Pavblu®
GoodRxAflibercept-ayyh · intravitreal injection
Injections & Implants
IndicationPAVBLU is a vascular endothelial growth factor (VEGF) inhibitor indicated 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 (DR)
Contraindications
- Ocular or periocular infections
- Active intraocular inflammation
- Known hypersensitivity to aflibercept or any of the excipients in PAVBLU
Available Forms2 mg (0.05 mL of 40 mg/mL solution) in a single-dose prefilled plastic syringe or a single-dose glass vial
Mechanism of ActionVascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leukocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. Aflibercept products act as a soluble decoy receptor that binds VEGF - A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors.
DosageNeovascular (Wet) Age-Related Macular Degeneration (AMD): The recommended dose for PAVBLU is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). Although PAVBLU may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months). Although not as effective as the recommended every 8 week dosing regimen, patients may also be treated with one dose every 12 weeks after one year of effective therapy. Patients should be assessed regularly.
Macular Edema Following Retinal Vein Occlusion (RVO): The recommended dose for PAVBLU is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR): The recommended dose for PAVBLU is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 5 injections followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months). Although PAVBLU may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly), additional efficacy was not demonstrated in most patients when aflibercept was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).
Warnings & Precautions
- Endophthalmitis, Retinal Detachments, and Retinal Vasculitis: Intravitreal injections, including those with aflibercept products, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering PAVBLU. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of these events without delay and should be managed appropriately.
- Increase in Intraocular Pressure: Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with aflibercept products. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular endothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
- Thromboembolic Events: There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including aflibercept products. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% with aflibercept compared with 1.5% with ranibizumab.
Common Side Effects
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.
Pregnancy & LactationPregnancy: Adequate and well-controlled studies with aflibercept have not been conducted in pregnant women. Aflibercept produced adverse embryofetal effects in rabbits, including external, visceral, and skeletal malformations. Based on the anti-VEGF mechanism of action for aflibercept, treatment with aflibercept may pose a risk to human embryofetal development. PAVBLU should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Females and Males of Reproductive Potential: Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of PAVBLU.
Lactation: There is no information regarding the presence of aflibercept products in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, PAVBLU is not recommended during breastfeeding.
Pediatric UseA pediatric assessment for PAVBLU demonstrates that PAVBLU is safe and effective for pediatric patients in an indication for which EYLEA (aflibercept) is approved. However, PAVBLU is not approved for such indication due to marketing exclusivity for EYLEA (aflibercept).