• Nurtec ODT is a brand (trade) name for rimegepant sulfate which is a medicine that may be used to treat or prevent migraines in adults.
• Nurtec ODT (rimegepant) works by preventing the CGRP from attaching to CGRP receptors on nerve endings. CGRP is a protein that is thought to play a role in migraine attacks by causing pain, dilation of blood vessels, and inflammation. Research in the 1980s found that intravenous infusions of CGRP triggered typical migraine attacks in people susceptible to migraines. By preventing CGRP from binding to its receptor Nurtec ODT stops migraine pain and other symptoms and helps to prevent future migraines.
• Nurtec ODT belongs to the class of medicines known as calcitonin gene-related peptide (CGRP) receptor antagonists (gepants).

• May be used to treat acute migraines with or without aura in adults.
• May also be used to prevent episodic migraine in adult patients (less than 15 headache days per month). When used to prevent episodic migraine, the recommended dosage of Nurtec ODT is 75mg every other day (every second day). The maximum dose in a 24-hour period is 75 mg.
• Taken orally (by mouth). Available as orally disintegrating tablets that may be placed on the tongue or taken sublingually (under the tongue). The tablets disintegrate in saliva and no additional liquid is needed.
• One tablet (75mg) is taken as soon as possible after the migraine starts. The maximum dose in 24 hours is 75mg. The safety of using more than 18 doses in a 30-day period has not been established.
• Short-acting (the effects of Nurtec ODT last just over a day).
• Not a narcotic and does not cause addiction.
• Well tolerated.
• Helps to relieve pain that occurs with migraine headaches as well as migraine-related symptoms such as light sensitivity, sound sensitivity, or nausea. In some people, Nurtec ODT completely stops the pain.
• Does not prolong the QT interval.
• CYP2C9 plays a small role in the metabolism of Nurtec ODT and CYP2C9 polymorphism is not expected to significantly affect its exposure.
• No dosage adjustment is required in mild, moderate, or severe kidney disease; or mild or moderate liver disease. Avoid use in severe liver disease.
• Nurtec ODT is the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both acute and preventive treatment.
• May be taken with or without food.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Nausea is the most common adverse effect reported, occurring in 2% of people who received Nurtec ODT. Hypersensitivity reactions, including shortness of breath and severe rash, occurred in less than 1% of people treated with Nurtec ODT.
• Hypersensitivity reactions have occurred with Nurtec ODT, with symptoms such as shortness of breath (dyspnea) and rash. These may be delayed. Discontinue Nurtec ODT and initiate treatment if an allergic reaction occurs.
• Not approved for use in children.
• Advise patients that they should not take more than 75 mg in 24 hours. It is not known if it is safe to treat more than 15 migraines in 30 days when used as acute treatment.
• Metabolized by CYP3A4 and to a lesser extent by CYP2C9. The administration of Nurtec ODT with strong inhibitors of CYP3A4 (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, or grapefruit) significantly increases Nurtec ODT levels and should be avoided. When used with moderate CYP3A4 inhibitors (such as amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, or conivaptan) avoid another dose of Nurtec ODT within 48 hours. Avoid concomitant administration with strong or moderate inducers of CYP3A4, such as phenobarbital, phenytoin, rifampicin, St. John's Wort, or glucocorticoids.
• There is not enough data to know the effect Nurtec ODT has during pregnancy on the unborn child. There are no data on the effect of Nurtec ODT during lactation.
• No generic form of Nurtec ODT is available.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Nurtec ODT is a disintegrating tablet that is taken orally (by mouth) or placed under the tongue when you have a migraine or taken once every other day to prevent a migraine from developing.
• Do not take more than one tablet per 24 hours (one day).
• Use dry hands when opening the blister pack. Peel back the foil covering one of the blisters and gently remove the tablet. Do not try pushing the tablet through the foil. As soon as you have opened the blister, place the tablet on or under the tongue and it will disintegrate in saliva. No additional liquid is needed. Do not store a tablet outside of the blister pack.
• Nurtec ODT can be taken with or without food.
• If you have frequent migraines, talk to your doctor. It is not known if it is safe to use Nurtec ODT to treat more than 15 migraines within 30 days.
• Tell your doctor or other health care provider about all the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Let them know if you eat grapefruit or drink grapefruit juice. Nurtec ODT interacts with several medicines and it may not be safe to take them together.
• See your doctor immediately if you develop any signs of an allergic reaction after taking Nurtec ODT, such as shortness of breath or a rash.
• There is no data on the use of Nurtec ODT during pregnancy. Tell your doctor immediately if you become pregnant.

• Pain relief and freedom from migraine symptoms have been reported within 60 minutes of taking Nurtec ODT.
• Clinical trials showed that after 2 hours 21.2% of patients taking Nurtec ODT 75mg were pain-free compared to 10.9% of patients taking placebo. 59.3% reported pain relief at 2 hours and 35.1% were free of migraine symptoms of photophobia, phonophobia, or nausea at 2 hours. 13.5% of those taking Nurtec ODT reported sustained pain freedom over 48 hours compared with 5.4% of those assigned placebo.
• A phase 3 double-blind, randomized, placebo-controlled trial demonstrated that Nurtec was superior to placebo, decreasing monthly migraine days by 4.3 days/month after three months of treatment. The preventive effects of Nurtec were seen as early as the first week of therapy. Further, a key secondary endpoint result showed that approximately half of Nurtec-treated patients had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.
• Nurtec is generally well tolerated with the most common side effects being nausea (2.7% vs 0.8% in placebo) and stomach pain/indigestion (2.4% vs. 0.8% in placebo).

Medicines that interact with Nurtec ODT may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Nurtec ODT. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Nurtec ODT include:

• antibiotics, such as clarithromycin, ciprofloxacin, or nafcillin
• anticonvulsants, such as phenobarbital, phenytoin, or primidone
• antifungals, such as itraconazole or ketoconazole
• BCRP and/or P-gp only inhibitors such as quinidine, carvedilol, eltrombopag, or curcumin
• cancer treatments such as ceritinib
• chloramphenicol
• cyclosporine
• CYP3A4 strong inhibitors (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, or grapefruit). Avoid coadministration
• CYP3A4 moderate inhibitors (such as amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, or conivaptan). Avoid another dose of Nurtec ODT within 48 hours
• CYP3A4 strong or moderate inducers (such as phenobarbital, phenytoin, rifampicin, rifabutin, St. John's Wort, or glucocorticoids [eg, dexamethasone]). Avoid coadministration
• HIV medications such as cobicistat, indinavir, and ritonavir
• modafinil
• serotonin modulators, such as nefazodone and trazodone
• some heart medications, such as diltiazem, or verapamil
• St John's wort.

Avoid eating grapefruit or drinking grapefruit juice during treatment with Nurtec ODT because it may increase blood levels. If grapefruit has been consumed, avoid another dose of Nurtec ODT for 48 hours.

Note that this list is not all-inclusive and includes only common medications that may interact with Nurtec ODT. You should refer to the prescribing information for Nurtec ODT for a complete list of interactions.