Patient Medication Information: uses, side effects, how to take - Xipere
What is XIPERE used for?
XIPERE is used in adults to treat macular edema associated with uveitis (inflammation of the uvea, the middle layer of the eye). Macular edema is when fluid builds up in the macula (in the back of the eye) causing swelling (‘edema’).
How does XIPERE work?
XIPERE is delivered through a space in the eye that has the potential to reach the back of the eye where the macular edema associated with uveitis is happening. This area is called the suprachoroidal space. XIPERE is a corticosteroid. It decreases the body’s reaction to some diseases and reduces inflammation. This will reduce symptoms such as swelling.
What are the ingredients in XIPERE?
Medicinal ingredients: Triamcinolone Acetonide
Non-medicinal ingredients: Calcium Chloride Dihydrate, Carboxymethylcellulose Sodium, Hydrochloric Acid (used to adjust pH), Magnesium Chloride Hexahydrate, Polysorbate 80, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Chloride, Sodium Citrate Dihydrate and Water for Injection.
XIPERE comes in the following dosage form:
- Suspension; 40 mg/mL
Do not use XIPERE if:
- You are allergic to triamcinolone acetonide or any of the other ingredients in XIPERE (see What are the ingredients in XIPERE).
- You have or may have an infection, such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections or fungal infections, in the eye or in the area surrounding the eye (such as eyelid, eyebrows or surrounding skin).
- You currently have a systemic fungal infection (a fungal infection that has spread throughout the body).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive XIPERE. Talk about any health conditions or problems you may have, including if you:
- have ever had a reaction to triamcinolone acetonide or to any of the other ingredients in XIPERE.
- recently had an eye infection.
- have a history of ocular herpes (herpes infection in your eye).
- have a fungal, viral or bacterial infection in your body.
- have hypothyroidism (your thyroid gland does not produce enough thyroid hormones).
- have hyperthyroidism (your thyroid gland produces too much thyroid hormones).
are pregnant or may become pregnant. XIPERE is not recommended for use during pregnancy.
- are breastfeeding or planning to breastfeed.
Other warnings you should know about:
Other eye problems
XIPERE is given as an injection into the eye. After the injection, you could develop an infection in or around the eye, eye inflammation, increased eye pressure or problems with your vision. Symptoms may include: eye pain, redness of the eye, swollen eyelids, watery eyes, discharge from the eye, blurry vision, trouble seeing, blind spots, vision loss, floaters (small specks or spots in your vision), or sensitivity to light. Tell your healthcare professional immediately if you develop any of these symptoms.
Your healthcare professional will monitor your eye pressure.
XIPERE is a corticosteroid. Corticosteroid can cause:
- cataracts
- increased eye pressure
- glaucoma.
See the Serious Side effects and what to do about them table, below, for more information on these and other serious side effects.
Hormone System and Metabolism Cushing Syndrome (too much corticosteroid getting into your blood), hyperglycemia (too much sugar in the blood) and Hypothalamic-pituitary-adrenal (HPA) axis suppression (your body has a lower cortisol response) have been reported following corticosteroid use. Your healthcare professional will monitor you for symptoms. Tell your healthcare professional if you have any problems with your thyroid.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take XIPERE:
- XIPERE is injected by your healthcare professional into the area of the eye called the suprachoroidal space.
Usual dose:
The usual dose of XIPERE is two injections of 4 mg per eye separated by 12 weeks.
Overdose:
Because XIPERE is administered by your healthcare professional, the risk of accidental overdose is very small.
If you think you, or a person you are caring for, have been given too much XIPERE, contact a 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:
XIPERE is administered by your healthcare professional. Any missed dose should be rescheduled by your healthcare professional.
What are possible side effects from using XIPERE?
These are not all the possible side effects you may have when taking XIPERE. If you experience any side effects not listed here, tell your healthcare professional.
Common side effects may include:
- Broken blood vessel on the surface of the eye that would cause a red spot
- Eye redness
- Swelling of the conjunctiva (mucus membrane of the eye)
- Inflammation of the conjunctiva (pink eye)
- Inflammation of the oil glands in the eye (swelling or redness of eyelid edges, frequent bumps on eyelid (styes), gritty and burning sensation in the eyes)
- Inflammation of the cornea (excess tears, eye pain/redness, a feeling that something is in your eye)
- Inflammation of the iris and its associated tissue in the eye (eye pain, redness)
- Damage to the clear layer of the eyeball that covers the iris (punctate keratitis)
- Eye irritation
- Eye pain
- Sensitivity to light
- Injection site discomfort
- Injection site redness
- Injection site pain
- Vomiting
- Headache
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| Very common | |||||
| Increased Intraocular Pressure / Ocular Hypertension (increased eye pressure): headache, eye pain, blurry vision | X | ||||
| Common | |||||
| Cataracts: clouding of the lens in the eye, blurry vision, reduced vision, glare, halos and/or eye pain | X | ||||
| Macular Pseudohole (indentation in the macula): distortion and blurriness of the central vision, difficulty reading | X | ||||
| Reduced Visual Acuity / Vision Blurred (Reduction of Clarity or Sharpness of vision): blurry vision | X | ||||
| Vitreous Detachment: spots and strands in vision, flashes of light | X | ||||
| Unknown | |||||
| Endophthalmitis (infection and inflammation of the fluids in your eye): red eyes, eye pain, decreased, blurred or lost vision, sensitivity to bright light, swollen eyelids, watery eyes, white or yellow pus or discharge from eye | X | ||||
| Glaucoma: increased pressure in your eyes, eye and head pain, swelling or redness in or around the eye, and changes in vision, Hazy or blurred vision, sudden sight loss | X | ||||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | X | ||
|---|---|---|---|
| Intraocular infection (infection in the eye): eye pain, sensitivity to light, discharge from eye, eye redness, fever, blurred or decreased vision | X | ||
| Vision loss | X |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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:
- Store at 15°C to 25°C; do not freeze.
- Protect from light.
- Discard unused portion.
- Keep out of sight and reach of children.
If you want more information about XIPERE:
- 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 website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website, or by calling 1-800-553-5340.
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