Elyxyb

Generic name: celecoxib
Dosage form: oral solution
Drug class: Cox-2 inhibitors

Medically reviewed by A Ras MD.

What is Elyxyb?

Elyxyb is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. Elyxyb is not used as a preventive treatment of migraine, It is not known if Elyxyb is safe and effective in children.

Description

ELYXYB is an oral solution of celecoxib, a nonsteroidal anti-inflammatory drug. Each unit dose of ELYXYB contains 120 mg of celecoxib. Celecoxib is a white or almost white, crystalline or amorphous powder with a pKa of 11. Celecoxib is hydrophobic (log P is 3.0) and practically insoluble in water. Celecoxib is chemically designated as p-[5-p-tolyl-3-(trifluoromethyl) pyrazol-1-yl] benzenesulfonamide. The empirical formula for celecoxib is C17H14 F3N3O2S, and the molecular weight is 381.37. It has the following chemical structure:

The inactive ingredients in ELYXYB include: 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.

Mechanism of Action

Celecoxib is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action by which celecoxib exerts therapeutic effects in migraine patients is not fully understood but may involve inhibition of prostaglandin synthesis, primarily via inhibition of COX-2.

What is the most important information I should know about Elyxyb?

Elyxyb contains celecoxib (a non-steroidal anti-inflammatory drug or NSAID). NSAIDs, including Elyxyb, can cause serious side effects, including:

Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
- with increasing doses of NSAIDs
- with longer use of NSAIDs

Do not take Elyxyb right before or after a heart surgery called a coronary artery bypass graft (CABG).

Avoid taking NSAIDs, including Elyxyb, after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
- anytime during use
- without warning symptoms
- that may cause death

The risk of getting an ulcer or bleeding increases with:

past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
taking medicines called “corticosteroids”, “antiplatelet drugs”, “anticoagulants”, “SSRIs” or “SNRIs”
increasing doses of NSAIDs
older age
longer use of NSAIDs
poor health
smoking
advanced liver disease
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems

Elyxyb should only be used:

exactly as prescribed
for the shortest time needed

Other information about NSAIDs

Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over- the-counter NSAIDs for more than 10 days.

Who should not take Elyxyb?

Do not take Elyxyb:

if you are allergic to celecoxib or any of the ingredients in Elyxyb. See the end of this Medication Guide for a complete list of ingredients in Elyxyb.
If you are allergic to sulfonamides.
if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
right before or after heart bypass surgery.

What should I tell my healthcare provider before taking Elyxyb?

Before taking Elyxyb, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
have a history of stomach ulcer or bleeding in your stomach or intestines.
have heart disease or risk factors that increase your chance of getting heart disease.
have high blood pressure.
have asthma.
are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Elyxyb during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy
are breastfeeding or plan to breast feed. Elyxyb may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take Elyxyb.

Tell your healthcare provider about all of the medicines you take, including prescription or overthe-counter medicines, vitamins or herbal supplements. NSAIDs, including Elyxyb, and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

How should I take Elyxyb?

See the detailed instructions for use that comes with Elyxyb on how to take Elyxyb solution.

Take Elyxyb exactly as your healthcare provider tells you to take it.
Take Elyxyb by mouth with or without food.
Do not take more than one dose in a 24-hour period.
Use Elyxyb for the fewest number of days a month, as needed.

What are the possible side effects of Elyxyb?

Elyxyb can cause serious side effects, including:

See “What is the most important information I should know about Elyxyb?”

liver problems including liver failure
new or worse high blood pressure
heart failure
kidney problems including kidney failure
life-threatening allergic reactions
asthma attacks in people who have asthma
life-threatening skin reactions
medication overuse headaches. Some people who use too much Elyxyb may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Elyxyb.
low red blood cells (anemia)
Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms:

shortness of breath or trouble breathing
slurred speech
chest pain
swelling of the face or throat
weakness in one part or side of your body

Stop taking Elyxyb and call your healthcare provider right away if you get any of the following symptoms:

nausea
vomit blood
more tired or weaker than usual
there is blood in your bowel movement or it is black and sticky like tar
diarrhea
unusual weight gain
itching
skin rash or blisters with fever
your skin or eyes look yellow
swelling of the arms, legs, hands and feet
indigestion or stomach pain
flu-like symptoms.

If you take too much Elyxyb, call your healthcare provider or get medical help right away.
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Elyxyb

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Elyxyb for a condition for which it was not prescribed. Do not give Elyxyb to other people, even if they have the same symptoms that you have. It may harm them

If you would like more information about Elyxyb, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Elyxyb that is written for health professionals.

How should I store Elyxyb?

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not refrigerate or freeze.

Unused portion should be discarded immediately after use.

What are the ingredients in Elyxyb?

Active ingredient: celecoxib

Inactive 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.

Label

PRINCIPAL DISPLAY PANEL – 4.8 ML BOTTLE CARTON

biodelivery
SCIENCES
NDC 59385-055-06
Elyxyb™
(celecoxib)
Oral Solution
120 mg/4.8 mL
(25 mg/mL)
For Oral use only
Rx Only
Discard unused portion immediately after use.
Do not store or reuse leftover Elyxyb oral solution.
Warning: Keep out of reach of children.
Warning: Check the dose your healthcare provider has prescribed.
Pharmacist:
Dispense in this sealed carton, which contains six (6) unit dose glass bottles.
Dispense the enclosed Medication Guide to each patient.

SRC: NLM .

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