Pluvicto 1 000 mbq/ml solucion inyectable y para perfusion

Patient Information Leaflet

Pluvicto 1000MBq/mL injectable solution and for perfusion

Lutetium (177Lu) vipivotida tetraxetán

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this leaflet carefully before starting to use this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine doctor who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine doctor,even if they are not listed in this leaflet. See section4.

1.What Pluvicto is and for what it is used

2.What you need to know before Pluvicto is administered

3.How Pluvicto is administered

4.Possible adverse effects

5.Storage of Pluvicto

6.Contents of the package and additional information

What is Pluvicto

Pluvicto contains lutetium (177Lu) vipivotida tetraxetán. This medication is a single radioisotope for treatment only.

What is Pluvicto used for

Pluvicto is used in adults with progressive castration-resistant prostate cancer that has spread to other parts of the body (metastatic) and has already been treated with other cancer treatments. Castration-resistant prostate cancer is a type of prostate cancer (male reproductive system gland) that does not respond to treatment to reduce male hormones. Pluvicto is used if prostate cancer cells have a protein on their surface called prostate-specific membrane antigen (PSMA).

How Pluvicto works

Pluvicto binds to PSMA found 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 see if PSMA is present on the surface of cancer cells. It is more likely that your cancer will respond to treatment with Pluvicto if the test result is positive.

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

If you have any doubts about how Pluvicto works or why you have been prescribed this medication, consult your nuclear medicine doctor.

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

Do not administer Pluvicto

• if you are allergic to lutetium (177Lu) vipivotida tetraxetán or to any of the other components of thismedication(including those listed in section6).

Warnings and precautions

If you have any of the following conditions, inform your nuclear medicine doctor before receiving Pluvicto:

• if you have low levels of certain types of blood cells (red blood cells, white blood cells, neutrophils, platelets)
• if you have or have had fatigue, weakness, pale skin, difficulty breathing, bleeding orhematomasthat occur spontaneously or last longer than usual, or frequent infections with symptoms such as fever, chills, sore throat or ulcers in the mouth (possible signs of myelosuppression [a condition in which the bone marrow cannot produce enough blood cells])
• ifyou haveor have had kidney problems
• if you have or have had any other type of cancer or cancer treatment, as Pluvictocontributesto your overall exposure to accumulated radiation over time

Before administration of Pluvicto you must:

• drinkabundant 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 medication in children and adolescents under 18years have not been established. This medication should not be administered to children or adolescents under 18years because there are no available data in 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, inform 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. Consult your nuclear medicine doctor about how this may affect you, especially if you are planning to have children in the future. You may wish to seek advice on sperm preservation before starting treatment.

Contraception in men

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

Driving and operating machinery

It is unlikely that Pluvicto will affect your ability to drive and operate machinery.

Pluvicto contains sodium

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

There are strict guidelines for 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 individuals will take special care in the safe use of this radiopharmaceutical and will inform you of their actions.

How much Pluvicto is administered

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

Administration of Pluvicto and procedure performance

Pluvicto is administered directly into a vein.

Duration of the procedure

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

If you have any doubts about how long you will receive Pluvicto, consult with your nuclear medicine physician.

Treatment monitoring

Your nuclear medicine physician 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 physician may decide to delay, change, or discontinue your treatment with Pluvicto if necessary.

After Pluvicto administration, 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

Since it is a radioactive medication, you must follow the instructions described below to minimize exposure to radiation from other people, unless your nuclear medicine physician instructs you otherwise.

Contact with other people who live with you, children, and/or pregnant women

• Limit close contact (less than 1 meter) with:
• people who live with you for 2 days
• children and pregnant women for 7 days
• Sleep in a separate room from:
• other people who live 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 activity during treatment with Pluvicto and for 14 weeks after your last dose.

Use of toilets

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

• You must sit down 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.
• Dispose of all wipes and toilet paper in the toilet immediately after use.
• Dispose of any materials containing bodily fluids, such as blood, urine, or feces, in the toilet. Items that cannot be disposed of in the toilet, such as sanitary napkins, should be placed in plastic bags (as recommended in the "Disposal Recommendations" section below).
• Any medical equipment that may become contaminated with bodily fluids (e.g., catheter bags, colostomy bags, urinals, water bottles) should be emptied immediately into the toilet and cleaned afterwards.

Shower and laundry

• Take a shower every day for at least 7 days after administration.
• Wash underwear, pajamas, sheets, and clothing that contains sweat, blood, or urine separately from the rest of the laundry of other people in your home, using a standard washing cycle. No need to use bleach or perform extra rinses.

Caregivers

For 2-3 days after administration:

• People who need to stay in bed or have reduced mobility will receive assistance from a caregiver. It is recommended that when assistance is provided in the bathroom, the caregiver wear disposable gloves.
• Caregivers who remove vomit, blood, urine, or feces must wear plastic gloves that should be disposed of in a separate plastic waste bag (see "Disposal Recommendations" below).

Disposal recommendations

• All materials to be disposed of must be placed in a separate plastic waste bag that is used only for this purpose.
• Store the plastic waste bags separate from regular trash and keep them out of reach of children and animals.
• A hospital staff member will inform you how and when to dispose of these waste bags.

Hospitalization and emergency care

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

Other precautions

• Your nuclear medicine physician will inform you if you need to take any other special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

If you have been administered 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 physician who supervises the procedure. An overdose is unlikely. However, in the event of an overdose, you will receive the appropriate treatment.

If you forgot to receive Pluvicto

If you missed an appointment to receive Pluvicto, speak with your nuclear medicine physician as soon as possible to reschedule.

If you have any other questions about the use of Pluvicto, ask your nuclear medicine physician who supervises the procedure.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

If you experience any serious side effects,inform your nuclear doctor immediately.

Very common:can affect more than 1 in 10people

• fatigue, weakness, pale skin, or difficulty breathing (possible signs of lowred blood cell levels [anemia])
• bleedingor spontaneous bruises or your bleeding takes longer than usual (possible signs of low platelet levels [thrombocytopenia])
• frequent infections with symptoms such as fever, sore throat, or mouth ulcers (possible signs of low white blood cell levels [leucopenia, lymphopenia]).

Common:can affect up to 1 in 10people

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

Other possible side effects

Other side effects include those listed below. If those side effects become serious, inform your nuclear doctor.

Very common:can affect more than 1 in 10people

• fatigue(fatigue)
• dry mouth
• nausea
• lossof appetite
• changesin bowel movements (constipationordiarrhea)
• vomiting
• urinating frequently with pain or burning sensation (urinary tract infection)
• abdominal pain
• weight loss

Common:can affect up to 1 in 10people

• swellingof hands, ankles, or feet (peripheral edema)
• dizziness
• headache
• alterationof taste (dysgeusia)
• fever(pyrexia)
• dry eyes
• dizziness, with sensation of spinning (vertigo)

Reporting side effects

If you experience any type of side effect, consult your nuclear doctor, even if it's a possible side effect not listed in this prospectus.You can also report them directlythrough thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist:

• Keepthis medication out of the sight and reach of children.
• Do notfreeze.
• Keep in the original packaging to protect against ionizing radiation (lead shielding).
• Pluvicto should not be used after the expiration date and time appearing on the labels of the lead shielding container and the vial after CAD.
• The disposal of unused medication and all materials that have come into contactwithit will be carried out in accordance with local regulations.

Composition of Pluvicto

• The active principle is lutetium (177Lu) vipivotida tetraxetan. One ml of solution contains 1000MBq 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 injection (see section2 “Pluvicto contains sodium”).

Appearance of Pluvicto and contents of the container

Pluvicto is a transparent, 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 volume of solution that may vary between 7.5ml and 12.5ml corresponding to a radioactivity of 7400MBq ±10% at the time of administration.

The vial is inside a lead container as a protective shield.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

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 and 2 La Almunia de Doña Godina

50100 Zaragoza

Spain

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

Last review date of this leaflet

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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