Rizatriptan ODT Viatris

What it is

RIZATRIPTAN is a medicine containing rizatriptan benzoate. Each orally disintegrating tablet contains 10 mg rizatriptan (as benzoate). This medicine is a rapidly dissolving tablet for which administration with liquid is not necessary. Rizatriptan is a potent, orally active serotonergic agonist that acts selectively at 5-HT 1B/1D receptors.

Approved indications

— Acute treatment of migraine attacks with or without aura.

Dosing overview

The recommended dose is 10 mg. Onset of relief can occur within 30 minutes after dosing. Doses should be separated by at least 2 hours; no more than 30 mg should be taken in any 24-hour period. For patients receiving propranolol, plasma concentrations of rizatriptan may be increased; the 10 mg dose is not appropriate for these patients, and the physician should consider alternative therapies such as other 5-HT 1B/1D agonists that do not have this drug interaction.

Key safety warnings

Rizatriptan should only be administered to patients in whom a clear diagnosis of migraine has been established. Rizatriptan should not be administered to patients with basilar or hemiplegic migraine. There have been rare reports of serious coronary events with this class of drugs including rizatriptan, and cardiovascular assessment should be considered in patients at risk for coronary artery disease such as patients with hypertension, diabetics, smokers, and those with strong family history for coronary artery disease. Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors and triptans; if concomitant treatment with rizatriptan and an SSRI or SNRI is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Overuse of acute migraine drugs may lead to medication overuse headache, which may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks, and detoxification of patients, including withdrawal of the overused drugs, may be necessary.

Contraindications

This medicine is contraindicated in patients with hypersensitivity to rizatriptan or any of the ingredients in the tablet, and in patients receiving concurrent monoamine oxidase inhibitor therapy or within 2 weeks of discontinuation of monoamine oxidase inhibitor therapy. Based on the mechanism of action of this class of compounds, rizatriptan is also contraindicated in patients with uncontrolled hypertension, established coronary artery disease (including ischemic heart disease, angina pectoris, history of myocardial infarction, or documented silent ischaemia), signs and symptoms of ischemic heart disease, Prinzmetal's angina, history of stroke or transient ischaemic attack, and peripheral vascular disease (including ischemic bowel disease).

PBS listing

Information regarding PBS listing for RIZATRIPTAN is not available in the provided source documents.

Regulatory history

RIZATRIPTAN was first approved on 19 February 2015. An orally disintegrating tablet formulation containing 10 mg rizatriptan (as benzoate) was registered on the Australian Register of Therapeutic Goods (ARTG 432350) on 31 May 2024.