Migraine and headache:
Indications for: ELYXYB
Acute treatment of migraine with or without aura in adults.
Limitations of Use:
Not for preventive treatment of migraine.
Adult Dosage:
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.
Children Dosage:
Not established.
ELYXYB Contraindications:
Sulfonamide, aspirin, or other NSAID allergy. Coronary artery bypass graft surgery.
Boxed Warning:
Risk of serious cardiovascular and gastrointestinal (GI) events.
ELYXYB Warnings/Precautions:
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.
ELYXYB Classification:
NSAID (COX-2 inhibitor).
ELYXYB Interactions:
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).
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).
Drug Elimination:
Fecal (57%), renal (27%). Half-life: ~6 hours.
Generic Drug Availability:
NO
How Supplied:
Soln—4.8mL
