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LOQTORZI toripalimab-tpzi 240 mg/6mL Injection — NDC 70114-340-01 (Billing 70114-0340-01)

by Coherus Oncology, Inc. · 1 VIAL, GLASS in 1 CARTON / 6 mL in 1 VIAL, GLASS

This is a package of LOQTORZI toripalimab-tpzi 240 mg/6mL Injection from Coherus Oncology, Inc., marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 70114-0340-01
🏷️ FDA NDC (as labeled) 70114-340-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70114-340-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70114 labeler · 340 product · 01 package
Package marketed since
Oct 27, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7011434001 0
Medicaid fills, this package
125 prescriptions in the last four reported quarters
FDA record last changed
Aug 6, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70114-340-01
Product NDC 70114-340
11-digit billing NDC 70114034001
NCPDP billing unit ML — per mL (volume)
RxCUI 2669413, 2669420
UNII 8JXN261VVA
Application # BLA761240
SPL Set ID 82e7921a-1e84-4988-9799-0ad7d19b2a75
Established class (EPC) Programmed Death Receptor-1 Blocking Antibody
Mechanism of action Programmed Death Receptor-1-directed Antibody Interactions
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-27
Route INTRAVENOUS
Dosage form INJECTION
Substance TORIPALIMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 085452
GCN 54945
HICL code 049284
Ingredient (HICL) Toripalimab-Tpzi
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3R
Therapeutic class — specific (HIC3) Antineoplastic,Anti-Programmed Death-1 (Pd-1) Mab
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name LOQTORZI 240 MG/6 ML VIAL
FDB brand name Loqtorzi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085452
  • GCN: 54945
  • HICL (First Databank): 049284
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2669413
Why two NDCs? The FDA registers this code as 70114-340-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70114-0340-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LOQTORZI 240 MG/6 ML VIAL Ingredient Toripalimab-Tpzi
📗 Our plain-language guide HelloPharmacist
  • Toripalimab-tpzi, sold as Loqtorzi, treats nasopharyngeal carcinoma in adults. It is used with cisplatin and gemcitabine as first treatment, or alone if the cancer returned or spre...
  • You get it as an IV infusion at your treatment center. The first one takes about an hour, and later ones may be about 30 minutes if all goes well. On chemo days, it is given first.
  • Common ones are nausea, vomiting, low appetite, tiredness, rash, fever, muscle pain and an underactive thyroid. Your team will check your thyroid and other labs along the way.
  • Call right away for cough or trouble breathing, ongoing diarrhea, yellow skin or eyes, severe rash or blistering, or unusual thirst, headache or vision changes. These immune reacti...
📖 Read our full Toripalimab-Tpzi guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $873.17 $873.17 / 1 vial
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3263 $40.893 / J3263 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)70114-340-01
11-digit billing NDC70114-0340-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3263
DescriptorINJECTION, TORIPALIMAB-TPZI, 1 MG
Billing units / pkg40 units
How the units are derivedThis package is 6 ML; the HCPCS unit is 1 MG, so one package = 40 billing units.
Medicare Part B spend (2026 (Q1))$2,346,830 · 234 claims · $10,029.19 per claim (all NDCs under J3263)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70114-0340-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 6 mL in 1 VIAL, GLASS 2023-10-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loqtorzi 240 mg/6mLthis 70114-0340-01 Coherus 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2023
First FDA approval
Oct 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2035. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 27, 2023 ⏳ ~9.1 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Loqtorzitoripalimab-tpzi
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateOct 27, 2035
Common questions
Is there a biosimilar for LOQTORZI 240 MG/6 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Toripalimab-Tpzi inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCoherus Oncology, Inc.
FDA applicationBLA761240 (BLA)
Labeler code70114
First marketedOct 2023
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Coherus Oncology, Inc. labeler code 70114

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 138 words ▾

1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 )

1.1First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).

1.2Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION In combination with cisplatin and gemcitabine: 240 mg intravenously every three weeks ( 2.1 ) As a single agent: 3 mg/kg intravenously every two weeks ( 2.1 ) First Infusion : Infuse over 60 minutes. Subsequent Infusions : If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes.

2.1Recommended Dosage The recommended dosages of LOQTORZI are provided in Table 1. Administer as recommended [see Dosage and Administration (2.3) ]. Table 1: Recommended Dosage Indication Recommended Dosage of LOQTORZI Duration of Treatment First-line NPC 240 mg every three weeks Until disease progression, unacceptable toxicity, or up to 24 months. Recurrent NPC 3 mg/kg every two weeks Until disease progression or unacceptable toxicity.

2.2Dosage Modifications No dose reductions of LOQTORZI are recommended. In general, withhold LOQTORZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue LOQTORZI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.

Dosage modifications for LOQTORZI for adverse reactions that require management different from these general guidelines are summarized in Table 2. Table 2: Recommended Dosage Modifications for Adverse Reactions Adverse Reaction Severity Based on National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version

5.0Dose Modification ALT=alanine aminotransferase, AST=aspartate aminotransferase, DRESS=drug rash with eosinophilia and systemic symptoms, SJS=Stevens Johnson syndrome, TEN=toxic epidermal necrolysis, ULN=upper limit of normal Immune-Related Adverse Reactions [see Warnings and Precautions (5.1) ] Pneumonitis Grade 2 Withhold Resume LOQTORZI in patients with complete or partial resolution to Grade 0-1 after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids.

Grades 3 or 4 Permanently discontinue Colitis Grade 2 or 3 Withhold Grade 4 Permanently discontinue Hepatitis with no tumor involvement of the liver AST/ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN Withhold AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Hepatitis with tumor involvement of the liver If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue LOQTORZI based on recommendations for hepatitis with no liver involvement.

Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN Withhold Baseline AST or ALT is above the ULN and increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN Permanently discontinue Endocrinopathies Grades 3 or 4 Withhold until clinically stable or permanently discontinue depending on severity Nephritis with Renal Dysfunction Grade 2 or 3 increased blood creatinine Withhold Grade 4 increased blood creatinine Permanently discontinue Exfoliative Dermatologic Conditions Suspected SJS, TEN, or DRESS Withhold Confirmed SJS, TEN, or DRESS Permanently discontinue Myocarditis Grades 2, 3, or 4 Permanently discontinue Neurological toxicities Grade 2 Withhold Grade 3-4 Permanently discontinue Other Adverse Reactions Infusion-related reactions [see Warnings and Precautions (5.2) ] Grade 1 or 2 Interrupt or slow the rate of infusion Grade 3 or 4 Stop infusion P… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 240 mg/6 mL (40 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial. Injection: 240 mg/6 mL (40 mg/mL) solution in a single-dose vial ( 3 )

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None . None

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.

( 5.1 ) Withhold or permanently discontinue based on severity and type of reaction. ( 5.1 ) Infusion-related reactions : Interrupt, slow the rate of infusion, or permanently discontinue LOQTORZI based on the severity of reaction. ( 5.2 ) Complications of allogeneic HSCT : Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

( 5.3 ) Embryo-fetal toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception. ( 5.4 , 8.1 , 8.3 )

5.1Severe and Fatal Immune-Mediated Adverse Reactions LOQTORZI is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under WARNINGS AND PRECAUTIONS may not include all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time after starting PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.

Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.

In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue LOQTORZI depending on severity [see Dosage and Administration (2.2) ] .

In general, if LOQTORZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-Mediated Pneumonitis LOQTORZI in Combination with Cisplatin and Gemcitabine LOQTORZI in combination with cisplatin and gemcitabine can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

Immune-mediated pneumonitis occurred in 2.1% (3/146) of patients receiving… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] LOQTORZI in Combination with Cisplatin and Gemcitabine The most common adverse reactions (≥ 20%) are nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise.

( 6.1 ) LOQTORZI as a Single Agent The most common adverse reactions (≥ 20%) are fatigue, hypothyroidism and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coherus Oncology, Inc. at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience 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 data described in the WARNINGS AND PRECAUTIONS section reflect exposure to LOQTORZI at a dose of 240 mg every 3 weeks in combination with up to 6 cycles of cisplatin and gemcitabine, followed by LOQTORZI 240 mg IV every 3 weeks, in 146 patients with NPC enrolled in a randomized, double-blind, placebo-controlled trial (JUPITER-02).

Among the 146 patients, 73% were exposed to LOQTORZI for 6 months or more and 54% were exposed for 12 months or more. The most common adverse reactions (≥ 20%) were: nausea (71%), vomiting (68%), decreased appetite (55%), constipation (39%), hypothyroidism (38%), rash (36%), pyrexia (32%), diarrhea (31%), peripheral neuropathy (30%), cough (26%), musculoskeletal pain (25%), upper respiratory infection (23%), insomnia (23%), dizziness (21%), and malaise (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were: decreased neutrophils (58%), decreased lymphocytes (57%), decreased hemoglobin (50%) decreased platelets (33%), decreased potassium (10%), decreased sodium (9%), increased alanine aminotransferase (6%) increased or decreased magnesium (4.2% each), decreased calcium (3.5%), increased aspartate aminotransferase (2.7%), and bilirubin increased (2.1%).

The data described in the WARNINGS AND PRECAUTIONS section also reflects exposure to LOQTORZI as a single agent at a dose of 3 mg/kg IV every 2 weeks in 851 patients enrolled in 12 trials: one randomized, active-controlled trial and 11 open-label, non-randomized trials. The tumor types included nasopharyngeal carcinoma (n=193) or other types of tumors (n=658). Among the 851 patients treated with LOQTORZI as a single agent, 35% were exposed for 6 months or more and 20% were exposed for 12 months or more.

In this pooled safety population, the most common (≥20%) adverse reactions were: fatigue (22%), hypothyroidism (20%), and musculoskeletal pain (20%). The most common Grade 3 or 4 laboratory abnormalities (≥2%), were decreased sodium (9%), decreased lymphocytes (8%), decreased hemoglobin (7%), decreased fibrinogen (4.5%), increased lipase (4.0%), increased amylase (2.9%), decreased phosphate (2.8%), increased aspartate aminotransferase (2.6%), increased glucose (2.5%), and increased triglycerides (2.1%). First-line Treatment of Metastatic or Recurrent, Locally Advanced Nasopharyngeal Carcinoma (NPC) The safety of LOQTORZI in combination with cisplatin and gemcitabine was evaluated in JUPITER-02 [see Clinical Studies (14) ] .

Key eligibility criteria were recurrent locally advanced or metastatic nasopharyngeal carcinoma (NPC) not previously treated with systemic chemotherapy for recurrent or metastatic disease. Patients with recurrent NPC after treatment with curative intent were required to have an interval of at least 6 months between… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on its mechanism of action, LOQTORZI can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] . There are no available data on the use of LOQTORZI in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus and result in fetal death (see Data ) .

Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LOQTORZI can potentially be transmitted from the mother to the developing fetus. Advise 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 Animal reproduction studies have not been conducted with LOQTORZI to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering LOQTORZI during pregnancy could include increased rates of abortion or stillbirth.

As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to toripalimab-tpzi may increase the risk of developing immune-mediated disorders or altering the normal immune response.

8.2Lactation Risk Summary There are no data on the presence of toripalimab-tpzi in human milk or its effects on the breastfed child or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to toripalimab-tpzi are unknown.

Because of the potential for serious adverse reactions in breastfed children, advise lactating women not to breastfeed during treatment with LOQTORZI and for 4 months after the last dose.

8.3Females and Males of Reproductive Potential LOQTORZI can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating LOQTORZI [see Use in Specific Populations (8.1) ] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with LOQTORZI and for 4 months after the last dose.

8.4Pediatric Use The safety and effectiveness of LOQTORZI have not been established in pediatric patients [see Indications and Usage (1) ].

8.5Geriatric Use Of the 146 patients with NPC who were treated with LOQTORZI in combination with cisplatin and gemcitabine 7 (4.8%) were 65 years or older; there were no patients 75 years and older. Clinical studies of LOQTORZI in combination with cisplatin and gemcitabine did not include a sufficient number of patients aged 65 years and over with NPC to determine whether they respond differently from younger patients. Of the 851 patients with tumor types including nasopharyngeal carcinoma or other types of tumors from the safety pool treated with LOQTORZI as a single agent, 171 (20%) patients were 65 years or older and 13 (1.5%) patients were 75 years and older.

No overall differences in safety were observed between elderly patients and younger patients [see Adverse Reactions (6.1) ]. Of the 190 patients with NPC treated with LOQTORZI as single agent, 10 (5%) patients were 65 years or older; there were no patients 75 years and older. Clinical studies of LOQTORZI did not include sufficient numbers of pati… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action, LOQTORZI can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] . There are no available data on the use of LOQTORZI in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus and result in fetal death (see Data ) .

Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LOQTORZI can potentially be transmitted from the mother to the developing fetus. Advise 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 Animal reproduction studies have not been conducted with LOQTORZI to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering LOQTORZI during pregnancy could include increased rates of abortion or stillbirth.

As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to toripalimab-tpzi may increase the risk of developing immune-mediated disorders or altering the normal immune response.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of LOQTORZI have not been established in pediatric patients [see Indications and Usage (1) ].

🧓 Geriatric Use 185 words ▾

8.5Geriatric Use Of the 146 patients with NPC who were treated with LOQTORZI in combination with cisplatin and gemcitabine 7 (4.8%) were 65 years or older; there were no patients 75 years and older. Clinical studies of LOQTORZI in combination with cisplatin and gemcitabine did not include a sufficient number of patients aged 65 years and over with NPC to determine whether they respond differently from younger patients. Of the 851 patients with tumor types including nasopharyngeal carcinoma or other types of tumors from the safety pool treated with LOQTORZI as a single agent, 171 (20%) patients were 65 years or older and 13 (1.5%) patients were 75 years and older.

No overall differences in safety were observed between elderly patients and younger patients [see Adverse Reactions (6.1) ]. Of the 190 patients with NPC treated with LOQTORZI as single agent, 10 (5%) patients were 65 years or older; there were no patients 75 years and older. Clinical studies of LOQTORZI did not include sufficient numbers of patients aged 65 years and over with NPC to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

12.2Pharmacodynamics The toripalimab-tpzi exposure-response relationships and time course of pharmacodynamic response are not fully characterized.

12.3Pharmacokinetics Toripalimab-tpzi pharmacokinetic parameters are presented as geometric mean (coefficient of variation [CV]%) unless otherwise noted. Toripalimab-tpzi concentrations increased in non-linearly over the dose range of 0.3 to 10 mg/kg every two weeks (0.1 to 3.3 times the approved recommended 3 mg/kg dosage in a 64 kg patient). Steady state was reached by Week 7.

The mean accumulation ratio was approximately 1.4 for maximum concentration (C max ) and 1.9 for area under the serum concentration curve (AUC) following multiple doses at the approved recommended dosages of 240 mg Q3W in combination with cisplatin and gemcitabine and 3 mg/kg Q2W as monotherapy. Distribution The mean volume of distribution at steady state (V ss ) of toripalimab-tpzi was

3.7L (27%). Elimination The mean clearance (CL) was 14.9 mL/h (31%) after the first dose and 9.5 mL/h (36%) at steady state. The mean terminal half-life (t 1/2 ) (± standard deviation) was 10 ± 1.5 days after the first dose and 18 ± 9.4 days at steady state.

Metabolism Toripalimab-tpzi is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics were observed based on age (21 to 85 years), body weight (32 to 164 kg), sex, race (White and Asian), concomitant chemotherapy, mild renal impairment (creatinine clearance [CLcr] 60 to 89 mL/min), mild hepatic impairment (total bilirubin > 1 to 1.5 times ULN with any AST or total bilirubin ≤ ULN with AST > ULN), tumor burden and primary cancer.

The effect of moderate (total bilirubin >1.5 to 3 times ULN and any AST) or severe (total bilirubin > 3 times ULN and any AST) hepatic impairment or of moderate (CLcr 30 to 59 mL/min) or severe (CLcr 15 to 29 mL/min ) renal impairment on the pharmacokinetics of toripalimab-tpzi has not been studied.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of LOQTORZI or of other toripalimab products. Of the 146 evaluable patients in JUPITER-02 with nasopharyngeal cancer who received LOQTORZI 240 mg every 3 weeks for a median duration of 15.1 months, in combination with gemcitabine and cisplatin, 3.4% tested positive for treatment-emergent ADA.

Of the 190 evaluable patients in study POLARIS-02 with nasopharyngeal cancer who received LOQTORZI 3 mg/kg every 2 weeks for a median duration of 3.3 months, 3.7% of patients developed treatment-emergent ADA. Neutralizing antibodies have not been tested. Due to the low incidence of ADA, the effect of these antibodies on the pharmacokinetics, pharmacodynamics, safety, or effectiveness of LOQTORZI is unknown.

🧬 Mechanism of Action 98 words ▾

12.1Mechanism of Action Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Toripalimab-tpzi is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

📦 How Supplied / Storage and Handling 57 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING LOQTORZI (toripalimab-tpzi), injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied in a carton containing one 240 mg/6 mL (40 mg/mL) single-dose vial (NDC 70114-340-01). Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

📋 Description 116 words ▾

11 DESCRIPTION Toripalimab-tpzi is a programmed death receptor-1 (PD-1) blocking antibody. Toripalimab-tpzi is a humanized immunoglobulin G4 (IgG4) kappa immunoglobulin that has a predicted molecular weight of approximately 150 kDa. It is expressed in a recombinant Chinese Hamster Ovary (CHO) mammalian cell expression system.

LOQTORZI (toripalimab-tpzi) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intravenous use supplied in a single-dose vial. Each vial contains 240 mg of LOQTORZI in 6 mL of solution. Each mL of solution contains 40 mg toripalimab-tpzi, citric acid monohydrate (0.51 mg), mannitol (25 mg), polysorbate 80 (0.20 mg), sodium chloride (2.92 mg), sodium citrate (4.65 mg), and Water for Injection, USP, at pH 6.0.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Immune-Mediated Adverse Reactions Inform patients of the risk of immune-mediated adverse reactions that may be severe or fatal, may occur after discontinuation of treatment, and may require corticosteroid treatment and interruption or discontinuation of LOQTORZI. These reactions may include: Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (5.1) ] .

Colitis: Advise patients to contact their healthcare provider immediately for diarrhea or severe abdominal pain [see Warnings and Precautions (5.1) ] . Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, or easy bruising or bleeding [see Warnings and Precautions (5.1) ] . Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, or Type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] .

Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis [see Warnings and Precautions (5.1) ] . Severe skin reactions: Advise patients to contact their healthcare provider immediately for any signs or symptoms of severe skin reactions, SJS or TEN [see Warnings and Precautions (5.1) ] . Other immune-mediated adverse reactions: Advise patients that other immune-mediated adverse reactions can occur and may involve any organ system.

Advise patients to contact their healthcare provider immediately for any new or worsening signs or symptoms [see Warnings and Precautions (5.1) ] . Advise patients of the risk of solid organ transplant rejection and to contact their healthcare provider immediately for signs or symptoms of organ transplant rejection [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions [see Warnings and Precautions (5.2) ] .

Complications of Allogeneic HSCT Advise patients of the risk of post-allogeneic hematopoietic stem cell transplantation complications [see Warnings and Precautions (5.3) ] . Embryo-Fetal Toxicity Advise females of reproductive potential that LOQTORZI can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] . Advise females of reproductive potential to use effective contraception during treatment with LOQTORZI and for 4 months after the last dose [see Warnings and Precautions (5.4) , Use in Specific Populations (8.1 , 8.3) ] .

Lactation Advise women not to breastfeed during treatment with LOQTORZI and for 4 months after the last dose [see Use in Specific Populations (8.2) ] . Laboratory Tests Advise patients of the importance of keeping scheduled appointments for blood work or other laboratory tests [see Warnings and Precautions (5.1) ] .

💬 Medication Guide ~3 min read ▾

Medication Guide LOQTORZI (lok tor zee) (toripalimab-tpzi) injection This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 07/2025 What is the most important information I should know about LOQTORZI?

LOQTORZI is a medicine that may treat nasopharyngeal cancer by working with your immune system. LOQTORZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death.

You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended. Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including: Lung problems cough shortness of breath chest pain Intestinal problems diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdomen) pain or tenderness Liver problems yellowing of skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach-area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting change in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems rash itching skin blistering or peeling painful sores or ulcers in your mouth or in your nose, throat, or genital area fever or flu-like symptoms swollen lymph nodes Problems can also happen in other organs and tissues.

These are not all of the signs and symptoms of immune system problems that can happen with LOQTORZI. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe or life-threatening .

Signs or symptoms of infusion reactions may include: chills or shaking itching or rash flushing shortness of breath or wheezing dizziness feeling like passing out fever back pain Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor, depending on the type of organ transplant that you have had. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LOQTORZI. Your healthcare provider will monitor you for these complications.

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 LOQTORZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines.

Your healthcare provider may also need to delay or completely stop treatment with LOQTORZI if you have severe side effects. What is LOQTORZI? LOQTORZI is a prescription medicine used to treat adults with a kind of cancer called… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Toripalimab-tpzi pharmacokinetic parameters are presented as geometric mean (coefficient of variation [CV]%) unless otherwise noted. Toripalimab-tpzi concentrations increased in non-linearly over the dose range of 0.3 to 10 mg/kg every two weeks (0.1 to 3.3 times the approved recommended 3 mg/kg dosage in a 64 kg patient). Steady state was reached by Week 7.

The mean accumulation ratio was approximately 1.4 for maximum concentration (C max ) and 1.9 for area under the serum concentration curve (AUC) following multiple doses at the approved recommended dosages of 240 mg Q3W in combination with cisplatin and gemcitabine and 3 mg/kg Q2W as monotherapy. Distribution The mean volume of distribution at steady state (V ss ) of toripalimab-tpzi was

3.7L (27%). Elimination The mean clearance (CL) was 14.9 mL/h (31%) after the first dose and 9.5 mL/h (36%) at steady state. The mean terminal half-life (t 1/2 ) (± standard deviation) was 10 ± 1.5 days after the first dose and 18 ± 9.4 days at steady state.

Metabolism Toripalimab-tpzi is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics were observed based on age (21 to 85 years), body weight (32 to 164 kg), sex, race (White and Asian), concomitant chemotherapy, mild renal impairment (creatinine clearance [CLcr] 60 to 89 mL/min), mild hepatic impairment (total bilirubin > 1 to 1.5 times ULN with any AST or total bilirubin ≤ ULN with AST > ULN), tumor burden and primary cancer.

The effect of moderate (total bilirubin >1.5 to 3 times ULN and any AST) or severe (total bilirubin > 3 times ULN and any AST) hepatic impairment or of moderate (CLcr 30 to 59 mL/min) or severe (CLcr 15 to 29 mL/min ) renal impairment on the pharmacokinetics of toripalimab-tpzi has not been studied.

🧬 Pharmacodynamics 16 words ▾

12.2Pharmacodynamics The toripalimab-tpzi exposure-response relationships and time course of pharmacodynamic response are not fully characterized.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine The efficacy of LOQTORZI in combination with cisplatin and gemcitabine was investigated in JUPITER-02 (NCT03581786), a randomized, multicenter, single region, double-blind, placebo-controlled trial in 289 patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. Patients with recurrent NPC after treatment with curative intent were required to have an interval of at least 6 months between the last dose of radiotherapy or chemotherapy and recurrence.

Patients with autoimmune disease, other than stable hypothyroidism or Type I diabetes, and patients who required systemic immunosuppression were ineligible. Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1) and disease stage (recurrent versus metastatic). Patients were randomized (1:1) to receive one of the following treatments: LOQTORZI 240 mg intravenously every 3 weeks in combination with cisplatin 80 mg/m 2 on Day 1 every 3 weeks gemcitabine 1000 mg/m 2 on Days 1 and 8 for up to 6 cycles, followed by LOQTORZI 240 mg once every 3 weeks, or Placebo intravenously every 3 weeks in combination with cisplatin 80 mg/m 2 on Day 1 every 3 weeks and gemcitabine 1000 mg/m 2 on Days 1 and 8 for up to 6 cycles, followed by placebo once every 3 weeks.

Treatment with LOQTORZI or placebo continued until disease progression per RECIST v1.1, unacceptable toxicity, or a maximum of 2 years. Administration of LOQTORZI was permitted beyond radiographic progression if the patient was deriving benefit as assessed by the investigator. Tumor assessments were performed every 6 weeks for the first 12 months and every 9 weeks thereafter.

The main efficacy outcome measure was Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS) according to RECIST v1.1. Additional efficacy outcome measures include BIRC-assessed overall response rate (ORR) and overall survival (OS). The study population characteristics were: median age of 48 years (range: 19 to 72), 4.8% age 65 or older, 83% male, 100% Asian, and 57% had ECOG PS of 0.

Eighty-six percent of patients had metastatic disease at study entry. Histological subtypes of NPC included 98% non-keratinizing, 1% keratinizing squamous cell carcinoma, and 1% did not have the subtype identified. Efficacy results of the pre-specified interim analysis of PFS and final analysis of OS are summarized in Table 7 and Figure 1 below.

The trial demonstrated statistically significant improvements in BIRC-assessed PFS, ORR and OS for patients randomized to LOQTORZI in combination with cisplatin/gemcitabine compared to cisplatin and gemcitabine with placebo. Table 7: Efficacy Results in JUPITER-02 Endpoints LOQTORZI Cisplatin/Gemcitabine N =146 Placebo Cisplatin/Gemcitabine N =143 BIRC=blinded independent review committee; CI= confidence interval; NR=Not Reached; NE=Not estimable. BIRC-Assessed Progression-free Survival PFS and ORR results are based on the pre-specified interim analysis with data cutoff of May 30, 2020.

Number of Events, n (%) 49 (34) 79 (55) Median, months (95% CI) 11.7 (11.0, NE) 8.0 (7.0, 9.5) Hazard Ratio (95% CI) Based on the stratified Cox proportional-hazards model using the stratification factors at randomization, ECOG performance status and disease stage. 0.52 (0.36, 0.74) p-value Two-sided p-value, based on the stratified log-rank test, as compared with an alpha boundary of 0.010. 0.0003 BIRC-Assessed Overall Response Rate ORR, % (95% CI) 77 (70, 84) 66 (58, 74) Complete Response Rate (%) 19 11 Partial Response Rate (%) 58 55 p-value Two-sided p-value, based upon Cochran-Mantel-Haenszel test.

0.0353 BIRC-Assessed Duration of Response Median, months (95% CI) 10.0 (8.8, NE) 5.7 (5.4, 6.8) Overall Survival OS results are based on the final analysis w… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 146 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to test the potential of toripalimab-tpzi for carcinogenicity or genotoxicity. Fertility studies have not been conducted with toripalimab-tpzi. In 4-week and 26-week repeat-dose toxicology studies in sexually mature cynomolgus monkeys, there were no adverse or notable effects in the male and female reproductive organs.

13.2Animal Toxicology and/or Pharmacology In animal models, inhibition of PD-1/PD-L1 signaling increased the severity of some infections and enhanced inflammatory responses. Mycobacterium tuberculosis -infected PD-1 knockout mice exhibit markedly decreased survival compared with wild-type controls, which correlated with increased bacterial proliferation and inflammatory responses in these animals. PD-1 blockade using a primate anti-PD1 antibody was also shown to exacerbate M. tuberculosis infection in rhesus macaques.

PD-1 and PD-L1 knockout mice and mice receiving PD-L1 blocking antibody have also shown decreased survival following infection with lymphocytic choriomeningitis virus.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 55 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to test the potential of toripalimab-tpzi for carcinogenicity or genotoxicity. Fertility studies have not been conducted with toripalimab-tpzi. In 4-week and 26-week repeat-dose toxicology studies in sexually mature cynomolgus monkeys, there were no adverse or notable effects in the male and female reproductive organs.

📄 Recent Major Changes 21 words ▾

Warnings and Precautions ( 5.1 ) 04/2024 Dosage and Administration ( 2 ) 10/2024 Warnings and Precautions ( 5.1 ) 07/2026

📄 Package Label / Principal Display Panel 54 words ▾

PRINCIPAL DISPLAY PANEL - 240 mg/6 mL Vial Carton NDC 70114-340-01 Rx Only LOQTORZI ™ (toripalimab-tpzi) injection 240 mg/6 mL (40 mg/mL) For Intravenous Infusion After Dilution ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide. 1 Single-dose vial. Discard unused portion. PRINCIPAL DISPLAY PANEL - 240 mg/6 mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
125
Units reimbursed last 4 qtrs
684
Gross reimbursed last 4 qtrs
$597.2K
Avg / prescription
$4,777.98
Avg / unit
$873.17
Latest quarter Q1 2026
12Rx
Fee-for-service vs managed care ⓘ
50% FFS 50% MCO
Fee-for-service · 62 Rx Managed care · 63 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 138 units · 2.4 per 100k residents MN Wisconsin: no data reported WI Michigan: 96 units · 1.0 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 36 units · 0.3 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 414 units · 1.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.32.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Minnesota 2.4 /100k
2 California 1.1 /100k
3 Michigan 1.0 /100k
4 Illinois 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Loqtorzi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Loqtorzi. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$277K
Claims incl. refills
30
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$9,234.25
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Coherus Oncology, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Coherus Oncology, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3263 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70114-0220-02 · Coherus 70114-0440-01 · Coherus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.