Registered Kenya · PPB

PAGENAX SOLUTION FOR INJECTION 120 MG/ML

BROLUCIZUMAB

H2022/CTD10072/20966 SOLUTION FOR INJECTION 120 MG/ML NEW/INNOVATOR sensory organs INN generic

What it does

Brolucizumab is a medication used to treat eye conditions that cause vision problems.

Commonly used for: age-related macular degeneration, diabetic macular edema

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD10072/20966
Registration date
-
Expiry date
2028 September 26
Status
Registered
Active ingredient
BROLUCIZUMAB
Strength
-
Pack size
1 VIAL AND 1 FILTER NEEDLE EACH VIAL CONTAINS 27.6 MG OF BROLUCIZUMAB IN 0.23 ML SOLUTION. THIS PROVIDES A USABLE AMOUNT TO DELIVER A SINGLE DOSE OF 0.05 ML CONTAINING 6 MG OF BROLUCIZUMAB.
Therapeutic class
NEW/INNOVATOR
ATC class (WHO)
S01LA - Antineovascularisation agents
Drug group
SENSORY ORGANS
RxNorm RxCUI
2204915
Manufacturer / MAH
Nvs Kenya
Country of origin
FOREIGN
Manufacturer location
Mogadishu Road, off Lunga Lunga Road, Industrial Area, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:37:49 · updated 2026-09-25 02:21:06

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

About this medicine

Brolucizumab is a medication used to treat eye conditions that cause vision problems.

What it treats

  • age-related macular degeneration
  • diabetic macular edema

How it works

It works by reducing swelling in the eye and preventing further vision loss.

Who it's for

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

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

Clinical monograph: Brolucizumab

BNF-referenced

Brolucizumab is a monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). It is primarily used in the treatment of certain retinal disorders, such as age-related macular degeneration (AMD) and diabetic macular edema. By blocking VEGF-A, brolucizumab suppresses endothelial cell proliferation, inhibits the growth of new blood vessels, and reduces retinal vascular permeability, thus helping to improve visual acuity in affected patients.

Indications

  • Age-related macular degeneration (AMD)
  • Diabetic macular edema (specialist use only)

Dosage

Children: Refer to the BNF for Children for appropriate dosages.

Adults: Initially, 6 mg once a month for the first 3 doses, then 6 mg every 6 weeks for the first 5 doses, to be administered into the affected eye.

Mechanism of action

Brolucizumab acts by binding to VEGF-A, preventing it from interacting with its receptors on endothelial cells. This inhibition leads to reduced angiogenesis (formation of new blood vessels) and decreased vascular permeability, which are key processes in the pathophysiology of diseases like AMD and diabetic macular edema.

Pharmacodynamics

The pharmacodynamic effects of brolucizumab include a significant reduction in retinal vascular leakage and the stabilization or improvement of visual acuity in patients with retinal diseases. The reduction in VEGF-A activity helps limit the progression of diseases characterized by abnormal blood vessel growth and leakage.

Pharmacokinetics

Brolucizumab is administered via intravitreal injection, allowing for localized action in the eye. The systemic absorption of the drug is limited, and it has a long half-life, which supports less frequent dosing. The pharmacokinetics can vary based on individual patient factors, including age, body weight, and the presence of any antibodies against the drug. Monitoring of intra-ocular pressure is recommended after administration.

Contra-indications

  • History of intra-ocular inflammation
  • History of retinal vascular occlusion
  • Hypersensitivity to brolucizumab or any excipients

Adverse effects

  • Intra-ocular inflammation
  • Retinal vasculitis
  • Retinal occlusion
  • Endophthalmitis
  • Eye discomfort
  • Cataract
  • Hemorrhage
  • Myocardial infarction
  • Stroke
  • Arterial thromboembolism

Precautions

  • Monitor intra-ocular pressure and visual acuity
  • Monitor for signs of ocular infection following injection
  • Patients should be advised to report any signs of infection immediately
  • Female patients of childbearing potential should use effective contraception during treatment and for 1 month after

Pregnancy

Manufacturer advises to avoid unless potential benefit outweighs risk; limited information available.

Breast-feeding

Manufacturer advises to avoid during and for 1 month after treatment; no information available.

Storage

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

Formulations

  • Solution for injection
BNF 85 (British National Formulary) p.1325 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.