TM Owner Pfizer Europe MA EEIG
Vydura 75mg Oral lyophilisate (dissolves on/under tongue)
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Indications & Clinical Uses
- Vydura 75mg orally disintegrating tablet (an oral lyophilisate, or freeze-dried wafer, in the EU) contains rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist.
- In the EU it is approved for the acute treatment of migraine with or without aura in adults, and for the prevention of episodic migraine in adults who have at least 4 migraine attacks a month.
- The dose is one 75 mg wafer as needed, with a maximum of 75 mg in 24 hours, or one 75 mg wafer every other day for prevention.
- It is placed on or under the tongue.
- Vydura is the EU brand from Pfizer Europe MA EEIG, authorised in April 2022; it is not a US brand name.
- In the US the same medicine is sold as Nurtec ODT by Pfizer.
Side Effects
- Nausea is the most common side effect, reported in about 2% of people using rimegepant for acute treatment in US trials and 2.7% of those using it for prevention, and abdominal pain or indigestion in about 2.4% of people using it for prevention.
- Serious hypersensitivity reactions, including anaphylaxis, difficulty breathing and rash, are uncommon and can appear several days after a dose; stop taking it and get urgent medical help if they occur.
- The US label also warns of new or worsening high blood pressure and Raynaud's phenomenon (fingers or toes turning pale or blue in the cold).
- Vydura is under additional monitoring in the EU.
- It has no boxed warning.
Precautions & Warnings
- Do not use Vydura if you are allergic to rimegepant or any ingredient.
- Avoid it in severe liver impairment and in end-stage kidney disease.
- Taking acute migraine medicines too often can cause medication-overuse headache.
- High blood pressure and Raynaud's phenomenon should be monitored, and hypersensitivity reactions can be delayed.
- The EU label says it is preferable to avoid Vydura in pregnancy; the US label says there are no adequate pregnancy data.
- Less than 1% of a dose passes into breast milk, and no effect on driving is expected.
- Keep each wafer in its blister until use, place it on or under the tongue immediately after opening, and store below 30°C.
- Pack sizes in the EU are 2, 8 or 16 blisters.
Avoid Interactions
- Medicines that can raise rimegepant levels: strong CYP3A4 inhibitors are contraindicated in the EU (avoid in the US); moderate CYP3A4 inhibitors and strong P-gp inhibitors mean you should not take another dose within 48 hours.
- Medicines that can lower its effect: CYP3A4 inducers are contraindicated in the EU and the US label says to avoid strong and moderate inducers.
- Ask your healthcare provider or pharmacist to check any new prescription, non-prescription or herbal medicine before you start it.
- Tell your healthcare provider about all prescription and non-prescription medicines and supplements you take.
References
Frequently Asked Questions
Vydura (rimegepant) is a migraine medicine for adults. It treats a migraine attack, with or without aura, and prevents episodic migraine in people with at least 4 attacks a month. It is a CGRP receptor blocker and is sold as Nurtec ODT in the US.
Place one Vydura (rimegepant) 75 mg wafer on or under your tongue, where it dissolves without water. For an attack, take one as needed, no more than 75 mg in 24 hours. For prevention, take one every other day. Take it right after opening the blister.
The most common side effect of Vydura (rimegepant) is nausea. Abdominal pain and indigestion can also occur. Rarely, serious allergic reactions such as anaphylaxis can happen, even days after a dose. Stop the wafer and get urgent help if you have trouble breathing, swelling or a rash.
Avoid strong CYP3A4-blocking medicines with Vydura (rimegepant); the EU label contraindicates them. Do not take a second dose within 48 hours of moderate CYP3A4 inhibitors or strong P-gp inhibitors. CYP3A4 inducers are also contraindicated. Tell your pharmacist about every medicine and herbal product you use.
Store Vydura (rimegepant) wafers below 30°C in the original blister to protect them from moisture. Open the blister only when you are ready to take the wafer, and place it on or under your tongue straight away. Do not keep wafers outside the blister.
The EU label says it is preferable to avoid Vydura (rimegepant) during pregnancy, and the US label notes there are no adequate data. Less than 1% of a dose reaches breast milk. Speak to your healthcare provider before using it if you are pregnant, planning pregnancy or breastfeeding.
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