Adverse Cardiac Events, Other Vasospasm-Related Events, and Cerebrovascular Events
Inform patients that AXERT® (almotriptan malate) may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech, and should ask for medical advice when observing any indicative signs or symptoms. Apprise the patient of the importance of this follow-up [see WARNINGS AND PRECAUTIONS (5.1), (5.2), (5.3), and (5.4)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with the use of AXERT® or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS (5.5)].
Medication Overuse Headache
Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see WARNINGS AND PRECAUTIONS (5.6)].
Pregnancy
Advise patients to notify their physician if they become pregnant during treatment or intend to become pregnant [see USE IN SPECIFIC POPULATIONS (8.1)].
Nursing Mothers
Advise patients to notify their physician if they are breastfeeding or plan to breastfeed [see USE IN SPECIFIC POPULATIONS (8.3)].
Ability to Operate Machinery or Vehicles
Counsel patients that AXERT® may cause dizziness, somnolence, visual disturbances, and other CNS symptoms that can interfere with driving or operating machinery. Accordingly, advise the patient not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience with AXERT® to gauge whether it affects their mental or visual performance adversely.
SPL UNCLASSIFIED SECTION
Product of Spain
AXERT® Tablets are manufactured by:
Janssen-Ortho, LLC
Gurabo, Puerto Rico 00778
AXERT® Tablets are manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Licensed from: Almirall, S.A.
U.S. Patent No. 5,565,447
© Janssen Pharmaceuticals, Inc. 2009
7560705
PATIENT PACKAGE INSERT
This Patient Information has been approved by the U.S. Food and Drug Administration Revised : May 2017
PATIENT INFORMATION
AXERT® (AX-ERT)
(almotriptan malate)
tablets
What is the most important information I should know about AXERT?
AXERT can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking AXERT and get emergency medical help right away if you have any of the following symptoms of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
AXERT is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
have high blood pressure
have h |
