Elyxyb

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

Usage of Elyxyb

Elyxyb is a ready-to-use oral solution containing Celecoxib that is used to treat migraine headaches in adults.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat conditions that cause pain and inflammation. Since 1998 celecoxib has been available in capsule form (Celebrex), but in 2020 the US Food and Drug Administration (FDA) approved Elyxyb oral solution.

Elyxyb oral solution is made using a self-micro emulsifying drug delivery system that enables celecoxib to be absorbed better and work faster. Elyxyb works within one hour to provide relief from a migraine attack.

Elyxyb is thought to work by inhibiting an enzyme called cyclooxygenase-2 (COX-2), which inhibits the production of a group of lipids called prostagladins. Prostagladins can cause inflammation and pain.

Elyxyb side effects

Elyxyb can cause serious side effects, including:

See "Important information" above

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

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

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

nausea

muscle aches

more tired or weaker than usual

diarrhea

itching

your skin or eyes look yellow

bruising

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

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.

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.

Before taking Elyxyb

Tell your doctor if you 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.

Tell your doctor if you 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.

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How to use Elyxyb

The recommended dose of Elyxyb is 120 mg taken orally, with or without food.

The recommended dose of Elyxyab is 60 mg for people with moderate liver impairment or who are poor metabolizers of CYP2CP substrates.

The maximum dosage in a 24-hour period is 120 mg.

See full prescribing information for further information about Elyxyb dosing.

Warnings

Elyxyb contains the NSAID celecoxib. 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, selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)

increasing doses of NSAIDs

longer use of NSAIDs

smoking

drinking alcohol

older age

poor health

advanced liver disease

bleeding problems

Elyxyb should only be used:

exactly as prescribed

for the shortest time needed

What other drugs will affect Elyxyb

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-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.

Especially tell your doctor if you take:

Corticosteroids

Antiplatelet and anticoagulant drugs such as warfarin and aspirin

SSRIs

SNRIs

Ace inhibitors, angiotensin receptor blockers or beta blockers

Diurectics

Digoxin

Other NSAIDs

If you are not sure if you take one of these medications then check with your doctor or pharmacist.

Disclaimer

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