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Gozellix GOZETOTIDE Kit — NDC 84552-0500-25 package photo

Gozellix GOZETOTIDE Kit

by Telix Innovations SA · 1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25)
NDC 84552-0500-25
🏷️ FDA NDC (as labeled) 84552-500-25 billing pads the product segment with a zero
This package
Contains1 kit in 1 carton * 2.5 mL in 1 vial, multi-dose * 6.4 mL in 1 vial, multi-dose * 2 mL in 1 ampule * 1 powder, for solution in 1 vial, multi-dose Pack sizes2 compare ↓
Also comes in: 1 kit 84552-0500-64
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 84552-500-25
Product NDC 84552-500
11-digit billing NDC 84552050025
NCPDP billing unit EA — each (per item)
Application # NDA219592
SPL Set ID abeab169-e38e-433a-b8a9-f1dab31518c8
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-20
Dosage form KIT
GCN Seq No 082959
GCN 51777
HICL code 047747
Ingredient (HICL) Kit Prep Of Ga-68/Gozetotide
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z9
Therapeutic class — intermediate (HIC2) Unclassified Drugs
HIC3 code Z9D
Therapeutic class — specific (HIC3) Diagnostic Preparations,Miscellaneous
AHFS code 36:00.00.00
AHFS class Diagnostic Agents
FDB label name GOZELLIX CONFIGURATION A KIT
FDB brand name Gozellix
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 84552-500-25 — 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 → 84552-0500-25. 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.

🏭 Manufacturer & labeler

LabelerTelix Innovations SA
Application holderTELIX INNOVATIONS SA
FDA applicationNDA219592 (NDA)
Labeler code84552
First marketedMar 2025
Product typeHuman Prescription Drug
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.

🩺 Clinical

Label name GOZELLIX CONFIGURATION A KIT Ingredient Kit Prep Of Ga-68/Gozetotide

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

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.

💲 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 kit
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gozellixthis 84552-0500-25 Telix 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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 & generic status

🏛️
2025
First FDA approval
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 20, 2025 RLD RS ⏳ ~8.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11027031 — method of use (U-3317)
2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 11027031 ↗ Method of use U-3317 Jul 28, 2035
Common questions
Is there a generic version of GOZELLIX CONFIGURATION A KIT?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for GOZELLIX CONFIGURATION A KIT. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, 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 Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Gozellix (this brand).

Top reported reactions

Injection Site Pain9
Chest Pain1
Dizziness1
Hyperhidrosis1
Hypersensitivity1
Injection Site Urticaria1
Nausea1

Age at onset

Adult4
Elderly3

Reporter sex

13 reports
Male · 100%
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84552-0500-25 You're viewing this 1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) 2025-03-20 Active
84552-0500-64 1 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) 2025-03-20 Active

Pack size FAQ

What quantity is in NDC 84552-0500-25?
NDC 84552-0500-25 is listed by the FDA — 1 kit in 1 carton * 2.5 ml in 1 vial, multi-dose * 6.4 ml in 1 vial, multi-dose * 2 ml in 1 ampule * 1 powder, for solution in 1 vial, multi-dose.
What NDC number is used to bill for this package of Gozellix GOZETOTIDE Kit?
Bill NDC 84552-0500-25 — the 11-digit billing format is 84552050025. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 ✓ Available
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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 FDA registers it as 84552-500-25, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84552-0500-25, written without dashes as 84552050025. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84552-0500-25, the first segment (84552) is the labeler code FDA assigned to Telix Innovations SA; the middle segment (0500) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Telix Innovations SA. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (84552-0500-64). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Telix Innovations SA 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.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 103 words ▾

1 INDICATIONS AND USAGE GOZELLIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy. With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. GOZELLIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy.

With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Use appropriate aseptic technique and radiation safety handling measures in the manipulation and administration of Gallium Ga 68 Gozetotide Injection. ( 2.1 ) The recommended amount of radioactivity for adults is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection.

( 2.2 ) Initiate imaging 50 minutes to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. The scan should begin caudally and proceed cranially.

( 2.10 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 )

2.1Radiation Safety - Drug Handling After radiolabeling of GOZELLIX, the vial contains Gallium Ga 68 Gozetotide Injection. Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection.

Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. Administration Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection. Calculate the necessary volume to administer based on calibration time and required dose.

Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Only use solutions that are clear, colorless to slightly yellow, and without visible particles. Assay the final dose in a dose calibrator immediately before administration to the patient.

After injection of Gallium Ga 68 Gozetotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations. Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.

2.3Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozetotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration [see Warnings and Precautions (5.2) ] .

2.4General Instructions for Drug Preparation Ga 68 Sources and GOZELLIX Carton Configurations GOZELLIX is supplied as a kit in two different carton configurations, A or B, for preparation of Gallium Ga 68 Gozetotide Injection with eluate from different Ga 68 sources. See Table 1 for GOZELLIX carton configurations to be used with different Ga 68 sources. Table 1.

Ga 68 Sources and GOZELLIX Carton Configuration Ga 68 Source GOZELLIX Carton Configuration to be Used Cyclotron-produced via GE FASTlab A Cyclotron-produced via Alternative Radioisotope Technologies for Medical Science (ARTMS) QUANTM Irradiation System (QIS) A Eckert & Ziegler (EZAG) GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator A IRE ELiT Galli Eo Ge 68/Ga 68 generator B The Ge 68/Ga 68 generators and cyclotron are not supplied with GOZELLIX. Follow the instructions for use…

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS Kit for the preparation of Gallium Ga 68 Gozetotide Injection contains: Vial 1 (Gozetotide): 25 mcg of gozetotide as a white to off-white lyophilized powder in a multiple-dose vial Vial 2A (2.5 mL) or Vial 2B (6.4 mL) (Acetate Buffer): 150 mg anhydrous sodium acetate as a sterile clear colorless solution Vial 2A in Configuration A for use with cyclotron-produced Ga 68 via GE FASTlab or ARTMS QIS, or EZAG Gallia Pharm generator Vial 2B in Configuration B for use with IRE EliT Galli Eo generator Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution After radiolabeling with Ga 68, Vial 1 contains up to 18,500 MBq (500 mCi) of Gallium Ga 68 Gozetotide Injection in 10 mL at calibration date and time as a clear, colorless to slightly yellow solution in a multiple-dose vial.

Kit for the preparation of Gallium Ga 68 Gozetotide Injection contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a lyophilized powder in a multiple-dose vial Vial 2A (2.5 mL) or Vial 2B (6.4 mL) (Acetate Buffer): 150 mg of anhydrous sodium acetate as a sterile solution Vial 2A in Configuration A for use with cyclotron-produced Ga 68 via GE FASTlab or ARTMS QIS, or EZAG generator Vial 2B in Configuration B for use with IRE generator Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) ascorbic acid (USP injection grade) as a sterile solution.

( 3 ) After radiolabeling with Ga 68, Vial 1 contains up to 18,500 MBq (500 mCi) of Gallium Ga 68 Gozetotide Injection in 10 mL in a multiple-dose vial at calibration date and time.

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake can be seen in a variety of tumor types and in non-malignant processes. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. ( 5.1 ) Radiation Risks: Ensure safe handling to protect patients and health care providers from unintentional radiation exposure.

( 2.1 , 5.2 ) Hypersensitivity Reactions to Sulfites: Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause life-threatening hypersensitivity reactions including anaphylaxis. ( 5.3 )

5.1Risk for Misinterpretation Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis.

The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [ see Clinical Studies (14.1 , 14.2) ] . Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

5.2Radiation Risks Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care providers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.3) ] .

5.3Hypersensitivity Reactions to Sulfites Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

🤒 Adverse Reactions 190 words ▾

6 ADVERSE REACTIONS The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Telix Pharmaceuticals (US) Inc. at 1-844-455-8638 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical 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 safety of GOZELLIX has been established based on two prospective studies of another formulation of gallium Ga 68 gozetotide in patients with prostate cancer [see Clinical Studies (14.1 , 14.2) ] . Below is a display of the adverse reactions in these studies. The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide.

The average injected activity was 188.7 ±

40.7MBq (5.1 ± 1.1 mCi) [see Clinical Studies (14.1 , 14.2) ] . The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

🔄 Drug Interactions 60 words ▾

7 DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary GOZELLIX is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including GOZELLIX, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide.

8.2Lactation Risk Summary GOZELLIX is not indicated for use in females. There are no data on the presence of gallium Ga 68 gozetotide in human milk, the effect on the breastfed infant, or the effect on milk production.

8.4Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established.

8.5Geriatric Use The efficacy of gallium Ga 68 gozetotide PET in geriatric patients with prostate cancer is based on data from two prospective studies [see Clinical Studies (14.1 , 14.2) ]. Of the total number of subjects in the PSMA-PreRP and PSMA-BCR studies, 691 of 960 (72%) patients were 65 years of age and older while 195 (20%) were 75 years of age and older. The efficacy and safety profiles of gallium Ga 68 gozetotide appear similar in younger adult and geriatric patients with prostate cancer and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

🤰 Pregnancy 81 words ▾

8.1Pregnancy Risk Summary GOZELLIX is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including GOZELLIX, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use The safety and effectiveness of gallium Ga 68 gozetotide in pediatric patients have not been established.

🧓 Geriatric Use 105 words ▾

8.5Geriatric Use The efficacy of gallium Ga 68 gozetotide PET in geriatric patients with prostate cancer is based on data from two prospective studies [see Clinical Studies (14.1 , 14.2) ]. Of the total number of subjects in the PSMA-PreRP and PSMA-BCR studies, 691 of 960 (72%) patients were 65 years of age and older while 195 (20%) were 75 years of age and older. The efficacy and safety profiles of gallium Ga 68 gozetotide appear similar in younger adult and geriatric patients with prostate cancer and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE In the event of an overdose of gallium Ga68 gozetotide, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.

🧬 Clinical Pharmacology 141 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 is a β+ emitting radionuclide that allows positron emission tomography.

12.2Pharmacodynamics The relationship between gallium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials.

12.3Pharmacokinetics Distribution Intravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low.

Elimination A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.

🧬 Mechanism of Action 38 words ▾

12.1Mechanism of Action Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 is a β+ emitting radionuclide that allows positron emission tomography.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied GOZELLIX (kit for the preparation of gallium Ga 68 gozetotide injection) is available in two different configurations. GOZELLIX Configuration "A" (NDC 84552-500-25), intended for use with Ga 68 produced from a cyclotron and purified via GE FASTlab or ARTMS QIS, or an Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator, contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 84552-501-25) Vial 2A (Acetate Buffer): 150 mg/2.5 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a red flip off cap (NDC 84552-502-25) Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution in a glass ampule (NDC 84552-504-25) GOZELLIX Configuration "B" (NDC 84552-500-64), intended for use with Ga 68 produced from an IRE Galli Eo Ge 68/Ga 68 generator, contains: Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 84552-501-25) Vial 2B (Acetate Buffer): 150 mg/6.4 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a green flip off cap (NDC 84552-503-64) Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution in a glass ampule (NDC 84552-504-25) The radionuclide is not part of the kit.

Before radiolabeling with Ga 68, the contents of this kit are not radioactive. Storage and Handling Store GOZELLIX refrigerated upright in the original packaging at 2° to 8°C (36° to 46°F). Do not freeze.

After radiolabeling, keep Gallium Ga 68 Gozetotide Injection upright with appropriate shielding to protect from radiation at room temperature (25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)). Use Gallium Ga 68 Gozetotide Injection within the time frames described in Table 9 below. Table 9: Shelf Life Per Activity of Gallium Ga 68 Gozetotide Injection Activity Shelf Life Less than 2,590 MBq (70 mCi) 4 hours 2,590 MBq to 18,500 MBq (70 mCi to 500 mCi) 6 hours Dispose of the product in accordance with all federal, state, and local laws and institutional requirements.

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

📦 Storage and Handling 141 words ▾

Storage and Handling Store GOZELLIX refrigerated upright in the original packaging at 2° to 8°C (36° to 46°F). Do not freeze. After radiolabeling, keep Gallium Ga 68 Gozetotide Injection upright with appropriate shielding to protect from radiation at room temperature (25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)).

Use Gallium Ga 68 Gozetotide Injection within the time frames described in Table 9 below. Table 9: Shelf Life Per Activity of Gallium Ga 68 Gozetotide Injection Activity Shelf Life Less than 2,590 MBq (70 mCi) 4 hours 2,590 MBq to 18,500 MBq (70 mCi to 500 mCi) 6 hours Dispose of the product in accordance with all federal, state, and local laws and institutional requirements. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

📋 Description ~2 min read ▾

11 DESCRIPTION

11.1Drug Characteristics GOZELLIX (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with Ga 68, is a radioactive diagnostic agent for intravenous use. Gozetotide is also known as PSMA-11. Gallium Ga 68 gozetotide is a radioconjugate composed of a human prostate specific membrane antigen (PSMA)-targeting ligand peptide conjugated via the acyclic radiometal chelator, N,N'-bis [2-hydroxy-5-(carboxyethyl)benzyl] ethylenediamine-N,N'-diacetic acid (HBED-CC) to the radioisotope Ga 68.

The amino acid sequence of the gozetotide peptide is Glu-NH-CO-NH-Lys(Ahx), (Ahx = 6-aminohexanoic acid). Gallium Ga 68 gozetotide has a molecular weight of 1011.9 g/mol and its chemical structure is shown in Figure 6. Figure 6: Chemical Structure of Gallium Ga 68 Gozetotide Chemical Structure Kit Characteristics GOZELLIX is supplied as a kit which contains the non-radioactive ingredients needed to produce Gallium Ga 68 Gozetotide Injection.

There are two configurations, A or B, available to allow preparation of Gallium Ga 68 Gozetotide Injection using Ga 68 from different generator or cyclotron sources. Each configuration consists of gozetotide (Vial 1), acetate buffer (Vial 2A or Vial 2B), and ascorbic acid stabilizer (Ampule). Vial 1 (Gozetotide): Each vial contains 25 mcg gozetotide and 10 mcg D-mannose.

Vial 2A (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 2.5 mL of 0.292 M hydrochloric acid. Vial 2B (Acetate Buffer): Each vial contains 150 mg anhydrous sodium acetate in 6.4 mL of 0.175 M hydrochloric acid. Ampule (Ascorbic Acid Stabilizer): Each ampule contains 500 mg of ascorbic acid (USP injection grade), 3 mg sodium metabisulfite, sodium hydroxide for pH adjustment, and water for injection in a volume of 2 mL.

The prepared Gallium Ga 68 Gozetotide Injection is a sterile, pyrogen free, clear, colorless to slightly yellow, buffered solution containing up to 18,500 MBq (500 mCi) of gallium Ga 68 gozetotide in 10 mL with a pH between 4.0 to 5.0.

11.2Nuclear Physical Characteristics Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable zinc-68. Table 4, Table 5, and Table 6 display the principal radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. Table 4: Principal Radiation Emission Data (>1%) for Ga 68 Radiation/ Emission % Disintegration Mean Energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 gamma 178% 0.5110 gamma 3.0% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 5: Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001 Table 6: Physical Decay Chart for Ga 68 Minutes Fraction Remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 360 0.025

💬 Information for Patients 65 words ▾

17 PATIENT COUNSELING INFORMATION Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of Gallium Ga 68 Gozetotide Injection, in order to reduce radiation exposure [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] .

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