Podcast 3: Best Treatment Practices
OCTOBER 03, 2017
MD Magazine Staff
On behalf of Pernix Therapeutics, Dr. Ira Turner (Neurologist/Headache specialist at Island Neurological Associates, Plainview, NY) describes how he approaches treating migraines, including best practices for different age groups and treatment during pregnancy.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
Gastrointestinal Bleeding, Ulceration, and Perforation
TREXIMET® (sumatriptan and naproxen sodium) is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
LIMITATIONS OF USE
- Use only if a clear diagnosis of migraine headache has been established.
- Not indicated for the prophylactic therapy of migraine attacks.
- Not indicated for the treatment of cluster headache.
- History of coronary artery disease or coronary vasospasm.
- In the setting of CABG surgery.
- Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders.
- History of stroke, transient ischemic attack, or hemiplegic or basilar migraine.
- Peripheral vascular disease.
- Ischemic bowel disease.
- Uncontrolled hypertension.
- Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of ergotamine-containing medication.
- Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor.
- History of asthma, urticaria, other allergic type reactions, rhinitis, or nasal polyps syndrome after taking aspirin or other NSAID/analgesic drugs.
- Known hypersensitivity to sumatriptan, naproxen, or any other component of TREXIMET® (angioedema and anaphylaxis seen).
- Third trimester of pregnancy.
- Severe hepatic impairment.
- Cardiovascular Thrombotic Events: Perform cardiac evaluation in patients with cardiovascular risk factors.
- Arrhythmias: Discontinue TREXIMET® if occurs.
- Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk.
- Cerebrovascular Events: Discontinue TREXIMET® if occurs.
- Other Vasospasm Reactions: Discontinue TREXIMET® if non-coronary vasospastic reaction occurs.
- 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.
- Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
- Heart Failure and Edema: Avoid use of TREXIMET® in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
- Medication overuse headache: Detoxification may be necessary.
- Serotonin syndrome: Discontinue TREXIMET® if occurs.
- Renal Toxicity and Hyperkalemia: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of TREXIMET® in patients with advanced renal disease.
- Anaphylactic reactions: TREXIMET® should not be given to patients with the aspirin triad. Seek emergency help if an anaphylactic reaction occurs.
- Serious skin reactions: Discontinue TREXIMET® at first sign of rash or other signs of hypersensitivity.
- Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
- Exacerbation of Asthma Related to Aspirin Sensitivity: TREXIMET® is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
The most common adverse reactions (incidence ≥2%) were:
- Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.
- Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness.
- Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking TREXIMET® with drugs that interfere with hemostasis. Concomitant use of TREXIMET® and analgesic doses of aspirin is not generally recommended.
- ACE Inhibitors and ARBs: Concomitant use with TREXIMET® in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function.
- Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
- Digoxin: Concomitant use with TREXIMET® can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.
- Lithium: Increases lithium plasma levels.
- Methotrexate: Increases methotrexate plasma levels.
To report adverse events, a product complaint, or for additional information about TREXIMET®, call Pernix Therapeutics at 1-877-745-3667.
Please see Full Prescribing Information, including Boxed WARNINGS, before prescribing TREXIMET®.