Active Ingredient: Padeliporfin
Padeliporfin is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥10 years and:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
3.66 - 3.66 mg per kg of body weight
From 3.66 To 3.66 mg per kg of body weight once every day for 1 day(s)
The recommended posology is one single dose of 3.66 mg/kg of padeliporfin.
Padeliporfin 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.
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.
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