What is PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan)?
PLUVICTO is a radiopharmaceutical used to treat adults with an advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that:
- has spread to other parts of the body (metastatic), and
- has already been treated with other anticancer treatments
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PLUVICTO?
Use of PLUVICTO involves exposure to radioactivity. Long-term, accruing radiation exposure is associated with an increased risk for cancer.
To minimize radiation exposure to others following administration of PLUVICTO, 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, and sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days.
PLUVICTO may cause serious side effects, including:
- Low level of blood cell counts. Tell your doctor right away if you develop any new or worsening symptoms, including:
- Tiredness or weakness
- Pale skin
- Shortness of breath
- Bleeding or bruising more easily than normal or difficulty stopping bleeding
- Frequent infections with signs such as fever, chills, sore throat, or mouth ulcers
- Kidney problems. Tell your doctor right away if you develop any new or worsening symptoms, including passing urine less often or passing much smaller amounts of urine than usual
Before you receive PLUVICTO, tell your doctor if any of these apply to you:
- You have low level of blood cell counts (hemoglobin, white blood cell count, absolute neutrophil count, platelet count)
- You have or have had 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 (possible signs of myelosuppression)
- You have or have had kidney problems
- You have or have had any other type of cancer or treatment for cancer, as PLUVICTO contributes to your long-term cumulative radiation exposure
- You are sexually active as:
- All radiopharmaceuticals, including PLUVICTO, have the potential to cause harm to an unborn baby
- You should use effective contraception for intercourse during treatment with PLUVICTO and for 14 weeks after your last dose
- PLUVICTO may cause temporary or permanent infertility
Before administration of PLUVICTO, you should drink plenty of water in order to urinate as often as possible during the first hours after administration.
The most common side effects of PLUVICTO include:
- Tiredness
- Dry mouth
- Nausea
- Low red blood cell count
- Loss of appetite
- Changes in bowel movements (constipation or diarrhea)
- Vomiting
- Low blood platelet count
- Urinary tract infection
- Weight loss
- Abdominal pain
These are not all of the possible side effects of PLUVICTO. Call your doctor for advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information.
