Pluvicto

Patient Information Leaflet

Pluvicto 1 000 MBq/mL solution for injection or infusion

lutetium (Lu) vipivotide tetraxetan
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, consult your nuclear medicine physician. See section 4.

Contents of this leaflet

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

1. What Pluvicto is and what it is used for

What Pluvicto is
Pluvicto contains lutetium (Lu) vipivotide tetraxetan. This medicine is a radiopharmaceutical for therapeutic use only.
What Pluvicto is used for
Pluvicto is used to treat adults with metastatic castration-resistant prostate cancer that has spread to other parts of the body and who have already received other anticancer treatments. Castration-resistant prostate cancer is a cancer of the prostate (a gland in the male reproductive system) that does not respond to treatments that reduce male hormones. Pluvicto is used when prostate cancer cells have a protein on their surface called prostate-specific membrane antigen (PSMA).
How Pluvicto works
Pluvicto binds to PSMA present on the surface of prostate cancer cells. Once bound, the radioactive substance in Pluvicto, lutetium-177, emits radiation that causes the death of prostate cancer cells.
Your doctor will perform tests to determine whether PSMA is present on the surface of the cancer cells. The cancer is more likely to respond to treatment with Pluvicto if the test result is positive.
The use of Pluvicto involves exposure to small doses of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit from the radiopharmaceutical procedure outweighs the risk from radiation exposure.
If you have any questions about how Pluvicto works or why this medicine has been prescribed for you, please consult your nuclear medicine physician.

2. What you should know before using Pluvicto

Carefully follow all instructions provided by your nuclear medicine physician. These may
differ from the general information contained in this leaflet.

Pluvicto must not be used

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

Warnings and precautions
If any of the following conditions apply to you, inform the nuclear medicine physician before receiving
Pluvicto:

• if you have low levels of certain types of blood cells (red blood cells, white blood cells, neutrophils, platelets)
• if you are experiencing or have experienced fatigue, weakness, pale skin, shortness of breath, bleeding or bruising more frequently than normal, prolonged bleeding, or frequent infections with signs such as fever, chills, sore throat, or mouth ulcers (possible signs of myelosuppression [a condition in which the bone marrow does not produce enough blood cells])
• if you have or have had kidney problems
• if you have or have had any other type of cancer or anticancer treatment, as Pluvicto contributes to your overall cumulative long-term radiation exposure

Before you are administered 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 have not been established in children and adolescents under 18 years of age. This medicine must not be administered to children or adolescents under 18 years of age, as data are not available in this age group.
Pregnancy, breastfeeding and fertility
The use of Pluvicto is not indicated in women.
Before receiving Pluvicto, inform the nuclear medicine physician if you are sexually active, as all radiopharmaceuticals, including Pluvicto, may potentially cause harm to the fetus.
Fertility
Pluvicto may cause infertility. Ask your nuclear medicine physician how this may affect you, especially if you are planning to have children in the future. You may need 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 not father a child and must use a condom during sexual intercourse throughout treatment with Pluvicto and for 14 weeks after the last dose.
• Inform your nuclear medicine physician immediately if you father a child at any time during this period.

Driving and using machines
It is unlikely that Pluvicto will affect your ability to drive or use machines.
Pluvicto contains sodium
This medicine contains up to 88.75 mg of sodium (a main component of cooking salt) per vial. This is equivalent to 4.4% of the maximum daily recommended dietary intake for an adult.

3. How to use Pluvicto

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Pluvicto will be used only in specially controlled areas. This radiopharmaceutical will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. These individuals will pay special attention to the safe use of this radiopharmaceutical and will keep you informed about the procedures followed.

How much Pluvicto is administered

The recommended treatment regimen of Pluvicto is 7,400 MBq (megabecquerel, a unit of measurement indicating radioactivity), administered approximately every 6 weeks for a total of 6 doses.

Administration of Pluvicto and procedure conduct

Pluvicto is administered directly into a vein.

Duration of the procedure

The nuclear medicine physician will inform you about the usual duration of the procedure.
If you have any questions about the duration of treatment with Pluvicto, please consult your nuclear medicine physician.

Treatment monitoring

The nuclear medicine physician will perform blood tests before and during treatment to monitor your condition and detect any adverse effects as early as possible. Based on the results, the nuclear medicine physician may decide, if necessary, to delay, modify, or discontinue treatment with Pluvicto.

After receiving 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.

Because this medicine is radioactive, to minimize radiation exposure to others, you must follow the instructions described below, unless otherwise instructed by your nuclear medicine physician.

Contact with other family members, children, and/or pregnant women

• Limit close contact (less than 1 meter) with:
  • other family members for 2 days
  • children and pregnant women for 7 days
• Sleep in a separate bedroom from:
  • other family members for 3 days
  • children for 7 days
  • pregnant women for 15 days
• Avoid sexual activity for 7 days.
• Do not conceive and use a condom during sexual intercourse during treatment with Pluvicto and for 14 weeks after the last dose.

Use of sanitary facilities

Take special precautions to avoid contamination for 2 days after administration:

• Always sit when using the toilet.
• It is essential to use toilet paper every time you use the toilet.
• Always wash your hands thoroughly after using the toilet.
• Flush all wipes and/or toilet paper down the toilet immediately after use.
• Flush all tissues or other materials containing bodily residues such as blood, urine, and feces down the toilet. Materials that cannot be disposed of in the toilet, such as bandages, must be placed in separate plastic bags for waste disposal (according to the "Waste Disposal Recommendations" outlined below).
• Any special medical equipment that could be contaminated by body fluids (e.g., catheter bags, colostomy bags, bedpans, irrigation lines) must be emptied immediately into the toilet and then cleaned.

Showering and laundry

• Take a shower every day for at least 7 days after administration.
• Wash underwear, pajamas, bed linens, and all clothing that has come into contact with sweat, blood, or urine separately from other family members’ laundry, using a standard washing cycle. There is no need to use bleach or extra rinse cycles.

Caregivers

For 2–3 days after administration:

• Patients who are bedridden or have limited mobility are generally assisted by caregivers. It is recommended that caregivers wear disposable gloves when assisting in the bathroom.
• Caregivers cleaning up vomit, blood, urine, or feces must wear plastic gloves, which should then be disposed of in a separate plastic bag for waste disposal (according to the "Waste Disposal Recommendations" outlined below).

Waste Disposal Recommendations

• All waste materials must be placed in a separate plastic bag designated for waste disposal and used only for this purpose.
• Keep plastic waste disposal bags separate from other household waste and out of reach of children and animals.
• A member of the hospital staff will inform you how and when to dispose of these waste disposal bags.

Hospital admission and emergency management

• If, for any reason, you require emergency medical assistance or are unexpectedly hospitalized within the first 7 days after administration, you must inform healthcare providers of the name, date, and dosage of the radiopharmaceutical treatment you received.

Other precautions

• The nuclear medicine physician will inform you if you need to take any additional special precautions after receiving this medicine. If you have any questions, contact your nuclear medicine physician.

If you have been given more Pluvicto than you should have

An overdose is unlikely because you will receive Pluvicto only in doses that are precisely controlled by the nuclear medicine physician responsible for the procedure. However, in the event of an overdose, you will receive appropriate treatment.

If you miss a dose of Pluvicto

If you miss an appointment to receive Pluvicto, contact your nuclear medicine physician as soon as possible to reschedule.

If you have further questions about the use of Pluvicto, please consult the nuclear medicine physician responsible for the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects may be serious
If you experience any serious side effect, contact your nuclear medicine doctor immediately.
Very common: may affect more than 1 in 10 people

• tiredness, weakness, pale skin or shortness of breath (possible signs of low red blood cell levels [ anaemia ])
• bleeding or bruising more than usual or prolonged bleeding (possible signs of low platelet levels [ thrombocytopenia ])
• frequent infections with signs such as fever, sore throat or mouth ulcers (possible signs of low white blood cell levels [ leucopenia, lymphopenia ])

Common: may affect up to 1 in 10 people

• passing urine less frequently than normal or in much smaller amounts than normal (possible signs of kidney problems [ acute kidney injury ])
• tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more than usual or prolonged bleeding, 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 are listed below. If these side effects become severe, inform 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
• frequent urination with pain or burning sensation ( urinary tract infection )
• abdominal pain
• weight loss

Common: may affect up to 1 in 10 people

• swollen hands, ankles or feet ( peripheral oedema )
• 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 effect, including those not listed in this leaflet, consult your nuclear medicine doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pluvicto

This medicinal product must not be stored by the patient. It is stored under the responsibility of a specialist in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only:

• Keep out of the sight and reach of children.
• Do not freeze.
• Store in the original packaging to protect from ionizing radiation (lead shielding).
• Pluvicto must not be used after the expiry date and time indicated on the labels of the lead-shielded container and the vial, following "Exp".
• Unused medicine and waste material must be disposed of in accordance with local regulations.

6. Package contents and other information

What Pluvicto contains

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

Description of the appearance of Pluvicto and contents of the pack
Pluvicto is a clear, colourless to slightly yellow solution supplied in a type I, transparent, colourless glass vial, closed with a bromobutyl rubber stopper and an aluminium seal.
Each vial contains a volume of solution ranging from 7.5 mL to 12.5 mL, corresponding to a radioactivity of 7,400 MBq ±10% at the date and time of administration.
The vial is enclosed in a lead container for protective shielding.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Advanced Accelerator Applications (Italy) S.R.L.
Via Ribes 5
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SAM Nordic
Tél/Tel: +32 2 246 16 11 Švedija
Tel: +46 8 720 58 22

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
M.G.P. spol. s r.o. Novartis Hungária Kft.
Tel: +420 602 303 094 Tel.: +36 1 457 65 00

Danmark Malta
SAM Nordic Novartis Pharma Services Inc.
Sverige Tel: +356 2122 2872
Tel: +46 8 720 58 22

Deutschland Nederland
Novartis Radiopharmaceuticals GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SAM Nordic SAM Nordic
Rootsi Sverige
Tel: +46 8 720 58 22 Tlf: +46 8 720 58 22

Ελλάδα Österreich
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Novartis Pharma GmbH
Τηλ: +30 22920 63900 Tel: +43 1 86 6570
or
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

España Polska
Advanced Accelerator Applications Ibérica, Advanced Accelerator Applications Polska Sp. z
S.L.U. o.o.
Tel: +34 97 6600 126 Tel.: +48 22 275 56 47

France Portugal
Advanced Accelerator Applications Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 63 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
SAM Nordic Novartis Slovakia s.r.o.
Svíþjóð Tel: +421 2 5542 5439
Sími: +46 8 720 58 22

Italia Suomi/Finland
Advanced Accelerator Applications (Italy) S.r.l SAM Nordic
Tel: +39 0125 561211 Ruotsi/Sverige
Puh/Tel: +46 8 720 58 22

Κύπρος Sverige
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ SAM Nordic
Τηλ: +30 22920 63900 Tel: +46 8 720 58 22
or
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Latvija United Kingdom (Northern Ireland)
SAM Nordic Novartis Ireland Limited
Zviedrija Tel: +44 1276 698370
Tel: +46 8 720 58 22

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

The complete Summary of Product Characteristics (SmPC) for Pluvicto is provided as a
separate document in the medicinal product's packaging, with the aim of providing healthcare
professionals with additional scientific and practical information on the administration and use of this
radiopharmaceutical.
Refer to the SmPC.