Migraine and headache:
Indications for: MAXALT-MLT
Acute treatment of migraine with or without aura.
Limitations of Use:
Use only where a clear diagnosis of migraine has been established. Not for use in the management of hemiplegic or basilar migraine. Not for prevention of migraine attacks. Safety and effectiveness has not been established for cluster headache.
Adults: Maxalt-MLT Orally Disintegrating Tablets
The efficacy of Maxalt-MLT was established in two multicenter, randomized, placebo-controlled trials that were similar in design to the trials of Maxalt Tablets (Studies 5 and 6) for the treatment of moderate to severe headache. Patients treated in these studies were primarily female (88%) and Caucasian (95%), with a mean age of 42 years (range 18-72).
In both studies, results showed that a significantly greater percentage of patients treated with Maxalt-MLT 5 or 10 mg achieved headache response 2 hours after treatment compared with those who received placebo. The following percentages of patients achieved headache response 2 hours after treatment of initial headache in Studies 5 and 6:
Maxalt-MLT 5 mg: 66% (n=100; P <.01 in comparison with placebo); Maxalt-MLT 10 mg: 66% (n=113; P <.01 in comparison with placebo) vs placebo: 47% (n=98)
Maxalt-MLT 5 mg: 59% (n=181; P <.01 in comparison with placebo); Maxalt-MLT 10 mg: 74% (n=186; P <.01 in comparison with 5 mg) vs placebo: 28% (n=180)
For patients with migraine-associated photophobia and phonophobia at baseline, there was a decreased incidence of these symptoms following administration of Maxalt-MLT as compared to placebo.
Pediatric Patients 6 to 17 Years of Age
The efficacy of Maxalt-MLT in pediatric patients 6 to 17 years was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial (Study 7). Patients had to have at least a 6-month history of migraine attacks (with or without aura) usually lasting 3 hours or more (when untreated), and were historically non-responsive to NSAIDs and acetaminophen therapy.
Patients were instructed to treat a single migraine attack with headache pain of moderate to severe intensity. The treatment phase of the study had two stages. Stage 1 was used to identify placebo non-responders, who then entered into Stage 2, in which patients were randomized to Maxalt-MLT or placebo. Patients who weighed between 20 kg to <40 kg (44 lb to <88 lb) received Maxalt-MLT 5 mg or placebo, and patients who weighed ≥40 kg (88 lb) received Maxalt-MLT 10 mg or placebo.
Results showed that a significantly greater percentage of patients who received Maxalt-MLT achieved no headache pain at 2 hours after treatment (primary efficacy endpoint) compared with those who received placebo (33% [n=126/382] vs. 24% [n=94/388]; P =.01).
There was no statistically significant difference between patients who received Maxalt-MLT and those who received placebo regarding the absence of migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose.
≥18yrs: Initially 5 or 10mg; may repeat after 2hrs; max 30mg/24hrs. Concomitant propranolol: 5mg; max 15mg/24hrs. The safety of treating, on average, more than 4 headaches in a 30-day period has not been established.
<6yrs: not established. 6–17yrs (<40kg): 5mg; (≥40kg): 10mg. Concomitant propranolol (≥40kg only): max 5mg/24hrs. The efficacy and safety of treating with ≥1 dose/24hrs have not been established.
Ischemic coronary artery disease (eg, angina pectoris, history of MI, documented silent ischemia). Other significant cardiovascular disease. Coronary artery vasospasm (eg, Prinzmetal's angina). History of stroke or TIA. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Basilar or hemiplegic migraine. Within 24 hours of other 5-HT1 agonists or ergot-type drugs. During or within 2 weeks after discontinuing MAOIs.
Confirm diagnosis. Exclude underlying cardiovascular disease; supervise 1st dose and monitor ECG in patients with multiple risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease). Monitor cardiovascular function in long-term intermittent use. Discontinue if life-threatening cardiac rhythm disturbances (including ventricular tachycardia/fibrillation), cerebrovascular events occur. Rule out non-coronary vasospastic reactions if suspected. ODT tabs: Phenylketonuria. Elderly. Pregnancy. Nursing mothers.
Selective 5-HT1B/1D receptor agonist.
See Contraindications. Potentiated by propranolol (see Adults, Children). Serotonin syndrome with concomitant SSRIs, SNRIs, TCAs, MAOIs; discontinue if suspected.
Asthenia, fatigue, somnolence, chest/throat/neck/jaw pressure/pain, dizziness; arrhythmias, cerebrovascular events, other vasospasms, hypertension, medication overuse headache.
The total radioactivity of the administered dose recovered over 120 hours in urine and feces was 82% and 12%, respectively, following a single 10-mg oral administration of 14C-rizatriptan. Following oral administration of 14C-rizatriptan, rizatriptan accounted for about 17% of circulating plasma radioactivity. Approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism. The plasma half-life of rizatriptan in males and females averages 2-3 hours.
Gender: The mean AUC0-∞ and Cmax of rizatriptan (10 mg orally) were about 30% and 11% higher in females as compared to males, respectively, while Tmax occurred at approximately the same time.
Hepatic impairment: Following oral administration in patients with hepatic impairment caused by mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of rizatriptan were similar in patients with mild hepatic insufficiency compared to a control group of subjects with normal hepatic function; plasma concentrations of rizatriptan were approximately 30% greater in patients with moderate hepatic insufficiency.
Renal impairment: In patients with renal impairment (creatinine clearance 10-60 mL/min/1.73 m2), the AUC0-∞ of rizatriptan was not significantly different from that in subjects with normal renal function. In hemodialysis patients, (creatinine clearance <2 mL/min/1.73 m2), however, the AUC for rizatriptan was approximately 44% greater than that in patients with normal renal function.
Generic Drug Availability: