Overview
11 DESCRIPTION IZERVAY contains avacincaptad pegol sodium, a complement C5 inhibitor. Avacincaptad pegol is a ribonucleic acid (RNA) aptamer, covalently bound to an approximately 43-kiloDalton (kDa) branched polyethylene glycol (PEG) molecule. The molecular formula of avacincaptad pegol (free acid form) is C 395 H 492 N 142 O 262 P 39 F 21 ((CH 2 ) 2 O) n where n~970 and the molecular weight is...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Avacincaptad pegol is an RNA aptamer, a PEGylated oligonucleotide that binds to and inhibits complement protein C5. By inhibiting C5, avacincaptad pegol may prevent its cleavage to C5a and C5b thus decreasing membrane attack complex (MAC) formation. 12.2 Pharmacodynamics Increased GA area growth is reflective of loss of photoreceptors and AMD disease progression. Reductions in the rate of GA growth were observed across avacincaptad pegol treatment groups in studies GATHER1 and GATHER2. 12.3 Pharmacokinetics Absorption/Distribution Following monthly dosing of avacincaptad pegol, at steady‑state maximum avacincaptad pegol plasma concentrations (C max ) are estimated to occur approximately 3 days post-dose and geometric mean (GeoCV%) free...
Indications
- 1 INDICATIONS AND USAGE IZERVAY ® is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). IZERVAY is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) ( 1 ).
Common Doses
- 2 mg
- 0.1 mL
- 20 mg
- 1 mL
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage for IZERVAY is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately 28 ± 7 days) ( 2.2 ). 2.1 General Dosing Information IZERVAY must be administered by a qualified physician. 2.2 Recommended Dosage The recommended dosage for IZERVAY is 2 mg (0.1 mL of 20 mg/mL solution) administered by intravitreal injection to each affected eye once monthly (approximately every 28 ± 7 days). 2.
Contraindications
- 4 CONTRAINDICATIONS • Ocular or periocular infections ( 4.1 ). • Active intraocular inflammation ( 4.2 ). 4.1 Ocular or Periocular Infections IZERVAY is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation IZERVAY is contraindicated in patients with active intraocular inflammation.
Side Effects
- 6 ADVERSE REACTIONS The following potentially serious adverse reactions are described elsewhere in the labeling: • Ocular and periocular infections [see Contraindications (4.1) ] • Active intraocular inflammation [see Contraindications (4.2) ] • Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] • Neovascular AMD [see Warnings and Precautions (5.2) ] • Increase in intraocular pressure [see Warnings and Precautions (5.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.