BYOOVIZ (ranibizumab-nuna)

BYOOVIZ (ranibizumab-nuna) injection

BYOOVIZ (ranibizumab-nuna)

BYOOVIZ (ranibizumab-nuna) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-nuna binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-nuna, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product.

BYOOVIZ (ranibizumab-nuna) injection is a sterile, clear to slightly opalescent and colorless to pale yellow solution in a single-dose glass vial for intravitreal use. BYOOVIZ is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL BYOOVIZ (0.5 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.

Mechanism of Action

Ranibizumab products bind to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, mCNV, and macular edema following RVO. The binding of ranibizumab products to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

INDICATIONS AND USAGE

BYOOVIZ is indicated for the treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Myopic Choroidal Neovascularization (mCNV)

DOSAGE AND ADMINISTRATION

FOR OPHTHALMIC INTRAVITREAL INJECTION.

Vials: A 5-micron sterile filter needle (19-gauge × 1-1/2 inch), a 1-mL Luer lock syringe and a 30- gauge × ½ inch sterile injection needle are needed but not included.

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

BYOOVIZ 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. In the 9 months after three initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. Patients should be assessed regularly.

Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly.

Macular Edema Following Retinal Vein Occlusion (RVO)

BYOOVIZ 0.5 mg (0.05 mL of 10 mg/mL solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

In Studies RVO-1 and RVO-2, patients received monthly injections of ranibizumab for 6 months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly.

Myopic Choroidal Neovascularization (mCNV)

BYOOVIZ 0.5 mg (0.05 mL of 10 mg/mL BYOOVIZ solution) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) for up to 3 months. Patients may be retreated if needed.

Preparation for Administration

Vial:

Using aseptic technique, all of the BYOOVIZ vial contents are withdrawn through a 5-micron (19-gauge × 1-1/2 inch), sterile filter needle attached to a 1 mL syringe (not included). The filter needle should be discarded after withdrawal of the vial contents and should not be used for intravitreal injection. The filter needle should be replaced with a sterile 30-gauge × ½ inch needle for the intravitreal injection.

Use aseptic technique to carry out the following preparation steps:

1. Prepare for intravitreal injection with the following medical devices for single use (not included):

  • 5-micron sterile filter needle (19-gauge × 1-1/2 inch)
  • 1 mL sterile Luer lock syringe (with marking to measure 0.05 mL)
  • sterile injection needle (30-gauge × 1/2-inch)

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

3. Place a 5-micron filter needle (19-gauge × 1-1/2 inch) onto a 1 mL Luer lock syringe using aseptic technique.

4. Push the filter needle into the center of the vial stopper until the needle touches the bottom edge of the vial.

5. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.

BYOOVIZ (ranibizumab-nuna) injection

6. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.

BYOOVIZ (ranibizumab-nuna) injection

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

8. Attach a 30-gauge × 1/2-inch sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock. Carefully remove the needle cap by pulling it straight off. Do not wipe the needle at any time.

BYOOVIZ (ranibizumab-nuna) injection

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.

BYOOVIZ (ranibizumab-nuna) injection

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.

BYOOVIZ (ranibizumab-nuna) injection

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 the 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. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection.

Each 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 (vial only), and injection needles should be changed before BYOOVIZ is administered to the other eye.

No special dosage modification is required for any of the populations that have been studied (e.g., gender, elderly).

CONTRAINDICATIONS

Ocular or Periocular Infections: BYOOVIZ is contraindicated in patients with ocular or periocular infections.

Hypersensitivity: BYOOVIZ is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.

Increases in Intraocular Pressure: Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately.

Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Adverse reactions

The following adverse reactions have been identified during postapproval use of ranibizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

DRUG INTERACTIONS

Drug interaction studies have not been conducted with ranibizumab products.

Ranibizumab intravitreal injection has been used adjunctively with Photodynamic Therapy (PDT). Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no adequate and well-controlled studies of ranibizumab products administered in pregnant women.

Lactation: There are no data available on the presence of ranibizumab products in human milk, the effects of ranibizumabproducts on the breastfed infant or the effects of ranibizumab products on milk production/excretion.

Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when BYOOVIZ is administered to a nursing woman.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BYOOVIZ and any potential adverse effects on the breastfed child from BYOOVIZ.

OVERDOSAGE

More concentrated doses as high as 2 mg ranibizumab in 0.05 mL have been administered to patients. No additional unexpected adverse reactions were seen.

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