Byooviz (ranibizumab-nuna)

No dosing information is available for this tab.

Ranibizumab is administered by intravitreal injection only into the affected eye(s).

Ranibizumab is commercially available as single-dose prefilled syringes containing 0.3 or 0.5 mg of the drug for intravitreal injection. Ranibizumab-nuna is available as single-dose vials containing 0.5 mg of the drug for intravitreal injection, and ranibizumab-eqrn is available as single-dose vials containing 0.3 mg or 0.5 mg of the drug for intravitreal injection.

Because of the risk of infection and endophthalmitis, proper aseptic technique must always be used when preparing and administering the drug.

Prior to intravitreal administration of ranibizumab-nuna and ranibizumab-eqrn, the entire contents of the appropriate vial should be withdrawn through a sterile 5-mcm, 19-gauge filter needle into a 1-mL sterile Luer lock syringe. The filter needle is then replaced with a sterile 30-gauge, 1/2-inch needle for intravitreal injection. To obtain the appropriate ranibizumab dose (0.3 or 0.5 mg), the contents in the Luer lock syringe should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.

To prepare a dose of ranibizumab, remove the prefilled syringe from the syringe tray using aseptic technique. Do not use the syringe if the cap is detached from the Luer lock, the syringe is damaged, or particulate matter, cloudiness, or discoloration is present. To remove the syringe cap, snap off (do not turn or twist) the syringe cap. Attach a 30-gauge, 1/2-inch sterile injection needle firmly onto the syringe. Dislodge any air bubbles in the syringe prior to administration.

Ranibizumab products should be injected under controlled aseptic conditions (including use of sterile gloves, a sterile drape, and a sterile eyelid speculum or equivalent) following adequate anesthesia and administration of a broad-spectrum anti-infective agent.

Each prefilled syringe and vial of the drug should be used only for the treatment of a single eye. If the contralateral eye requires treatment, a new prefilled syringe or vial should be used and the sterile field, syringe, gloves, drape, eyelid speculum, and filter and injection needles should be changed prior to administration to the other eye.

Ranibizumab products should be stored at 2-8degreesC in the original carton; the injection should not be frozen and should be protected from light. Prior to use, unopened vials of ranibizumab-nuna can be stored at up to 30degreesC for up to 72 hours.

No dosing information is available for this tab.

Specific drug interaction studies have not been conducted to date with ranibizumab.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Ocular or periocular infections.

*Known hypersensitivity (e.g., severe intraocular inflammation) to ranibizumab products or any ingredient in the formulation.

• Ocular infection

• Cerebrovascular accident
• Ocular inflammation
• Pregnancy

• Endophthalmitis
• Ocular hypertension
• Retinal detachment
• Retinal vasculitis
• Thromboembolic disorder

The most common adverse effects occurring more frequently in patients receiving ranibizumab than those receiving sham injections include conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP.

More Frequent

• Cataracts
• Conjunctival hemorrhage
• Conjunctival hyperemia
• Ocular hypertension
• Ocular pain

Less Frequent

• Blepharitis
• Bronchitis
• Impaired wound healing
• Maculopathy
• Visual changes

Rare or Very Rare

• Acute myocardial infarction
• Arterial thrombosis
• Cerebrovascular accident
• Endophthalmitis
• Influenza
• Retinal detachment
• Retinal vascular occlusion
• Tear of retinal pigment epithelium
• Thromboembolic disorder

More Frequent

• Foreign body sensation of eye
• Ocular irritation
• Vitreous floater

Less Frequent

• Arthralgia
• Cough
• Dry eye
• Eye tearing
• Headache disorder
• Nausea
• Ocular discomfort
• Ocular itching
• Ocular redness
• Pharyngitis
• Posterior capsule opacification
• Upper respiratory infection

Rare or Very Rare

• Retinal vasculitis

No enhanced messaging available.

Safety and efficacy of ranibizumab products have not been established in pediatric patients.

Studies have not been conducted with ranibizumab products in pregnant women; it is not known whether ranibizumab can cause fetal harm when administered during pregnancy. In embryofetal studies in animals, fetal skeletal abnormalities were observed when pregnant animals were exposed to serum ranibizumab concentrations higher than those produced with single eye treatments in humans. Based on its mechanism as a VEGF antagonist, it is possible that ranibizumab may adversely affect embryofetal development or reproductive capacity. The drug should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.

It is not known whether ranibizumab products are distributed into human milk, or if they have any effects on the breastfed infant or on milk production. Because many drugs are excreted in human milk, caution is advised if ranibizumab products are administered in nursing women.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ranibizumab and any potential adverse effects of the drug on the breastfed child.

The manufacturers make no specific dosage recommendations for geriatric patients.

In clinical studies, approximately 76% of patients randomized to ranibizumab were 65 years of age or older and 51% were 75 years of age or older. No substantial differences in efficacy, safety, or systemic exposure relative to younger adults were observed.