Revakinagene Taroretcel Dosage

Usual Adult Dose for Macular Telangiectasia

1 implant per affected eye

Comments:

• Each implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant 129 human ciliary neurotropic factor, a neurotrophic factor.

Use: For the treatment of patients with idiopathic macular telangiectasia type 2

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Active or suspected ocular or periocular infections
• Hypersensitivity to endothelial serum free media

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This implant is administered by a single surgical intravitreal procedure performed by a qualified ophthalmologist.
• Inspect the implant packaging for any signs of damage or leakage.
• The manufacturer product information should be consulted for implant placement and removal procedure.

Storage requirements:

• Store in corepack at 16C to 37C (61F to 99F) until ready for use.
• Do not freeze or refrigerate.
• Protect from light.
• Do not use beyond the "use by" date identified on corepack label.
• Do not use if pH is outside of acceptable range (refer to pH colour guide card provided in the manufacturer product information).
• Inspect disposable temperature recording device; if a check mark is displayed, the product has remained within acceptable temperature range and may be used. If "X" is displayed, the product was exposed to temperatures outside acceptable range and must not be used. Contact the manufacturer immediately at (833) 963-927.

General:

• To report suspected adverse reactions, contact Neurotech at 1-833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Monitoring:

• Ocular: Signs and symptoms of vision loss, retinal tear, retinal detachment, infectious endophthalmitis

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Consult an ophthalmologist immediately if signs or symptoms of increased floaters, appearance of spider webs, flashing lights, sensitivity to light, or loss of vision or visual field, increasing eye pain, progressive redness in the white of the eye, a sudden sensation that something is in their eye occurs.
• Patients may temporarily experience mild sensation of something in the eye, eye redness, irritation, pain or discomfort, or dryness, blurred vision, or floaters.
• Delayed dark adaptation may impair ability to see objects, pedestrians, or road signs when moving rapidly from a brightly lit environment to a dimly lit environment. Avoid driving or operating machinery until the eye shield has been removed and your ophthalmologist informs that your vision has recovered to an acceptable level.
• Consider wearing sunglasses or tinted lenses in bright environments to reduce the impact of transitioning from light to dark.
• This implant is MR conditional.
• Avoid heavy lifting (over 20 pounds) for one week.
• Avoid exposure of the operated eye to water (e.g., keep the eye closed during showering) for a period of one week.
• Protect eyes by wearing glasses or protective eyewear during the day and using an eye shield at night for one week.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer