pegcetacoplan intravitreal

Pegcetacoplan intravitreal is a medication injected into the vitreous of the eye to treat geographic atrophy secondary to age-related macular degeneration (AMD). Vitreous is a transparent gel-like substance that fills the eyeball space between the lens and retina. Macula is the central part of the retina that is responsible for central and color vision, and fine details of images. Geographic atrophy is the advanced stage of dry AMD, a chronic progressive macular degeneration that can affect vision.

Dry AMD, a more common condition than wet AMD progresses slowly and is caused by small white or yellow deposits known as drusen that form on the macula which gets thinner. Wet AMD is caused by formation of abnormal new blood vessels (neovascularization) in the retina, which leak blood or fluids into the retina, leading to scarring and degeneration of the macula. The complement system, a part of the innate immune system is believed to play a major role in disease progression in AMD.

The complement system consists of multiple circulating proteins in the blood that enhance the ability of antibodies and phagocytes to attack and remove pathogens. Studies show that drusen contains many complement proteins indicating that localized inflammation plays a large part in AMD. Pegcetacoplan controls inflammation by inhibiting the activity C3 protein, the most important and abundant protein in the complement system, and minimizing the activation of the complement cascade.

• Do not administer pegcetacoplan intravitreal in the presence of:
  • Infections in and around the eye
  • Active intraocular inflammation
• Intravitreal injections, including pegcetacoplan, can cause infection of the aqueous and vitreous fluids and tissue inside the eyeball (endophthalmitis) and retinal detachment. Exercise care and use proper aseptic technique for the injections to reduce the risk of endophthalmitis. Advise patients to report symptoms of endophthalmitis or retinal detachment immediately and treat appropriately.
• Pegcetacoplan intravitreal may increase the incidence of neovascularization and wet AMD. Monitor patients for signs of wet AMD and if required, administer anti-vascular endothelial growth factor (anti-VEGF) treatment separately.
• Pegcetacoplan intravitreal can cause intraocular inflammation. Interrupt treatment and resume once inflammation is resolved.
• Intravitreal injections, including pegcetacoplan, may be followed by acute increase in intraocular pressure within minutes of administration. Monitor the perfusion of the optic nerve head and manage as needed.

Common side effects of pegcetacoplan intravitreal include:

• Discomfort in the eye including:
  • Pain
  • Irritation
  • Foreign body sensation
  • Abnormal sensation
• Neovascular age-related macular degeneration
• Vitreous floaters
• Bleeding in the conjunctiva, the membrane over the eye whites and inner eyelid surfaces (conjunctival hemorrhage)
• Bleeding in the retina (retinal hemorrhage)
• Corneal inflammation with pinpoint lesions (punctate keratitis)
• Vitreous detachment
• Vitreous opacity
• Intraocular inflammation
• Opacification of the posterior capsule
• Increase in intraocular pressure
• Optic nerve damage from impaired blood flow (optic ischemic neuropathy)
• Secondary cataract

Less common side effects of pegcetacoplan intravitreal include:

• Pooling of blood in the anterior chamber (hyphema)
• Retinal tears
• Retinal detachment
• Infection/inflammation of the eye fluids, aqueous and vitreous (endophthalmitis)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Solution for intravitreal injection

• 150 mg/mL single use vial

Adult:

Geographic Atrophy

• Indicated for geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
• 15 mg (0.1 mL of 150 mg/mL solution) by intravitreal infection to each affected eye once every 25-60 days

Dosing Considerations

• Monitor intraocular pressure (IOP) using tonometry before the intravitreal injection
• Monitor perfusion of the optic nerve head following the injection and manage as needed

Pediatric:

• Safety and efficacy not established

Overdose

There is no information on overdose of pegcetacoplan intravitreal. Overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Pegcetacoplan intravitreal has no known severe or serious interactions with other drugs.
• Moderate interactions of pegcetacoplan include:
  • pegloticase
  • pegvaliase
• Pegcetacoplan intravitreal has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the administration of pegcetacoplan intravitreal in pregnant women. Systemic absorption from administration in the eye is minimal. The use of pegcetacoplan intravitreal may be considered in pregnant women after assessing the risks and benefits.
• Women of pregnancy potential should use effective contraception during treatment with pegcetacoplan intravitreal and for 40 days after the last dose.
• It is not known if intravitreal administration of pegcetacoplan results in sufficient systemic absorption to be present in breastmilk or cause harm to the infant. Pegcetacoplan intravitreal should be used with caution in nursing mothers, because many drugs are excreted in breastmilk and because of the potential for systemic absorption and risk to the breastfed infant.

• You may experience temporary visual disturbances of pegcetacoplan intravitreal injection. Avoid hazardous activities such as driving and operating heavy machinery until vision is completely restored to normalcy.
• Report to your ophthalmologist immediately if you experience blurred vision, changes in vision, loss of vision, flashes of light, floaters, eye discomfort or pain, red eyes, watery eyes, swollen eyelids or light sensitivity following administration of pegcetacoplan intravitreal.