8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
Open the linked representative label on DailyMed ↗

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. Coherus Oncology, Inc. 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.