What is Maxalt?

Maxalt (rizatriptan) tablets is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist used to treat the pain of migraine headache. Maxalt is believed to work by narrowing the blood vessels around the brain and by decreasing levels of substances involved in the development of migraine pain. Maxalt will only treat a headache that has already begun. Maxalt will not prevent headaches or reduce the number of attacks. Side effects of Maxalt can include:

  • mild headache (not a migraine),
  • dry mouth,
  • nausea;
  • feeling of pain or tightness in the jaw, neck, or throat;
  • pressure or heavy feeling in any part of your body,
  • dizziness,
  • drowsiness,
  • tired feeling,
  • weakness,
  • feelings of tingling/numbness/prickling/heat, or
  • flushing (warmth, redness, or tingling feeling under your skin).

The recommended starting dose of Maxalt is either 5 mg or 10 mg for the acute treatment of migraines in adults. Maxalt may interact with other migraine headache medicines, propranolol, or antidepressants. Tell your doctor all medications and supplements you use. It is not known whether this medication is harmful to an unborn baby. Before taking rizatriptan, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is also not known whether rizatriptan passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have:

  • sudden and severe stomach pain and bloody diarrhea;
  • cold feeling or numbness in your feet and hands;
  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • dangerously high blood pressure–severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Common side effects may include:

  • dizziness, drowsiness, tired feeling; or
  • pain or a feeling of pressure in your throat or chest.

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina
  • Arrhythmias
  • Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure
  • Cerebrovascular Events
  • Other Vasospasm Reactions
  • Medication Overuse Headache
  • Serotonin Syndrome
  • Increase in Blood Pressure
  • Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adults

Incidence in Controlled Clinical Trials

Adverse reactions to MAXALT were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of MAXALT Tablets. The most common adverse reactions during treatment with MAXALT (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness. These adverse reactions appeared to be dose related.

The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (including propranolol), oral contraceptives, or analgesics. The incidences of adverse reactions were not affected by age or gender. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Other Events Observed In Association With The Administration Of MAXALT In Adults

In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling. Because the reports include events observed in open studies, the role of MAXALT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used MAXALT and reported an event divided by the total number of patients exposed to MAXALT (N=3716). All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least ( > )1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

  • General: Infrequent was facial edema. Rare were syncope and edema/swelling.
  • Atypical Sensations: Frequent were warm sensations.
  • Cardiovascular: Frequent was palpitation. Infrequent were tachycardia, cold extremities, and bradycardia.
  • Digestive: Frequent were diarrhea and vomiting. Infrequent were dyspepsia, tongue edema and abdominal distention.
  • Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.
  • Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor. Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation.
  • Respiratory: Frequent was dyspnea. Infrequent was pharyngeal edema.
  • Special Senses: Infrequent were blurred vision and tinnitus. Rare was eye swelling.
  • Skin and Skin Appendage: Frequent was flushing. Infrequent were sweating, pruritus, rash, and urticaria. Rare was erythema, hot flashes.

The adverse reaction profile seen with MAXALT-MLT Orally Disintegrating Tablets was similar to that seen with MAXALT Tablets.

Pediatric Patients 6 To 17 Years Of Age

Incidence in Controlled Clinical Trials in Pediatric Patients

Adverse reactions to MAXALT-MLT were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (MAXALT-MLT and/or placebo) [see Clinical Studies]. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received MAXALT to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.

Other Events Observed in Association with the Administration of MAXALT-MLT in Pediatric Patients

In the following section, the frequencies of less commonly reported adverse events are presented. Because the reports include events observed in open studies, the role of MAXALT-MLT in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.

Event frequencies are calculated as the number of pediatric patients 6 to 17 years of age who used MAXALT-MLT and reported an event divided by the total number of patients exposed to MAXALT-MLT (N=1068). All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug. Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in ( > )1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

  • General: Frequent was fatigue.
  • Ear and labyrinth disorders: Infrequent was hypoacusis.
  • Gastrointestinal disorders: Frequent was abdominal discomfort.
  • Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope.
  • Psychiatric disorders: Infrequent was hallucination.

Postmarketing Experience

The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of MAXALT in their causation cannot be reliably determined.