New medicines
Lucentis
Composition: Ranibizumab.
Presentation: Solution for injection.
Class: Humanised recombinant monoclonal antibody fragment
targeted against human vascular endothelial growth factor
(VEGF) A.
Indications: Neovascular (wet) age-related macular degeneration.
Dosage: 0.5mg (0.05ml) given by intravitreal injection
once a month for three consecutive months. Patients should be monitored
monthly thereafter
and given further doses if loss of visual acuity (>5 letters) occurs.
Contraindications: Active or suspected ocular or periocular
infection; active severe intraocular inflammation.
Precautions: The interval between two doses should be
at least one month. Lucentis should be inspected visually for particulate
matter and discolouration
before administration. Patient should self-administer antimicrobial drops
four times a day for three days before and after each injection. The
injection procedure should be carried out under aseptic conditions. The
periocular skin, eyelid and ocular surface should be disinfected, and
anaesthesia and a broad-spectrum topical microbicide should be administered
before the injection. A different scleral site should be selected for
each injection. Intravitreal injections, including those with Lucentis,
have been associated with endophthalmitis, intraocular inflammation,
rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic
cataract; patients should be instructed to report any symptoms suggestive
of these conditions without delay. Patients should be monitored for infection
during the week following injection. Intraocular pressure and perfusion
of the optic nerve must be monitored after administration. Use of Lucentis
in both eyes has not been studied and could lead to increased risk of
systemic adverse events. Lucentis should not be administered concurrently
with other anti-VEGF agents. The dose should be withheld and treatment
should not be continued earlier than the next scheduled treatment in
the event of: visual acuity reduced >=30 letters; intraocular pressure
>=30mmHg; retinal break; subretinal haemorrhage involving the centre
of the fovea
or >=50 per cent of the total lesion area; intraocular surgery planned
or performed 28 days before or after. Treatment should be discontinued
in patients with rhegmatogenous retinal detachment or stage 3 or 4 macular
holes. Lucentis treatment may induce temporary visual disturbances which
may affect the ability to drive or operate machinery.
Side effects: Very common (>=1/10) headache, conjunctival haemorrhage,
eye pain, vitreous floaters, retinal haemorrhage, increased intraocular
pressure, vitreous detachment, intraocular inflammation, eye irritation,
cataract, foreign body sensation in eyes, visual disturbance, blepharitis,
subretinal fibrosis, ocular hyperaemia, visual acuity decreased, dry
eye, vitritis, hypertension. Common (>=1/100, <1/10) ocular discomfort,
conjunctival hyperaemia, posterior capsule opacification, retinal exudates,
injection site reactions, lacrimation increased, eye pruritus, conjunctivitis,
maculopathy, detachment of the retinal pigment epithelium, nausea, arthralgia,
back pain, bronchitis, anaemia.
Legal category: POM.
Net price: 1 x 3mg/0.3ml vial, £761.20.
Contact details: Novartis Pharmaceuticals UK Ltd, Frimley
Business Park, Frimley, Surrey GU16 7SR (tel 01276 692255).
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