TEKTROTYD Kit for radiopharmaceutical preparation Ref.[11075] Active ingredients: Technetium ⁹⁹ᵐTc hynic-octreotide

Posology

The recommended posology is 370-740 MBq for planar scintigraphy and for SPECT studies.

Adults

The suggested activity range is 370 to 740 MBq in one single intravenous injection. The activity to be administered depends on the sensitivity of the available equipment.

Elderly population (above 65 years)

The recommended activity to be given to adults is 370 to 740 MBq in one single intravenous injection. No dose adjustment is required for elderly.

Renal impairment

Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients, see section 4.4.

Hepatic impairment

Dosage reduction in hepatic impairment is not necessary, see section 5.2.

Paediatric population

There are no data on safety and efficacy of technetium ^99mTc-EDDA/HYNIC-TOC for the use in paediatric patients.

Method of administration

This medicinal product should be radiolabeled before administration to the patient.

For instructions for preparation of the radiopharmaceutical, see section 12. ^99mTc-EDDA/HYNIC-TOC is administered intravenously in a single dose.

For patient preparation, see section 4.4.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely diagnostic benefit and risk from radiation exposure.

For more convenient administration, the solution of ^99mTc-EDDA/HYNIC-TOC may be diluted with sodium chloride injection, see section 6.2.

Image acquisition

Image acquisition should be carried out at 1-2 and 4 hours after intravenous administration. Images at 1-2 hours post-injection may be useful for comparison and evaluation of abdominal activity imaged at 4 hours.

The examination may be complemented depending on the clinical need by acquisition 15 minutes and 24 hours post-injection of the tracer. An additional 24-hour image acquisition can improve specificity in ambiguous cases, especially in the abdomen.

It is recommended to carry out the examinations using Whole Body technique and SPECT (or SPECT/CT) of selected body areas.

Dosimetry

Technetium (^99mTc) is obtained from a ^99^Mo/99m^Tc radionuclide generator and decays by gamma emission (energy 141 keV) with a physical half-life of 6.02 hours to technetium-99, which in view of its long half-life of 2.13 × 10⁵ years may be regarded as quasi stable.

Patient-specific 3-dimensional (3D) image-based dosimetry of 99mTc-EDDA/HYNICTOC in NETs was assessed with the OLINDA/EXAM software with time-integrated activity coefficients estimated from a hybrid planar/SPECT technique in the study of Grimes et al. 2011. Absorbed doses in children and adolescents were calculated on the basis of the EANM paediatric dosage card Cluster B. The average organ absorbed doses and effective dose of ^99mTc-EDDA/HYNIC-TOC are given in the table below.

The effective dose resulting from the administration of a maximal recommended activity of 740MBq for an adult weighing 70 kg is about 3.7mSv. For an administered activity of 740 MBq the typical radiation dose to the critical organ, i.e. the kidneys, is 14.8 mGy.

Reference: Grimes J, Celler A, Birkenfeld B, et al. Patient-Specific Radiation Dosimetry of ^{99m^Tc-HYNIC-Tyr3}-octreotide in Neuroendocrine Tumours. J Nucl Med 2011; 52: 1474-1481.

No case of overdose has been reported.

Overdose is unlikely when the radiopharmaceutical is administered by diagnostic monodose injection.

In the event of administration of a radiation overdose with 99mTc-EDDA/HYNICTOC the adsorbed dose to the patient should be reduced by increasing the elimination of the radionuclide from the body by administration of liquids and frequent bladder voiding

1 year.

After radiolabelling 4 hours when stored below 25°C.

Store in a refrigerator at 2°C-8°C.

Store in the original package in order to protect from light.

For storage conditions after radiolabelling of the medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials

Glass vials (Type I Ph. Eur.) of 10 mL nominal capacity, sealed with a rubber stopper and an aluminium cap with flip off seal.

Vials I and II contain components for the radiopharmaceutical preparation of 99mTcEDDA/HYNIC-TOC.

Each vial contains a white or nearly white lyophilisate for preparation of a solution for injection.

Vial I: active substance: HYNIC-[D-Phe¹, Tyr³octreotide] TFA salt, excipients: stannous chloride dihydrate, tricine (N[Tris(hydroxymethyl)methyl]glycine), mannitol, nitrogen

Vial II: active substance: EDDA (ethylenediamine-N,N'-diacetic acid), excipients: disodium hydrogen phosphate dodecahydrate, sodium hydroxide, nitrogen

Pack size: 2 vials.

Tektrotyd is supplied as kit consisting of two vials which cannot be used separately.

The radionuclide is not part of the kit.

General warning

Contents of the kit vials are intended only for use in the preparation of ^99mTcEDDA/HYNIC-TOC and are not to be administered directly to a patient without first undergoing the preparative procedure.

After radiolabelling of Tektrotyd the common protective measures for radioactive medicinal product must be applied.

Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.

Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. Contents of the vials are intended only for use in the preparation of ^99mTcEDDA/HYNIC-TOC and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on radiolabelling of the medicinal product before administration, see section 12.

If at any time in the preparation of this product the integrity of the vial is compromised, the product should not be used.

Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The content of the kit before extemporary preparation is not radioactive. However, after sodium pertechnetate (^99mTc) injection, Ph. Eur. is added, adequate shielding of the final preparation must be maintained.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.