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VABYSMO is a brand name for Faricimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet)…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION For intravitreal injection. 05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; 2) Weeks 24, 36 and 48; or 3) Weeks 20, 28, 36 and 44.
Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; or 2) 6 mg dose of VABYSMO can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months).
Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
05 mL of 120 mg/mL) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly). 1 General Dosing Information For intravitreal injection. VABYSMO must be administered by a qualified physician.
VABYSMO is available as:
Prefilled syringe: A sterile injection filter needle (30-gauge × ½-inch, Extra Thin Wall) with an integrated filter in the hub is provided. Each prefilled syringe should only be used for the treatment of a single eye.
Vial:
A sterile 5-micron, blunt transfer filter needle (18-gauge × 1½-inch) is provided. Each vial should only be used for the treatment of a single eye. 05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; 2) Weeks 24, 36 and 48; or 3) Weeks 20, 28, 36 and 44.
4) ] The most common adverse reactions (≥ 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%). gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice.
3) ] .
Table 1:
Common Adverse Reactions (≥ 1%) Adverse Reactions VABYSMO Active Control (aflibercept) AMD N=664 DME N=1,262 RVO N=641 AMD N=662 DME N=625 RVO N=635 Cataract 3% 15% < 1% 2% 12% 1% Conjunctival hemorrhage 7% 8% 3% 8% 7% 4% Vitreous detachment 3% 5% 2% 3% 4% 2% Vitreous floaters 3% 4% 2% 2% 3% 2% Retinal pigment epithelial tear AMD only 3% 1% Intraocular pressure increased 3% 4% 1% 2% 3% 3% Eye pain 3% 3% < 1% 3% 3% < 1% Intraocular inflammation Including iridocyclitis, iritis, uveitis, vitritis 2% 1% 1% 1% 1% < 1% Eye irritation 1% < 1% < 1% < 1% 1% < 1% Lacrimation increased 1% 1% 0 1% < 1% < 1% Ocular discomfort 1% 1% < 1% < 1% < 1% < 1% Less common adverse reactions reported in < 1% of the patients treated with VABYSMO were corneal abrasion, eye pruritus, ocular hyperemia, blurred vision, sensation of foreign body, endophthalmitis, conjunctival hyperaemia, visual acuity reduced, visual acuity reduced transiently, vitreous hemorrhage, retinal tear and rhegmatogenous retinal detachment.
2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of VABYSMO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders : retinal vasculitis with or without retinal vascular occlusion.
5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.
1 ) Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. 2 ) There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition. 1) ] . Proper aseptic injection techniques must always be used when administering VABYSMO.
6) and Patient Counseling Information (17) ]. 1) ]. 6) ]. 3 Thromboembolic Events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors.
ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). 1) ] . 2) ] . 3) ] . 2) ] . Discontinue treatment with VABYSMO in patients who develop these events. Patients should be instructed to report any change in vision without delay.
1 Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections. 2 Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation. 3 Hypersensitivity VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO.
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; or 2) 6 mg dose of VABYSMO can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months).
Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly). 3) ] . 5 Preparation for Administration - Prefilled Syringe Before you start Read all the instructions carefully before using VABYSMO.
The VABYSMO carton includes:
A sterile prefilled syringe in a sealed tray. The prefilled syringe is for treatment of a single eye. A sterile injection filter needle (30-gauge × ½ inch, Extra Thin Wall) with an integrated filter in the hub. The injection filter needle is for single use only.
Only use the provided injection filter needle for the administration. VABYSMO should be refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Do not freeze. Allow VABYSMO to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration.
Prior to use, keep the sealed tray in the original carton to protect the prefilled syringe from light . The prefilled syringe may be kept at room temperature in the original carton for up to 24 hours . VABYSMO should be inspected visually prior to administration.
Do not use if the carton seals have been tampered with. Do not use if the packaging, prefilled syringe, injection filter needle is expired, damaged, or have been tampered with. Do not use if the injection filter needle is missing. Do not remove the finger grip from the syringe.
Do not use if the syringe cap is detached from the Luer lock. Do not use if particulates, cloudiness, or discoloration are visible. VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid solution. 05 mL dose mark.
Use aseptic technique to carry out the following preparation steps:
Open Tray and Remove Syringe Cap 1 Peel the lid off the syringe tray and aseptically remove the prefilled syringe. 2 Hold the syringe by the white collar; snap off the syringe cap ( see Figure B ). Do not twist off the cap. Figure B Attach Injection Filter Needle 3 Aseptically remove the provided injection filter needle from its packaging.
4 Aseptically and firmly attach the injection filter needle onto the syringe Luer lock ( see Figure C ). Figure C 5 Carefully remove the needle cap by pulling it straight off. Dislodge Air Bubbles 6 Hold the syringe with the injection filter needle pointing up.
Check the syringe for air bubbles. 7 If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top ( see Figure D ). 05 mL dose mark ( see Figure E ). 05 mL. Ensure that the injection is given immediately after preparation of the dose.
6 Preparation for Administration - Vial Before you start Read all the instructions carefully before using VABYSMO. The VABYSMO kit includes a glass vial and transfer filter needle. The glass vial is for a single dose only. The filter needle is for treatment of a single eye.
VABYSMO should be stored refrigerated at temperatures between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Allow VABYSMO to reach room temperature, 20°C to 25°C (68°F to 77°F) before proceeding with the administration. Keep the vial in the original carton to protect from light.
The VABYSMO vial may be kept at room temperature for up to 24 hours . The VABYSMO vial should be inspected visually for particulate matter and discoloration prior to administration. VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid solution.
Do not use if particulates, cloudiness, or discoloration are visible. Do not use if the packaging, vial and/or transfer filter needle are expired, damaged, or have been tampered with (see Figure F ). Figure F Use aseptic technique to carry out the preparation of the intravitreal injection.
05 mL dose mark ( not included ) Note that a 30-gauge injection needle is recommended to avoid increased injection forces that could be experienced with smaller diameter needles. One sterile injection needle 30-gauge × ½ inch ( not included ) Alcohol swab ( not included ).
2 To ensure all liquid settles at the bottom of the vial, place the vial upright on a flat surface (for about 1 minute) after removal from packaging (see Figure G ). Gently tap the vial with your finger (see Figure H ), as liquid may stick to the top of the vial.
Figure G Figure H 3 Remove the flip-off cap from the vial (see Figure I ) and wipe the vial septum with an alcohol swab (see Figure J ). Figure I Figure J 4 Aseptically and firmly attach the included 18-gauge × 1½ inch transfer filter needle onto a 1 mL Luer lock syringe (see Figure K ).
Figure K 5 Using aseptic technique, push the transfer filter needle into the center of the vial septum (see Figure L ), push it all the way in, then tilt the vial slightly so that the needle touches the bottom edge of the vial (see Figure M ).
Figure L Figure M 6 Hold the vial slightly inclined and slowly withdraw all the liquid from the vial (see Figure N ). Keep the bevel of the transfer filter needle submerged in the liquid, to avoid introduction of air. Figure N 7 Ensure that the plunger rod is drawn sufficiently back when emptying the vial, in order to completely empty the transfer filter needle (see Figure N ).
8 Disconnect the transfer filter needle from the syringe and dispose of it in accordance with local regulations. Do not use the transfer filter needle for the intravitreal injection. 9 Aseptically and firmly attach a 30-gauge × ½ inch injection needle onto the Luer lock syringe (see Figure O ).
Figure O 10 Carefully remove the plastic needle shield from the needle by pulling it straight off. 11 To check for air bubbles, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure P ).
05 mL dose mark. The syringe is ready for the injection (see Figure Q ). Ensure that the injection is given immediately after preparation of the dose. 7 Injection Procedure The intravitreal injection procedure must 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), and the availability of sterile paracentesis equipment (if required).
Adequate anesthesia and a broad-spectrum microbicide should be administered prior to the injection. 05 mL.
Note for the prefilled syringe:
Do not recap or detach the injection filter needle from the syringe. Any unused drug product or waste material should be disposed of in accordance with local regulations. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. , vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay [see Patient Counseling Information (17) ] .
Each syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before VABYSMO is administered to the other eye.