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 (Gl) 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 Gl 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
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.
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Eligibility criteria
Eligible patients will pay $0 on their first fill and $25 for their
subsequent fills of ELYXYB (celecoxib) Oral Solution. Offer valid for up to
12 uses. A valid Prescriber ID# is required on the prescription. This offer is
valid in the United States. Offer not valid for prescriptions reimbursed
under Medicaid, a Medicare drug benefit plan, Tricare or other federal or
state health programs (such as medical assistance programs). Cash Discount
Cards and other non-insurance plans are not valid as primary under this
offer. If the patient is eligible for drug benefits under any such program,
the patient cannot use this offer. By using this offer, the patient certifies
that he or she will comply with any terms of his or her health insurance
contract requiring notification to his or her payor of the existence and/or
value of this offer. It is illegal to (or offer to) sell, purchase, or trade
this offer. This offer is not transferable and is limited to one offer per
person. Not valid if reproduced. Void where prohibited by law. Program
managed by ConnectiveRx on behalf of Scilex Pharmaceuticals. The parties
reserve the right to rescind, revoke or amend this offer without notice at
any time.
