Ubrelvy 50mg Tablets
It is used to treat migraine headaches.
Drug Class
Antimigraine agent
Pharmacologic Class
Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
Pregnancy Category
Not assigned (narrative)
FDA Approved
Dec 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ubrelvy is a medication used to treat migraine headaches once they start. It works by blocking a protein in your body called CGRP, which is involved in causing migraine pain. It is not used to prevent migraines.
How to Use This Medicine
Taking Your Medication
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines. You can take this medication with or without food. It is best to take it as soon as possible after the onset of an attack. If necessary, a second dose may be taken, but consult your doctor first to determine if an additional dose is suitable for you. Be sure to understand the required waiting period between doses.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. This will help maintain its potency and ensure safety.
Missing a Dose
Since this medication is taken as needed, you do not need to follow a strict dosing schedule. However, do not take it more frequently than prescribed by your doctor. If you have any questions or concerns about your medication regimen, consult your healthcare provider for guidance.
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines. You can take this medication with or without food. It is best to take it as soon as possible after the onset of an attack. If necessary, a second dose may be taken, but consult your doctor first to determine if an additional dose is suitable for you. Be sure to understand the required waiting period between doses.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. This will help maintain its potency and ensure safety.
Missing a Dose
Since this medication is taken as needed, you do not need to follow a strict dosing schedule. However, do not take it more frequently than prescribed by your doctor. If you have any questions or concerns about your medication regimen, consult your healthcare provider for guidance.
Lifestyle & Tips
- Take Ubrelvy as soon as a migraine attack begins.
- Do not take more than 200 mg in a 24-hour period.
- Avoid known migraine triggers (e.g., certain foods, stress, lack of sleep).
- Maintain good hydration and a regular sleep schedule.
- Discuss all other medications, including over-the-counter drugs and herbal supplements, with your doctor to avoid drug interactions.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg or 100 mg orally, once. May repeat 50 mg or 100 mg dose at least 2 hours after the initial dose if needed.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
Maximum daily dose:
200 mg within a 24-hour period
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-89 mL/min)
Moderate:
No adjustment needed (CrCl 30-59 mL/min)
Severe:
Initial 50 mg, optional second 50 mg dose after 2 hours. Max 100 mg/24 hours (CrCl <30 mL/min)
Dialysis:
Not studied in patients with end-stage renal disease on dialysis. Use with caution.
Hepatic Impairment:
Mild:
No adjustment needed (Child-Pugh A)
Moderate:
No adjustment needed (Child-Pugh B)
Severe:
Initial 50 mg, optional second 50 mg dose after 2 hours. Max 100 mg/24 hours (Child-Pugh C)
Pharmacology
Mechanism of Action
Ubrogepant is a small molecule CGRP receptor antagonist. It works by blocking the binding of CGRP to its receptor, thereby inhibiting CGRP-induced vasodilation and nociceptive transmission, which are believed to play a role in migraine pathophysiology.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 8%
Tmax:
1 to 1.5 hours
FoodEffect:
High-fat meal delays Tmax by 2-4 hours and decreases Cmax by 25-35%, but AUC is not significantly affected. Can be taken with or without food.
Distribution:
Vd:
350 L
ProteinBinding:
Approximately 92%
CnssPenetration:
Yes
Elimination:
HalfLife:
5 to 7 hours
Clearance:
Not available
ExcretionRoute:
Feces (42%), Urine (33%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 1 hour for pain relief
PeakEffect:
Not specifically quantified for peak effect on migraine symptoms, but Tmax is 1-1.5 hours.
DurationOfAction:
Up to 24 hours for sustained pain relief
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
- 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:
- Upset stomach
- Feeling sleepy
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. 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 immediate medical attention:
- 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:
- Upset stomach
- Feeling sleepy
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice about side effects, contact your doctor. 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 an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Severe nausea or vomiting that persists
- Unusual fatigue or somnolence
- Any new or worsening symptoms
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, including any symptoms that occurred.
If you have kidney disease, as this may affect your ability to take this medication.
* Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken concurrently.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. Therefore, it is vital to discuss all of your medications and health issues with your doctor and pharmacist to ensure safe treatment.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one. This will help prevent potential interactions or adverse effects and ensure that you can take this medication safely with your other medications and health conditions.
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, including any symptoms that occurred.
If you have kidney disease, as this may affect your ability to take this medication.
* Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this drug and should not be taken concurrently.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may be relevant to your treatment with this medication. Therefore, it is vital to discuss all of your medications and health issues with your doctor and pharmacist to ensure safe treatment.
To guarantee your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one. This will help prevent potential interactions or adverse effects and ensure that you can take this medication safely with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
Be aware that allergic reactions can occur with this medication. These reactions often happen within minutes or hours after administration, but in some cases, they may occur days later. If you experience any unusual symptoms after receiving this drug, contact your doctor immediately.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.
Be aware that allergic reactions can occur with this medication. These reactions often happen within minutes or hours after administration, but in some cases, they may occur days later. If you experience any unusual symptoms after receiving this drug, contact your doctor immediately.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Limited clinical experience with overdose. Symptoms may include nausea, somnolence, or other exaggerated adverse effects.
What to Do:
No specific antidote. Treatment should be symptomatic and supportive. Consider contacting a poison control center (e.g., 1-800-222-1222).
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir)
Major Interactions
- Strong or moderate CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) - Avoid co-administration.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., cyclosporine, fluconazole, verapamil, ciprofloxacin, diltiazem, erythromycin, grapefruit juice) - Reduce Ubrelvy dose to 50 mg, avoid second dose within 24 hours.
- P-gp/BCRP inhibitors (e.g., cyclosporine, quinidine, elacestrant) - Monitor for increased ubrogepant exposure.
Confidence Interactions
Monitoring
Symptom Monitoring
- Migraine headache pain relief
- Resolution of associated migraine symptoms (nausea, photophobia, phonophobia)
- Occurrence of adverse reactions (e.g., nausea, somnolence, dry mouth)
- Signs of hypersensitivity reaction (e.g., rash, urticaria, angioedema)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Ubrelvy in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No human data; animal studies showed adverse developmental effects at high doses.
Second Trimester:
No human data.
Third Trimester:
No human data.
Lactation
There are no data on the presence of ubrogepant in human milk, the effects on the breastfed infant, or the effects on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Ubrelvy and any potential adverse effects on the breastfed infant from Ubrelvy or from the underlying maternal condition.
Infant Risk:
Risk unknown; low oral bioavailability suggests low systemic exposure in infant, but caution advised due to lack of data.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly (≥65 years) and younger patients. No specific dose adjustment is required based on age, but consider age-related decreases in renal and hepatic function and concomitant medications.
Clinical Information
Clinical Pearls
- Ubrelvy is an acute migraine treatment, not for prevention.
- It can be taken with or without food.
- Patients should be advised to take the medication as soon as migraine symptoms begin.
- Crucial to review concomitant medications for potential CYP3A4 interactions, especially strong inhibitors or inducers.
- Unlike triptans, Ubrelvy is not vasoconstrictive and may be an option for patients with cardiovascular risk factors, though data is still accumulating.
Alternative Therapies
- Other CGRP receptor antagonists (gepants) for acute treatment (e.g., rimegepant, zavegepant)
- Triptans (e.g., sumatriptan, zolmitriptan)
- NSAIDs (e.g., ibuprofen, naproxen)
- Ditans (e.g., lasmiditan)
- Ergot alkaloids (e.g., dihydroergotamine)
- Combination analgesics (e.g., acetaminophen/aspirin/caffeine)
Cost & Coverage
Average Cost:
$1000 - $1200 per 8 tablets
Insurance Coverage:
Tier 3 or Tier 4 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.