Pegcetacoplan (ophthalmic)
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Complement Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Injection Procedure Only 0.1 mL (15 mg of SYFOVRE) should be administered to deliver a single dose. Any excess volume should be disposed. Ensure that the injection is given immediately after the preparation of the dose. Prior to the intravitreal injection, patients should be monitored for elevated intraocular pressure (IOP) using tonometry [see Warnings and Precautions ] .
If necessary, ocular hypotensive medication can be given to lower the IOP. The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface should be administered prior to the injection.
Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.1 mL. Confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel. Immediately following the intravitreal injection, patients should be monitored for elevations in IOP. Additional evaluation may include checking for perfusion of the optic nerve head and tonometry.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay [see Patient Counseling Information ] . Each vial should only be used for the treatment of a single eye. If the fellow eye requires treatment, a new sterile, vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before SYFOVRE administration.
Repeat same procedure steps as above. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Preparation and administration
Preparation for Administration [See table below.] [See table below.] Figure Figure Figure Figure Figure 1a Figure 1b Figure 2 Figure 3a Figure 3b Figure 3c Figure 4 Figure 5
| STEP 1 Gather the supplies needed: | |||
| One SYFOVRE vialOne sterile 5-micron filter needleOne sterile 1-mL Luer-lock syringe with a 0.1 mL dose markOne sterile ½ inch: 29-gauge (extra) thin-wall injection needle with Luer-lock hub (included with vial kit) or a 27-gauge needle with Luer-lock hub (not included) Note: Increased injection forces and/or increased injection time could be experienced if a smaller diameter injection needle is used (e.g., 30-gauge)Alcohol swab (not included) | |||
| Use aseptic technique to carry out the following preparation steps: | |||
| STEP 2 Remove the flip-off cap from the vial (see Figure 1a) and clean the vial septum with an alcohol swab and wait for the alcohol to dry out (see Figure 1b). | |||
| Figure 1a: | Figure 1b: | ||
| STEP 3 Attach the 5-micron filter needle onto a 1-mL Luer-lock syringe (see Figure 2) by twisting it onto the Luer-lock syringe tip. | |||
| Figure 2: | |||
| STEP 4 Push the filter needle into the center of the vial septum until the needle is submerged in the drug product to prevent withdrawal of air (see Figure 3a). To withdraw the entire contents of the vial into the syringe, hold the vial at a slightly inclined position. Withdraw the drug product slowly to prevent air bubbles. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid until all of the fluid is withdrawn from the vial (see Figure 3b). *Do not tap the syringe to remove air bubbles. While maintaining the filter needle within the vial, invert the syringe and move the plunger down and up until bubbles move to the top (see Figure 3c). | |||
| Figure 3a: | Figure 3b: | ||
| Figure 3c: | |||
| STEP 5 Using aseptic technique, disconnect the filter needle from the syringe and dispose of it. Do not use the filter needle for injection. | |||
| STEP 6 Aseptically and firmly attach the injection needle onto the 1-mL Luer-lock syringe (see Figure 4). | |||
| Figure 4: | |||
| STEP 7 Check for air bubbles by holding the syringe with the needle pointing up. *Do not tap the syringe to remove air bubbles. If there are any air bubbles, remove the needle cap and with the needle end facing up gently advance the plunger to the 0.1 mL dose mark (see Figure 5). Only 0.1 mL (15 mg of SYFOVRE) should be administered to deliver a single dose. Any excess volume should be disposed. The syringe is ready for injection. | |||
| Figure 5: | |||
Contraindications
Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 )
4.1 Ocular or Periocular Infections SYFOVRE is contraindicated in patients with ocular or periocular infections [see Warnings and Precautions (5.1) ] .
4.2 Active Intraocular Inflammation SYFOVRE is contraindicated in patients with active intraocular inflammation.
4.3 Hypersensitivity SYFOVRE is contraindicated in patients with hypersensitivity to pegcetacoplan or to any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred in patients treated with SYFOVRE [see Adverse Reactions (6.2) ] .
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Pegcetacoplan is a small peptide inhibitor of complement that is used to treat adults with paroxysmal nocturnal hemoglobinuria. Serum aminotransferase elevations occur in a proportion of patients treated pegcetacoplan, but episodes of clinically apparent liver injury with jaundice have not been reported with its use.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of SYFOVRE administration in pregnant women to inform a drug-associated risk. The use of SYFOVRE may be considered following an assessment of the risks and benefits. Systemic exposure of SYFOVRE following ocular administration is low [see Clinical Pharmacology (12.3) ] .
Subcutaneous administration of pegcetacoplan to pregnant monkeys from the mid gestation period through birth resulted in increased incidences of abortions and stillbirths at systemic exposures 1040-fold higher than that observed in humans at the maximum recommended human ophthalmic dose (MRHOD) of SYFOVRE (based on the area under the curve (AUC) systemically measured levels). No adverse maternal or fetal effects were observed in monkeys at systemic exposures approximately 470-fold higher than that observed in humans at the MRHOD (see Data ) . In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryofetal development studies, subcutaneous administration of pegcetacoplan to pregnant cynomolgus monkeys from the mid gestation period through birth produced increased incidences of abortions and stillbirths at doses of 28 mg/kg/day [approximately 1040-fold higher than the MRHOD based on exposure (AUC)]. Pegcetacoplan was not maternally toxic and did not produce adverse embryofetal effects in the monkey at subcutaneous doses of 7 mg/kg/day. (approximately 470-fold higher than the MRHOD).
No developmental effects were observed in infants up to 6 months postpartum. Minimal systemic exposure to pegcetacoplan (less than 1%, not pharmacologically significant) was detected in fetuses from monkeys treated subcutaneously with 28 mg/kg/day from the period of organogenesis through the second trimester.
Breastfeeding (LactMed)
No information is available on the use of pegcetacoplan during breastfeeding. Since only a small dose in injected intravitreally into the eye, it is unlikely that a clinically relevant amount would reach the infant in breastmilk. Pegcetacoplan was undetectable in the milk of one mother after systemic use; however, the manufacturer recommends that breastfeeding be discontinued during treatment and for 40 days after the last dose.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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