Nurtec ODT

What is Nurtec ODT?

Nurtec ODT is a prescription medicine used in adults for the: acute treatment of migraine attacks with or without aura and to preventive treatment of episodic migraine

It is not known if Nurtec ODT is safe and effective in children.

Description

NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)-1-piperidinecarboxylate hemisulfate sesquihydrate and its structural formula is:

Its empirical formula is C 28H 28F 2N 6O 3 0.5 H 2SO 4 1.5 H 2O, representing a molecular weight of 610.63. Rimegepant free base has a molecular weight of 534.56. Rimegepant sulfate is a white to off-white, crystalline solid that is slightly soluble in water.

NURTEC ODT (orally disintegrating tablets) is for sublingual or oral use and contains 85.7 mg rimegepant sulfate, equivalent to 75 mg rimegepant free base, and the following inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin.

Mechanism of Action

Rimegepant is a calcitonin gene-related peptide receptor antagonist.

Who should not take Nurtec ODT?

Do not take Nurtec ODT if you are:

• allergic to rimegepant or any of the ingredients in Nurtec ODT.

See the end of this guide for a complete list of ingredients in Nurtec ODT.

What should I tell my healthcare provider before taking Nurtec ODT?

Before you take Nurtec ODT, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if Nurtec ODT will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Nurtec ODT passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Nurtec ODT?

• Take Nurtec ODT exactly how your healthcare provider tells you to.
• Take Nurtec ODT immediately after opening the blister pack. Do not store Nurtec ODT outside the blister pack for future use.
• For the acute treatment of migraine attacks when they occur, Nurtec ODT can be taken 1 time each day as needed. You should not take more than 1 tablet in 24 hours.
  • It is not known if it is safe to take more than 18 doses of Nurtec ODT in 30 days.
• For the preventive treatment of episodic migraine, take Nurtec ODT 1 time every other day.
• To take Nurtec ODT:
  • Use dry hands when opening the blister pack.
  • Peel back the foil covering of one blister and gently remove Nurtec ODT. Do not push Nurtec ODT through the foil.
  • As soon as the blister is opened, remove Nurtec ODT and place on or under the tongue.
  • Nurtec ODT will dissolve and no drink or water is needed.
  • Take Nurtec ODT immediately after opening the blister pack. Do not store Nurtec ODT outside the blister pack for future use.
• If you take too much Nurtec ODT, go to the nearest emergency room right away.If you take too much Nurtec ODT, go to the nearest emergency room right away.

What are the possible side effects of Nurtec ODT?

Nurtec ODT may cause serious side effects including:

• Allergic reactions. Allergic reactions, including trouble breathing and rash, can happen after you take Nurtec ODT. This can happen days after you take Nurtec ODT. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction:
  • Swelling of the face, mouth, tongue, or throat
  • Trouble breathing

The most common side effect of Nurtec ODT in acute treatment of migraine attacks with or without aura is:

• nausea

The most common side effects of Nurtec ODT in preventive treatment of episodic migraine are:

• nausea
• stomach pain
• indigestion

These are not the only possible side effects of Nurtec ODT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800 FDA-1088

General information about the safe and effective use of Nurtec ODT

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not use Nurtec ODT for a condition for which it was not prescribed. Do not give Nurtec ODT to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Nurtec ODT that is written for health professionals.

How should I store Nurtec ODT?

• Store Nurtec ODT in the blister package that it comes in.
• Store Nurtec ODT at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Nurtec ODT and all medicines out of the reach of children.

What are the ingredients in Nurtec ODT?

Active ingredient: rimegepant

Inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin

Label

NURTEC CARTON