Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Samsung Bioepis NL B.V., Olof Palmestraat 10, 2616 LR Delft, The Netherlands
Byooviz is indicated in adults for:
Byooviz must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Byooviz in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml. The interval between two doses injected into the same eye should be at least four weeks.
Treatment in adults 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 and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.
Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.
If, in the physician’s opinion, visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, Byooviz should be discontinued.
Monitoring for disease activity may include clinical examination, functional testing or imaging techniques (e.g. optical coherence tomography or fluorescein angiography).
If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.
The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).
There is some experience of ranibizumab administered concomitantly with laser photocoagulation (see section 5.1). When given on the same day, ranibizumab should be administered at least 30 minutes after laser photocoagulation. Ranibizumab can be administered in patients who have received previous laser photocoagulation.
There is no experience of concomitant administration of ranibizumab and verteporfin.
Ranibizumab has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.
Dose adjustment is not needed in patients with renal impairment (see section 5.2).
No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.
The safety and efficacy of ranibizumab in children and adolescents below 18 years of age have not been established. Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.
Single-use vial for intravitreal use only.
Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 ml for adults), a portion of the volume contained in the vial must be discarded prior to administration.
Byooviz should be inspected visually for particulate matter and discoloration prior to administration.
For information on preparation of Byooviz, see section 6.6.
The 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) and the availability of sterile paracentesis (if required). 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, in accordance with local practice.
In adults, 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; a different scleral site should be used for subsequent injections.
Cases of accidental overdose have been reported from the clinical studies in wet AMD and post-marketing data. Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain. If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.
3 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.
Prior to use, the unopened vial may be stored at temperatures not exceeding 30°C for up to 1 month.
Vial-only pack:
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution.
Vial + filter needle + injection needle pack:
One vial (type I glass) with a stopper (chlorobutyl rubber) containing 0.23 ml sterile solution, 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 µm), and 1 injection needle (30G x ½″, 0.3 mm x 13 mm).
Not all pack types may be marketed.
The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the packaging seal remains intact.
For preparation and intravitreal injection the following medical devices for single use are needed:
These medical devices are not included within this pack.
The vial, filter needle, and injection needle are for single use only. Re-use may lead to infection or other illness/injury. All components are sterile. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact.
For preparation and intravitreal injection the following medical devices for single use are needed:
To prepare Byooviz for intravitreal administration to adults, please adhere to the following instructions:
1. Before withdrawal, the outer part of the rubber stopper of the vial should be disinfected.
2. Assemble a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm) onto a 1 ml syringe using aseptic technique. Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.
3. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
4. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.
5. Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.
6. Aseptically and firmly assemble an injection needle (30G x ½″, 0.3 mm x 13 mm) onto the syringe.
7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe. Note: Grip at the hub of the injection needle while removing the cap.
8. Carefully expel the air along with the excess solution and adjust the dose to the 0.05 ml mark on the syringe. The syringe is ready forinjection. Note: Do not wipe the injection needle. Do not pull back on the plunger.
After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.
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