MANY MIGRAINE NEEDS * 1
ONE SIMPLE SOLUTION † 2
* Migraine is defined as occurring with or without aura and further characterised as being treated with acute and / or prophylactic medications . 1 † One Nurtec ® ODT 75 mg tablet as needed , for the acute treatment of migraine with or without aura and every other day for the prophylactic treatment of episodic migraine . 1,2
NURTEC ® ODT — the first and only medicine to TREAT and PREVENT migraine attacks 1 , 3 , 4
NURTEC ® ODT is indicated for the
• Acute treatment of migraine with or without aura in adults ;
• Prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month .
48h
Works Within 1 Hour 1 , 2 |
Provides Sustained Pain Relief for Up to 48 Hours 2 |
Reduces Monthly Migraine Days ( MMDs ) 5 |
Tolerability Safety Profile Similar to Placebo 1 , 2 |
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Significant improvement in :
• Percent of patients achieving pain freedom at 2 hours 1 * [ primary endpoint ]
• Percent of patients with pain relief at 60 minutes 2 † [ secondary endpoint ]
* 21.2 % of patients taking NURTEC ® ODT achieved pain freedom at 2 hours vs 10.9 % on placebo ( p < 0.0001 ). 1
†
36.8 % of patients taking NURTEC ® ODT had pain relief at 60 minutes vs 31.2 % on placebo . 2 ‡
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P-value not available , outcome was statistically significant in hierarchical testing .
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Significant improvement in percent of patients with sustained pain relief from 2 to 48 hours 2 ‡
[ secondary endpoint ]
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42.2 % of patients taking NURTEC ® ODT had pain relief sustained up to 48 hours vs 25.2 % with placebo . 2
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Significant reduction in MMDs at Weeks 9-12 3 §
[ primary endpoint ]
§
MMDs for patients taking Rimegepant * reduced by 4.3 vs 3.5 MMDs with placebo ( p-value = 0.0099 ). 3
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The most common adverse reaction was nausea for acute treatment ( 1.2 %) and for migraine prophylaxis ( 1.4 %).
Most reactions were mild or moderate in severity . 1
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P-value not available , all comparisons are statistically significant in hierarchical testing . |
* Rimegepant 75mg tablet formulation bioequivalent to Nurtec ® ODT was used . |
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With NURTEC ® ODT , dosing is simple . Treat and prevent with one 75 mg orally dissolving tablet . 1 ||
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Acute treatment : taken as needed up to once daily . Prophylactic treatment : taken every other day . The maximum dose per day is 75 mg rimegepant . 1
Minimum Product Information NURTEC ® ODT ( rimegepant , 75 mg ) orally disintegrating tablet . Indications : acute treatment of migraine with or without aura in adults ; prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month . Contraindications : hypersensitivity to rimegepant or to any of the excipients . Precautions : hypersensitivity reactions ; limited data to support additional daily doses for acute treatment of same migraine attack or whilst taking a CGRP blocking monoclonal antibody as prophylaxis or for acute treatment of migraine attacks occurring whilst using rimegepant as prophylaxis ; using for ≥18 doses per month ; MOH ; severe hepatic impairment ; end-stage renal disease ; strong inhibitors of CYP3A4 ; concomitant use with strong or moderate inducers of CYP3A4 . See PI for details . Interactions with other Medicines : not recommended with strong CYP3A4 inhibitors ( e . g . clarithromycin , itraconazole , ritonavir ), strong CYP3A4 inducers ( e . g . phenobarbital , rifampicin , St John ’ s wort ( Hypericum perforatum )) or moderate CYP3A4 inducers ( e . g . bosentan , efavirenz , modafinil ); exposure to rimegepant may increase with moderate inhibitors of CYP3A4 ( e . g . diltiazem , erythromycin , fluconazole ); another dose within 48 hours should be avoided when concomitantly administered with strong inhibitors of P gp ( e . g . ciclosporin , verapamil , quinidine ). Adverse Effects : acute – nausea ; prophylaxis – nasopharyngitis , nausea , abdominal pain / dyspepsia , urinary tract infection , upper respiratory tract infection , sinusitis . See PI for details . Dosage and Administration : acute - 75 mg rimegepant orally disintegrating tablet as needed - maximum dose in 24-hour period is 75 mg ; prophylaxis - 75 mg rimegepant every other day - maximum dose in 24 hour period is 75 mg if also requiring rimegepant for acute treatment of migraine . See PI for details . V10723
Before prescribing , please review Product Information available at PFIZER . COM . AU .
PBS Information : This product is not listed on the PBS .
This medicinal product is subject to additional monitoring in Australia . This will allow quick identification of new safety information . Healthcare professionals are asked to report any suspected adverse events at www . tga . gov . au / reporting-problems .
References : 1 . Nurtec ® ODT Approved Product Information 2 . Croop R , Goadsby PJ , Stock DA , et al . Efficacy , safety , and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine : a randomised , phase 3 , double-blind , placebo-controlled trial . Lancet . 2019 ; 394 ( 10200 ): 737-745 . 3 . Ailani J , Burch RC , Robbins MS , et al . The American Headache Society Consensus Statement : Update on integrating new migraine treatments into clinical practice . Headache 2021 ; 61 : 1021-39 4 . Lipton RB . The promise of dual treatment for migraine - use of 1 drug for preventive and acute migraine treatment represents paradigm shift . Practical Neurology : Headache Horizons . Available at : https :// practicalneurology . com / articles / 2021-oct / headache-horizons-the-promise-of-dual-treatment-for-migraine [ accessed Aug2023 ] 5 . Croop R , Lipton RB , Kudrow D , et al . Oral rimegepant for preventive treatment of migraine : a phase 2 / 3 , randomised , double-blind , placebo-controlled trial . Lancet . 2021 ; 397 ( 10268 ): 51-60 .
Nurtec ® ODT is a registered trademark . Pfizer Australia Pty Limited , Sydney . www . pfizer . com . au . Medical Information : 1800 675 229 . PP-NNT-AUS-0018 . 09 / 23