ARTG Entry

MAXALT

ARTG entry for MAXALT (rizatriptan), ARTG 69076 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

MAXALT is a medicine containing rizatriptan benzoate. MAXALT is available as lyophilised wafers containing either 5 mg or 10 mg of rizatriptan. MAXALT wafers are rapidly dissolving wafers that do not require administration with liquid.

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; no more than 30 mg should be taken in any 24-hour period. Patients receiving propranolol may have increased plasma concentrations of rizatriptan, and the 10 mg dose is not appropriate for these patients.

Key safety warnings

MAXALT 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, and cardiovascular assessment should be considered prior to prescribing in patients at risk for coronary artery disease, such as those 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, and careful observation of the patient is advised if concomitant treatment is clinically warranted. 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 may be necessary.

Contraindications

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

Key safety warnings (continued)

Phenylketonuric patients should be informed that MAXALT Wafers contain phenylalanine; each 5 mg wafer contains 1.05 mg phenylalanine, and each 10 mg wafer contains 2.10 mg phenylalanine.

Regulatory history

MAXALT 5 mg and 10 mg wafer formulations were first registered on the ARTG on 23 June 1999.

TGA Public Summary — ARTG 69076