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Lutetium Lu-177 Vipivotide Tetraxetan: uses, dosing, side effects & brands

Lutetium Lu-177 Vipivotide Tetraxetan is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Available as
Injectable
Sold as
Pluvicto
Prescription?
Prescription only
Generic available?
Not in our catalog

How lutetium lu-177 vipivotide tetraxetan is dosed

From the FDA label for Pluvicto (application NDA215833). Other lutetium lu-177 vipivotide tetraxetan products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. ( 2.2 ) Recommended Dosage: Administer 7.4 GBq (200 mCi) every 6 weeks for 6 doses. ( 2.3 ) Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions. ( 2.4 ) 2.1 Important Safety Instructions PLUVICTO is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)] . Use waterproof gloves and effective radiation shielding when handling PLUVICTO. Radiopharmaceuticals, including PLUVICTO, 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 radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. 2.2 Patient Selection Select patients with previously treated mCRPC for treatment with PLUVICTO using LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. Additional selection criteria were used in clinical studies [see Clinical Studies (14)] . 2.3 Recommended Dosage The recommended PLUVICTO dosage is 7.4 GBq (200 mCi) intravenously every 6 weeks for 6 doses, or…

Lutetium Lu-177 Vipivotide Tetraxetan side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.2)] Renal Toxicity [see Warnings and Precautions (5.3)] Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased platelets, decreased estimated glomerular filtration rate, nausea, decreased neutrophils, decreased calcium, decreased sodium, increased aspartate aminotransferase, increased alkaline phosphatase, arthralgia, decreased appetite, increased potassium, constipation, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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. In the pooled safety population for the PSMAfore and VISION studies (N = 756), the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (83%), decreased hemoglobin (65%), fatigue (49%), dry mouth (46%), decreased platelets (40%), decreased estimated…

Who shouldn’t take lutetium lu-177 vipivotide tetraxetan

None. None. ( 4 )

Every lutetium lu-177 vipivotide tetraxetan product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Pluvicto.

What people report to the FDA about lutetium lu-177 vipivotide tetraxetan

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 226 reports naming lutetium lu-177 vipivotide tetraxetan, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • malignant neoplasm progression24 reports
  • hot flush20 reports
  • hormone-refractory prostate cancer17 reports
  • anaemia16 reports
  • fatigue16 reports
  • erectile dysfunction15 reports
  • thrombocytopenia10 reports
  • pathological fracture9 reports

Read these as a signal, not a rate. A report does not mean lutetium lu-177 vipivotide tetraxetan caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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Frequently asked questions

What is lutetium lu-177 vipivotide tetraxetan?

PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent. Lutetium Lu 177 vipivotide tetraxetan is a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177.

Can you take lutetium lu-177 vipivotide tetraxetan with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lutetium lu-177 vipivotide tetraxetan against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does lutetium lu-177 vipivotide tetraxetan come in?

Across the brands we track, lutetium lu-177 vipivotide tetraxetan is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic lutetium lu-177 vipivotide tetraxetan?

We do not currently list a generic-labelled lutetium lu-177 vipivotide tetraxetan product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Lutetium Lu-177 Vipivotide Tetraxetan: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lutetium-lu-177-vipivotide-tetraxetan
MLA
“Lutetium Lu-177 Vipivotide Tetraxetan: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lutetium-lu-177-vipivotide-tetraxetan.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for lutetium lu-177 vipivotide tetraxetan on DailyMed (NIH) ↗.