Meloxicam / rizatriptan

Class
Antimigraine agents
Subclass
Nonsteroidal anti-inflammatory drug / triptan combination
Substance name
Meloxicam / rizatriptan
Brand names
Symbravo®
Contains
Meloxicam
Rizatriptan
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of migraine attacks
•
Maintenance: 20/10 mg PO daily, as needed, for up to 7 days in a 30-day period
•
Maximum: 20/10 mg per day
Indications for use
Labeled indications
Adults
•
Treatment of migraine attacks
Safety risks
Boxed warnings
Cardiovascular thrombotic events
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. Avoid using in patients with a recent myocardial infarction.
•
Do not use in patients undergoing CABG.
Serious gastrointestinal adverse events
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation, especially in elderly patients and patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding. Monitor for signs of bleeding.
Contraindications
Hypersensitivity to rizatriptan/rizatriptan or its components or to other NSAIDs
Coronary artery disease
•
Do not use meloxicam/rizatriptan in patients with coronary artery disease, coronary artery vasospasm, including vasospastic angina, or other significant CVDs.
Hemiplegic or basilar migraine
History of hypersensitivity reactions to NSAIDs
•
Do not use in patients with a history of asthma, urticaria, or other allergic-type reactions after aspirin or other NSAIDs. Use caution in patients with asthma.
History of stroke or TIA
Ischemic bowel disease
PAD
Uncontrolled hypertension
Concomitant use of other 5-HT1 agonists or ergots
•
Do not use meloxicam/rizatriptan within 24 hours of taking other 5-HT1 agonists or ergotamine-containing or ergot-type medications, such as dihydroergotamine or methysergide.
Concomitant use of propranolol
Warnings and precautions
Anemia
•
Maintain a high level of suspicion, as NSAIDs have been associated with an increased risk of anemia. Monitor hemoglobin levels and for signs of bleeding.
Cardiac arrhythmias
•
Maintain a high level of suspicion, as life-threatening cardiac arrhythmias, including VT and VF, have been reported within a few hours following the administration of 5-HT1 agonists.
Cerebrovascular events
•
Maintain a high level of suspicion, as 5-HT1 agonists have been associated with an increased risk of cerebrovascular events, including cerebral hemorrhage, subarachnoid hemorrhage, and stroke.
Chest tightness, chest pain, neck pain, jaw pain
•
Maintain a high level of suspicion, as 5-HT1 agonists have been associated with an increased risk of non-cardiac chest pain and related symptoms.
Edema
•
Use caution in patients taking diuretics, ACEis, or ARBs, as meloxicam may blunt the cardiovascular effects of these agents. Avoid using in patients with severe HF unless the benefits are expected to outweigh the risk of worsening HF.
Hepatotoxicity
•
Maintain a high level of suspicion, as meloxicam has been associated with an increased risk of elevations of serum transaminases and, rarely, severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure. Monitor liver enzymes periodically in patients on long-term treatment.
Hypertension
•
Maintain a high level of suspicion, as meloxicam has been associated with an increased risk of new-onset or worsening of pre-existing hypertension, and rizatriptan has been associated with significant BP elevations, including hypertensive crisis. Monitor BP.
Increased serum potassium
•
Maintain a high level of suspicion, as meloxicam has been associated with an increased risk of hyperkalemia. Monitor liver enzymes periodically in patients on long-term treatment.
Mask symptoms of infection
•
Maintain a high level of suspicion, as meloxicam reduces inflammation and fever, potentially diminishing the utility of diagnostic signs in detecting infections.
Medication overuse headache
•
Use caution in patients taking the drug for a prolonged period.
Renal toxicity
•
Maintain a high level of suspicion, as long-term use of meloxicam has been associated with an increased risk of renal papillary necrosis, renal insufficiency, AKI, and other renal injury, especially in patients with renal or hepatic impairment, HF, dehydration or hypovolemia, taking diuretics, ACEis, or ARBs, and in the elderly. Monitor renal function in patients with renal or hepatic impairment, HF, dehydration, or hypovolemia.
Serotonin syndrome
•
Use caution in patients taking SSRIs, SNRIs, or TCAs.
Severe cutaneous adverse reactions
•
Maintain a high level of suspicion, as meloxicam has been associated with an increased risk of severe cutaneous adverse reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and DRESS syndrome.
Vasospastic reactions
•
Maintain a high level of suspicion, as 5-HT1 agonists have been associated with an increased risk of non-coronary vasospastic reactions, including peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud's syndrome.
Specific populations
Renal impairment
eGFR > 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function.
eGFR ≤ 30 mL/min/1.73 m²
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for adverse reactions.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for adverse reactions.
Child-Pugh C (severe)
•
Use with caution. Monitor renal function. Monitor for adverse reactions.
Pregnancy and breastfeeding
Pregnancy
< 20 weeks of gestation
•
Use only if benefits outweigh potential risks.
20-30 weeks of gestation
•
Use only if benefits outweigh potential risks. Limit use to the lowest effective dose and shortest duration possible. Consider obtaining ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue if oligohydramnios develops.
> 30 weeks of gestation
•
Avoid use. NSAIDs may cause premature closure of fetal ductus arteriosus.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Somnolence, dizziness
Unknown frequency
•
Acute liver failure, acute urinary retention, interstitial nephritis, erythema multiforme, anaphylaxis, exfoliative dermatitis, fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis, myocardial infarction, stroke, gastrointestinal perforation, peptic ulcer disease, cardiac arrhythmias, acute mesenteric ischemia, splenic infarction, medication overuse headache, serotonin syndrome, agranulocytosis, jaundice, mood changes, female infertility, angioedema, wheezing, dysgeusia, seizure, gastrointestinal bleeding, chest tightness, throat tightness, neck pain, jaw pain, raynaud's phenomenon, angina pectoris, ↑ serum potassium, edema, hepatotoxicity, ↑ serum transaminases, hypertension, anemia
Interactions
Drug(s)
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