Nurtec 75mg ODT Tablets
It is used to treat migraine headaches. It is used to prevent migraine headaches.
Drug Class
Antimigraine agent
Pharmacologic Class
Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
Pregnancy Category
Not available
FDA Approved
Feb 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nurtec ODT is a medication used to treat migraine headaches when they occur (acute treatment) and to help prevent them from happening as often (preventive treatment). It works by blocking a protein in your body called CGRP, which is involved in causing migraine pain.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. When you're ready to take your dose, remove the tablet from the blister pack. To do this, peel back the foil on the blister, but avoid pushing the tablet out of the foil. Use dry hands to carefully take the tablet out of the foil. Place the tablet on your tongue and let it dissolve. You don't need to drink water with it, and be sure not to chew, break, or crush the tablet. If needed, you can also dissolve the tablet under your tongue.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep the tablets in their original blister pack. Make sure to store all medications in a safe location, out of the reach of children and pets. When you're finished with your medication or it's expired, dispose of it properly. Don't flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you're taking this medication to treat migraines, use it as needed, but don't take it more often than your doctor advises. If you're taking it to prevent migraines and you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Never take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. When you're ready to take your dose, remove the tablet from the blister pack. To do this, peel back the foil on the blister, but avoid pushing the tablet out of the foil. Use dry hands to carefully take the tablet out of the foil. Place the tablet on your tongue and let it dissolve. You don't need to drink water with it, and be sure not to chew, break, or crush the tablet. If needed, you can also dissolve the tablet under your tongue.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep the tablets in their original blister pack. Make sure to store all medications in a safe location, out of the reach of children and pets. When you're finished with your medication or it's expired, dispose of it properly. Don't flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you're taking this medication to treat migraines, use it as needed, but don't take it more often than your doctor advises. If you're taking it to prevent migraines and you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Never take two doses at the same time or take extra doses.
Lifestyle & Tips
- Identify and avoid migraine triggers (e.g., certain foods, stress, lack of sleep).
- Maintain a regular sleep schedule.
- Stay hydrated.
- Manage stress through relaxation techniques.
- Engage in regular, moderate exercise.
- Limit caffeine and alcohol intake.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
75 mg orally as needed for acute treatment (max 75 mg/24 hours); or 75 mg orally every other day for preventive treatment.
Dose Range:
75 - 75 mg
Condition-Specific Dosing:
acute_migraine:
75 mg orally once daily as needed. Maximum 75 mg in 24 hours.
preventive_migraine:
75 mg orally every other day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
75 mg orally as needed for acute treatment (12 to <18 years of age); or 75 mg orally every other day for preventive treatment (12 to <18 years of age).
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed.
Moderate:
No dose adjustment needed.
Severe:
Avoid use (CrCl < 30 mL/min).
Dialysis:
Avoid use in ESRD.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A).
Moderate:
No dose adjustment needed (Child-Pugh B).
Severe:
Avoid use (Child-Pugh C).
Pharmacology
Mechanism of Action
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It reversibly blocks the CGRP receptor, thereby inhibiting the biological activity of CGRP, which is implicated in migraine pathophysiology.
Pharmacokinetics
Absorption:
Bioavailability:
64%
Tmax:
1.5 hours
FoodEffect:
High-fat meal delays Tmax by 1 hour and reduces Cmax by 42%, but AUC is not significantly affected. Can be taken with or without food.
Distribution:
Vd:
120 L
ProteinBinding:
96%
CnssPenetration:
Limited
Elimination:
HalfLife:
11 hours
Clearance:
Not available
ExcretionRoute:
Fecal (77%), Renal (18%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 1 hour (for acute migraine)
PeakEffect:
Not available
DurationOfAction:
Up to 48 hours (for acute migraine relief)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Upset stomach
- Stomach pain
- Heartburn
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Upset stomach
- Stomach pain
- Heartburn
Note: This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Signs of liver problems: unusual tiredness, nausea, vomiting, dark urine, yellowing of skin or eyes (jaundice), pain in the upper right side of your stomach.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Existing health conditions, particularly kidney disease or liver disease.
Recent use (within the last 48 hours) of certain medications, including amiodarone, cyclosporine, lapatinib, quinidine, or ranolazine.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. This is especially important for medications used to treat HIV, infections, seizures, and other conditions.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing regimen.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Existing health conditions, particularly kidney disease or liver disease.
Recent use (within the last 48 hours) of certain medications, including amiodarone, cyclosporine, lapatinib, quinidine, or ranolazine.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. This is especially important for medications used to treat HIV, infections, seizures, and other conditions.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing regimen.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, you must discuss this with your doctor. This conversation will help you understand the benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- No specific overdose symptoms reported in clinical trials. Doses up to 600 mg were well-tolerated. Symptoms would likely be an exaggeration of known side effects (e.g., nausea, somnolence).
What to Do:
Contact a poison control center immediately (1-800-222-1222) or seek emergency medical attention. No specific antidote. Treatment is supportive.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ritonavir)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)
- Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin)
Major Interactions
- Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole, verapamil) - avoid concomitant use.
Moderate Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, quinidine, amiodarone) - may increase rimegepant exposure.
- CYP2C9 inhibitors (e.g., fluconazole, amiodarone) - may increase rimegepant exposure.
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: Rimegepant is primarily metabolized by the liver. While not routinely required for all patients, consider for those with pre-existing liver disease or risk factors.
Timing: Prior to initiating treatment, if clinically indicated.
Routine Monitoring
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, if clinically indicated (e.g., signs/symptoms of liver injury, or in patients with pre-existing liver conditions).
Target: Within normal limits
Action Threshold: Discontinue if transaminase levels increase to >3 times ULN or if patient develops jaundice or other signs/symptoms of liver injury.
Migraine frequency and severity
Frequency: Ongoing
Target: Reduction in migraine days/severity
Action Threshold: Lack of efficacy may warrant re-evaluation of treatment plan.
Symptom Monitoring
- Signs/symptoms of hypersensitivity reactions (e.g., rash, urticaria, facial swelling, dyspnea)
- Signs/symptoms of liver injury (e.g., nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice)
- Efficacy in reducing migraine frequency/severity
- Common adverse effects (e.g., nausea, somnolence, dry mouth)
Special Patient Groups
Pregnancy
There are no adequate data on the developmental risk associated with the use of rimegepant in pregnant women. Animal studies did not show adverse developmental effects at clinically relevant exposures. A pregnancy exposure registry is available.
Trimester-Specific Risks:
First Trimester:
No human data. Animal data suggest no increased risk.
Second Trimester:
No human data. Animal data suggest no increased risk.
Third Trimester:
No human data. Animal data suggest no increased risk.
Lactation
Low levels of rimegepant are present in human milk. The amount is unlikely to cause adverse effects in a breastfed infant. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Nurtec ODT, and any potential adverse effects on the breastfed infant from Nurtec ODT or from the underlying maternal condition.
Infant Risk:
Low risk
Pediatric Use
Approved for acute and preventive treatment of migraine in adolescents 12 to <18 years of age. Safety and effectiveness in pediatric patients younger than 12 years of age have not been established.
Geriatric Use
No dose adjustment is required. Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Nurtec ODT is an orally disintegrating tablet (ODT) that does not require water, making it convenient for patients experiencing migraine symptoms.
- It has a dual indication for both acute treatment and preventive treatment of migraine, offering flexibility in management.
- Unlike triptans, rimegepant does not cause vasoconstriction, making it a potential option for patients with cardiovascular risk factors where triptans may be contraindicated.
- Patients should be advised on the proper administration of the ODT: peel back the foil, do not push through, and place on or under the tongue where it will dissolve rapidly.
- Due to significant CYP3A4 metabolism, careful consideration of drug-drug interactions is crucial, especially with strong/moderate CYP3A4 inhibitors and inducers.
Alternative Therapies
- Other CGRP receptor antagonists (e.g., ubrogepant, zavegepant, atogepant)
- Injectable CGRP monoclonal antibodies (e.g., erenumab, fremanezumab, galcanezumab, eptinezumab)
- Triptans (e.g., sumatriptan, zolmitriptan, rizatriptan)
- NSAIDs (e.g., ibuprofen, naproxen)
- Ergot alkaloids (e.g., dihydroergotamine)
- Other preventive migraine medications (e.g., topiramate, valproic acid, beta-blockers, tricyclic antidepressants, botulinum toxin type A)
Cost & Coverage
Average Cost:
$1000 - $1200 per 8 tablets
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.