Drug information of Ranibizumab
Mechanism of effect
Humanized monoclonal antibody to VEGF-A, inhibits VEGF-A-induced ocular neovascularization .
Peak plasma time: ~1 day
Peak plasma concentration: 1.7 ng/mL (0.5 mg-dose)
Half-life: ~9 days (vitreous)
- Diabetic macular edema
- Diabetic retinopathy
- Macular degeneration: Treatment of neovascular (wet) age-related macular degeneration (AMD)
- Macular edema
- Myopic choroidal neovascularization
Age-related macular degeneration (AMD), neovascular (wet): Intravitreal: 0.5 mg once a month (approximately every 28 days). Frequency may be reduced (eg, 4 to 5 injections over 9 months) after the first 3 injections or may be reduced after the first 4 injections to once every 3 months if monthly injections are not feasible.
Diabetic macular edema (DME): Intravitreal: 0.3 mg once a month (approximately every 28 days); in clinical trials, monthly doses of 0.5 mg were also studied
Diabetic retinopathy (DR): Intravitreal: 0.3 mg once a month (approximately every 28 days)
Macular edema following retinal vein occlusion (RVO): Intravitreal: 0.5 mg once a month (approximately every 28 days).
Myopic choroidal neovascularization (mCNV): Intravitreal: 0.5 mg once a month (approximately every 28 days) for up to 3 months; may retreat if necessary.
- Ocular/periocular infections
Arterial thromboembolism, Foreign body sensation of eye , headache ,Anemia ,Arthralgia ,Conjunctival hemorrhage , eye pain , vitreous opacity , increased intraocular pressure , blurred vision , intraocular inflammation ,Nasopharyngitis , bronchitis ,Peripheral edema , atrial fibrillation , cerebrovascular accident ,Peripheral neuropathy ,Hypercholesterolemia ,Nausea , constipation , gastroesophageal reflux disease ,Chronic renal failure ,Antibody formation , seasonal allergy ,Influenza ,Bleeding at injection site ,Retinal degeneration,Upper respiratory tract infection , cough , sinusitis , chronic obstructive pulmonary disease ,Wound healing impairment ,Anterior chamber inflammation, anxiety, back pain, corneal edema, corneal erosion, coronary artery occlusion, decreased visual acuity, dizziness, endophthalmitis, epithelial keratopathy, eye discharge (lid margin), eyelid pain, hypoglycemia, iatrogenic traumatic cataracts, intestinal obstruction, photophobia, retinal pigment epithelium tear, rhegmatogenous retinal detachment, rhinorrhea, urticaria
-Risk of endophthalmitis or retinal detachment with intravitreous injections
-Possibility of intraocular pressure increase within 60 min of intravitreal injection
-Potential for adverse thromboembolic events (eg, nonfatal stroke, nonfatal MI, vascular death)
-Temporary visual disturbances may occur
-Fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly compared with control
-No studies on effects of ranibizumab on fertility conducted; not known whether ranibizumab can affect reproduction capacity; based on anti-VEGF mechanism of action for ranibizumab, therapy may pose risk to reproductive capacity
Points of recommendation
-Monitoring Intraocular pressure (prior to and 30 minutes following injection via tonometry);
-consider checking for perfusion of the optic nerve head immediately following injection;
-Monitoring signs of infection/inflammation (for first week following injection);
-Monitoring retinal perfusion, endophthalmitis; visual acuity.
There are no adequate and well-controlled studies in pregnant women.
Ranibizumab should be given to a pregnant woman only if clearly needed. Until additional information is available, use during the first trimester should be avoided and use later in pregnancy should be based on patient specific risks versus benefits.