Aflibercept Intravitreal

Aflibercept Intravitreal is a prescription medication indicated for the treatment of patients with:

• Neovascular (Wet) age-related macular degeneration (nAMD) 
• Diabetic macular edema (DME) 
• Diabetic retinopathy (DR) 
• Macular edema following retinal vein occlusion (RVO) 

Retinopathy of prematurity (ROP) [Eylea]

• Aflibercept Intravitreal is available under the following different brand names: Eylea, Eylea HD, Yesafili, Ahzantive, Enzeevu, aflibercept intravitreal-abzv, Pavblu, aflibercept intravitreal-ayyh, Opuviz, aflibercept intravitreal-boav, aflibercept intravitreal-yszy, aflibercept intravitreal-jbvf, Eydenzelt, aflibercept intravitreal-mrbb

Common side effects of Aflibercept Intravitreal include:

• conjunctival hemorrhage
• eye pain
• cataract
• vitreous detachment
• vitreous floaters
• intraocular pressure increased

Serious side effects of Aflibercept Intravitreal include:

• endophthalmitis, retinal detachments and retinal vasculitis with or without occlusion
• increase in intraocular pressure
• thromboembolic events
• hypersensitivity

Rare side effects of Aflibercept Intravitreal 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 drug. 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.

 Adult and pediatric dosage

Injectable solution for intravitreal use

• 2 mg/0.05 mL single-dose vial (Eylea, Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, Yesafili)
• 2 mg/0.05 mL single-dose prefilled syringe (Eylea, Enzeevu, Eydenzelt, Pavblu)
• 8 mg/0.07 mL (114.3 mg/mL single-dose vial) (Eylea HD)

Biosimilars to Eylea

• Ahzantive (aflibercept intravitreal-mrbb)
• Enzeevu (aflibercept intravitreal-abzv)
• Eydenzelt (aflibercept intravitreal-boav)
• Opuviz (aflibercept intravitreal-yszy)
• Pavblu (aflibercept intravitreal-ayyh)
• Yesafili (aflibercept intravitreal-jbvf)

Macular Degeneration

Adult dosage

• Eylea, Ahzantive, Enzeevu, Eydenzelt, Opuviz, Pavblu, Yesafili
  • 2 mg (0.05 mL) by intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8 weeks (approximately every 2 months)
  • Some patients may need to be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when dosed every 4 weeks compared to every 8 weeks
  • Although not as effective as the recommended every 8-week dosing regimen, after 1 year of effective therapy, patients may be treated with 1 dose every 12 weeks
• Eylea HD
  • Initial 3 doses: 8 mg (0.07 mL of 114.3 mg/mL) by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days)
  • Followed by extended dosing interval: 8 mg every 8-16 weeks (+/- 1 week)
  • Some patients may not maintain a response with extended dosing intervals after a successful response to the first 3 initial monthly doses; these patients may benefit from resuming every 4 weeks dosing

Macular Edema

Adult dosage

• Eylea, Eydenzelt, Opuviz, Pavblu, Yesafili
  • 2 mg (0.05 mL) by intravitreal injection every 4 weeks (approximately every 25 days, monthly)
• Eylea HD
  • Initial 3-5 doses: 8 mg (0.07 mL) by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days)
  • Followed by extended dosing interval: 8 mg by intravitreal injection every 8 weeks (+/- 1 week)
  • Some patients may not maintain a response with extended dosing intervals after a successful response to the first 3-5 initial monthly doses; these patients may benefit from resuming every 4 weeks dosing

Diabetic Macular Edema (DME)

Adult dosage

• Eylea, Ahzantive, Eydenzelt, Opuviz, Pavblu, Yesafili
  • 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks
  • It may be dosed as frequently as 2 mg every 4 weeks; however, additional efficacy was not demonstrated when dosed every 4 weeks compared to every 8 weeks
  • Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months)
• Eylea HD
  • Initial 3 doses: 8 mg (0.07 mL of 114.3 mg/mL) by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days)
  • Followed by extended dosing interval: mg every 8-16 weeks (+/- 1 week)
  • Some patients may not maintain a response with extended dosing intervals after a successful response to the first 3 initial monthly doses; these patients may benefit from resuming every 4 weeks dosing

Diabetic Retinopathy

Adult dosage

• Eylea, Ahzantive, Eydenzelt, Opuviz, Pavblu, Yesafili
  • 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks
  • It may be dosed as frequently as 2 mg every 4 weeks; however, additional efficacy was not demonstrated when dosed every 4 weeks compared to every 8 weeks
  • Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months)
• Eylea HD
  • Initial 3 doses: 8 mg (0.07 mL of 114.3 mg/mL) by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days)
  • Followed by extended dosing interval:8 mg every 8-16 weeks (+/- 1 week)
  • Some patients may not maintain a response with extended dosing intervals after a successful response to the first 3 initial monthly doses; these patients may benefit from resuming every 4 weeks dosing

Retinopathy of Prematurity

Pediatric dosage

Eylea only

• Eylea vial: 0.4 mg (0.01 mL) administered by intravitreal injection
• Initiate treatment with a single injection per eligible eye; may be administered bilaterally on the same day
• Injections may be repeated in each eye
• The treatment interval between doses injected into the same eye should be at least 10 days

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

• Aflibercept Intravitreal has no noted severe interactions with any other drugs.
• Aflibercept Intravitreal has no noted serious interactions with any other drugs.
• Aflibercept Intravitreal has no noted moderate interactions with any other drugs.
• Aflibercept Intravitreal has no noted minor interactions with any 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 about all your products. 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 or concerns.

Contraindications

• Hypersensitivity reactions
• Ocular or periocular infection
• Active intraocular inflammation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Aflibercept Intravitreal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Aflibercept Intravitreal?”

Cautions

• Endophthalmitis and retinal detachments are reported with intravitreal injections; patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately
• Acute increases in intraocular pressure (IOP) were observed within 60 minutes of intravitreal injection; sustained increases were also reported after repeat dosing; monitor and manage IOP and perfusion of the optic nerve head
• The potential risk of arterial thromboembolic events (.g, nonfatal stroke, nonfatal myocardial infarction, or vascular death) following intravitreal use of VEGF inhibitors (incidence over 1 year varies depending on the study ranging from 1.5-6.4%); no thromboembolic events reported within the first 6 months of RVO studies
• Hypersensitivity reactions may present as severe intraocular inflammation
• Females of reproductive potential should use effective contraception before the initial dose, during treatment, and for at least 3 months after the last intravitreal injection

Pregnancy & Lactation

• Adequate and well-controlled studies have not been conducted in pregnant women; aflibercept produced adverse embryofoetal effects in rabbits, including external, visceral, and skeletal malformations
• Animal reproduction studies are not always predictive of human response; not known whether a product can cause fetal harm when administered to the pregnant woman; based on the anti-VEGF mechanism of action for aflibercept, treatment may pose a risk to human embryofoetal development

Contraception

• Females of reproductive potential are advised to use effective contraception before the initial dose, during treatment, and for at least 3 months after the last intravitreal injection

Infertility

• There are no data regarding effects on human fertility; aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed in humans with an intravitreal dose of 2 mg; a No Observed Adverse Effect Level (NOAEL) was not identified; aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was below 0.1 mg/kg; findings were reversible within 20 weeks after cessation of treatment

Lactation

• There is no information regarding the presence of aflibercept in human milk, effects on the breastfed infant, or milk production/excretion; because many drugs are excreted in human milk, and the potential for absorption and harm to infant growth and development exists, therapy is not recommended during breastfeeding
• Developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and potential adverse effects on the breastfed child