VYDURA 75 mg oral lyophilisate is a prescription-only medicine containing 75 mg of rimegepant. It is taken by mouth as an oral lyophilisate that dissolves when placed on or under the tongue, without needing water.

VYDURA 75 mg is licensed in adults for the acute treatment of migraine with or without aura. For treating a migraine attack, the recommended dose is 75 mg as needed, no more than once daily.

Rimegepant works by attaching to receptors for calcitonin gene-related peptide (CGRP), reducing the ability of CGRP to activate these receptors. CGRP activity is associated with migraine, and reducing its activity can help treat an active migraine attack and reduce the number of attacks when VYDURA is taken preventively.

What is Vydura 75 mg used for?

VYDURA 75 mg is used in adults to treat a migraine attack once it has started. It can be used for the acute treatment of migraine with or without aura.

How do you take Vydura 75 mg?

Place one VYDURA 75 mg oral lyophilisate on or under your tongue and allow it to dissolve in your mouth. Use dry hands to peel back the foil and gently remove it from the blister. Do not push it through the foil. No drink or water is needed, and VYDURA can be taken with or without food.

How often can you take Vydura 75 mg?

For an active migraine attack, the recommended dose is one 75 mg oral lyophilisate as needed, not more than once daily. For migraine prevention, the recommended dose is one 75 mg oral lyophilisate every other day. The maximum dose is 75 mg per day.

Some medicines can affect how VYDURA is processed by the body. If you are taking certain medicines, including fluconazole, erythromycin, diltiazem, quinidine, verapamil or cyclosporin, another dose of VYDURA should not be taken within 48 hours. Tell your doctor or pharmacist about other medicines you take.

Can you take Vydura 75 mg with food or water?

Yes. VYDURA 75 mg can be taken with or without food or water. Place the oral lyophilisate on or under your tongue and allow it to dissolve. You do not need a drink to take it.

How does Vydura work for migraine?

VYDURA contains rimegepant, which reduces the activity of calcitonin gene-related peptide (CGRP) by attaching to the CGRP receptor. People with migraine may have increased levels of CGRP. By reducing CGRP activity, rimegepant can help treat an active migraine attack and can decrease the number of migraine attacks when taken preventively.

Patient Information Leaflet: https://www.medicines.org.uk/emc/files/pil.13928.pdf

Our service does not include a prescription. Instead, your treatment is supplied under a legal framework known as a Patient Group Direction (PGD). The process follows these steps:

1. Complete a health questionnaire

Provide information about your health, medical history, migraine symptoms, previous diagnosis and any medicines you currently take.

2. Pharmacist review

A pharmacist will review your responses and may contact you by phone or video call if further information is needed to support a safe and appropriate supply decision.

3. Private consultation

All interactions are confidential. You can discuss any questions about your migraine treatment and the appropriate use of sumatriptan.

4. Identity verification

You may be asked to provide identification to confirm that you are the intended user. This is typically required for your first order only.

5. Supporting information

You may be asked to provide additional information about your migraine history, previous treatments, medical conditions or medicines to support the pharmacist's assessment.

Your GP can be notified of your request and the outcome of the supply decision, if you wish us to do that.

Purchasing this medication does not guarantee supply. The decision to supply is made by the pharmacist based on the information provided. If supply is not appropriate, your order will be refunded.

Main ingredient: Rimegepant 75 mg (as rimegepant sulfate).

Excipients: gelatin, mannitol (E421), mint flavour, sucralose.

VYDURA 75 mg oral lyophilisate is used in adults for:

• The acute treatment of migraine with or without aura.

Dose for treating a migraine attack

• Take one VYDURA 75 mg oral lyophilisate as needed once a migraine attack has started.
• Do not take more than one 75 mg dose in a day.
• The maximum dose is 75 mg in any 24-hour period.

How to take VYDURA 75 mg

• VYDURA is for oral use.
• Use dry hands when opening the blister.
• Peel back the foil and gently remove the oral lyophilisate. Do not push it through the foil.
• As soon as the blister is opened, place the oral lyophilisate on or under your tongue and allow it to dissolve in your mouth.
• No drink or water is needed.
• VYDURA can be taken with or without food or water.
• Do not store an oral lyophilisate outside the blister for future use.

Taking VYDURA with certain other medicines

Some medicines can increase the amount of rimegepant in your body. When VYDURA is taken with certain medicines, including fluconazole, erythromycin, diltiazem, quinidine, verapamil or cyclosporin, another dose of VYDURA should be avoided within 48 hours.

If you take more VYDURA than you should

Talk to your doctor or pharmacist or go to a hospital straight away. Take the medicine pack and Patient Information Leaflet with you.

If you have any questions about how to use VYDURA, speak to your doctor or pharmacist.

Do not use this medicine if

• You are allergic to rimegepant or any of the other ingredients in VYDURA.

Speak to your doctor or pharmacist before use

Tell your doctor or pharmacist before taking VYDURA if:

• You have severe liver problems.
• You have reduced kidney function or are receiving kidney dialysis.

VYDURA should be avoided in people with severe hepatic impairment or end-stage renal disease. Caution is advised with frequent use in people with severe renal impairment.

Age restrictions

VYDURA should not be given to children or adolescents under 18 years of age. Its safety and efficacy have not been established in this age group.

Serious allergic reactions

Stop taking VYDURA and contact your doctor straight away if you develop signs of an allergic reaction. These may include:

• Trouble breathing or shortness of breath.
• Severe rash.
• Swelling of the tongue, mouth or face.
• Trouble swallowing.
• Throat tightness.
• Hoarseness.

Serious allergic reactions, including anaphylaxis, have been reported with rimegepant. Some allergic reactions can occur several days after taking a dose.

Interactions with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Examples of medicines that should be avoided while taking VYDURA include:

• Itraconazole or clarithromycin.
• Ritonavir or efavirenz.
• Bosentan.
• St John's wort.
• Phenobarbital.
• Rifampicin.
• Modafinil.

Certain other medicines can increase exposure to rimegepant. Do not take another dose of VYDURA within 48 hours when it is being used with medicines such as:

• Fluconazole or erythromycin.
• Diltiazem, quinidine or verapamil.
• Cyclosporin.

This is not a complete list of possible medicine interactions. Tell your doctor or pharmacist about the medicines and herbal products you use.

Medication overuse headache

Overuse of medicines used for headaches can make headaches worse. If you develop frequent or daily headaches despite, or because of, regular use of medicines for acute headache, seek medical advice. Treatment should be discontinued if medication overuse headache is experienced or suspected.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking VYDURA. It is preferable to avoid VYDURA during pregnancy, as there are limited data on its use in pregnant women.

Breastfeeding

If you are breastfeeding or planning to breastfeed, talk to your doctor or pharmacist before using VYDURA. You and your doctor should decide whether you will use VYDURA while breastfeeding.

Driving and using machines

VYDURA is not expected to affect your ability to drive or use machines.

Like all medicines, VYDURA can cause side effects, although not everybody gets them.

Serious side effects requiring urgent medical attention

Signs of an allergic or severe allergic reaction can include severe rash, shortness of breath, swelling of the tongue, mouth or face, difficulty swallowing or breathing, throat tightness or hoarseness. Allergic reactions can occur several days after taking VYDURA.

Frequency definitions

• Very common: may affect at least 1 in 10 people.
• Common: may affect at least 1 in 100 but fewer than 1 in 10 people.
• Uncommon: may affect at least 1 in 1,000 but fewer than 1 in 100 people.
• Rare: may affect at least 1 in 10,000 but fewer than 1 in 1,000 people.
• Very rare: may affect fewer than 1 in 10,000 people.
• Frequency not known: the frequency cannot be estimated from the available data.

Other side effects

Nausea is a common side effect of VYDURA for both the acute treatment and preventive treatment of migraine.

If you experience any side effects, including effects not listed here, speak to your doctor, pharmacist or nurse.