Elyxyb: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is ELYXYB used for?

ELYXYB is used in adults for short term treatment of migraine headaches. These migraine headaches may or may not be accompanied by an aura. This is when you see black spots, flashes of light or shimmering spots or stars. ELYXYB should not be used to prevent or reduce the number of headaches you experience. ELYXYB should only be used to treat an actual migraine headache attack.

How does ELYXYB work?

ELYXYB belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body which cause pain and swelling.

What are the ingredients in ELYXYB?

Medicinal ingredients: celecoxib

Non-medicinal ingredients: acesulfame potassium, banana flavor, bubble gum flavor, ethyl alcohol, glycerin, glyceryl monocaprylate, L-menthol, lauroyl polyoxyl-32 glycerides, medium chain triglycerides, monoammonium glycyrrhizinate, peppermint flavor, polyoxyl 35 castor oil, polyoxyl 40 hydrogenated castor oil, propyl gallate, purified water, and sucralose.

ELYXYB comes in the following dosage form:

Oral solution: 120 mg/4.8 mL (25 mg/mL) of celecoxib.

Do not use ELYXYB if:

• you recently had, or are planning to have, heart bypass surgery.
• you have severe, uncontrolled heart failure.
• you have bleeding in the brain.
• you are pregnant and in a later stage of pregnancy (i.e., 28 weeks or later).
• you are currently breastfeeding or planning to breastfeed.
• you are allergic to celecoxib or any of the other ingredients in ELYXYB or its container.
• you have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs.
• you are allergic to a group of medicines known as sulfonamides or “sulfa” drugs.
• you have an active stomach or intestine ulcer.
• you have active bleeding from the stomach or gut.
• you have inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis).
• you have severe or active liver disease.
• you have severe or worsening kidney disease.
• you were told by a healthcare professional that you have high levels of potassium in your blood.
• you are under 18 years of age.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ELYXYB. Talk about any health conditions or problems you may have, including if you:

• are 65 years of age or older.
• have a condition that makes you physically weak.
• are currently taking any other medicines.
• have high blood pressure, high cholesterol or diabetes.
• have, or have had, heart attacks, chest pain, heart disease, stroke or heart failure.
• have, or have had, temporary vision loss in one or both eyes due to a lack of blood flow to the retina (amaurosis fugax).
• have poor blood flow to your extremities (like your hands and feet).
• smoke or used to smoke.
• drink a lot of alcohol.
• have a stomach infection.
• have liver or kidney problems, urinary problems, are dehydrated or on a salt-restricted diet.
• have a history of ulcer or bleeding from the stomach or gut (small or large intestine).
• have other bleeding or blood problems.
• ever had bleeding in the brain.
• have a family history of allergy to sulfonamide drugs.
• have a family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list).
• have asthma.
• are pregnant, think you might be pregnant or planning on becoming pregnant.
• have immune system problems.
• are known or suspected to metabolize certain medicines very slowly (i.e., CYP2C9 substrates).

Other warnings you should know about:

ELYXYB can cause serious side effects, including:

• Blood and bleeding problems:

  • ELYXYB can cause blood problems (i.e., low levels of platelets, red or white blood cells), bleeding and prolonged bleeding.

  • Taking ELYXYB with the following medicines can increase the risk of bleeding:

    • Anticoagulants (prevents blood clots), corticosteroids (anti-inflammatory), or antidepressants like selective serotonin reuptake inhibitors (SSRIs).

• Serious skin reactions: In rare cases, serious, life-threatening allergic and skin reactions have been reported with some NSAIDs, such as ELYXYB. These skin problems most often happen during the first month of treatment. Tell your healthcare professional immediately if you notice any changes in your skin both during and after treatment.

  ELYXYB might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, talk to your healthcare professional.

See Serious side effects and what to do about them table for more information on these and other serious side effects.

Overuse of ELYXYB: As with other migraine treatments, using too much ELYXYB can cause daily headaches or make your migraine headaches worse. Ask your healthcare professional if you think this is the case for you. You may need to stop using ELYXYB to correct the problem.

Check-ups and testing: You will have regular visits with your healthcare professional during treatment with ELYXYB. They will:

• Check your blood pressure.
• Check your eyes. ELYXYB can cause blurred or reduced vision.
• Do blood and urine tests to check your liver, kidney and blood health.

Surgery: Tell any doctor, dentist, pharmacist or healthcare professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.

Driving and using machinery: ELYXYB may cause eye or nervous system problems. This includes tiredness, trouble sleeping, blurred vision, spinning or dizziness (vertigo), hearing problems or depression. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking ELYXYB, do NOT drive or operate machinery.

Fertility in women: ELYXYB may affect your fertility. This means that it may be difficult for you to have a child. If you have trouble having a child, you might need to stop taking ELYXYB. Talk to your healthcare professional if you have any questions about this.

Adults (65 years of age or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of ELYXYB. They will monitor your health during and after treatment.

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 ELYXYB:

• Acetylsalicylic acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like celecoxib, diclofenac, ibuprofen, naproxen.
• Antacids, used to treat symptoms of excess stomach acid.
• Omeprazole, used to treat stomach problems.
• Medicines used to treat depression, like citalopram, fluoxetine, paroxetine, sertraline, lithium.
• Medicines used to treat high blood pressure like enalapril, ramipril, candesartan, irbesartan, propranolol, lisinopril, metoprolol.
• Medicines used as blood thinners or to prevent blood clots like warfarin, ASA, clopidogrel.
• Medicines used to move extra fluid and salt out of your body (also known as diuretics), like furosemide, hydrochlorothiazide.
• Medicines used to treat diabetes, like sulfonylureas or other oral hypoglycemics.
• Medicines used to lower the risk of organ rejection, like tacrolimus and cyclosporine.
• Corticosteroids (including glucocorticoids such as prednisone), used to treat inflammation and overactive immune system responses.
• Digoxin, used to treat heart disorders.
• Medicines used to treat seizures, like phenytoin, carbamazepine, barbiturates.
• Methotrexate, used to treat cancer.
• Medicines used to treat bacterial infections, like sulfonamide, rifampicin.
• Oral birth control, used to prevent pregnancy.
• Dextromethorphan, found in some cough medications.
• Fluconazole, used to treat fungal infections.
• Alcohol.

How to take ELYXYB:

Take ELYXYB exactly as your healthcare professional has told you:

• If your healthcare professional has prescribed 120 mg of ELYXYB, take all of the medicine in the bottle as described below in Instructions for use for a full dose (120 mg).
• If your healthcare professional has prescribed 60 mg of ELYXYB, take 2.4 mL of the medicine, as described below in Instructions for use for a half dose (60 mg). You will need a dosing syringe from the pharmacy to give the right amount of medicine. Do not use a household teaspoon to measure ELYXYB.

• ELYXYB can be taken with or without food.

  Instructions for use for a full dose (120 mg)

	Step 1: When you need to take ELYXYB, push down the cap and turn it to the left (counterclockwise) to open it.

	Step 2: When taking 120 mg of ELYXYB, drink it directly from the bottle. Hold the bottle upside down for 10 seconds to make sure the full amount of medicine is taken.
	Step 3: Close the bottle by turning the cap to the right (clockwise) right away after drinking the medicine.
	Step 4: Throw away (discard) the bottle.
	Step 5: After you take ELYXYB, you may drink up to 8 ounces (240 mL) of water.

Instructions for use for a half dose (60 mg)

Usual dose:

• The usual adult dose is 120 mg (1 bottle) as needed
• The maximum dose is 120 mg (1 bottle) per day.
• Take ELYXYB for the fewest number of days per month. This is to avoid potential side effects that may affect your heart, blood vessels, stomach or intestines.
• Your healthcare professional may prescribe you a reduced dose depending on your condition.

Overdose:

What are possible side effects from using ELYXYB?

These are not all the possible side effects you may have when taking ELYXYB. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with ELYXYB may include:

• Nausea, vomiting, diarrhea, constipation, stomach upset/abdominal pain, heartburn, indigestion, feeling gassy
• Changes in tastes or loss of taste
• Headache, dizziness, light-headedness
• Feeling of burning/prickliness/numbing
• Confusion, hard to concentrate or think, short-term memory loss, nervousness
• Bruises
• Rash
• Thirst, dry mouth
• Muscle pain
• Mouth sores
• Hair loss
• Increased sweating
• Problems with your period (women)

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

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, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store between 15°C to 30°C.
• Do not refrigerate or freeze.
• Unused portion should be discarded immediately after use.
• Keep out of reach and sight of children.

If you want more information about ELYXYB:

• 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:

  • -canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website [scilexholding.com], or by calling 1-866-285-9177.

Last Revised APR 09, 2025