Rizatriptan ODT Viatris

What it is

Rizatriptan ODT Viatris contains rizatriptan benzoate in orodispersible tablet form, with each tablet containing either 5 mg or 10 mg of rizatriptan. The orodispersible tablets are rapidly dissolving and do not require administration with liquid. Rizatriptan is a potent, orally active serotonergic agonist that acts selectively at 5-HT1B/1D receptors.

Approved indications

— Acute treatment of migraine attacks with or without aura.

Dosing overview

The recommended dose is 10 mg, which provides optimal clinical benefit. Onset of relief can occur within 30 minutes after dosing. Doses should be separated by at least 2 hours, with no more than 30 mg taken in any 24-hour period. Plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol, and the 10 mg dose is not appropriate for these patients.

Key safety warnings

Rizatriptan should only be administered to patients in whom a clear diagnosis of migraine has been established and 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 prior to prescribing. Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors and triptans, and careful observation of the patient is advised if concomitant treatment is clinically warranted. Overuse of acute migraine drugs may lead to exacerbation of headache presenting as migraine-like daily headaches or marked increase in frequency of migraine attacks.

Contraindications

Rizatriptan ODT Viatris is contraindicated in patients with hypersensitivity to rizatriptan or any of the ingredients, and in patients receiving concurrent monoamine oxidase inhibitors or within 2 weeks of discontinuation of monoamine oxidase inhibitor therapy. Based on the mechanism of action of this class of compounds, Rizatriptan ODT Viatris is also contraindicated in patients with uncontrolled hypertension, established coronary artery disease including ischemic heart disease or Prinzmetal's angina, history of stroke or transient ischaemic attack, and peripheral vascular disease including ischaemic bowel disease.

Regulatory history

Rizatriptan ODT Viatris was first registered on the Australian Register of Therapeutic Goods on 19 February 2015, with both the 5 mg and 10 mg orodispersible tablet formulations listed under licence category RE.