Patizra

Patizra

ranibizumab

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Ranibizumab
Indications/Uses
Adults w/ neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM); proliferative diabetic retinopathy (PDR). Preterm infants w/ retinopathy of prematurity (ROP).
Dosage/Direction for Use
Intravitreal Adult 0.5 mg as single inj. Interval between 2 doses inj into the same eye should not be <1 mth. Wet AMD Initially w/ a loading phase of 1 inj mthly for 3 consecutive mth, followed by maintenance phase base on mthly monitoring of visual acuity. May be reduced to 1 inj every 3 mth after the 1st 4 inj if mthly inj are not feasible. Alternative dose: 1 inj mthly until max visual acuity is achieved &/or there are no signs of disease activity. May be extended by 2 wk at a time. Visual impairment due to DME 1 inj mthly until max visual acuity is achieved &/or there are no signs of disease activity. May be extended by 2 wk at a time. Laser photocoagulation in DME & branch RVO When given on the same day, administer at least 30 min after laser photocoagulation. PDR 1 inj mthly until max visual acuity is achieved &/or there are no signs of disease activity. Treatment intervals may be extended & shortened accordingly if disease activity recurs. Visual impairment due to CNV secondary to PM 1 or 2 inj during the 1st yr. Some patients may need more frequent treatment. Visual impairment due to macular edema secondary to RVO Given mthly & continued until max visual acuity is achieved. Pre-term infant ROP 0.2 mg as single inj, may be given bilaterally on the same day. Interval between 2 doses inj into the same eye should not be <1 mth.
Contraindications
Hypersensitivity. Patients w/ active or suspected ocular or periocular infections & active intraocular inflammation.
Special Precautions
Endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear & iatrogenic traumatic cataract. Proper aseptic inj techniques must be used. Transient increases in IOP w/in 60 min of inj & sustained IOP increases. Monitor IOP & optic nerve head perfusion. Potential risk of arterial thromboembolic events; immunogenicity. Patients w/ known risk factors for stroke, history of prior stroke or transient ischemic attack; active systemic infections or concurrent eye conditions eg, retinal detachment or macular hole. Increased risk of systemic adverse events w/ bilateral treatment. May induce temporary visual disturbances. Women of childbearing potential should use effective contraception during treatment. Not to be used during pregnancy. Not recommended during breast-feeding. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Nasopharyngitis, URTI; headache, dizziness; intraocular inflammation, vitritis, vitreous detachment & floaters, retinal & conjunctival hemorrhage, visual disturbance, eye pain, irritation & pruritus, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, ocular hyperemia, cataract, subretinal fibrosis, visual acuity blurred/decreased; arthralgia, back pain, arthritis; increased IOP; HTN/elevated BP. Flu, UTI; anaemia; anxiety; stroke; retinal degeneration, disorder, detachment, tear & pigment epithelium tear, detachment of retinal pigment epithelium, reduced visual acuity, vitreous haemorrhage & disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior cap opacification, punctuate keratitis, corneal abrasion, anterior chamber flare, blurred vision, inj site & eye haemorrhage, conjunctivitis, allergic conjunctivitis, eye discharge, photopsia, photophobia, ocular discomfort, eyelid oedema & pain, conjunctival hyperaemia retinal exudates, maculopathy; cough; nausea, constipation; allergic reactions (rash, urticaria, pruritus, erythema).
MIMS Class
Other Eye Preparations
ATC Classification
S01LA04 - ranibizumab ; Belongs to the class antineovasculatisation agents. Used in the management of neovascular macular degeneration.
Presentation/Packing
Form
Patizra soln for inj 10 mg/mL
Packing/Price
(vial) 0.23 mL x 1's (Rp4,785,000/boks)
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