Voretigene neparvovec injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of voretigene neparvovec.
Drugs List
Therapeutic Indications
Uses
Inherited retinal dystrophy caused by biallelic RPE65 mutations
Treatment of vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
Dosage
Treatment should be administered by a retinal surgeon experienced in macular surgery.
Adults
1.5x10 to the power of 11 vg voretigene neparvovec given as a subretinal injection in a volume of 0.3ml into each eye. Administration into each eye is performed on separate days, at least 6 days apart.
Children
1.5x10 to the power of 11 vg voretigene neparvovec given as a subretinal injection in a volume of 0.3ml into each eye. Administration into each eye is performed on separate days, at least 6 days apart.
Additional Dosage Information
Prior to administration of voretigene neparvovec in the first eye, it is recommended that an immunomodulatory regimen is initiated, starting three days before.
Initiation of the immunomodulatory regimen for the second eye should follow the same schedule and supersede that of the first eye.
Pre-operative
3 days prior to administration of voretigene neparvovec: 1mg/kg/day of prednisone (maximum 40mg/day).
Post-operative
4 days (including the day of administration): 1mg/kg/day of prednisone (maximum 40mg/day).
Followed by 5 days: 0.5mg/kg/day of prednisone (maximum 20mg/day).
Followed by 5 days of one dose every other day: 0.5mg/kg/day of prednisone (maximum 20mg/day).
Administration
For subretinal use only.
Contraindications
Children under 4 years
Breastfeeding
Ocular infection
Ocular inflammation
Periocular infection
Pregnancy
Precautions and Warnings
Postpone treatment if there is active or suspected infection
Advise visual disturbances may affect ability to drive or operate machinery
Monitor and manage intraocular pressure before and after administration
Systemic corticosteroids should be given to reduce risk of immunogenicity
Advise patient and carers to wear gloves when changing dressings
Aseptic technique should be used throughout
Record name and batch number of administered product
Treatment to be administered by or under supervision of specialist
Vector shedding may occur in patient tears and nasal secretions
Advise patient to report any symptoms of endophthalmitis immediately
Advise patient to report any symptoms of retinal detachment immediately
Advise patient to report any unexpected changes in eye symptoms immediately
Advise patient to avoid air travelling for 1 week after administration
Advise patient to avoid donating blood, organs, tissues or cells
Avoid strenuous exercise or swimming for at least 1-2 weeks after treatment
Air travel (or other travel at high elevations) should be avoided until the air bubble formed, as a result of administration, has completely dissipated from the eye. An increase in altitude while the air bubble is still present can cause a rise in eye pressure and irreversible vision loss. Dissipation of the air bubble should be verified by ophthalmic examination.
Transient and low-level vector shedding may occur in patient tears. Patients and caregivers should be advised to wear gloves for dressing changes and waste disposal. It is also advised that waste material generated from dressings, tears and nasal secretion appropriately. These handling precautions should be followed by 14 days after administration.
Pregnancy and Lactation
Pregnancy
Voretigene neparvovec is contraindicated during pregnancy.
The manufacturer does not recommend using voretigene neparvovec during pregnancy. At the time of writing there is limited published information regarding the use of voretigene neparvovec during pregnancy. Potential risks are unknown.
Lactation
Voretigene neparvovec is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues voretigene neparvovec or discontinues breastfeeding. The presence of voretigene neparvovec in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Abdominal pain
Anxiety
Cataracts
Chorioretinal atrophy
Conjunctival hyperaemia
Corneal dellen
Dehiscence
Dizziness
ECG changes
Endophthalmitis
Eye disorder
Facial oedema
Headache
Increased intra-ocular pressure
Lip pain
Macular degeneration
Macular hole
Maculopathy
Nausea
Ocular inflammation
Ocular irritation
Ocular oedema
Ocular pain
Optic atrophy
Photophobia
Rash
Retinal detachment
Retinal haemorrhage
Retinal tear
Sensation of foreign body in eye
Visual disturbances
Vitreous opacities
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2021
Reference Sources
Summary of Product Characteristics: Luxturna 5 tera vector genomes/ml concentrate and solvent for solution for injection. Novartis Pharmaceuticals UK Ltd. Revised February 2022.
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