Pluvicto 1,000 MBq/mL solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
• If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.

1. What Pluvicto is and what it is used for
2. What you need to know before Pluvicto is used
3. How Pluvicto is used
4. Possible side effects
5. How Pluvicto is stored
6. Contents of the pack and other information

Pluvicto contains lutetium (¹⁷⁷Lu) vipivotide tetraxetan. This medicine is a radiopharmaceutical product for therapy only.

Pluvicto is used to treat adults with a certain type of advanced prostate cancer (called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer [PSMA-positive mCRPC]) that is metastatic (this means it has spread to other parts of the body) and:

• who have progressed on or after treatment with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy

or

• who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

Pluvicto binds to a protein called PSMA that is found on the surface of prostate cancer cells. Once bound, the radiation emitted from the lutetium-177 causes the prostate cancer cells to die.

Tests will be performed to see if PSMA is present on the surface of the cancer cells. Your cancer is likely to respond to treatment with Pluvicto if the test result is positive.

The use of Pluvicto involves exposure to radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

If you have any questions about how Pluvicto works or why this medicine has been prescribed for you, ask your nuclear medicine doctor.

• if you are allergic to lutetium (¹⁷⁷Lu) vipivotide tetraxetan or any of the other ingredients of this medicine (listed in section 6).

If any of these apply to you, tell your nuclear medicine doctor before receiving Pluvicto:

• if you have low level of blood cell counts (haemoglobin, white blood cell count, absolute neutrophil count, platelet count)
• if you have or have had tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding, or frequent infections with signs such as fever, chills, sore throat or mouth ulcers (possible signs of myelosuppression)
• if you have or have had kidney problems
• if you have or have had any other type of cancer or treatment for cancer, as Pluvicto contributes to your overall long-term cumulative radiation exposure

Before treatment with Pluvicto you should:

• drink plenty of water in order to urinate as often as possible during the first hours after treatment.

The safety and efficacy of this medicine have not been established in children and adolescents under 18 years of age.

The safety and efficacy of Pluvicto have not been established in females.

Before you receive Pluvicto, tell your nuclear medicine doctor if you are sexually active as:

• All radioactive emissions, including those from Pluvicto, can cause harm to an unborn baby.
• You should not father a child and should use a condom for intercourse during treatment with Pluvicto and for 14 weeks after your last dose.
• Pluvicto may cause infertility.

It is considered unlikely that Pluvicto will affect your ability to drive or use machines.

This medicine contains up to 88.75 mg sodium (main component of cooking/table salt) in each vial.

This is equivalent to 4.4% of the recommended maximum daily dietary intake of sodium for an adult.

Pluvicto is administered directly into a vein.

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

If you have questions about how long you will receive Pluvicto, talk to your nuclear medicine doctor.

Your nuclear medicine doctor will do blood tests before and during treatment to check your condition and to detect any side effects as early as possible. Based on the results, your nuclear medicine doctor may decide to delay, modify or stop your treatment with Pluvicto if necessary.

After treatment with Pluvicto, you should:

• remain hydrated and urinate frequently in order to eliminate the radiopharmaceutical product from your body
• limit close contact (less than 1 meter) with others for 2 days or with children and pregnant women for 7 days
• avoid sexual activity for 7 days
• sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. This may include special precautions for you or your caregiver with regard to toilet use, showering, laundry, waste disposal, emergency medical assistance, unplanned hospitalisation or travelling. Contact your nuclear medicine doctor if you have any questions.

An overdose is unlikely. However, in the event of an overdose, you will receive the appropriate treatment.

If you miss an appointment for treatment, contact your nuclear medicine doctor as soon as possible to reschedule.

Should you have any further questions on the use of Pluvicto, please ask the nuclear medicine doctor who supervises the procedure.

If you experience any of the following serious side effects, tell your nuclear medicine doctor right away.

Very common: may affect more than 1 in 10 people

• tiredness, weakness, pale skin or shortness of breath (possible signs of low level of red blood cells) (anaemia)
• bleeding or bruising more easily than normal or difficulty to stop bleeding and frequent infections with signs such as fever, sore throat or mouth ulcers (possible signs of low level of white blood cells) (thrombocytopenia, leukopenia, lymphopenia)

Common: may affect up to 1 in every 10 people

• passing urine less often than usual or passing much smaller amounts of urine than usual (possible sign of kidney problems) (acute kidney injury)
• tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (possible signs of low level of blood cells) (pancytopenia)

Uncommon: may affect up to 1 in every 100 people

• Weakness, pale skin, bleeding or bruising more easily than normal or difficulty to stop bleeding and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (bone marrow failure)

Other side effects include the following listed below. If these side effects become severe, tell your nuclear medicine doctor.

Very common: may affect more than 1 in 10 people

• tiredness (fatigue)
• dry mouth
• nausea
• loss of appetite
• changes in bowel movements (constipation or diarrhoea)
• vomiting
• urinary tract infection
• abdominal pain
• weight loss
• swollen hands, ankles or feet (peripheral oedema)

Common: may affect up to 1 in every 10 people

• dizziness
• headache
• disturbed sense of taste (dysguesia)
• fever (pyrexia)
• trouble swallowing and/or heartburn (oesophageal disorder)
• dry eye
• oral fungal infection
• vertigo
• mouth sores (stomatitis)
• dry skin

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep this medicine out of the sight and reach of children.
• Do not freeze.
• Store in the original package to protect from ionising radiation (lead shielding).
• Do not use Pluvicto after the expiry date and time which are stated on the label after EXP.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements

• The active substance is lutetium (¹⁷⁷Lu) vipivotide tetraxetan. One mL of solution contains 1,000 MBq lutetium (¹⁷⁷Lu) vipivotide tetraxetan at the date and time of calibration.
• The other ingredients are: acetic acid, sodium acetate, gentisic acid, sodium ascorbate, pentetic acid, water for injections (see “Pluvicto contains sodium” in section 2).

Pluvicto is a clear, colourless to slightly yellow solution supplied in a clear, colourless type I glass vial, closed with a bromobutyl rubber stopper and aluminum seal.

Each vial contains a volume of solution that can range from 7.5 mL to 12.5 mL corresponding to a radioactivity of 7,400 MBq at the date and time of administration.

The vial is enclosed within a lead container for protective shielding.