Razumab

Uses

Razumab is used for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (Non Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR)) in patients with Diabetic Macular Edema (DME)
• Myopic Choroidal Neovascularization (mCNV)

Razumab is also used to associated treatment for these conditions: Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema, Subfoveal Choroidal Neovascularization, Wet Age-Related Macular Degeneration

How Razumab works

Razumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF₁₁₀. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

Dosage

Razumab dosage

Intravitreal (Adult)-

Neovascular (wet) age-related macular degeneration: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth.

Choroidal neovascularisation secondary to pathologic myopia: 0.5 mg into the affected eye as a single dose. Further injections may be given if monitoring reveals signs of disease activity (1-2 inj during the 1st yr; some patients may need more frequent treatment). Doses are given at intervals of at least 1 mth.

Diabetic macular oedema, Macular oedema secondary to retinal vein occlusion: 0.5 mg mthly into the affected eye as a single dose. Continue treatment until visual acuity is stable for 3 consecutive mth. Doses are given at intervals of at least 1 mth. Discontinue treatment if no improvement in visual acuity after 3 initial inj.

Side Effects

Ocular pain, hyperaemia, irritation and pruritus; increased intraocular pressure, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, vitreous floaters, conjunctival haemorrhage, foreign body sensation in eyes, increased lacrimation, blepharitis, dry eye, headache, nasopharyngitis, arthralgia, thromboembolic events. Less frequently, endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract.

Toxicity

The most common toxic effects to the eye are eye pain, vitreous floaters, increased intraocular pressure, conjunctival hemorrhage, intraocular inflammation, and foreign body sensation. Also arterial thromboembolic events have occurred in patients.

Precaution

Patient with risk factors for retinal pigment epithelial tears, history of stroke or transient ischaemic attack, uncontrolled HTN, previous intravitreal inj, active systemic infections, proliferative diabetic retinopathy, diabetic macular oedema due to type 1 DM. Discontinue treatment if rhegmatogenous retinal detachment or stage 3 or 4 macular hole develops. Diabetic patients w/ glycosylated Hb over 12%.

Interaction

May enhance the adverse/toxic effect of belimumab. Serious intraocular inflammation may occur when used adjunctively with verteporfin photodynamic therapy (PDT).

Food Interaction

• Take with or without food.

Volume of Distribution

Volume of distribution is insignificant.

Elimination Route

After monthly intravitreal injections, maximum serum concentrations are minimal around 0.3 ng/mL to 2.36 ng/mL.

Half Life

Approximately 9 days.

Clearance

Clearance was not quantified.

Pregnancy & Breastfeeding use

Pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Active or suspected ocular or periocular infection, active severe intraocular inflammation, signs of irreversible ischaemic visual function loss in patients with retinal vein occlusion.

Acute Overdose

Symptoms: Increased intraocular pressure, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain.

Management: Intraocular pressure should be monitored and treated by the attending physician, if necessary.

Storage Condition

Store between 2-8° C. Protect from light.

Innovators Monograph

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