BEOVU® is indicated for the treatment of Neovascular
(Wet) Age-related Macular Degeneration (AMD).
DOSAGE AND ADMINISTRATION
General Dosing Information
For ophthalmic intravitreal injection. BEOVU must be
administered by a qualified physician.
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The recommended dose for BEOVU is 6 mg (0.05 mL of 120
mg/mL solution) administered by intravitreal injection monthly (approximately
every 25-31 days) for the first three doses, followed by 6 mg (0.05 mL) by
intravitreal injection once every 8-12 weeks.
Preparation For Administration
Store BEOVU in the refrigerator between 2 to 8°C (36 to
46°F); do not freeze. Keep the vial in the outer carton to protect from light.
Prior to use, the unopened glass vial of BEOVU may be
kept at room temperature, 20 to 25°C (68 to 77°F) for up to 24 hours. After
opening the glass vial, proceed under aseptic conditions.
BEOVU is a clear to slightly opalescent and colorless to
slightly brownish-yellow solution.
BEOVU should be inspected visually upon removal from the
refrigerator and prior to administration. If particulates, cloudiness, or
discoloration are visible, the glass vial must not be used.
The BEOVU kit includes the sterile glass vial and filter needle
which are for single use only. Do not use if the packaging, vial and/or filter
needle are damaged or expired [see HOW SUPPLIED/Storage And Handling].
Use aseptic technique for preparation of the intravitreal
STEP 1: Gather the supplies needed.
- One BEOVU vial (included)
- One sterile 5-micron blunt filter needle (18-gauge x 1½
inch, 1.2 mm x 40 mm) (included)
- One sterile 30-gauge x ½ inch injection needle (not
- One sterile 1 mL syringe with a 0.05 mL dose mark (not
- Alcohol swab (not included)
STEP 2 : Allow vial to come to room temperature
and inspect the solution. If particulates, cloudiness, or discoloration are
visible, discard the vial and obtain a new vial.
STEP 3 : Remove the vial cap and clean the vial
septum (e.g., with alcohol swab).
STEP 4 : Assemble the 5-micron filter needle
(18-gauge x 1½ inch) onto a 1-mL syringe using aseptic technique.
STEP 5 : Push the filter needle into the center of
the vial septum until the needle touches the bottom of the vial.
STEP 6 : To withdraw the liquid, hold the vial
slightly inclined and slowly withdraw all the liquid from the vial and filter
needle. Ensure that the plunger rod is drawn sufficiently back when emptying
the vial in order to completely empty the filter needle.
STEP 7 : Disconnect the filter needle from the
syringe in an aseptic manner and dispose of it. The filter needle is not to be
used for the intravitreal injection.
STEP 8 : Aseptically and firmly assemble a
30-gauge x ½ inch injection needle onto the syringe.
STEP 9 : Check for air bubbles by holding 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.
STEP 10 : Carefully expel the air from the syringe
and adjust the dose to the 0.05 mL mark. The syringe is ready for the
Ensure that the injection is
given immediately after preparation of the dose.
The intravitreal injection
procedure must 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
equipment (if required). Adequate anesthesia and a broad-spectrum topical
microbicide to disinfect the periocular skin, eyelid, and ocular surface should
be administered prior to the injection.
Inject slowly until the rubber
stopper reaches the end of the syringe to deliver the volume of 0.05 mL.
Confirm delivery of the full dose by checking that the rubber stopper has
reached the end of the syringe barrel.
Immediately following the
intravitreal injection, patients should be monitored for elevation in
intraocular pressure (IOP). Appropriate monitoring may consist of a check for
perfusion of the optic nerve head or tonometry. If required, a sterile
paracentesis needle should be available.
injection, patients should be instructed to report any symptoms suggestive of
endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye,
photophobia, blurring of vision) without delay [see Patient Counseling
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, and injection needles should be changed before BEOVU
is administered to the other eye.
Any unused medicinal product or
waste material should be disposed of in accordance with local regulations.
Dosage Forms And Strengths
Intravitreal Injection: 6 mg/0.05 mL, clear to slightly
opalescent and colorless to slightly brownish-yellow solution in a single-dose
injection is supplied as a clear to slightly opalescent and colorless to
slightly brownish-yellow 6 mg/0.05 mL solution in a single-dose vial. Each
BEOVU carton (NDC 0078-0827-61) contains one BEOVU vial and one sterile 5
μm blunt filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm).
Storage And Handling
Refrigerate BEOVU between 2 to
8°C (36 to 46°F). Do not freeze. Store the vial in the outer carton to protect
Prior to use, the unopened
glass vial of BEOVU may be kept at room temperature, 20 to 25°C (68 to 77°F)
for up to 24 hours.
Manufactured by: Novartis
Pharmaceuticals Corporation East Hanover, New Jersey 07936. ÃÂ Revised: Oct 2019