PLUVICTO 1000 MBq/mL Injectable Solution and Perfusion Solution

2. What you need to know before you are given Pluvicto

Follow carefully all instructions given by your nuclear medicine doctor. They may differ from the general information contained in this leaflet.

You should not be given Pluvicto

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

Warnings and precautions

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

• if you have low levels of certain types of cells in your blood (red blood cells, white blood cells, neutrophils, platelets)
• if you have or have had fatigue, weakness, pale skin, difficulty breathing, bleeding or bruising easily or your bleeding takes longer than usual, or frequent infections with signs such as fever, chills, sore throat or mouth ulcers (possible signs of bone marrow suppression [a condition in which the bone marrow cannot produce enough blood cells])
• if you have or have had kidney problems
• if you have or have had any other type of cancer or cancer treatment, as Pluvicto contributes to your overall exposure to accumulated long-term radiation

Before administration of Pluvicto you must:

• drink plenty of water to stay hydrated and urinate as frequently as possible during the first hours after administration

Children and adolescents

The safety and efficacy of this medicine in children and adolescents under 18 years have not been established. This medicine should not be given to children or adolescents under 18 years because there are no data available for this age group.

Pregnancy, breastfeeding and fertility

The safety and efficacy of Pluvicto have not been established in women. Pluvicto is not intended for use in women.

Before receiving Pluvicto, tell your nuclear medicine doctor if you are sexually active, as all radiopharmaceuticals, including Pluvicto, have the potential to cause harm to the fetus.

Fertility

Pluvicto may cause infertility. Ask your nuclear medicine doctor how this may affect you, especially if you are planning to have children in the future. You may want to seek advice on sperm preservation before starting treatment.

Contraception in men

• You must avoid sexual activity for 7 days after administration of Pluvicto.
• You must avoid pregnancy and use a condom during sexual intercourse throughout treatment with Pluvicto and for 14 weeks after your last dose.
• Inform your nuclear medicine doctor immediately if you father a child at any time during this period.

Driving and using machines

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

Pluvicto contains sodium

This medicine contains up to 88.75 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 4.4% of the maximum recommended daily intake of sodium for an adult.

3. How Pluvicto is given

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. Pluvicto will only be used in specially controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel to use it safely. Those people will take special care in the safe use of this radiopharmaceutical and will inform you of their actions.

How much Pluvicto is given

The recommended treatment schedule for Pluvicto is 7,400 MBq (megabecquerel, unit used to express radioactivity), which is administered approximately every 6 weeks up to a total of 6 doses.

Administration of Pluvicto and performance of the procedure

Pluvicto is administered directly into a vein.

Duration of the procedure

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

If you have any doubts about how long you will receive Pluvicto, ask your nuclear medicine doctor.

Monitoring of treatment

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

After administration of Pluvicto, you must:

• drink plenty of water for 2 days to stay hydrated and urinate as frequently as possible to eliminate the radiopharmaceutical from your body

As this is a radioactive medicine, you must follow the instructions described below to minimize radiation exposure to others, unless your nuclear medicine doctor tells you otherwise.

Contact with others living with you, children, and/or pregnant women

• Limit close contact (less than 1 meter) with:
• people living with you for 2 days
• children and pregnant women for 7 days
• Sleep in a separate room from:
• other people living with you for 3 days
• children for 7 days
• pregnant women for 15 days
• Avoid sexual activity for 7 days
• Avoid pregnancy and use a condom during sexual intercourse throughout treatment with Pluvicto and for 14 weeks after your last dose.

Use of toilets

Take special precautions to avoid contamination during the 2 days after administration:

• You must always sit down when using the toilet.
• It is essential that you use toilet paper every time you use the toilet.
• Always wash your hands well after using the toilet.
• Flush all wipes and/or toilet paper down the toilet immediately after use.
• Flush down the toilet any tissues or other materials that contain any bodily fluids, such as blood, urine, or feces. Items that cannot be flushed down the toilet, such as sanitary products, should be placed in separate plastic trash bags (as shown in the "Disposal Recommendations" section below).
• Any medical equipment that may be contaminated with your bodily fluids (e.g., catheter bags, colostomy bags, urinals, water bottles) should be emptied immediately into the toilet and cleaned afterwards.

Showering and laundry

• Shower at least once a day for 7 days after administration.
• Wash your underwear, pajamas, sheets, and clothing that contain sweat, blood, or urine separately from the rest of your household laundry, using a standard wash cycle. You do not need to use bleach or perform extra rinses.

Caregivers

For 2-3 days after administration:

• People who are bedridden or have reduced mobility should preferably receive assistance from a caregiver. It is recommended that when assisting in the bathroom, the caregiver wears disposable gloves.
• Caregivers who remove vomit, blood, urine, or feces should wear plastic gloves that should be disposed of in a separate plastic trash bag (see "Disposal Recommendations" below).

Disposal recommendations

• All materials to be disposed of must be thrown away in a separate plastic trash bag used only for this purpose.
• Keep the separate plastic trash bags away from the rest of the trash and out of the reach of children and animals.
• A member of the hospital staff will tell you how and when you can dispose of these trash bags.

Hospitalization and emergency care

• If you require emergency medical attention or unplanned hospitalization within the first 7 days after administration, you must inform healthcare professionals about the name, date, and dose of your radioactive treatment.

Other precautions

• Your nuclear medicine doctor will inform you if you need to take any other special precautions after receiving this medicine. Ask your nuclear medicine doctor if you have any doubts.

If you have been given more Pluvicto than you should

It is unlikely that an overdose will occur because you will only receive Pluvicto in carefully controlled doses by your nuclear medicine doctor supervising the procedure. An overdose is unlikely. However, in the event of an overdose, you will receive appropriate treatment.

If you miss a dose of Pluvicto

If you did not attend an appointment to receive Pluvicto, talk to your nuclear medicine doctor as soon as possible to reschedule.

If you have any other questions about the use of Pluvicto, ask your nuclear medicine doctor supervising the procedure.

4. Possible side effects

As with all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious

If you experience any serious side effect, tell your nuclear medicine doctor immediately.

Very common:may affect more than 1 in 10 people

• fatigue, weakness, pale skin, or difficulty breathing (possible signs of low red blood cell counts [anemia])
• bleeding or bruising easily or your bleeding takes longer than usual (possible signs of low platelet counts [thrombocytopenia])
• frequent infections with signs such as fever, sore throat, or mouth ulcers (possible signs of low white blood cell counts [leukopenia, lymphopenia]).

Common:may affect up to 1 in 10 people

• urinating less frequently or in much smaller amounts than usual (possible signs of kidney problems [acute kidney injury])
• fatigue, weakness, pale skin, difficulty breathing, bleeding or bruising easily or your bleeding takes longer than usual, or frequent infections with signs such as fever, chills, sore throat, or mouth ulcers (possible signs of low blood cell counts [pancytopenia])

Other possible side effects

Other side effects include those listed below. If these side effects become serious, tell your nuclear medicine doctor.

Very common:may affect more than 1 in 10 people

• fatigue
• dry mouth
• nausea
• loss of appetite
• changes in bowel movements (constipation or diarrhea)
• vomiting
• urinating frequently with pain or burning sensation (urinary tract infection)
• abdominal pain
• weight loss

Common:may affect up to 1 in 10 people

• swelling of hands, ankles, or feet (peripheral edema)
• dizziness
• headache
• altered sense of taste (dysgeusia)
• fever (pyrexia)
• dry eyes
• dizziness with a spinning sensation (vertigo)

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pluvicto

You will not need to store this medicine. This medicine is stored under the responsibility of a specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist:

• Keep this medicine out of the sight and reach of children.
• Do not freeze.
• Keep in the original package to protect from ionizing radiation (lead shielding).
• Pluvicto should not be used after the expiry date and time stated on the labels of the lead shielding container and the vial after EXP.
• Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Container contents and additional information

Composition of Pluvicto

• The active ingredient is lutetium (177Lu) vipivotida tetraxetan. One milliliter of solution contains 1,000 MBq of lutetium (177Lu) vipivotida tetraxetan at the date and time of calibration.
• The other components are: acetic acid, sodium acetate, gentisic acid, sodium ascorbate, pentetic acid, water for injectable preparations (see section 2 "Pluvicto contains sodium").

Appearance of Pluvicto and container contents

Pluvicto is a clear, colorless or slightly yellowish solution, supplied in a type I colorless and transparent glass vial, closed with a bromobutyl rubber stopper and an aluminum seal.

Each vial contains a solution volume that may range between 7.5 ml and 12.5 ml, corresponding to a radioactivity of 7,400 MBq ±10% at the date and time of administration.

The vial is inside a lead container as protective shielding.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Advanced Accelerator Applications (Italy) S.R.L.

Via Ribes 5

10010

Colleretto Giacosa (TO)

Italy

Advanced Accelerator Applications Ibérica, S.L.U.

Polígono Industrial la Cuesta – Sector 3

Parcelas 1 y 2 La Almunia de Doña Godina

50100 Zaragoza

Spain

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

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This information is intended for healthcare professionals only:

The complete summary of product characteristics of Pluvicto is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics.