Pluvicto

Pluvicto is a targeted radiopharmaceutical treatment for adults with prostate-specific membrane antigen (PSMA)-positive metastatic prostate cancer. It is used in combination with androgen receptor pathway inhibitor (ARPI) therapy to treat metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.

Pluvicto is also used to treat metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer (previously called metastatic castration-resistant prostate cancer) in people who have already been treated with ARPI therapy and who:

• are considered appropriate to delay taxane-based chemotherapy, or
• have received prior taxane-based chemotherapy

Patients will need a scan before receiving Pluvicto, using Locametz or another approved PSMA PET (positron emission tomography) imaging agent, to identify the PSMA-positive tumors.

Pluvicto may cause harm to an unborn baby.

Men with female partners should use effective contraception for intercourse during treatment with Pluvicto, and for 14 weeks after the last dose.

Pluvicto may cause temporary or permanent infertility in males.

Pluvicto contributes to your overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer.

To minimize radiation exposure to others after you receive Pluvicto you should:

• Limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days
• Refrain from sexual activity for 7 days
• Sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, and from pregnant women for 15 days

Pluvicto can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia.

Pluvicto can cause severe renal toxicity. You should remain well hydrated and urinate frequently before and after administration of Pluvicto to prevent kidney injury. You will receive kidney function tests, including serum creatinine and calculated creatinine clearance, before and during your treatment.

Who should not receive Pluvicto?

There are no contraindications listed for Pluvicto in the prescribing information. As with any medicine, tell your healthcare provider if you have ever had an allergic reaction to lutetium Lu 177 vipivotide tetraxetan or any of the ingredients in Pluvicto.

Pluvicto pregnancy and breastfeeding warnings (more detail)

Before you receive Pluvicto, tell your doctor if you:

• have low blood cell counts (hemoglobin, white blood cell count, absolute neutrophil count, platelet count)
• have signs of myelosuppression (tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty stopping bleeding, or frequent infections with signs such as fever, chills, sore throat, or mouth ulcers)
• have kidney problems
• have any other type of cancer or treatment for cancer, as Pluvicto contributes to long-term cumulative radiation exposure
• have a female partner who is pregnant or planning to become pregnant. All radiopharmaceuticals, including Pluvicto, have the potential to cause harm to an unborn baby. Patients should use effective contraception for intercourse during treatment with Pluvicto, and for 14 weeks after the last dose. Pluvicto may cause temporary or permanent infertility in males.

How will I receive Pluvicto?

Before you receive Pluvicto, you will receive a scan to identify the tumors that express PSMA.

Pluvicto is a radiopharmaceutical, and your healthcare provider will take appropriate safety measures to minimize radiation exposure including the wearing of waterproof gloves and effective radiation shielding.

Pluvicto is administered via intravenous injection every 6 weeks for up to 6 doses, or until disease progression or unacceptable toxicity. For mAPMN/S prostate cancer, Pluvicto is given in combination with an ARPI.

Everyone treated with Pluvicto for metastatic prostate cancer should also receive gonadotropin-releasing hormone (GnRH) therapy at the same time, or should have had surgical removal of both testicles (bilateral orchiectomy).

Before administration of Pluvicto, patients should drink plenty of water to urinate as often as possible during the first hours after administration.

Pluvicto may cause serious side effects, including:

• Myelosuppression. Contact your healthcare provider if you experience any signs or symptoms of myelosuppression, such as tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty stopping bleeding, or frequent infections with signs, such as fever, chills, sore throat, or mouth ulcers.
• Renal toxicity. Contact your healthcare provider if you experience any signs or symptoms of renal toxicity, such as passing urine less often than usual or passing much smaller amounts of urine than usual.

Common side effects may include:

• tiredness (fatigue)
• dry mouth
• nausea
• low blood counts, including low red blood cells (anemia), low white blood cells, and low platelets
• reduced kidney function
• changes in blood electrolytes (such as sodium, potassium, magnesium, and calcium) and raised liver enzymes

Tell your healthcare provider about any side effects that bother you or that do not go away. These are not all the possible side effects of Pluvicto. You may report side effects to Novartis Pharmaceuticals Corporation at 1-888-669-6682 or to the FDA at 1-800-FDA-1088.

Pluvicto side effects (more detail)

Usual adult dosage for prostate cancer

• 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses
• For metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, Pluvicto is given in combination with ARPI therapy

Uses: treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, in combination with ARPI therapy; or PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer in patients who have been treated with ARPI therapy and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

Detailed Pluvicto dosage information

Pluvicto is not thought to interact with other medicines.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Pluvicto drug interactions (more detail)

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is distributed by Novartis Pharmaceuticals Corporation, with U.S. headquarters in East Hanover, New Jersey 07936. Novartis acquired the rights to Pluvicto when it purchased Endocyte in 2018.