ELYXYB is the first of its kind in the acute treatment of migraine

ELYXYB is the only ready-to-use liquid solution for people who need fast relief from migraine.

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Fast acting

In some patients, ELYXYB starts to work as early as 15 minutes, and many patients experience complete freedom from pain as early as 60 minutes.

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Long lasting

Most patients in clinical trials reported sustained pain relief up to 24 hours after taking ELYXYB.*

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Safe

Rare incidence of drowsiness was reported and no serious adverse events occurred during clinical studies. The most common side effect reported with ELYXYB was a taste disorder (dysgeusia).*

Please see the full Important Safety Information for possible side effects.

*As shown in clinical studies vs placebo.

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.

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Find out how to take ELYXYB when you need it most.

How to Take ELYXYB

APPROVED USE

ELYXYB (celecoxib) oral solution is:

A prescription nonsteroidal anti-inflammatory drug (NSAID) used for the acute treatment of migraine 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.

IMPORTANT SAFETY INFORMATION about ELYXYB

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.

APPROVED USE

ELYXYB (celecoxib) oral solution is:

A prescription nonsteroidal anti-inflammatory drug (NSAID) used for the acute treatment of migraine 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.

Important information about ELYXYB:

ELYXYB contains celecoxib, a 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

IMPORTANT SAFETY INFORMATION about ELYXYB

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.
  • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.

ELYXYB should only be used:

  • exactly as prescribed
  • for the shortest time needed

Do not take ELYXYB:

  • if you are allergic to celecoxib or any of the 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.

Don’t start a new medication before talking to your healthcare provider and telling them about all of the medications you take.

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. Taking NSAIDs, including ELYXYB, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
  • are breastfeeding or plan to breastfeed. ELYXYB may pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take ELYXYB.

When taking ELYXYB

See the detailed “Instructions for Use” 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.

The possible side effects of ELYXYB are:

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, low red blood cells (anemia). Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

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

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

Get emergency help right away if you have:

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

If you take too much ELYXYB, call your healthcare provider or get medical help right away.

These are not all the side effects associated with ELYXYB. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Please see full Prescribing Information, including Boxed Warning and Medication Guide for ELYXYB.