Patient Information Leaflet

TEKTROTYD 16 micrograms kit for radiopharmaceutical preparation

Hydrochloride salt of HYNIC-[D-Phe1, Tyr3-octreotide]

EDDA (ethylenediamine-N,N'-diacetic acid)

Read this leaflet carefully before you start using 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 is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

It is used to obtain images of specific cells in the stomach, intestines, and pancreas, such as:

•abnormal tissue or

•tumors

The administration of TEKTROTYD involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

TEKTROTYD should not be usedif you are allergic to TFA HYNIC-[D-Phe1, Tyr3-octreotida] sodium, EDDA (ethylenediamine-N-N’-diacetic acid) or any of the excipients of this medication (listed in section 6), or to the injectable solution of sodium pertecnetate (99mTc).

Warnings and precautions

Be especially careful with TEKTROTYD

• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you have been diagnosed with renal insufficiency

Inform your nuclear medicine doctor if any of the above points apply to you.

Before using TEKTROTYD

To obtain the best possible images, it is necessary to prepare the patient properly before administering the radiopharmaceutical.

Unless your doctor tells you otherwise, it is recommended to follow a soft diet for two days before the study.

Your doctor may instruct you to use laxatives the day before the study.

On the day of the study, you should remain fasting until the first images are obtained.

The method for preparing the patient may be different, depending on the study protocol used and the location of the lesions to be imaged. Your doctor will determine the necessary preparation.

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old.

Use of TEKTROTYD with other medications

Certain medications may adversely affect the outcome of the scheduled study. Therefore, it is recommended to consult with your doctor about which medications should be discontinued before the study and when they should be resumed.

Inform your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medication, as some medications may interfere with the interpretation of the images.

Pregnancy and lactation

You must inform your nuclear medicine doctor before administering TEKTROTYD if there is any possibility of pregnancy, if you have a delayed menstrual period, or if you are breastfeeding.

In case of doubt, it is essential to consult with the nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Please consult with your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machinery

There are no studies on the effects of TEKTROTYD on the ability to drive and operate machinery.

It is considered unlikely that TEKTROTYD will affect the ability to drive or operate machinery.

TEKTROTYD contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per vial, making it essentially “sodium-free”.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. TEKTROTYD will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who will use it safely. Those individuals will take special care in the safe use of this product and will keep you informed of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of TEKTROTYD to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult varies between 370 and 740 MBq (megabecquerel, the unit used to express radioactivity).

Administration of TEKTROTYD and procedure performance

After radioactive labeling, the medication is administered as a single intravenous injection. This medication is not indicated for regular or continuous administration.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

Procedure duration

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

After TEKTROTYD administration, you must

Urinate frequently to eliminate the product from your body.

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

If you have been administered more TEKTROTYD than necessary

A overdose is unlikely because you will receive a single, precisely controlled dose of TEKTROTYD from the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive appropriate treatment to increase the elimination of the radionuclide from your body, for example, the administration of fluids and frequent bladder emptying.

If you have any other questions about the use of TEKTROTYD, consult the nuclear medicine physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

During the evaluation of adverse effects, the following frequency data are taken as a basis:

Very frequent:more than 1 patient in every 10

Frequent:1 to 10 patients in every 100

Infrequent:1 to 10 patients in every 1,000

Rare:1 to 10 patients in every 10,000

Very rare:less than 1 patient in every 10,000

Unknown:cannot be calculated from the available data

In very rare cases, transient headache or epigastric pain may occur after administration of TEKTROTYD.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation. It is very rare for this to be associated with a risk of cancer and hereditary defects.

Reporting Adverse Effects

If you experience side effects, consult your nuclear physician, even if they are side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in appropriate 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.

Do not use TEKTROTYD after the expiration date appearing on the labels.

Composition of TEKTROTYD

Vials 1 and 2 contain the components for the preparation of technetium-99m labeled TEKTROTYD.

Vial 1:

The active ingredient is the HYNIC-[D-Phe1, Tyr3-octreotide] TFA salt.

The excipients are:

stannous chloride dihydrate, tricine (N-[tris(hydroxymethyl)methyl]glycine), mannitol, and nitrogen.

Vial 2:

The active ingredient is EDDA (ethylenediamine-N,N'-diacetic acid).

The excipients are:

sodium dihydrogen phosphate dodecahydrate, sodium hydroxide, and nitrogen.

Appearance of TEKTROTYD and packaging contents

The packaging contains 2 different 10 ml glass vials in a cardboard box.

Each vial contains a white or almost white lyophilisate for the preparation of an injectable solution.

Packaging size:2 vials for simultaneous administration

Marketing Authorization Holder

ROTOP Pharmaka GmbH

Bautzner Landstrasse 400

01328 Dresden, Germany

Telephone:+49 351 26 31 02 10

Fax:+ 49 351 26 31 03 13

Email: [email protected]

Responsible for manufacturing

National Centre for Nuclear Research

Andrzej Soltan 7, 05-400 Otwock-Swierk

Poland

+48 22 718 07 00

+48 22 718 03 50

[email protected]

For further information about this medication, please contact the local representative of the marketing authorization holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

Last review date of this leaflet: 12/2020

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://wwww-aemps.gob.

This information is intended solely for medical professionals or healthcare professionals:

The complete Technical Dossier for TEKTROTYD is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the Technical Dossier.