Lytenava Injection Uses, Dosage & Side Effects

• Ocular or periocular infections (4.1)
• Active intraocular inflammation (4.2)
• Hypersensitivity (4.3) 4.1 Ocular or Periocular Infections

LYTENAVA is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation

LYTENAVA is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity

LYTENAVA is contraindicated in patients with known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation.

• 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 (5.1).

• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection (5.2).

• There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition (5.3). 5.1 Endophthalmitis and Retinal Detachments

Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [

see Dosage and Administration

(2.3)

and Patient Counseling Information

(17)]. 5.2 Increases in Intraocular Pressure

Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately [

see Dosage and Administration

(2.4)]. 5.3 Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA 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).

The recommended dose for LYTENAVA is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once monthly (approximately 28 days) (2). 2.1 General Dosing Information FOR OPHTHALMIC INTRAVITREAL INJECTION. LYTENAVA must only be administered by a qualified physician. A 5-micron sterile filter needle (18-gauge x 1½-inch), a 1 mL syringe (with marking to measure 0.05 mL), and a 30-gauge x ½-inch sterile injection needle are needed. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) The recommended dose for LYTENAVA is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once monthly (approximately 28 days). 2.3 Preparation for Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The glass vial is for one-time use in one eye only. Using aseptic technique, the total vial volume of a LYTENAVA vial should be withdrawn through a 5-micron (18-gauge x 1½-inch) sterile filter needle attached to a 1 mL syringe. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection. The filter needle should be replaced with a sterile 30-gauge x ½-inch needle for the intravitreal injection. The contents should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe. Use aseptic technique to carry out the following preparation steps: 1. Prepare for intravitreal injection with the following recommended devices for one-time use (not provided): • 5-micron sterile filter needle (18-gauge x 1½-inch) • 1 mL sterile syringe (with marking to measure 0.05 mL) • sterile injection needle (30-gauge x ½-inch) • alcohol swab 2. Remove the protective plastic cap from the vial. Clean the top of the vial with an alcohol swab. 3. Attach the 5-micron filter needle (18-gauge x 1½-inch) to the syringe by twisting it onto the syringe tip. 4. Push the filter needle into the center of the vial stopper and ensure the tip of the needle remains within the solution to minimize the potential for air bubbles. 5. Withdraw the total volume of LYTENAVA, keeping the vial in an upright position, slightly inclined to ease sufficient withdrawal. 6. Ensure that the plunger rod is drawn sufficiently back when drawing up LYTENAVA in order to completely empty the filter needle. 7. The filter needle should be discarded after withdrawal of the vial contents and must not be used for the intravitreal injection. 8. Attach the 30-gauge x ½-inch sterile injection needle to the syringe by firmly screwing it onto the syringe hub. Carefully remove the needle cap by pulling it straight off. Do not wipe the needle at any time. 9. 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. 10. Hold the syringe at eye level and slowly push the plunger rod until the plunger tip is aligned with the line that marks 0.05 mL on the syringe. 2.4 Administration The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to injection. Prior to and 30 minutes following the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry. Monitoring may also consist of a check for perfusion of the optic nerve head immediately after the injection [ see Warnings and Precautions (5.2)]. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection [ see Warnings and Precautions (5.1)]. Each single-dose vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used, and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle, and injection needles should be changed before LYTENAVA is administered to the other eye.

Injection: 1.25 mg (0.05 mL of 25 mg/mL) colorless to light brown, opalescent solution for intravitreal injection in a single-dose vial.