Ranibizumab

Ranibizumab intravitreal injection is a prescription medicine used to treat the symptoms of neovascular (wet) age-related macular degeneration (AMD), macular edema, diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization (mCNV).

• Ranibizumab intravitreal injection is available under the following different brand names: Lucentis, Byooviz, ranibizumab-nuna

Adult dosage

Intravitreal injectable preservative-free solution

• 6mg/mL (0.05mL [0.3mg/vial]) (Lucentis)
• 10mg/mL (0.05mL [0.5mg/vial]) (Lucentis, Byooviz)
• 6mg/mL (0.05mL [0.3mg/prefilled syringe]) (Lucentis)
• 10mg/mL (0.05mL [0.5mg/prefilled syringe]) (Lucentis)

Neovascular (Wet) Age-related Macular Degeneration

Adult dosage

• 0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal every month (approximately every 28 days)

Less frequent dosing

• Although not as effective, patients may be treated with an initial 3 once-monthly doses followed by less frequent dosing with regular assessment
• Over 9 months after 3 initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain
• Assess patients regularly

Macular Edema

Adult dosage

• 0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection every month (approximately every 28 days) x6 months

Diabetic Macular Edema

Adult dosage

• 0.3 mg (0.05 mL of 6 mg/mL solution) intravitreally every month (approximately every 28 days)

Diabetic Retinopathy

Adult dosage

• 0.3 mg (0.05 mL of 6 mg/mL solution) intravitreally every month (approximately every 28 days)

Myopic Choroidal Neovascularization

Adult dosage

• 0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection every month initially, for up to 3 months

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ranibizumab intravitreal injection include:

• discomfort and increased tears in the affected eye(s),
• itchy or watery eyes,
• dry eyes,
• swelling of the eyelids,
• eye "floaters,"
• blurred vision,
• sinus pain,
• sore throat,
• cough, and
• joint pain.

Serious side effects of Ranibizumab intravitreal injection include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe dizziness,
• poor night vision,
• sensitivity to light and glare,
• fading or yellowing of color,
• blood spots in the whites of the eyes (conjunctival hemorrhage),
• infection inside the eye,
• flashes of light in one or both eyes,
• sudden appearance of floaters,
• gradually reduced side (peripheral) vision,
• curtain-like shadow over the visual field,  
• increased intraocular pressure (before and after injection),
• sudden numbness or weakness in the face, arm, or leg (especially on one side of the body)
• sudden confusion,
• trouble speaking,
• difficulty understanding,
• trouble walking,
• dizziness,
• loss of balance or coordination,  
• nonfatal myocardial infarction, and
• death.

Rare side effects of Ranibizumab intravitreal injection include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this druag. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ranibizumab intravitreal injection has severe interactions with no other drugs.
• Ranibizumab intravitreal injection has serious interactions with no other drugs.
• Ranibizumab intravitreal injection has moderate interactions with the following drugs:
  • verteporfin
• Ranibizumab intravitreal injection has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Ocular/periocular infections

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ranibizumab intravitreal injection?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ranibizumab intravitreal injection?”

Cautions

• Hypersensitivity reactions may manifest as severe intraocular inflammation
• Risk of endophthalmitis or retinal detachment with intravitreous injections; proper aseptic injection technique should always be used when administering therapy; patients should be monitored following the injection to permit early treatment should an infection occur
• Possibility of IOP increase within 60 min of intravitreal injection; monitor intraocular pressure before and following intravitreal injection with drug and manage appropriately
• 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 the effects of ranibizumab on fertility conducted; not known whether ranibizumab can affect reproduction capacity; based on the anti-VEGF mechanism of action for ranibizumab, therapy may pose risk to reproductive capacity

Pregnancy and Lactation

• There are no adequate and well-controlled studies in pregnant women
• Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [Cmax]) after a single eye treatment at the recommended clinical dose
• Ranibizumab should be given to a pregnant woman only if clearly needed
• Lactation
  • There are no data available on the presence of ranibizumab in human milk; effects of ranibizumab on breastfed infants or effects of ranibizumab on milk production/excretion; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from ranibizumab