Aflibercept intravitreal

Name: Aflibercept intravitreal

Uses

Aflibercept is used to treat certain serious eye conditions (such as wet age-related macular degeneration - wet AMD, macular edema following central retinal vein occlusion, diabetic macular edema). This medication can help preserve vision and prevent blindness. Aflibercept belongs to a class of drugs known as growth factor inhibitors. It works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How to use Aflibercept Solution

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

The dosage and treatment schedule are based on your medical condition and response to treatment. Your doctor will give you regularly scheduled injections, usually every 1 or 2 months. For the best effect, carefully follow your doctor's directions. Use this medication regularly to get the most benefit from it.

Tell your doctor if your condition worsens.

Side Effects

Injection site pain, feeling as if something is in the eye, or increased tears may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: floaters (blurry shapes that seem to float in front of your eyes), swollen eyelids.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, slurred speech, confusion.

This medication may rarely increase your risk for developing certain serious eye conditions (endophthalmitis or retinal detachment). Get medical help right away if you notice any of these symptoms in the affected eye(s): pain, redness, sensitivity to light, blurred vision, sudden change in vision, loss of vision.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Aflibercept Solution side effects by likelihood and severity.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: products applied to the eye (such as eye drops).

Dosing & Uses

Dosage Forms & Strengths

intravitreal injectable solution

  • 40mg/mL

Macular Degeneration

Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)

2 mg (0.05 mL) by intravitreal injection q4wk for the first 3 injections, followed by 2 mg q8wk

Additional efficacy was not demonstrated for continuation therapy when dosed once monthly compared to q2months

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Macular Edema

Indicated for treatment of macular edema following retinal vein occlusion (branched or central retinal vein occlusion)

2 mg (0.05 mL) by intravitreal injection q4wk

Diabetic Macular Edema

2 mg (0.05 mL or 50 microliters) administered by intravitreal injection q4wk for the first 5 injections, followed by 2 mg q8wk

May be dosed as frequently as 2 mg q4wk; however, additional efficacy was not demonstrated when dosed q4wk compared to q8wk

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Diabetic Retinopathy with DME

Indicated for diabetic retinopathy in patients with diabetic macular edema (DME)

2 mg (0.05 mL or 50 microliters) administered by intravitreal injection q4wk for the first 5 injections, followed by 2 mg q8wk

May be dosed as frequently as 2 mg q4wk; however, additional efficacy was not demonstrated when dosed q4wk compared to q8wk

Some patients may need q4wk (monthly) dosing after first 20 weeks (5 months)

Safety and efficacy not established

Warnings

Contraindications

Hypersensitivity reactions that may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation

Ocular or periocular infection

Active intraocular inflammation

Cautions

Edophthalmitis and retinal detachments reported with intravitreal injections

Acute increases in intraocular pressure have been observed within 60 minutes of intravitreal injection

Potential risk of arterial thromboembolic events (eg, nonfatal stroke, nonfatal myocardial infarction, or vascular death) following intravitreal use of VEGF inhibitors (incidence over 1 yr varies depending on the study ranging from 0% to 3.3%)

Hypersensitivity reactions may present as severe intraocular inflammation

Females of reproductive potential should use effective contraception prior to initial dose, during treatment, and for at least 3 months after last intravitreal injection

Administration

Intravitreal Injection Preparation

Vial contains 0.278 mL of 40 mg/mL solution

Use provided 5-micron filter needle

Using aseptic technique, withdraw all contents of vial (keep vial in upright position, slightly inclined to ease complete withdrawal)

Remove and discard filter needle

Replace needle with 30-gauge x 0.5-inch needle (provided in kit)

Gently tap syringe to remove bubbles

To eliminate all of the bubbles and to expel excess drug, slowly depress the plunger to the plunger tip aligns with the 0.05 mL measurement line

Each vial should only be used for a single eye

Storage

Refrigerate unopened vials at 2-8°C (36-46°F); do not freeze

Protect from light

Store in the original carton until time of use

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