Tauvid

Patient Information Leaflet

Tauvid 800 MBq/mL solution for injection, 1 900 MBq/mL solution for injection

flortaucipir (F)
This medicinal product is under additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while receiving
this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist in charge of performing the examination.
• If you experience any side effect, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

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

1. What Tauvid is and what it is used for

This medicinal product is a radiopharmaceutical (radioactive medicinal product) for diagnostic use only. Tauvid
contains the active substance flortaucipir ( F).
Tauvid is administered to adults with memory problems who are being evaluated for Alzheimer's disease, so that physicians can perform a type of brain scan called PET (positron emission tomography). A PET scan, together with other tests of brain function, can help the physician identify the cause of memory problems. Tauvid can help the physician determine whether or not abnormal forms of tau protein are present in the brain. Abnormal forms of tau protein are found in the brains of people with Alzheimer's disease.
Use of Tauvid involves exposure to radioactivity. Your physician and the nuclear medicine specialist have determined that the clinical benefit you will gain from this radiopharmaceutical procedure outweighs the radiation risk (see section 3).

2. What you need to know before Tauvid is used

Tauvid must not be used

• if you are allergic to flortaucipir (F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Inform your doctor or nurse before you are given Tauvid

• if you have liver or kidney problems, as this may lead to increased radiation exposure
• if you are pregnant or think you might be pregnant
• if you are breastfeeding (see section 2, “Pregnancy, breastfeeding and fertility”).

Before receiving Tauvid you should
Drink plenty of water before the start of the scan to urinate as frequently as possible during the first
hours after the PET scan.
Children and adolescents
There is no specific indication for the use of Tauvid in children and adolescents, as it is intended for use
in adults with memory problems being evaluated for Alzheimer’s disease.
Other medicines and Tauvid
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning a pregnancy, please
consult the nuclear medicine specialist before receiving this medicine.
You must inform the nuclear medicine specialist before administration of Tauvid if there is any
possibility you might be pregnant, if you have missed your menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist responsible for performing the
examination.
If you are pregnant
Any radiopharmaceutical, including Tauvid, may have harmful effects on the unborn child. The use of
Tauvid is not recommended in pregnant women. The nuclear medicine specialist will administer this
product during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
The use of Tauvid is contraindicated during breastfeeding. You must stop breastfeeding for 24 hours
after injection and discard the breast milk produced during this time. Ask your nuclear medicine
specialist when you can resume breastfeeding (see section 3, “After administration of Tauvid, you
should”).
Driving and using machines
Tauvid is unlikely to affect your ability to drive or operate machinery.
Tauvid 800 MBq/mL and 1 900 MBq/mL contains ethanol
This medicine contains 790 mg of alcohol (ethanol) per dose, equivalent to less than 20 mL of beer or
8 mL of wine. The small amount of alcohol in this medicine will not produce any significant effects.
Tauvid contains sodium
Tauvid 800 MBq/mL injectable solution contains up to 32 mg of sodium (main component of table salt)
per dose. This corresponds to 1.6% of the maximum daily recommended dietary intake for an adult.
Tauvid 1 900 MBq/mL injectable solution contains up to 34 mg of sodium (main component of table
salt) per dose. This corresponds to 1.7% of the maximum daily recommended dietary intake for an
adult.

3. How Tauvid is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Tauvid will only be used in designated controlled areas. This medicinal product will be handled and administered exclusively by qualified personnel trained to use it safely. Qualified staff will pay particular attention to the safe use of this radiopharmaceutical and will inform you about how they will perform the examination.

The nuclear medicine specialist supervising the examination will determine the amount of Tauvid to be used in your case. This will be the minimum quantity necessary to obtain the required information from the PET scan. The recommended amount for an adult is normally 370 MBq. The megabecquerel (MBq) is the unit of measurement used to express radioactivity.

Administration of Tauvid and performance of the examination
Drink plenty of water before the examination begins, so you can urinate as frequently as possible during the first few hours after the PET scan. Tauvid is administered by intravenous injection, followed by another intravenous injection of sodium chloride solution to ensure you receive the complete dose of Tauvid. A single injection of flortaucipir (F) is sufficient to perform the brain scan.

Duration of the examination
The nuclear medicine specialist will inform you how long the examination usually takes. A brain scan lasts 20 minutes and is normally performed approximately 80–100 minutes after the injection of Tauvid.

After receiving Tauvid, you must:

• Avoid close contact with newborns, young children, children, and pregnant women for 4 hours after the injection.

The nuclear medicine specialist will advise you to urinate as frequently as possible during the first few hours after the examination to reduce radiation exposure. If you have any questions, speak to the nuclear medicine specialist supervising the examination.

If you have been given more Tauvid than you should have
An overdose is unlikely because you will receive only a single dose of Tauvid, carefully controlled by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, appropriate treatment will be given.

If you have any doubts about the use of Tauvid, consult the nuclear medicine specialist supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Uncommon (may affect up to 1 in 100 people):

• headache
• dysgeusia (altered sense of taste)
• pain at the injection site
• increased blood pressure

This radiopharmaceutical will emit small amounts of ionizing radiation, which is associated with a minimal risk of cancer and hereditary abnormalities (see section 1, "What Tauvid is and what it is used for").
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult the nuclear medicine specialist. You may also report side effects directly via 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 Tauvid is stored

You must not store this medicinal product. This medicinal product is stored under the responsibility of the specialist in appropriate locations. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for healthcare professionals only.
Tauvid must not be used after the expiry date stated on the label of the shielded container and vial following EXP.
Tauvid must not be administered if particles are present or if there is any change in colour.
This medicinal product does not require any special temperature storage conditions.

6. Package contents and other information

What Tauvid contains

• The active substance is flortaucipir (F).
  Tauvid 800 MBq/mL solution for injection: 1 mL of solution for injection contains 800 MBq of flortaucipir (F) at the date and time of calibration.
  Tauvid 1 900 MBq/mL solution for injection: 1 mL of solution for injection contains 1 900 MBq of flortaucipir (F) at the date and time of calibration.
• The other components are:
  Tauvid 800 MBq/mL solution for injection: anhydrous ethanol, sodium chloride, water for injections (see section 2 “Tauvid contains ethanol and sodium”).
  Tauvid 1 900 MBq/mL solution for injection: anhydrous ethanol, dibasic sodium phosphate (for pH adjustment), diluted hydrochloric acid, sodium chloride, water for injections (see section 2 “Tauvid contains ethanol and sodium”).

Description of the appearance of Tauvid and contents of the pack
Tauvid is a clear, colourless solution for injection. It is supplied in a 15 mL transparent glass vial.
Tauvid 800 MBq/mL solution for injection (injection): A 15 mL multidose vial containing 1 to 15 mL of solution, corresponding to 800–12 000 MBq at the date and time of calibration.
Tauvid 1 900 MBq/mL solution for injection (injection): A 15 mL multidose vial containing 1 to 15 mL of solution, corresponding to 1 900–28 500 MBq at the date and time of calibration.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands

Manufacturers
Curium Pet France
14 Rue De La Grange Aux Belles
75010 Paris,
France
Alliance Medical RP Berlin GmbH
Max-Planck-Straße 4
12489 Berlin
Germany
Alliance Medical RP GmbH
Spessartstraße 9
53119 Bonn
Germany

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

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf.: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

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

The following information is intended exclusively for healthcare professionals:

The Summary of Product Characteristics (SmPC) for Tauvid is provided as a separate document within the medicinal product's packaging, with the aim of supplying healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
See the Summary of Product Characteristics [the SmPC must be included in the packaging].