General MedicationsORALBlack Box

SYMBRAVO

MELOXICAM, RIZATRIPTAN

Standard Dose

2 DOSAGE AND ADMINISTRATION The recommended dose of SYMBRAVO is one tablet by mouth as needed ( 2.1 ). The maximum daily dose is 20 mg meloxicam and 10 mg rizatriptan (1 tablet) ( 2.1 ). 2.1 Recommended Dose The recommended dose of SYMBRAVO is one tablet (containing 20 mg meloxicam and 10 mg rizatriptan) by mouth, as needed for the acute treatment of migraine. The maximum daily dose should not exceed one tablet. The safety and effectiveness of a second dose for the same migraine attack have not been established. The safety of treating, on average, more than 7 headaches in a 30-day period has not been established. Use for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . 2.2 Administration Swallow SYMBRAVO tablets whole. Do not crush, divide, or chew the tablets. SYMBRAVO can be taken with or without food. 2.3 Not Substitutable with Other Formulations of Meloxicam and of Rizatriptan SYMBRAVO tablets have not shown equivalent systemic exposures to other formulations of oral meloxicam and of oral rizatriptan. Therefore, SYMBRAVO tablets are not substitutable with other formulations of oral meloxicam or oral rizatriptan products, even if the milligram strengths are the same. Do not substitute SYMBRAVO with similar dose strengths of other meloxicam or rizatriptan products [see Clinical Pharmacology (12.3) ] .

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults.

Summary

Indications and usage 1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache. SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a serotonin (5-HT) 1B/1D receptor agonist (triptan)), indicated for the acute treatment of migraine with or without aura in adults ( 1 ). Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established ( 1 ). SYMBRAVO is not indicated for the preventive treatment of migraine ( 1 ). SYMBRAVO is not indicated for the treatment of cluster headache ( 1 ). Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended dose of SYMBRAVO is one tablet by mouth as needed ( 2.1 ). The maximum daily dose is 20 mg meloxicam and 10 mg rizatriptan (1 tablet) ( 2.1 ). 2.1 Recommended Dose The recommended dose of SYMBRAVO is one tablet (containing 20 mg meloxicam and 10 mg rizatriptan) by mouth, as needed for the acute treatment of migraine. The maximum daily dose should not exceed one tablet. The safety and effectiveness of a second dose for the same migraine attack have not been established. The safety of treating, on average, more than 7 headaches in a 30-day period has not been established. Use for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . 2.2 Administration Swallow SYMBRAVO tablets whole. Do not crush, divide, or chew the tablets. SYMBRAVO can be taken with or without food. 2.3 Not Substitutable with Other Formulations of Meloxicam and of Rizatriptan SYMBRAVO tablets have not shown equivalent systemic exposures to other formulations of oral meloxicam and of oral rizatriptan. Therefore, SYMBRAVO tablets are not substitutable with other formulations of oral meloxicam or oral rizatriptan products, even if the milligram strengths are the same. Do not substitute SYMBRAVO with similar dose strengths of other meloxicam or rizatriptan products [see Clinical Pharmacology (12.3) ] . Warnings and cautions 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ). Arrhythmias: Discontinue dosing if arrhythmia occurs ( 5.3 ). Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke: Discontinue dosing if occurs ( 5.4 ). Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5 ). Chest/Throat/Neck/Jaw Pain, Tightness, Pressure, or Heaviness: Generally not associated with myocardial ischemia; evaluate patients at high risk ( 5.6 ). Gastrointestinal Ischemic Events, Peripheral Vasospastic Reactions: Discontinue dosing if occurs ( 5.7 ). Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop ( 5.8 ). Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure ( 5.9 , 7.1 ). Heart Failure and Edema: Avoid use of SYMBRAVO in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure ( 5.10 ). Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Use is not recommended in patients with moderate to severe renal insufficiency; avoid the use in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function ( 4 , 5.11 ). Serious Skin Reactions: Discontinue SYMBRAVO at first appearance of skin rash or other signs of hypersensitivity ( 5.12 ). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue SYMBRAVO and evaluate clinically ( 5.13 ). Fetal Toxicity: Limit use of NSAIDs, including SYMBRAVO, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.14 , 8.1 ). Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia ( 5.15 , 7.1 ). Exacerbation of Asthma Related to Aspirin Sensitivity: SYMBRAVO is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with pree

Boxed Warning

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk Non-steroidal 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 treatment and may increase with duration of use [see Warnings & Precautions (5.1) ] . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) , Warnings & Precautions (5.1) ] . Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 GI bleeding are at greater risk for serious GI events [see Warnings & Precautions (5.2) ] . WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. Non-steroidal 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 treatment and may increase with duration of use (5.1) . SYMBRAVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ). NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 GI bleeding are at greater risk for serious GI events ( 5.2 ).

Monitoring

• 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ).
• Arrhythmias: Discontinue dosing if arrhythmia occurs ( 5.3 ).
• Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke: Discontinue dosing if occurs ( 5.4 ).
• Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5 ).

Interaction Notes

• 7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking SYMBRAVO with drugs that interfere with hemostasis.
• Concomitant use of SYMBRAVO and analgesic doses of aspirin is not generally recommended ( 7.1 ).
• ACE Inhibitors, ARBs, or Beta-Blockers: Concomitant use with SYMBRAVO may diminish the antihypertensive effect of these drugs.
• Monitor blood pressure ( 7.1 ).