VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML

F. Hoffmann-La Roche AG (SWITZERLAND)🇸🇬 Health Sciences Authority

Approval Date: Jun 16, 2022
Approval ID: aad2c33bf635a912
Company: F. Hoffmann-La Roche AG (SWITZERLAND)
Type: Therapeutic

Approval Details

Approval Id: aad2c33bf635a912
Drug Name: VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML
Product Name: VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML
Approval Number: SIN16514P
Approval Date: 2022-06-16
Registrant: ROCHE SINGAPORE PTE. LTD.
Licence Holder: ROCHE SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 2.2 DOSAGE AND ADMINISTRATION General For intravitreal injection only. Vabysmo must be administered by a qualified physician experienced in intravitreal injections. Each vial should only be used for the treatment of a single eye. Neovascular (wet) age-related macular degeneration (nAMD) The recommended dose for Vabysmo is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks for the first 3 doses. Thereafter, an assessment of disease activity based on anatomic and visual acuity evaluations is recommended 16 and/or 20 weeks after treatment initiation so that the dosing interval may be modified using a treat-and-extend approach. In patients without disease activity, administration of faricimab every 16 weeks should be considered. In patients with disease activity, treatment every 8 weeks or 12 weeks should be considered. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly by increase of up to 4-week intervals or decrease of up to 8-week intervals. Interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients should be assessed regularly. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion. Diabetic macular edema (DME) The recommended dose for Vabysmo is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks for at least 3 doses or until macular edema is resolved based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography. Thereafter, the dosing interval may be modified using a treat-and-extend approach based on anatomic and/or visual acuity outcomes at dosing visits. The dosing interval may be extended up to every 16 weeks, in up to 4-week increments. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and dosing interval reductions of up to 8 weeks may be implemented if deemed necessary (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients should be assessed regularly. Monitoring between the dosing visits should be scheduled based on the patient's status and at the physician's discretion. Macular edema secondary to retinal vein occlusion (RVO) The recommended dose for Vabysmo is 6mg (0.05 mL solution) administered by intravitreal injection every 4 weeks; 3 or more consecutive monthly injections may be needed. Thereafter, the dosing interval may be modified using a treat-and-extend approach based on anatomic and/or visual acuity outcomes at dosing visits. The dosing interval may be extended in up to 4-week increments. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment intervals longer than 16 weeks between injections have not been studied. Patients should be assessed regularly. Monitoring between the dosing visits should be scheduled based on the patient’s status and at the physician’s discretion Method of Administration Vabysmo should be inspected visually for particulate matter and discoloration prior to administration, and if present, the vial should not be used. The 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). Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection. The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. 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. Sterile equipment for paracentesis should be available. Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. vision loss, eye pain, redness of the eye, photophobia, blurring of vision) without delay. Comprehensive instructions for the administration of Vabysmo are given in the Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Delayed or Missed Dose If a dose is delayed or missed, the patient should return to be assessed by physician at the next available visit and continue dosing depending on physician’s discretion. If visual and/or anatomic outcomes indicate that the patient is not benefitting from continued treatment, Vabysmo should be discontinued. Dose Modifications No dose modifications of Vabysmo are recommended. 2.2.1 Special Dosage Instructions Pediatric use The safety and efficacy of Vabysmo in pediatric patients have not been established. Geriatric use No dose adjustment is required in patients ≥ 65 years of age (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal Impairment No dose adjustment is required in patients with renal impairment. Hepatic Impairment No specific studies in patients with hepatic impairment have been conducted with Vabysmo. However, no special considerations are needed in this population because metabolism occurs via proteolysis and does not depend on hepatic function. No dose adjustment is required in patients with hepatic impairment.
Route Of Administration: INTRAVITREOUS
Indication Info: 2.1 THERAPEUTIC INDICATION(S) Vabysmo is indicated for the treatment of adult patients with: <ul> <li>neovascular (wet) age-related macular degeneration (nAMD) (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>visual impairment due to diabetic macular edema (DME) (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> <li>macular edema secondary to retinal vein occlusion (RVO) (see section 3.1.2 Clinical Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).</li> </ul>
Contraindications: 2.3 CONTRAINDICATIONS Vabysmo is contraindicated in patients with ocular or periocular infections. Vabysmo is contraindicated in patients with active intraocular inflammation. Vabysmo is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.
Atc Code: S01LA09
Atc Item Name: faricimab
Pharma Manufacturer Name: ROCHE SINGAPORE PTE. LTD.

Active Ingredients

Faricimab

6.00mg/0.05ml

FARICIMAB

6 MG/0.05 ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 16, 2022

Approval ID

aad2c33bf635a912

Type

Therapeutic

Back to HSA Approvals