International reference: 2 US FDA recalls for this ingredient

Lack of Assurance of Sterility: Complaints of syringe breakage (aflibercept)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (aflibercept)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

Registered Kenya · PPB

EYLEA, 40 MG / ML SOLUTION FOR INJECTION

AFLIBERCEPT

H2016/CTD4588/716 ONE MILLILITER SOLUTION FOR INJECTION CONTAINS 40 MG AFLIBERCEPT. NEW/INNOVATOR antineoplastic and immunomodulating agents INN generic

What it does

Aflibercept is a medication used to treat serious eye conditions that can cause vision loss.

Commonly used for: age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO)

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Registration & product details

Registration no.
H2016/CTD4588/716
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
AFLIBERCEPT
Strength
-
Pack size
PRE-FILLED SYRINGEL 1X1 VIALS,1 X 5 VIALS.
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
L01XX - Other antineoplastic agents
RxNorm RxCUI
1232150
Manufacturer / MAH
Bayer
Applicant / LTR
BAYER EAST AFRICA LIMITED
Country of origin
FOREIGN
Manufacturer location
Thika Super Highway/ Outering Road Junction, Ruaraka, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:23:49 · updated 2026-07-26 09:23:06

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Aflibercept is a medication used to treat serious eye conditions that can cause vision loss.

What it treats

  • age-related macular degeneration (AMD)
  • diabetic macular edema (DME)
  • retinal vein occlusion (RVO)

How it works

Aflibercept works by blocking certain proteins in the eye that can lead to swelling and vision problems.

Who it's for

This medication is for adults with specific eye diseases that affect their vision.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Aflibercept

BNF-referenced

Aflibercept is a recombinant fusion protein that functions as a soluble decoy receptor, effectively inhibiting the action of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). It is primarily used in the management of various retinal disorders, particularly in conditions characterized by abnormal vascular growth and leakage.

Indications

  • Neovascular (wet) age-related macular degeneration
  • Diabetic macular edema
  • Retinal vein occlusion
  • Myopic choroidal neovascularization

Dosage

Children: Safety and efficacy in children have not been established. Refer to the BNF for Children for guidance.

Adults: Aflibercept is typically administered via intravitreal injection. The recommended dosage for neovascular age-related macular degeneration is 2 mg every 4 weeks for the first 12 weeks, followed by 2 mg every 8 weeks. For other conditions, refer to specific clinical guidelines and the BNF.

Mechanism of action

Aflibercept binds to VEGF-A, VEGF-B, and PlGF, preventing these growth factors from interacting with their receptors on endothelial cells. This action inhibits angiogenesis and vascular permeability, making it useful in treating diseases like neovascular age-related macular degeneration and diabetic macular edema.

Pharmacodynamics

The pharmacodynamic effects of aflibercept include reduced vascular permeability and inhibition of neovascularization. By blocking the action of VEGF, aflibercept helps to stabilize the retinal vasculature and prevent further vision loss associated with retinal diseases.

Pharmacokinetics

Aflibercept exhibits a biphasic elimination profile following intravitreal injection, with a half-life of approximately 4 to 7 days. It is primarily eliminated by proteolytic degradation, and its systemic absorption is minimal, as it is administered directly into the vitreous cavity. The pharmacokinetics may vary based on the disease state and individual patient characteristics.

Contra-indications

  • Moderate or severe congestive heart failure
  • Uncontrolled hypertension
  • Severe renal impairment

Adverse effects

  • Hypertension
  • Headache
  • Gastrointestinal disorders
  • Proteinuria
  • Neutropenia
  • Thrombocytopenia
  • Increased risk of hemorrhage
  • Impaired wound healing
  • Heart failure
  • Aneurysm
  • Artery dissection
  • Cerebrovascular insufficiency
  • Posterior reversible encephalopathy syndrome (PRES)
  • Thrombotic microangiopathy
  • Nephrotic syndrome
  • Osteonecrosis of the jaw
  • Weight decreased
  • Alopecia
  • Anemia
  • Constipation
  • Nausea
  • Vomiting
  • Oropharyngeal pain
  • Rhinorrhea
  • Skin reactions
  • Infection
  • Febrile neutropenia

Precautions

  • Patients with a history of cardiovascular disease should be monitored closely due to increased risk of hypertension.
  • Careful consideration of modifiable risk factors (such as smoking and hypertension) is advised.
  • Patients should be monitored for hypertension and treated as required.
  • Counseling on pregnancy and contraceptive measures is essential before and during treatment.
  • Risk of neutropenia and thrombocytopenia should be considered.
  • Aflibercept may impair wound healing; treatment should be withheld for at least 4 weeks before elective surgery and until wound healing is complete after major surgery.

Pregnancy

Aflibercept has a teratogenic risk and may cause severe birth defects and embryo-fetal death. Pregnancy must be excluded before treatment and effective contraception is required during treatment and for at least 24 months after the final dose.

Breast-feeding

Avoid during treatment and for 24 months after the final dose.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

Formulations

  • Intravitreal injection solution
BNF 85 (British National Formulary) p.1132 BNF 85 (British National Formulary) p.1324 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.