Instructions for use and marketing status of Rimegepant orally disintegrating tablets (Rimegepant)

1. Common name: Rimegepant orally disintegrating tablets, Rimegepant

Product name: Loctite, NURTEC, Vydura

2. Indications:

1. Acute treatment of migraine

Rimegepant orally disintegrating tablets (Rimegepant) are indicated for the acute treatment of migraine with or without aura in adults.

2. Preventive treatment of episodic migraine

Rimegepant orally disintegrating tablets (Rimegepant) are suitable for the preventive treatment of episodic migraine in adults.

3. Usage and dosage:

1. Recommended dosage:

(1) Acute treatment of migraineheadache: The recommended dose of Remegipan orally disintegrating tablets is75 mg, taken orally as needed. The maximum dose within 24 hours is 75 mg. The safety of using more than 18 doses in 30 days has not been established.

(2) Preventive treatment of episodic migraine: The recommended dose of Remegipan orally disintegrating tablets is 75 mg, taken orally once every other day.

2. Drug interactions:

(1)Strong or moderate CYP3A4 inhibitors: Avoid coadministration of remegipan orally disintegratingT and strong CYP3A4 inhibitors. When coadministered with a moderate inhibitor of CYP3A4, avoid taking another dose of Remedigipan within 48 hours.

(2)Strong or moderate CYP3A inducers: Avoid coadministration of Remedigelpan orally disintegrating tablets with strong or moderate inducers of CYP3A, which may result in loss of efficacy of Remedigelpan orally disintegrating tablets.

(3) EffectiveP-gp inhibitors: As powerful as they areWhen taking P-gp inhibitors concurrently, avoid taking Remedigipan orally disintegrating tablets again within 48 hours.

4. Adverse reactions:

In clinical studies of Remedipam orally disintegrating tablets, the most common side effects were nausea, hypersensitivity reactions (anaphylaxis) including difficulty breathing, and severe rash.

5. Supply and storage:

Remedypan orally disintegrating tablets may be stored at controlled room temperature between 20°C and 25°C (68°F and 77°F); tolerances are allowed between 15°C and 30°C (59°F and 86°F).

6. Taboo:

Rimegepan orally disintegrating tablets are contraindicated in patients with a history of allergic reaction to Rimegepant, NURTEC, or any of their components. A delayed severe allergic reaction occurred.

7. Mechanism of action:

A chemical messenger called calcitonin gene-related peptide (CGRP) contributes to the development of migraines. Rimegepant is a calcitonin gene-related peptide receptor antagonist that attaches to the receptor (target) of CGRP. By attaching to this receptor, the drug prevents CGRP from binding to it. This helps treat migraines and also prevents them from occurring.

8. Listing situation:

1. Original drug:

United States: 2020-02-27, approved for marketing (trade name: Nurtec)

EU: 2022-04-25, approved for marketing (trade name: Vydura)

China: 2024-01-23, approved for listing (trade name: Loctite)

2. Generic drugs: None

Reference materials:https://en.wikipedia.org/wiki/Rimegepant