Lucentis/Lucentis PFS

One mL contains Ranibizumab 10 mg.

Vial: Each vial contains Ranibizumab 2.3 mg in 0.23 mL solution.

Pre-filled Syringe: One pre-filled syringe contains 0.165 mL, equivalent to 1.65 mg Lucentis/Lucentis PFS. The extractable volume of one pre-filled syringe is 0.1 mL. This provides a usable amount to deliver a single dose of 0.05 mL containing 0.5 mg Lucentis/Lucentis PFS.

Lucentis/Lucentis PFS is a humanized monoclonal antibody fragment produced by Escherichia coli cells by recombinant DNA technology.

Excipients/Inactive Ingredients: L-histidine hydrochloride, monohydrate, L-histidine, trehalose dihydrate, polysorbate 20, water for injection.

Lucentis/Lucentis PFS is indicated for the treatment of patients with:

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

Macular Edema Following Retinal Vein Occlusion (RVO)

Diabetic Macular Edema (DME)

​1.4 Diabetic Retinopathy (Non Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR)) in patients with Diabetic Macular Edema (DME)

Lucentis/Lucentis PFS (Lucentis/Lucentis PFS) is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with a certain type of eye disease, new blood vessels grow under the retina where they leak blood and fluid. This is known as the "wet form" of macular degeneration.

Lucentis/Lucentis PFS is used to treat wet age-related macular degeneration. Lucentis/Lucentis PFS is also used to treat swelling in the retina caused by diabetes or by a blockage in the blood vessels.

Lucentis/Lucentis PFS is also used to treat diabetic retinopathy in patients with diabetic macular edema.

Lucentis/Lucentis PFS may also be used for purposes not listed in this medication guide.

General Dosing Information

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

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

Lucentis/Lucentis PFS 0.5 mg (0.05 mL of 10 mg/mL Lucentis/Lucentis PFS 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 nine months after 3 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)

Lucentis/Lucentis PFS 0.5 mg (0.05 mL of 10 mg/mL Lucentis/Lucentis PFS 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 Lucentis/Lucentis PFS 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.

Diabetic Macular Edema (DME)

Lucentis/Lucentis PFS 0.3 mg (0.05 mL of 6 mg/mL Lucentis/Lucentis PFS solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Diabetic Retinopathy In Patients With Diabetic Macular Edema

Lucentis/Lucentis PFS 0.3 mg (0.05 mL of 6 mg/mL Lucentis/Lucentis PFS solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days).

Preparation For Administration

Using aseptic technique, all of the Lucentis/Lucentis PFS vial contents are withdrawn through a 5-micron, 19-gauge filter needle attached to a 1-cc tuberculin syringe. 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 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.

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, and injection needles should be changed before Lucentis/Lucentis PFS 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).

How supplied

Dosage Forms And Strengths

Single-use glass vial designed to provide 0.05 mL for intravitreal injection.

• 10 mg/mL solution (Lucentis/Lucentis PFS 0.5 mg)
• 6 mg/mL solution (Lucentis/Lucentis PFS 0.3 mg)

Storage And Handling

Each Lucentis/Lucentis PFS 0.5 mg carton (NDC 50242-080-01) contains a single-use, 2-cc glass vial with a BLUE CAP designed to deliver 0.05 mL of 10 mg/mL Lucentis/Lucentis PFS.

Each Lucentis/Lucentis PFS 0.3 mg carton (NDC 50242-082-01) contains a single-use, 2-cc glass vial with a WHITE CAP designed to deliver 0.05 mL of 6 mg/mL Lucentis/Lucentis PFS.

In addition, each carton contains one 5-micron, 19-gauge x 1-½-inch filter needle for withdrawal of the vial contents; one 30-gauge x ½-inch injection needle for the intravitreal injection; and one package insert. VIALS ARE FOR SINGLE-EYE USE ONLY.

Lucentis/Lucentis PFS should be refrigerated at 2°-8°C (36°-46°F). DO NOT FREEZE. Do not use beyond the date stamped on the label. Lucentis/Lucentis PFS vials should be protected from light. Store in the original carton until time of use.

Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990. Revised: Feb 2015

See also:
What is the most important information I should know about Lucentis/Lucentis PFS?

You should not receive Lucentis/Lucentis PFS if you are allergic to it, or if you have any type of infection in or around your eyes.

Before you receive this medication, tell your doctor if you have glaucoma, or a history of blood clots or stroke.

Call your doctor at once if you have sudden vision problems, eye pain or irritation, discharge or bleeding from the eye, swelling around your eye, seeing flashes of light or "floaters" in your vision, sudden numbness or weakness in your body, sudden severe headache, or problems with speech or balance.

Call your doctor for instructions if you miss an appointment to receive your Lucentis/Lucentis PFS injection. The timing of your monthly injections is very important for this medication to be effective.

Use Lucentis/Lucentis PFS as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lucentis/Lucentis PFS is given as an injection into the eye at your doctor's office, hospital, or clinic.
• Do not use Lucentis/Lucentis PFS if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Lucentis/Lucentis PFS is for injection into the eye only.
• If you miss a dose of Lucentis/Lucentis PFS, contact your doctor right away.

This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema). It is used to help prevent decreased vision and blindness. Lucentis/Lucentis PFS works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How to use Lucentis/Lucentis PFS intravitreal

Read the Patient Information Leaflet if available from your pharmacist before you start receiving Lucentis/Lucentis PFS and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into the affected eye(s) by a health care professional. The affected eye is numbed before each injection. Your eye will be monitored before the injection. After the injection, you will remain in the doctor's office for a while, and your eye will continue to be monitored.

Dosage is based on your medical condition and response to treatment. This medication is usually given once a month or as directed by your doctor.

When treating age-related macular degeneration, if you are not able to have monthly injections after your first few doses, getting injections once every 2 or 3 months may be an option, although not as effective as monthly injections. Consult your doctor for more details.

Use this medication regularly to get the most benefit from it.

Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Lucentis/Lucentis PFS?

No formal interaction studies have been performed.

In clinical trials for treatment of visual impairment due to DME, the outcome with regards to visual acuity or CRT in patients treated with Lucentis/Lucentis PFS was not affected by concomitant treatment with thiazolidinediones.

For the adjunctive use of verteporfin photodynamic therapy (PDT) and Lucentis/Lucentis PFS in wet AMD and PM, see

Pharmacology: Pharmacodynamics: Clinical Studies under Actions.

For the adjunctive use of laser photocoagulation and Lucentis/Lucentis PFS in DME and BRVO, see

Pharmacology: Pharmacodynamics: Clinical Studies under Actions and Dosage & Administration.

Incompatibilities: In the absence of compatibility studies, Lucentis/Lucentis PFS must not be mixed with other medicinal products.

See also:
What are the possible side effects of Lucentis/Lucentis PFS?

Summary of the Safety Profile: Wet Age-Related Macular Degeneration Population: A total of 1,315 constituted the safety population in the 3 phase III studies in wet AMD with 24 months exposure to Lucentis/Lucentis PFS and 440 patients were treated with the recommended dose of 0.5 mg.

Serious adverse events related to the injection procedure included endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract.

Other serious ocular events observed among Lucentis/Lucentis PFS-treated patients included intraocular inflammation and increased IOP.

The adverse events listed as follows occurred at a higher rate (at least 2 percentage points) in patients receiving treatment with Lucentis/Lucentis PFS 0.5 mg than in those receiving control treatment [sham injection or verteporfin PDT] in the pooled data of the 3 controlled wet AMD phase III FVF2598g (MARINA), FVF2587g (ANCHOR) and FVF3192g (PIER) studies. These were therefore, considered potential adverse drug reactions. The safety data described as follows also include all adverse events suspected to be at least potentially related to the injection procedure or Lucentis/Lucentis PFS in the 440 patients of the combined 0.5 mg treatment groups in wet AMD.

Diabetic Macular Edema Population: The safety of Lucentis/Lucentis PFS was studied in a 1-year, sham-controlled trial (RESOLVE) and in a 1-year, laser-controlled trial (RESTORE) conducted respectively in 102 and 235 Lucentis/Lucentis PFS-treated patients with visual impairment due to DME. The event of urinary tract infection in the common frequency category met the adverse reaction criteria mentioned as follows; otherwise ocular and non-ocular events in the RESOLVE and RESTORE trials were reported with a frequency and severity similar to those seen in the wet AMD trials.

Retinal Vein Occlusion Population: The safety of Lucentis/Lucentis PFS was studied in two 12-month trials (BRAVO and CRUISE) conducted respectively in 264 and 261 Lucentis/Lucentis PFS-treated patients with visual impairment due to macular edema secondary to BRVO and CRVO, respectively. Ocular and non-ocular events in the BRAVO and CRUISE trials were reported with a frequency and severity similar to those seen in the wet AMD trials.

Pathologic Myopia Population: The safety of Lucentis/Lucentis PFS was studied in the 12-month clinical study (RADIANCE), which included 224 Lucentis/Lucentis PFS-treated patients with PM. Ocular and non-ocular events in this trial were reported with a frequency and severity similar to those seen in the wet-AMD trials.

Tabulated Summary of Adverse Drug Reactions from Clinical Trials: The adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).