Avacincaptad Pegol
Generic Name: avacincaptad pegol
Brand Names:
Izervay
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 approximately 56 kDa. The structure of avacincaptad pegol sodium is presented below.
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 approximately 56 kDa. The structure of avacincaptad pegol sodium is presented below.
Uses
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 ).
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose 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 dose 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). 2.3 Preparation for Administration Important information you should know before you begin: • Read all the instructions carefully before using IZERVAY. • The IZERVAY kit includes a glass vial, filter needle, and an empty syringe. The glass vial, filter needle, and empty syringe are for single use only.
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 (5.3) ] The most common adverse reactions were conjunctival hemorrhage (13%), increased IOP (9%), blurred vision (8%) and neovascular age-related macular degeneration (7%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
5 WARNINGS AND PRECAUTIONS • Endophthalmitis and Retinal Detachments ( 5.1 ). • Neovascular AMD ( 5.2 ) • Increase in Intraocular Pressure (IOP) ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection techniques must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] . Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Patient Counseling Information (17) ] . 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of IZERVAY administration in pregnant women. The use of IZERVAY may be considered following an assessment of the risks and benefits. Administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (IV) doses 5.5 times and 3.4 times the human exposure, respectively, based on Area Under the Curve (AUC), following a single 2 mg intravitreal (IVT) dose (see Data ) . In the U.S.
Storage
16.2 Storage and Handling Store IZERVAY in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the vial in the original carton to protect from light. Prior to use, the unopened glass vial of IZERVAY may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Ensure that the injection is given immediately after preparation of the dose.
Frequently Asked Questions
What is Avacincaptad Pegol used for?▼
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 ).
What are the side effects of Avacincaptad Pegol?▼
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 (5.3) ] The most common adverse reactions were conjunctival hemorrhage (13%), increased IOP (9%), blurred vision (8%) and neovascular age-related macular degeneration (7%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Avacincaptad Pegol during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of IZERVAY administration in pregnant women. The use of IZERVAY may be considered following an assessment of the risks and benefits. Administration of avacincaptad pegol to pregnant rats and rabbits throughout the period of organogenesis resulted in no evidence of adverse effects to the fetus or pregnant female at intravenous (IV) doses 5.5 times and 3.4 times the human exposure, respectively, based on Area Under the Curve (AUC), following a single 2 mg intravitreal (IVT) dose (see Data ) . In the U.S.
What are the important warnings for Avacincaptad Pegol?▼
5 WARNINGS AND PRECAUTIONS • Endophthalmitis and Retinal Detachments ( 5.1 ). • Neovascular AMD ( 5.2 ) • Increase in Intraocular Pressure (IOP) ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection techniques must always be used when administering IZERVAY in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] . Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management [see Patient Counseling Information (17) ] . 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.