TOOKAD Powder for solution for injection Ref.[7650] Active ingredients: Padeliporfin

TOOKAD is restricted to hospital use only. It should only be used by personnel trained in the Vascular-Targeted Photodynamic therapy (VTP) procedure.

Posology

The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.

TOOKAD is administered as part of focal VTP. The VTP procedure is performed under general anaesthetic after rectal preparation. Prophylactic antibiotics and alpha-blockers may be prescribed at the physician’s discretion. Retreatment of the same lobe or sequential treatment of the contralateral lobe of the prostate are not recommended (see section 4.4).

Special populations

Hepatic impairment

No data are available in patients with hepatic impairment. Exposure to padeliporfin is expected to be increased and/or prolonged in patients with hepatic impairment. No specific dosage recommendation can be given. TOOKAD should be used with caution in patients with severe hepatic impairment.

TOOKAD is contraindicated in patients who have been diagnosed with cholestasis (see section 4.3).

Renal impairment

There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.

This medicinal product contains potassium. This should be taken into consideration (see section 4.4).

Elderly

No specific posology adjustment is necessary in this population (see section 5.2).

Paediatric population

There is no relevant use of TOOKAD in the paediatric population in the treatment of low-risk localised prostate cancer.

Method of administration

TOOKAD is for intravenous use. For instructions on reconstitution of TOOKAD before administration, see section 6.6.

Illumination for photoactivation of TOOKAD

The solution is administered by intravenous injection over 10 minutes. Then the prostate is illuminated immediately for 22 minutes 15 seconds by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm. Planning of optical fibre positioning should be performed at the beginning of the procedure using the treatment guidance software. During the procedure, the number and the length of the optical fibres are selected depending on the shape and the size of the prostate and the optical fibres are positioned transperineally into the prostate gland under ultrasound guidance to achieve a Light Density Index (LDI) ≥1 in the targeted tissue. Treatment should not be undertaken in patients where an LDI ≥1 cannot be achieved (see section 5.1).

There is limited clinical information on overdose involving TOOKAD. Healthy subjects have been exposed to doses up to 15 mg/kg of padeliporfin di-potassium (corresponding to 13.73 mg/kg of padeliporfin) without light activation and 23 patients have been treated with 6 mg/kg of padeliporfin di-potassium (corresponding to 5.49 mg/kg of padeliporfin) without significant safety issues. However, a prolongation of photosensitisation is possible and precautions against light exposure should be maintained for an additional 24 hours (see section 4.4).

An overdose of the laser light may increase the risk of undesirable extraprostatic necrosis (see section 4.4).

Shelf life

Unopened vial: 5 years.

After reconstitution: The chemical and physical stability of TOOKAD after reconstitution with 5% glucose solution, in its vial, has been demonstrated for 8 hours at 15°C-25°C and at 5°C ± 3°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Store in a refrigerator (2°C-8°C).

Keep the vial in the outer carton in order to protect from light.

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

TOOKAD 183 mg powder for solution for injection: Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a blue plastic flip-off cap, containing 183 mg padeliporfin.

Pack size: 1 vial

TOOKAD 366 mg powder for solution for injection: Amber type I glass vial, sealed with a rubber stopper crimped with an aluminium seal and covered with a white plastic flip-off cap, containing 366 mg padeliporfin.

Pack size: 1 vial

The preparation of the solution should take place in a dimmed-light environment.

TOOKAD is prepared by reconstituting the powder for solution for injection with:

• 20 mL of 5% glucose solution for TOOKAD 183 mg,
• 40 mL of 5% glucose solution for TOOKAD 366 mg.

The vial should then be swirled gently for 2 minutes. Each mL of the resulting solution will contain 9.15 mg of padeliporfin. The vial should rest in an upright position for 3 minutes without further shaking or moving. Due to the photosensitising properties of TOOKAD, the content of the vial should then be transferred into an opaque syringe that should be held in an upright position for 3 minutes to ensure any foam disappears. An injection filter of 0.22 μm and an opaque tubing should be used to administer the medicinal product to the patient. Standard handling of syringes should follow.

The reconstituted solution is dark. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

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