Diabetic macular edema
Diabetic retinopathy
Exudative age-related macular degeneration
Macular retinal edema - Thrombosis of retinal vein
Myopic choroidal neovascularization

Ranibizumab inhibits the human vascular endothelial growth factor A (VEGF-A) by binding to its active forms, thereby preventing ocular angiogenesis by VEGF-A including reduced endothelial cell proliferation, vascular leakage, and new blood vessel formation

Absorption
Tmax, intravitreal: Approximately 1 day
Elimination Half Life
Vitreous t(1/2): Approximately 9 days

Hypersensitivity to ranibizumab or any component of the product; reactions may manifest as severe intraocular inflammation
Ocular or periocular infections

Fetal risk cannot be ruled out.

Infant risk cannot be ruled out

>10%:
Cardiovascular: Arterial thromboembolism (AMD trials during first year: 2%; DME trials at 3 years: 11%)
Central nervous system: Foreign body sensation of eye (7% to 16%), headache (6% to 12%)
Hematologic & oncologic: Anemia (4% to 11%)
Neuromuscular & skeletal: Arthralgia (2% to 11%)
Ophthalmic: Conjunctival hemorrhage (47% to 74%), eye pain (17% to 35%), vitreous opacity (7% to 27%), increased intraocular pressure (7% to 24%), blurred vision (5% to 18%), intraocular inflammation (1% to 18%)
Respiratory: Nasopharyngitis (5% to 16%), bronchitis (6% to 11%)
1% to 10%:
Cardiovascular: Peripheral edema (6%), atrial fibrillation (1% to 5%), cerebrovascular accident (AMD trials during 2 years: 3%; DME trials at 3 years: 2%)
Central nervous system: Peripheral neuropathy (1% to 5%)
Endocrine & metabolic: Hypercholesterolemia (3% to 7%)
Gastrointestinal: Nausea (9% to 10%), constipation (8%), gastroesophageal reflux disease (1% to 6%)
Genitourinary: Chronic renal failure (6%)
Immunologic: Antibody formation (1% to 9%), seasonal allergy (8%)
Infection: Influenza (3% to 7%)
Local: Bleeding at injection site (1% to 5%)
Ophthalmic: Retinal degeneration (1% to 8%)
Renal: Renal failure (7%)
Respiratory: Upper respiratory tract infection (9%), cough (5% to 9%), sinusitis (3% to 8%), chronic obstructive pulmonary disease (3% to 6%)
Miscellaneous: Wound healing impairment (1%)
<1%：
postmarketing, and/or case reports: 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

Diabetic macular edema、Diabetic retinopathy：
Premedication, give adequate anesthesia and broad-spectrum microbicide prior to ranibizumab
0.3 mg (0.05 mL of 6 mg/mL ranibizumab solution) by intravitreal injection once monthly (approximately 28 days)
Exudative age-related macular degeneration：
Premedication, give adequate anesthesia and a broad-spectrum microbicide prior to injection
0.5 mg (0.05 mL of 10 mg/mL ranibizumab solution) by intravitreal injection once a month FDA dosage)
(Alternative dosing) May reduce to 0.5 mg by intravitreal injection every 3 months after the first 4 monthly injections if monthly injections are not feasible; dose will be less effective, leading to an approximate 5-letter (1-line) average loss of visual acuity over the following 9 months OR may reduce to 0.5 mg by intravitreal injection monthly for 3 months followed by less frequent injections (mean, 4 to 5 injections over 9 months) if monthly injections are not feasible; dose will be less effective, leading to a maintenance of visual acuity compared with a 1- to 2-letter gain with monthly injections (FDA dosage)
(Treat and extend protocol; TREX) 0.5 mg intravitreally once monthly for 3 treatments, with treatment interval thereafter determined by exudative disease activity and maintained between 4 and 12 weeks. If no intra- or sub-retinal fluid or hemorrhages, sequentially extend treatment intervals by 2 weeks to a maximum of 12 weeks. If signs of exudation or new hemorrhage occur, revert treatment interval back to the maximum recurrent-free interval (2 weeks shorter than the failed interval period), to a minimum of 4 weeks (off-label dosage)
Macular retinal edema - Thrombosis of retinal vein：
Premedication, give adequate anesthesia and broad-spectrum microbicide prior to ranibizumab
0.5 mg (0.05 mL of 10 mg/mL ranibizumab solution) by intravitreal injection once a month (approximately 28 days) (FDA dosage)
0.5 mg by intravitreal injection once a month for 7 doses; beginning at month 7, evaluate monthly and give 0.5 mg only as needed, if visual acuity and optical coherence tomography measurements are not stable (off-label dosage)
Myopic choroidal neovascularization：
Premedication, give adequate anesthesia and broad-spectrum microbicide prior to ranibizumab
0.5 mg (0.05 mL of a 10 mg/mL ranibizumab solution) by intravitreal injection once a month (about every 28 days) for up to 3 months; may retreat if needed (FDA dosage)
Retreatment, may be guided by visual acuity stabilization or guided by disease activity (off-label dosage)

Retinopathy of prematurity, Type 1：
a) Off-Label Dosage
1) Premedication: Administer topical anesthesia prior to ranibizumab .
2) Dosage: 0.25 mg or 0.3 mg via intravitreal injection for 1 dose .
3) Concomitant medications: Administer topical antibiotic for 1 week .
General Dosage Information
a) The safety and efficacy of ranibizumab have not been established in pediatric patients

Vials and prefilled syringes should be refrigerated, in original carton, between 2 and 8 degrees C (36 and 46 degrees F); do not freeze and protect from light