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PAVBLU is a brand name for Aflibercept, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between PAVBLU and the reference biologic drug EYLEA®. PAVBLU is indicated for: • the treatment of neovascular (wet) age-related macular degeneration (AMD) • the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY. • The PAVBLU prefilled syringe or vial is for single-use only. • The prefilled syringe or vial contents should not be split or further compounded. Use of more than one injection from a prefilled syringe or vial may increase the risk of contamination and subsequent infection.
• PAVBLU must only be administered by a qualified physician experienced in administering intravitreal injections. 05 mL) via intravitreal injection every 2 months (8 weeks). Based on the treating ophthalmologist’s judgement of visual and anatomic outcomes, the treatment interval may be maintained at two months or extended in 2-week increments if visual outcomes remain stable, no fluid is indicated by Optical Coherence Tomography and no hemorrhage is observed.
4 Clinical Trials – Reference Biologic Drug). The maximum treatment interval between injections should not exceed 12 weeks in the first year of treatment and not exceed 16 weeks after the first year. Patients should be evaluated regularly.
The schedule of monitoring visits may be more frequent than the injection visits. In AMD clinical trials, aflibercept dosed every 4 weeks or every 8 weeks was shown to be non- inferior to ranibizumab. 4 Clinical Trials – Reference Biologic Drug).
At the discretion of the treating ophthalmologist and based on the monitoring of visual and anatomic outcomes, dosing every month (4 weeks) after the first 3 months (12 weeks) may be considered on an individual patient basis. 05 mL or 50 microliters) administered by intravitreal injection once every month (4 weeks).
The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months (12 weeks) based on visual and anatomic outcomes. Prescribers are advised to periodically assess (every 1 to 2 months) the need for continued therapy.
Clinical trial experience of a monthly dosing regimen of 2 mg aflibercept beyond 6 months in the CRVO and BRVO indications is limited. The dosing regimen of once every 4 weeks changed at 24 weeks to a regimen that allowed for extension of the treatment interval based on visual and anatomic outcomes in the CRVO clinical trials and to once every 8 weeks in the BRVO clinical trial (see 14 CLINICAL TRIALS).
PAVBLU™ (aflibercept injection) Page 6 of 74 Treatment of DME The recommended dose for PAVBLU is 2 mg aflibercept (equivalent to 50 microliters solution for injection) administered by intravitreal injection monthly (once every 4 weeks) for the first 5 consecutive doses, followed by one injection every 2 months (8 weeks).
). 4 Administration). Patients should be instructed to report any symptoms suggestive of any event listed above without delay and should be managed appropriately. Increase in Intraocular Pressure Increases in intraocular pressure (IOP) have been observed within 60 minutes of an intravitreal injection, including with aflibercept (see 8 ADVERSE REACTIONS).
3%) patients treated with laser in the BRVO clinical trial. 4% (7/287) of patients initiated treatment with laser. In all cases, both IOP and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Aflibercept has not been tested in patients with poorly controlled glaucoma. Other As with other intravitreal anti-VEGF treatments, treatment should be withheld and resumed only when considered appropriate in cases of: • An IOP of ≥ 30 mmHg • Within the previous or next 28 days in the event of a performed or planned intraocular surgery • A retinal break.
The treatment should not be resumed until the break is adequately repaired There is only limited experience in the treatment of subjects with DME due to type I diabetes or in diabetic patients with an HbA1c over 12% or with proliferative diabetic retinopathy.
Aflibercept has not been studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole. There is also no experience of treatment with aflibercept in diabetic patients with uncontrolled hypertension.
This lack of information should be considered by the physician when treating such patients. In myopic CNV, a clinical trial was conducted in Japan, South Korea, Singapore, Taiwan and Hong Kong. Thus, there is no clinical trial experience with aflibercept in the treatment of non- Asian patients for this indication.
Furthermore, there is also no clinical trial experience in patients who have previously undergone treatment for myopic CNV, and in the patients with extrafoveal lesions. This lack of information should be considered by the physician before treating such patients.
Driving and Operating Machinery Patients may experience temporary visual disturbances after an intravitreal injection with PAVBLU and the associated eye examinations. They should not drive or use machines until visual function has recovered sufficiently.
Hepatic/Biliary/Pancreatic Aflibercept has not been studied in patients with hepatic impairment. Immune Hypersensitivity As with all therapeutic proteins, there is a risk of hypersensitivity reactions including anaphylaxis. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation.
Patients should be instructed to report any symptoms of anaphylaxis, allergic reactions or intraocular inflammation (eg, pain, photophobia, or redness, which, although non-specific, should also be assessed as potential hypersensitivity reactions).
3 Immunogenicity). Ophthalmologic Endophthalmitis, Retinal detachments and Cataracts Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis, retinal detachment, retinal tear, retinal pigment epithelium tear, cataract including traumatic cataract, vitreous hemorrhage and hyphema (see
• Patients who are hypersensitive to this drug, to any ingredient in the formulation, or to any component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • Patients with ocular or periocular infection • Patients with active intraocular inflammation PAVBLU™ (aflibercept injection) Page 5 of 74
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Based on the treating ophthalmologist’s judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at every two months or extended by up to 2-week increments at a time if visual and/or anatomic outcomes remain stable.
There are limited data for treatment intervals longer than 4 months (16 weeks). If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly. Treatment intervals shorter than 4 weeks between injections have not been studied.
Patients should be evaluated regularly. The schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections. 4 Clinical Trials – Reference Biologic Drug). 2 Clinical Trial Adverse Reactions).
Treatment of myopic CNV The recommended dose for PAVBLU is a single intravitreal injection of 2 mg aflibercept (equivalent to 50 microliters solution for injection). Additional doses should be administered only if visual and/or anatomic outcomes indicate that the disease persists.
The interval between two doses should not be shorter than one month (4 weeks). Recurrences are treated like a new manifestation of the disease.
Special Populations Hepatic and/or renal impairment:
No specific studies in patients with hepatic and/or renal impairment were conducted with aflibercept.
Geriatrics (≥ 65 years of age):
No special dosing considerations are needed in elderly populations.
Pediatrics (< 18 years of age):
The safety and efficacy of aflibercept have not been studied in pediatric patients. Health Canada has not authorized an indication for pediatric use. 4 Administration Intravitreal injections must be carried out by a qualified physician experienced in administering intravitreal injections, and according to medical standards and under controlled aseptic conditions, which include surgical hand disinfection and the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).
The peri-ocular skin, eyelid and ocular surface should be disinfected. Adequate anesthesia and a topical broad-spectrum microbicide should be used prior to the injection. PAVBLU™ (aflibercept injection) Page 7 of 74 Prior to administration visually inspect the solution for injection.
The solution is clear to opalescent and colourless to slightly yellow. Do not use the prefilled syringe or vial if particulates, cloudiness, or discoloration are […]
In clinical trials of AMD, CRVO, BRVO and myopic CNV, only one eye per patient was treated with aflibercept. The safety and efficacy of aflibercept therapy administered to both eyes concurrently or consecutively have not been studied.
3 Pharmacokinetics). 1 Pregnant Women). PAVBLU™ (aflibercept injection) Page 16 of 74 Systemic Effects Thromboembolic Events Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition. There is a potential risk of ATEs following intravitreal use of VEGF inhibitors, including aflibercept.
ATEs, as defined by the Antiplatelet Trialists’ Collaboration (APTC) criteria, include nonfatal myocardial infarction, nonfatal stroke, or vascular death (including deaths of unknown cause). There are limited data on safety in the treatment of patients with CRVO, BRVO, DME or myopic CNV with a history of stroke or transient ischemic attacks or myocardial infarction within the last 6 months.
2% (19 out of 595) in patients treated with ranibizumab. 4% (2 out of 142) in the group of patients receiving only sham treatment. 2% (2 out of 92) in the laser + aflibercept control group through week 52. One of these patients in the laser group had received aflibercept rescue treatment.
7% (22 out of 287) at Week 148 in the combined group of patients treated with aflibercept and in the control (laser) group, respectively. 4% (4 out of 287) at Week 148 in the combined aflibercept groups and in the control (laser) group, respectively.
1% (1 out of 91) in the group of patients treated with aflibercept compared to 0% (0 out of 31) in the group of patients in the control (sham) group. Non-ocular Hemorrhages Non-ocular hemorrhages have been reported following intravitreal injection of VEGF inhibitors, including aflibercept, and there is a theoretical risk that these may relate to VEGF inhibition.
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