LYTENAVA Solution for injection Ref.[110288] Active ingredients: Bevacizumab

This medicinal product must be administered by a qualified healthcare professional, experienced in intravitreal injections.

Posology

The recommended dose is 1.25 mg administered by intravitreal injection every 4 weeks (monthly). This corresponds to an injection volume of 0.05 mL.

Treatment is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity, i.e., no change in visual acuity or in other signs and symptoms of the disease under continued treatment. The kinetics of bevacizumab gamma efficacy (see section 5.1) indicate that three or more consecutive monthly injections may be needed initially. Thereafter, the healthcare professional may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters.

Monitoring and treatment intervals should then be determined by the healthcare professional and should be based on disease activity, including clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).

If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, the medicinal product should be discontinued. Treatment should also be withheld if clinically indicated, (see section 4.4).

Special populations

Elderly

No dose adjustment is required in patients aged 65 years and older.

Renal impairment

Bevacizumab gamma has not been studied in patients with renal impairment. Available data do not suggest a need for a dose adjustment is required in patients with renal impairment.

Hepatic impairment

Bevacizumab gamma has not been studied in patients with hepatic impairment. Available data do not suggest a need for a dose adjustment is required in patients with hepatic impairment.

Paediatric population

There is no relevant use of Lytenava in the paediatric population for the treatment of nAMD.

Method of administration

The medicinal product is for intravitreal use only. Each vial should only be used for the treatment of a single eye.

Since the volume contained in the vial (0.3 mL) is greater than the recommended dose (0.05 mL), a portion of the volume contained in the vial must be discarded prior to administration.

Ensure that the injection is given immediately after preparation of the dose.

The intravitreal injection procedure should 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). Sterile paracentesis equipment should be available as a precautionary measure. The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4). Adequate anaesthesia 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 3.5-4.0 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.

For instructions on preparation of the medicinal product before administration, see section 6.6.

Overdosing with greater than recommended injection volume may increase intraocular pressure. In the event of overdose, intraocular pressure should therefore be monitored and, if deemed necessary by the treating healthcare professional, appropriate treatment should be initiated.

2 years.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

The unopened vial may be stored outside the refrigerator below 25°C for up to 12 hours.

Lytenava 25 mg/mL solution for injection contains 0.3 mL solution in a 2 mL vial (Type 1 glass) with a stopper (butyl rubber) containing 7.5 mg of bevacizumab gamma.

Pack size of 1 vial.

The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used, and appropriate replacement procedures must be followed.

The content of the vial is sterile and for single use only. Do not use if the packaging or vial are damaged or expired.

The vial contains more than the recommended dose of 1.25 mg. Injecting the entire volume of the vial could result in overdose. The excess medicinal product and any air bubbles should be carefully expelled from the syringe prior to injection. The injection dose must be set to the 0.05 mL dose mark (1.25 mg bevaiczumab gamma). Ensure that the injection is given immediately after preparation of the dose.

Use aseptic technique to carry out the following preparation steps:

1. Prepare for intravitreal injection with the following recommended commercially available medical devices for single use (not provided):

• 5 micron sterile filter needle, 18-gauge × 1½ inch (micro acrylic copolymer filter; polycarbonate/stainless steel 304 needle or equivalent)
• 1 mL sterile silicone-free syringe with marking to measure 0.05 mL (polypropylene/polyethylene or equivalent)
• Sterile injection needle, 30-gauge × ½ inch (polypropylene/stainless steel or equivalent)
• Alcohol swab

2. Before withdrawal, disinfect the outer part of the rubber stopper of the vial.

3. Place the 5 micron filter needle onto the 1 mL syringe using aseptic technique.

4. Push the filter needle into the centre of the vial stopper and ensure the tip of the needle remains within the Lytenava solution to minimise the potential for air bubbles.

5. Withdraw the contents of Lytenava to ensure a full dose can be prepared in the syringe, 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 to provide for sufficient volume to prepare a 0.05 mL injection.

7. The filter needle should be discarded after withdrawal of the vial content and must not be used for the intravitreal injection.

8. Attach a 30-gauge × ½ inch sterile injection needle firmly onto the syringe by screwing it tightly 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 carefully push the plunger rod until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.