Melvizo: Uses, Side Effects and Dosage

What MELVIZO is used for:

MELVIZO is given as an injection into the eye by a healthcare professional under a local anesthetic.

MELVIZO is used to treat damage to the retina (the light-sensitive back part of the eye) caused by growth of leaky abnormal blood vessels (choroidal neovascularization, CNV) in diseases that may cause decreased vision such as:

• Wet age-related macular degeneration (AMD),
• Diabetic macular edema (DME), or edema due to retinal vein occlusion (RVO), where fluid accumulates in the back of the eye, causing swelling (“edema”),
• CNV secondary to pathologic myopia (PM),
• CNV due to other causes.

How MELVIZO works:

The active substance in MELVIZO is ranibizumab which is part of an antibody. Antibodies are proteins which specifically recognize and bind to other unique proteins in the body.

Ranibizumab binds selectively to all active forms of a protein called human vascular endothelial growth factor A (VEGF-A), which is present in the retina. Ranibizumab helps to stop the growth and leakage of new blood vessels in the eye, abnormal processes that contribute to several eye diseases that may cause decreased vision.

The ingredients in MELVIZO are:

The medicinal ingredient is called ranibizumab.

The non-medicinal ingredients are (in alphabetical order): α,α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polysorbate 20; water for injection.

MELVIZO contains no preservatives.

MELVIZO comes in the following dosage forms:

Vial:

MELVIZO is a solution for injection supplied in a clear, colourless glass vial. The vial contains 0.23 mL of a sterile clear colourless to pale yellow solution.

Vial + filter needle + injection needle pack

MELVIZO is supplied as a pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper, one filter needle for withdrawal of the vial contents and one injection needle.

Vial only

MELVIZO is supplied as a pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper.

Do not use MELVIZO if:

• You are allergic to ranibizumab or any of the other ingredients of MELVIZO listed above, if you think you may be allergic, ask your healthcare professional for advice.
• You have already experienced an allergic reaction tell your healthcare professional before receiving MELVIZO.
• You have or suspect you have an infection in or around your eye.
• You have pain or redness in your eye.

If any of these apply to you tell your healthcare professional. You should not be given MELVIZO.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MELVIZO.

Take special care with MELVIZO:

• Inform your healthcare professional if you have already had a stroke or experienced short-lasting signs of stroke (weakness or paralysis of limbs or face, difficulty speaking or understanding). This information will be taken into account to evaluate if MELVIZO is the appropriate treatment for you.
• MELVIZO is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye, pain or redness, detachment or tear of retina, or clouding of the lens may occur after MELVIZO treatment. It is important to identify and treat such a type of infection or retinal detachment as soon as possible. Please tell your healthcare professional immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
• In some patients the eye pressure may increase for a short period directly after the injection. There have also been reports of long-lasting eye pressure increases. This is something you may not notice; therefore, your healthcare professional should monitor this after each injection.
• Non-ocular hemorrhages have been reported after ranibizumab treatment.

If you notice any changes after you have been given MELVIZO, please inform your healthcare professional immediately.

BEFORE you take MELVIZO, talk to your healthcare professional or pharmacist if:

• You are pregnant or planning to become pregnant. There is no clinical data on the use of ranibizumab in pregnant women. Pregnancy should be avoided until at least three months after finishing MELVIZO treatment. You should discuss with your healthcare professional the potential risk of MELVIZO during pregnancy.

• You are using or plan to use birth control during treatment with MELVIZO.
• You are breast-feeding. MELVIZO is not recommended during breast-feeding because ranibizumab passes into human milk. Ask your healthcare professional or pharmacist for advice before MELVIZO treatment.

The use of MELVIZO in children and adolescents has not been studied and is therefore not recommended.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MELVIZO:

No relevant interactions are known.

How to take MELVIZO:

All MELVIZO injections will be administered by your healthcare professional. Before the injection, your healthcare professional will use an eye drop that kills germs or wash your eye carefully to prevent infection. Your healthcare professional will also give you a local anesthetic to reduce or prevent any pain you might have with the injection.

Follow your healthcare professional’s instructions carefully.

If you are treated for wet age-related macular degeneration, the injection is given once a month in the first 3 months. Afterwards, your healthcare professional will continue to monitor your vision and the frequency of dosing can be between 1 and 3 months. MELVIZO given every 3 months was not as effective as when given once a month.

If you are treated for visual loss due to diabetic macular edema or macular edema in RVO, the injection is given once a month. Your healthcare professional will monitor your vision monthly. If your vision remains the same while you are being given MELVIZO treatment, your healthcare professional may decide to stop the treatment with MELVIZO. Your healthcare professional will continue to monitor your vision monthly and will decide if treatment with MELVIZO should be resumed or not. Your healthcare professional may decide that you also need to be treated with laser for these conditions, if so, laser treatment can be administered together with MELVIZO.

If you are treated for visual loss due to CNV secondary to PM, the treatment is started with one injection of MELVIZO. Your healthcare professional will continue to monitor the condition of your eye. Depending on how you respond to the treatment, your healthcare professional will decide whether and when you need to receive the next injection of MELVIZO.

If you are treated for visual loss due to CNV, the treatment is started with one injection of MELVIZO. Your healthcare professional will continue to monitor frequently the condition of your eye. Depending on how you respond to the treatment, your healthcare professional will decide whether and when you need to receive the next injection of MELVIZO.

If you have further questions on the use of this product, ask your healthcare professional.

Usual dose:

Adults: MELVIZO is given as a single injection into your eye. The usual dose is 0.05 mL (which contains 0.5 mg of medicine). The time between two doses injected into the same eye should not be shorter than one month.

Older people (age 65 years and over): Elderly people can receive MELVIZO without adjusting the dose.

Overdose:

If you think you, or a person you are caring for, have been given too much MELVIZO, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you forget to attend an appointment

Contact your healthcare professional or hospital as soon as possible to reschedule your appointment.

Before stopping MELVIZO treatment

If you are considering stopping MELVIZO treatment, please go to your next appointment and discuss this with your healthcare professional. Your healthcare professional will advise you and decide how long you should be treated with MELVIZO.

Possible side effects from using MELVIZO:

As with all medicines, patients treated with MELVIZO may experience side effects, although not everybody gets them. These are not all the possible side effects you may feel when receiving MELVIZO. If you experience any side effects not listed here, contact your healthcare professional.

With administration of MELVIZO, there may be some side effects, mostly in the eye and due to the injection procedure. Occasionally an infection in the internal portion of the eye, detachment or tear of the retina, or clouding of the lens may occur in the two weeks after MELVIZO treatment. Other side effects include pain or redness and increased eye pressure. The symptoms you might experience are described in the “Take special care with MELVIZO” section. Please read this section. It tells you what to do if you have any of these symptoms.

Very common side effects (These may affect more than 1 in every 10 patients)

The most common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:

• Bloodshot eye
• Eye pain
• Seeing spots or cobwebs (floaters)
• Increased pressure inside the eye
• Displacement of the jelly-like portion inside the eye (vitreous body)
• Swelling of the eye
• Blurred vision
• Eye irritation
• Clouding of the lens
• A feeling of having something in the eye
• Vision change
• Swelling or infection of the rim of the eye
• Formation of fibrous tissue under the retina
• Redness of the eye
• Blurred or decreased sharpness of vision
• Dry eye
• Inflammation of the jelly-like portion inside the eye
• Temporary blindness
• Increased tear production
• Itching of the eye
• Detachment of a layer of the retina

The most common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include:

• Headache
• Elevated blood pressure
• Sore throat
• Pain in the joints

Common side effects (These may affect between 1 and 10 in every 100 patients)

Other common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:

• Discomfort of the eye
• Clouding of a part of the lens
• Deposits in the back of the eye
• Infection of the surface of the eye
• Changes in the part of the retina responsible for central vision
• Bleeding in the back of the eye
• Degeneration of the retina
• Small scratches on the cornea (front part of the eye)
• Bleeding in the eye or at the site of injection
• Tear or detachment of the retina
• Redness of the eye
• Light sensitivity
• Swelling of the eyelid
• Eyelid pain
• Eye discharge
• Bleeding in the jelly-like portion inside the eye

Other common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include:

• Stroke
• Infection of the lower part of the airways
• Reduced number of red blood cells (you may experience tiredness, breathlessness, dizziness, pale skin)
• Feeling of tension or fullness in the nose, cheeks and behind the eyes sometimes with a throbbing ache
• Urinary tract (bladder) infection
• Flu
• Cough
• Nausea
• Back pain
• Inflammation of the joints
• Fatigue
• General feeling of being unwell
• Allergic reactions (rash, hives, itching, skin reddening)
• Changes in heart rhythm

Uncommon side effects (These may affect between 1 and 10 in every 1000 patients)

Uncommon side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include:

• Irritation and edema of the eyelids
• Blindness
• Inflammatory deposits in the front part of the eye
• Reactions at the site of injection
• Abnormal sensation in the eye
• Blurred vision with light sensitivity
• Double vision
• Visual loss
• Distorted vision
• Serious allergic reaction

Other uncommon non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include:

• Wheezing
• Increased secretion of the upper airways
• Inflammatory disease of the skin
• Heart attack
• Inflammation of the sinuses
• Increased skin sensitivity
• Feeling faint
• Low blood sugar
• Anxiety

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Driving and using machines: After MELVIZO treatment you may experience some short term vision blurring. If this happens, do not drive or use machines until this resolves.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Do not use MELVIZO after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
• Do not use any pack that is damaged.

Vial:

• Store in a refrigerator (2ºC – 8ºC). DO NOT FREEZE.
• Prior to use, the unopened vial may be stored at room temperatures up to a maximum of 30°C for a period up to 60 days.
• Keep the vial in the outer carton in order to protect from light.

If you want more information about MELVIZO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database); the Canadian distributor (Biogen Canada Inc.) website www.biogen.ca, or by calling 1-866-477-3462

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