Elyxyb Generic Name & Formulations
Celecoxib 120mg/4.8mL (25mg/mL); oral soln.
NSAID (COX-2 inhibitor).
Mechanism of Action
Celecoxib has 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.
Acute treatment of migraine with or without aura in adults.
Limitations of Use
Not for preventive treatment of migraine.
Elyxyb Dosage and Administration
Use calibrated measuring device. Take with or without food. 120mg once. Max: 120mg/day. Use for the fewest number of days per month, as needed. Moderate hepatic impairment, CYP2C9 poor metabolizers: max 60mg dose.
Sulfonamide, aspirin, or other NSAID allergy. Coronary artery bypass graft surgery.
Elyxyb Boxed Warnings
Risk of serious cardiovascular and gastrointestinal (GI) events.
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Severe hepatic or severe renal impairment: not recommended. Dehydration. Hypovolemia. Hyperkalemia. Pre-existing asthma. Discontinue at 1st sign of skin rash or other hypersensitivity. Medication overuse headache; detoxification may be needed. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. May mask signs of infection or fever. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.
Fecal (57%), renal (27%). Half-life: ~6 hours.
Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate), or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazide), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).
Elyxyb Adverse Reactions
Dysgeusia; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia, serious skin reactions (eg, erythema multiforme, exfoliative dermatitis, SJS, TEN, DRESS, AGEP).
Elyxyb Clinical Trials
Elyxyb Patient Counseling