Faricimab

Faricimab is a prescription medication used for the treatment of neovascular age-related macular degeneration and diabetic macular edema  

• Faricimab is available under the following different brand names: Vabysmo, faricimab-svoa.

Common side effects of Faricimab include:

• dark, floating spots in your vision (floaters), 
• sudden vision loss (retinal pigment epithelial tear), 
• severe headache, 
• nausea, 
• vomiting, 
• seeing halos around lights, 
• redness of the eye, 
• eye pain, 
• light sensitivity, 
• blurred vision,
• decreased vision, 
• eye irritation, and
• eye discomfort

Serious side effects of Faricimab include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• severe dizziness, 
• fever, 
• decreased vision, 
• blurred vision, 
• eye redness, 
• eye pain,  
• flashes of light in one or both eyes,
• reduced side (peripheral) vision, 
• curtain-like shadow over the visual field,  
• severe headache, 
• nausea, 
• vomiting, 
• seeing halos around lights, 
• eye redness, 
• leg pain, swelling or tenderness of the thigh or calf, 
• swelling of the leg, 
• skin that feels warm to touch, and
• reddish discoloration or red streaks

Rare side effects of Faricimab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for intravitreal use

• 120 mg/mL (single-dose vial)

Neovascular Age-Related Macular Degeneration

Adult dosage

• 6 mg (0.05 mL) by intravitreal injection every 4 weeks (every 28 days ± 7 days) for first 4 doses; followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give 1 of the following regimens
• Regimens
  • 6 mg by intravitreal injection at Weeks 28 and 44, OR
  • 6 mg by intravitreal injection at Weeks 24, 36, and 48, OR
  • 6 mg by intravitreal injection at Weeks 20, 28, 36, and 44

Diabetic Macular Edema

Adult dosage

• Regimen 1
  • 6 mg (0.05 mL) by intravitreal injection every 4 weeks (every 28 days ± 7 days) for at least 4 doses
  • If after at least 4 doses, edema resolves based on central subfield thickness (CST) of macula as measured by optical coherence tomography, then dosing may be modified by extending the interval up to 4-week increments or reducing up to 8-week increments based on CST and visual acuity evaluations through week 52, OR
• Regimen 2
  • 6 mg (0.05 mL) by intravitreal injection every 4 weeks for 6 doses; followed by 6 mg by intravitreal injection every 8 weeks (2 months) over the next 28 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Faricimab has no noted severe interactions with any other drugs.
• Faricimab has no noted serious interactions with any other drugs.
• Faricimab has no noted moderate interactions with any other drugs.
• Faricimab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Ocular or periocular infection
• Active intraocular inflammation
• Hypersensitivity to faricimab or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Faricimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Faricimab?”

Cautions

• Endophthalmitis and retinal detachments may occur following intravitreal injection; instruct patients to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, vision loss, eye pain, eye redness, photophobia, blurred vision) without delay, to treat promptly and appropriately
• Increases in intraocular pressure observed within 60 minutes of administration
• Potential risk of arterial thromboembolic events (ATEs) associated with vascular endothelial growth factor (VEGF) inhibition; ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

Pregnancy and Lactation

• There are no adequate and well-controlled studies on use in pregnant females
• Do not use during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus
• Contraception
  • Females of reproductive potential: Use effective contraception before initiating, during treatment, and for more than 3 months following the last dose
• Infertility
  • No studies conducted and unknown whether faricimab can affect reproduction capacity
  • Based on the mechanism of action, treatment may pose a risk to reproductive capacity
• Lactation
  • There is no information regarding the presence of faricimab in human milk, its effects on breastfed infants, or its effects on milk production
  • Many drugs are transferred in human milk with the potential for absorption and adverse reactions in breastfed children