Rizatriptan Benzoate

⛔ FDA Black Box Warning

BOXED WARNING

Contraindications

4 CONTRAINDICATIONS Rizatriptan benzoate orally disintegrating tablets are contraindicated in patients with: • Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] . • Coronary artery vasospasm including Prinzmetal’s angina [see Warnings and Precautions (5.1) ] . • History of stroke or transient ischemic attack (TIA) [s ee Warnings and Precautions (5.4) ] . • Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5) ] . • Ischemic bowel disease [see Warnings and Precautions (5.5) ] . • Uncontrolled hypertension [see Warnings and Precautions (5.8) ] . • Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.2 and 7.3) ] . • Hemiplegic or basilar migraine [see Indications and Usage (1) ]. • Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.5) and Clinical Pharmacology (12.3) ] . • Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen) [see Adverse Reactions (6.2) ] . • History of ischemic heart disease or coronary artery vasospasm (4) • History of stroke or transient ischemic attack (4) • Peripheral vascular disease (4) • Ischemic bowel disease (4) • Uncontrolled hypertension (4) • Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or of an ergotamine-containing medication (4) • Hemiplegic or basilar migraine (4) • MAO-A inhibitor used in the past 2 weeks (4) • Hypersensitivity to rizatriptan or any of the excipients (4)

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available human data on the use of rizatriptan benzoate in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans [see Animal Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine range from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension. Data Human Data The Pregnancy Registry for rizatriptan benzoate did not identify any pattern of congenital anomalies or other adverse birth outcomes over the period of 1998 to 2018. However, the lack of identification of any pattern should be viewed with caution, as the number of prospective reports with outcome information was low and did not provide sufficient power to detect an increased risk of individual birth defects associated with the use of rizatriptan benzoate. Additionally, there was significant loss to follow-up in the prospective pregnancy reports, further complicating this assessment of an association between rizatriptan benzoate and any pattern of congenital anomalies or other adverse birth outcomes. In a study using data from the Swedish Medical Bi