Ubrelvy 100mg Tablets
It is used to treat migraine headaches.
Drug Class
Antimigraine agent
Pharmacologic Class
Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
Pregnancy Category
Not available
FDA Approved
Dec 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ubrelvy is a medication used to treat migraine headaches once they have started. 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 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
Keep your medication at room temperature in a dry location, avoiding storage in a bathroom.
Missing a Dose
Since this medication is taken as needed, do not take it more frequently than prescribed by your doctor.
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided 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
Keep your medication at room temperature in a dry location, avoiding storage in a bathroom.
Missing a Dose
Since this medication is taken as needed, do not take it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Take Ubrelvy as soon as a migraine attack begins.
- Do not take more than 200 mg in a 24-hour period.
- Inform your doctor about all other medications you are taking, especially antifungals, antibiotics, or seizure medications, as they can interact with Ubrelvy.
- Avoid grapefruit juice while taking Ubrelvy, as it can increase drug levels.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg or 100 mg orally, once. May take a second dose at least 2 hours after the initial dose if needed, not to exceed 200 mg in any 24-hour period.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
initial_dose:
50 mg or 100 mg
second_dose_interval:
at least 2 hours after initial dose
max_daily_dose:
200 mg within 24 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed (CrCl 60-89 mL/min)
Moderate:
No dose adjustment needed (CrCl 30-59 mL/min)
Severe:
Avoid 100 mg dose. Max 50 mg/24 hours (CrCl < 30 mL/min, including ESRD)
Dialysis:
Max 50 mg/24 hours. Not studied in patients on dialysis.
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
Ubrogepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist. It works by blocking the binding of CGRP to its receptor, thereby inhibiting CGRP-mediated vasodilation and pain signal transmission associated with migraine.
Pharmacokinetics
Absorption:
Bioavailability:
27%
Tmax:
1.5 hours
FoodEffect:
High-fat meal delays Tmax by 2 hours, decreases Cmax by 23%, and AUC by 12%. Can be taken with or without food.
Distribution:
Vd:
95 L
ProteinBinding:
97%
CnssPenetration:
Limited
Elimination:
HalfLife:
5-7 hours
Clearance:
Not available
ExcretionRoute:
Fecal (42%), Renal (33%)
Unchanged:
4.2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour for pain relief
PeakEffect:
1.5 hours
DurationOfAction:
Up to 24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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
- 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
Note that this list is not exhaustive, and you may experience other side effects. 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 medical attention 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
- 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
Note that this list is not exhaustive, and you may experience other side effects. 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:
- Severe allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of liver problems (unusual tiredness, yellowing of skin/eyes, dark urine, nausea, vomiting, abdominal pain)
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 the safety and efficacy of the 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 problems with your doctor and pharmacist to ensure safe and effective 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 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 the safety and efficacy of the 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 problems with your doctor and pharmacist to ensure safe and effective 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 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. While most reactions happen within minutes or hours after taking the drug, some may occur days later. If you experience any unusual symptoms after receiving this medication, 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. While most reactions happen within minutes or hours after taking the drug, some may occur days later. If you experience any unusual symptoms after receiving this medication, 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:
- Nausea
- Somnolence
- Other adverse effects experienced at higher intensity
What to Do:
Call 1-800-222-1222 (Poison Control) or seek emergency medical attention immediately.
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)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., cyclosporine, fluconazole, verapamil, ciprofloxacin, grapefruit juice)
- P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP) inhibitors (e.g., cyclosporine, quinidine)
Monitoring
Routine Monitoring
Migraine pain and associated symptoms
Frequency: As needed after dosing
Target: Reduction or resolution of symptoms
Action Threshold: Lack of efficacy after 2 hours, consider second dose or alternative treatment
Adverse effects (e.g., nausea, somnolence, dry mouth)
Frequency: During treatment
Target: Tolerable
Action Threshold: Severe or persistent adverse effects warrant re-evaluation
Symptom Monitoring
- Headache pain intensity
- Nausea
- Photophobia
- Phonophobia
- Somnolence
- Dry mouth
Special Patient Groups
Pregnancy
Limited data on Ubrelvy use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies did not show adverse developmental effects. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal data suggest low risk.
Second Trimester:
Limited human data, animal data suggest low risk.
Third Trimester:
Limited human data, animal data suggest low risk.
Lactation
Low levels of ubrogepant are present in human milk. 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:
Low risk (L3)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly (≥65 years) and younger patients. However, 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
- Ubrelvy is an acute migraine treatment and is not indicated for migraine prevention.
- It can be taken with or without food.
- Patients should be advised to take the medication as soon as migraine symptoms begin.
- Unlike triptans, Ubrelvy does not cause vasoconstriction, making it a potential option for patients with cardiovascular risk factors, though caution is still advised.
- Ensure patients are aware of significant drug interactions, especially with strong CYP3A4 inhibitors and inducers.
Alternative Therapies
- Other CGRP receptor antagonists (gepants) for acute treatment (e.g., rimegepant, zavegepant)
- Triptans (e.g., sumatriptan, zolmitriptan)
- NSAIDs (e.g., ibuprofen, naproxen)
- Ergot alkaloids (e.g., dihydroergotamine)
- Combination analgesics (e.g., acetaminophen/aspirin/caffeine)
Cost & Coverage
Average Cost:
$1000 - $1200 per 8 tablets (50mg or 100mg)
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
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 medication taken, the amount, and the time it occurred.