Nurtec ODT

Nurtec (rimegepant) is a prescription medicine used to treat acute migraine attacks (with or without aura) and to prevent episodic migraines in adults. It is an orally disintegrating tablet (ODT) that dissolves on or under the tongue and is taken without water. Nurtec ODT is taken at the onset of a migraine to treat an acute migraine, or on an every-other-day schedule, to help prevent future migraines.

Nurtec belongs to a class of medications called CGRP inhibitors, also known as gepants.

The FDA first approved Nurtec in 2020. There is no generic version of Nurtec available.

Nurtec is FDA-approved for use in adults for two purposes:

• the acute treatment of migraine with or without aura, meaning it is taken to relieve a migraine attack when it happens
• the preventive treatment of episodic migraine, meaning it is taken regularly to reduce how often attacks occur

Nurtec has not been established as safe or effective in children. It is not approved for chronic migraine or for other types of headache.

Nurtec ODT works by blocking calcitonin gene-related peptide (CGRP) receptors. CGRP is a protein that is released during migraine attacks and is thought to play a role in migraine pain. When Nurtec blocks CGRP from acting at its receptor, it can help relieve an attack in progress and, taken every other day, help prevent attacks from starting. The exact way that the active ingredient rimegepant produces these effects is not fully understood.

Nurtec is a CGRP receptor antagonist.

Take Nurtec exactly as prescribed by your doctor. Nurtec is an orally disintegrating tablet (ODT) that dissolves on or under the tongue and is taken without water.

Nurtec is taken at the onset of a migraine to treat an acute migraine.

To prevent migraines, Nurtec is taken every-other-day.

Keep the tablet sealed in its blister pack until you are ready to take it, then:

• use dry hands to open the blister pack
• peel back the foil and gently remove the tablet, rather than pushing it through the foil
• place the tablet on or under your tongue right away
• let the tablet dissolve in saliva and swallow without water

Take the tablet immediately after opening the blister pack, and do not store it outside the packaging for later use. Nurtec can be taken with or without food.

Do not take this medicine if you have ever had an allergic reaction to the active ingredient rimegepant or any of its inactive ingredients.

Before taking this medicine, tell your healthcare provider about all of your medical conditions, especially if you:

• have high blood pressure
• have circulation problems in your fingers or toes
• have liver problems, as it should be avoided in people with severe liver impairment
• have kidney problems, as it should be avoided in people with end-stage kidney disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

There is a pregnancy exposure registry called MONITOR for women who take this medicine during pregnancy. You can enroll or get more information by calling 1-877-366-0324 or visiting nurtecpregnancyregistry.com. Only very small amounts of the active ingredient rimegepant pass into breast milk, so ask your healthcare provider about the best way to feed your baby while taking this medicine.

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

Common side effects

The most common side effects of Nurtec are nausea and stomach pain or indigestion (abdominal pain or dyspepsia) when used for the preventive treatment of episodic migraine.

When used for the acute treatment of migraine, the most common side effect is nausea.

Serious side effects

This medicine may cause serious side effects including high blood pressure, Raynaud's phenomenon, and hypersensitivity reactions.

Hypersensitivity reactions. Get emergency medical help or call your healthcare provider right away if you have signs of a serious allergic reaction (anaphylaxis), such as:

• swelling of the face, mouth, tongue, or throat
• trouble breathing
• a rash

Allergic reactions, including anaphylaxis, shortness of breath (dyspnea), and rash, can happen days after taking these tablets. If an allergic reaction occurs, stop taking this medicine and get medical care.

High blood pressure. This medicine can cause new or worsening high blood pressure (hypertension), which is most often reported within 7 days of starting treatment. This may require treatment for hypertension, and some cases may need hospitalization.

Raynaud’s phenomenon. This medicine has caused new or worsening Raynaud's phenomenon, a circulation problem that can make your fingers or toes feel numb, cool, or painful, or change color. Symptoms occurred a median of 1.5 days following dosing; some cases included hospitalization and disability due to debilitating pain.

These are not all of the possible side effects of this medicine Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Nurtec for acute treatment of migraine

• one tablet when needed for migraine
• maximum dose is one tablet (75mg) in 24 hours.
• The safety of using more than 18 doses in 30 days has not been established
• tablet may be taken with or without food.

Dose of Nurtec for prevention of episodic migraine

• one tablet (75mg) taken every other day (every 48 hours)
• tablet can be taken with or without food

This medicine is not intended to be used both ways at the same time. Follow the schedule your doctor prescribes for your situation.

This medicine should be avoided in people with severe liver impairment (Child-Pugh C) and in people with end-stage kidney disease (creatinine clearance under 15 mL/min). No dose change is needed for mild or moderate liver or kidney problems.

If you take this medicine every other day for prevention and you miss a dose, take it as soon as you remember, then continue with your regular schedule. Do not take two tablets to make up for a missed dose. If you are using Nurtec only as needed for attacks, there is no missed-dose schedule to keep. If you are unsure, ask your pharmacist or healthcare provider.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking Nurtec ODT. Grapefruit can raise the amount of rimegepant in your body, which may increase the risk of side effects. Also follow your doctor's advice about other medicines that can interact with Nurtec ODT (see below).

Some medicines can change how much of the active ingredient, rimegepant, is in your body, so tell your doctor and pharmacist about everything you take. The main interactions are grouped by how the medicine affects rimegepant.

This is not a complete list, and other medicines may interact with this medicine Your doctor may change how or when you take it. Do not start or stop any medicine without checking first.

How well does Nurtec work for acute migraine?

In a clinical trial Study 1 for acute migraine treatment, a single 75 mg dose of Nurtec ODT was more effective than placebo across the main outcomes measured at 2 hours.

For acute migraine, 59.3% of Nurtec patients had pain relief within 2 hours compared to 10.9% of placebo patients, and 21.2% of Nurtec patients were pain-free at 2 hours compared with 10.9% on placebo.

The table below shows the full set of 2-hour outcomes from Study 1, in which patients took one 75 mg dose to treat a moderate to severe migraine.

How well does Nurtec work for migraine prevention?

In a prevention trial (Study 2), which used a different oral form of rimegepant taken every other day, patients had fewer migraine days than those on placebo over weeks 9 to 12.

People taking rimegepant had 4.3 fewer migraine days per month, compared with 3.5 fewer on placebo, and 49.1% cut their moderate to severe migraine days by at least half, compared with 41.5% on placebo.

The table below shows these prevention outcomes, measured over weeks 9 to 12 of the trial.

The cost of Nurtec depends on your insurance and the pharmacy you use. There is no generic version, so price varies with your coverage and any manufacturer savings program you qualify for.

Eligible commercially insured patients may be able to use the manufacturer savings program to lower their out-of-pocket cost. Savings programs like this are generally not available to patients enrolled in Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs, or where prohibited by law. Check the current program terms for eligibility details and how much you may save.

For more information, see the Nurtec ODT prices, coupons, and patient assistance page.

• keep the tablets in their original blister packaging
• store at room temperature, 20°C to 25°C (68°F to 77°F), with brief exposure allowed between 15°C and 30°C (59°F to 86°F)
• keep all medicines out of the reach of children and pets

Active ingredient: rimegepant 75 mg

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