Lutetium Lu 177 Vipivotide Tetraxetan Injection
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent used to treat PSMA-positive metastatic prostate cancer in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Lutetium Lu 177 Vipivotide Tetraxetan Injection: Patient Information Guide
A plain-language walkthrough of Lutetium Lu 177 Vipivotide Tetraxetan Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent approved for adults with PSMA-positive metastatic prostate cancer. Patients must first be tested using an approved PSMA PET imaging scan to confirm their tumors express the PSMA protein.
- Pluvicto is approved in combination with ARPI therapy for adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer — meaning the cancer has spread and hormone-based therapy is still working or hasn't been tried yet.
- Pluvicto is approved alone for adults with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have already received ARPI therapy and for whom it is appropriate to delay taxane-based chemotherapy, or who have already received taxane-based chemotherapy.
⚙️How it works▾
Pluvicto is a radioligand — a two-part drug made of a targeting molecule and a radioactive payload (lutetium-177). The targeting molecule seeks out PSMA (prostate-specific membrane antigen), a protein found on the surface of prostate cancer cells. Once it binds to PSMA-expressing cancer cells, lutetium-177 emits beta radiation directly at those cells and nearby tissue. This radiation damages the DNA inside the cancer cells, which can lead to cell death.
Because the drug actively seeks out PSMA-expressing cells, it delivers radiation in a more targeted way than traditional radiation therapy — though surrounding healthy cells can still be affected by the radiation emitted.
💊How it's taken▾
Pluvicto is given as an intravenous (IV) injection or infusion by a specially trained healthcare provider in a certified medical facility — it is never taken at home. It is administered once every 6 weeks, for up to 6 total doses, or until the disease progresses or side effects become too severe.
- For mAPMN/S prostate cancer: Pluvicto is given alongside an ARPI medication every 6 weeks.
- For mAPMR prostate cancer: Pluvicto is given every 6 weeks; patients should also be receiving a GnRH analog or have had surgical removal of the testes.
- Doses may be delayed, reduced, or stopped permanently based on how your body responds — your care team will manage this closely.
- Drink plenty of fluids and urinate frequently before and after each dose to help protect your kidneys and bladder from radiation.
🤒Side effects — in detail▾
The most common side effects reported with Pluvicto include:
- Fatigue
- Dry mouth
- Nausea
- Decreased appetite
- Constipation
- Altered taste (dysgeusia)
- Low lymphocyte counts (a type of white blood cell)
- Low red blood cell counts (anemia) and low platelet counts
- Decreased kidney filtration rate (eGFR)
More serious reactions include severe drops in all blood cell counts (myelosuppression), life-threatening infections due to low white blood cells, dangerous bleeding from low platelets, and acute kidney injury. Deaths have occurred in clinical trials related to bone marrow failure, bleeding complications, and serious infections. Contact your doctor immediately if you develop fever, unusual bleeding or bruising, severe fatigue, or signs of kidney problems such as decreased urination or swelling.
⚠️Warnings & precautions▾
- Myelosuppression (low blood cell counts): Pluvicto can cause severe, potentially life-threatening drops in red blood cells, white blood cells, and platelets. Deaths have occurred. Blood counts are monitored before every dose, and your doctor may pause, reduce, or stop treatment based on results.
- Renal toxicity (kidney damage): Pluvicto can cause serious kidney injury. Stay well hydrated and urinate frequently around each dose. Kidney function is monitored throughout treatment, and doses may be adjusted if problems arise.
- Radiation exposure: As a radioactive drug, Pluvicto adds to your lifetime radiation dose, which is associated with an increased long-term cancer risk. After each dose, you will need to follow specific precautions — such as limiting close contact with others (especially children and pregnant women) for several days, sleeping separately, and refraining from sexual activity for 7 days.
- Embryo-fetal toxicity: Pluvicto can cause serious harm to a fetus. Male patients with female partners who could become pregnant must use effective contraception during treatment and for 14 weeks after the last dose.
- Infertility: The cumulative radiation dose from a full course of Pluvicto may cause temporary or permanent infertility in males. Discuss sperm preservation with your doctor before starting treatment.
🔀What it interacts with▾
Based on laboratory studies, Pluvicto's active component (vipivotide tetraxetan) does not interact with the major drug-processing enzymes or transport proteins in the body, so drug-drug interactions through these pathways are not expected. No specific drug, food, or supplement interactions are identified in the label. Always tell your full care team about every medication, supplement, and herbal product you take.
- Vipivotide tetraxetan is not processed by CYP450 liver enzymes and does not inhibit or induce them — meaning it is unlikely to affect how many common medications are broken down.
- Vipivotide tetraxetan does not interact with common drug transporter proteins in the body.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Kidney problems: Pluvicto is cleared mainly through the kidneys. If you have reduced kidney function, the drug may build up and increase toxicity risk. Those with mild to moderate kidney impairment need closer monitoring; those with severe impairment have not been studied.
- Reproductive potential: Males with female partners of reproductive potential must use effective contraception during treatment and for 14 weeks after the final dose.
- Fertility concerns: Talk to your doctor about sperm banking before starting, as Pluvicto may cause temporary or permanent infertility.
- Pregnancy: Pluvicto has not been studied in females. Radioactive emissions from Pluvicto can cause fetal harm.
- Breastfeeding: It is not known whether Pluvicto passes into breast milk. The safety in breastfed children has not been established.
- Children: Safety and effectiveness in pediatric patients have not been established.
- Older adults (75+): Patients 75 and older were included in clinical trials with no difference in effectiveness, but experienced higher rates of serious and Grade 3 or higher adverse reactions compared with younger patients — closer monitoring is important.
- PSMA testing required: Patients must have PSMA-positive tumors confirmed by an approved PSMA PET scan before starting Pluvicto.
🚑If you take too much▾
If too much radioactivity is accidentally administered, the primary goal is to help remove the radioactive drug from the body as quickly as possible. This is done by encouraging frequent urination — through drinking more fluids or, in a clinical setting, forced diuresis (medically increasing urine output). Your care team will estimate how much extra radiation was received and provide any additional supportive treatment needed.
📡Pharmacodynamics — effects in the body▾
At the recommended dose, Pluvicto does not cause significant changes in heart rhythm (specifically, it does not meaningfully prolong the QTc interval, a measure of electrical activity in the heart). The full relationship between drug exposure and its effects on cancer — and how quickly those effects develop — has not been completely characterized.
🔬Pharmacokinetics — how your body processes it▾
After IV administration, Pluvicto distributes widely throughout the body within about 2.5 hours, reaching the gastrointestinal tract, liver, lungs, kidneys, heart, bone marrow, and salivary glands. It is 60–70% bound to proteins in the blood. The drug is not broken down by the liver or kidneys — it is excreted largely unchanged through the urine. Its terminal half-life (the time it takes for half the drug to leave the body) is about 41.6 hours. In patients with reduced kidney function, the drug stays in the body at higher levels for longer, which may increase the risk of side effects.
📦How to store it▾
Store below 30°C (86°F). Do not freeze. Store in the original package to protect from ionizing radiation (lead shielding).
📄 Written from Lutetium Lu 177 Vipivotide Tetraxetan Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Lutetium Lu 177 Vipivotide Tetraxetan Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Pluvicto, and how is it different from regular chemotherapy? ▾
Why do I have to stay away from my family after each treatment? ▾
What side effects should I definitely call my doctor about? ▾
Will Pluvicto affect my ability to have children? ▾
How do I know if I qualify for Pluvicto? ▾
What happens if my body doesn't tolerate the treatment well — can the dose be changed? ▾
Is Lutetium Lu 177 Vipivotide Tetraxetan Injection available over the counter? ▾
When was Lutetium Lu 177 Vipivotide Tetraxetan Injection first available? ▾
Who makes Lutetium Lu 177 Vipivotide Tetraxetan Injection? ▾
💬 Answers drafted from Lutetium Lu 177 Vipivotide Tetraxetan Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Lutetium Lu 177 Vipivotide Tetraxetan Injection comes
Lutetium Lu 177 Vipivotide Tetraxetan Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Pluvicto injection is used to treat adults with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, given together with ARPI therapy
- Pluvicto injection is used to treat adults with PSMA-positive metastatic androgen pathway modulation-resistant prostate cancer who have received ARPI therapy and are appropriate to delay or have already received taxane-based chemotherapy
- Pluvicto is administered intravenously by a trained healthcare provider — it can be given as a slow injection using a syringe, or as an infusion using a gravity or peristaltic pump method
- Pluvicto must not be injected directly into any other intravenous solution, and a dedicated IV catheter flushed with saline must be used
- Pluvicto is given once every 6 weeks for up to 6 doses; patients should drink plenty of fluids and urinate frequently before and after each dose
- Pluvicto is handled and administered only by healthcare providers with specialized training in radiopharmaceutical safety, using protective shielding throughout
📊 Lutetium Lu 177 Vipivotide Tetraxetan Injection across the U.S. market
How Lutetium Lu 177 Vipivotide Tetraxetan Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Lutetium Lu 177 Vipivotide Tetraxetan Injection products
A representative set of FDA-listed product records for Lutetium Lu 177 Vipivotide Tetraxetan Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 27 mCi/mL | Intravenous | Advanced Accelerator Applications USA, Inc × 2 listings | NDA | View NDC → |
| 27 mCi/mL | Intravenous | Novartis Pharmaceuticals Corporation × 3 listings | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Lutetium Lu 177 Vipivotide Tetraxetan Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lutetium Lu 177 Vipivotide Tetraxetan Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lutetium Lu 177 Vipivotide Tetraxetan Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Lutetium Lu 177 Vipivotide Tetraxetan Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Lutetium Lu 177 Vipivotide Tetraxetan Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Lutetium Lu 177 Vipivotide Tetraxetan Injection belongs to the Radioligand Therapeutic Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.