Qulipta 30mg Tablets
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
Sep 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Qulipta is a medication used to prevent migraine headaches in adults. 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. You can take this medication with or without food. If you're undergoing dialysis, take your dose after the dialysis treatment on the day of your procedure. If you have any questions or concerns, consult your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If you're undergoing dialysis, take your dose after the dialysis treatment on the day of your procedure. If you have any questions or concerns, consult your doctor.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Maintain a regular sleep schedule.
- Manage stress through relaxation techniques.
- Identify and avoid migraine triggers (e.g., certain foods, strong smells, lack of sleep).
- Stay hydrated and eat regular meals.
- Engage in regular, moderate exercise.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg once daily or 60 mg once daily
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
episodic_migraine:
10 mg, 30 mg, or 60 mg once daily
chronic_migraine:
60 mg once daily
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:
Recommended dose is 10 mg once daily (CrCl 15-29 mL/min)
Dialysis:
Avoid use in end-stage renal disease (CrCl <15 mL/min) or patients on dialysis
Hepatic Impairment:
Mild:
No adjustment needed (Child-Pugh A)
Moderate:
Recommended dose is 10 mg once daily (Child-Pugh B)
Severe:
Avoid use (Child-Pugh C)
Pharmacology
Mechanism of Action
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It works by blocking the binding of CGRP to its receptor, thereby inhibiting the CGRP pathway, which is implicated in migraine pathophysiology.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 24%
Tmax:
1 to 2 hours
FoodEffect:
High-fat meal reduces Cmax by 22% and AUC by 9% but is not considered clinically meaningful. Can be taken with or without food.
Distribution:
Vd:
292 L
ProteinBinding:
Approximately 96%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 11 hours
Clearance:
Not available
ExcretionRoute:
Primarily fecal (79%), minor renal (9%)
Unchanged:
Approximately 79% (fecal), 9% (renal)
Pharmacodynamics
OnsetOfAction:
Not directly measured for migraine prevention, but CGRP receptor blockade is rapid.
PeakEffect:
Not directly measured for migraine prevention.
DurationOfAction:
Sustained CGRP receptor blockade for 24 hours with once-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical help immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you notice any of the following or any other side effects that bother you or do not go away, contact your doctor:
- Upset stomach
- Constipation
- Feeling sleepy
- Feeling tired or weak
Important Note
This list does not include all possible 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.
If you experience any of the following symptoms, call your doctor or seek medical help immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you notice any of the following or any other side effects that bother you or do not go away, contact your doctor:
- Upset stomach
- Constipation
- Feeling sleepy
- Feeling tired or weak
Important Note
This list does not include all possible 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:
- Severe constipation or abdominal pain
- Unusual or severe nausea
- Signs of liver problems (though rare): yellowing of skin/eyes, dark urine, severe stomach pain, unusual tiredness
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 symptoms you experienced as a result of the allergy.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 symptoms you experienced as a result of the allergy.
If you have a history of kidney disease or liver disease, as these conditions may affect how your body processes the medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your treatment. Additionally, numerous medications can interact with this drug, so it is crucial that your doctor and pharmacist are aware of all the other medications you are taking, especially if you are using this medication to treat chronic migraine, as certain drugs should not be taken concurrently. If you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 300 mg were well-tolerated.
What to Do:
In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. Treatment should be symptomatic and supportive. Call 1-800-222-1222
Drug Interactions
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Co-administration significantly reduces atogepant exposure, leading to loss of efficacy. Avoid concomitant use.
Moderate Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): Co-administration increases atogepant exposure. Reduce atogepant dose to 10 mg once daily.
- Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin): Co-administration may reduce atogepant exposure. Consider increasing atogepant dose to 60 mg once daily if co-administered with moderate CYP3A4 inducers.
- OATP inhibitors (e.g., cyclosporine, rifampin, gemfibrozil): Co-administration may increase atogepant exposure. Reduce atogepant dose to 10 mg once daily.
Monitoring
Symptom Monitoring
- Frequency and severity of migraine attacks
- Nausea
- Constipation
- Fatigue
- Weight changes (rarely reported)
Special Patient Groups
Pregnancy
Limited human data on atogepant use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Consider the benefits and risks of Qulipta for the mother and any potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown, limited data.
Second Trimester:
Risk unknown, limited data.
Third Trimester:
Risk unknown, limited data.
Lactation
Atogepant is present in breast milk in animals. There are no data on the presence of atogepant 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 Qulipta and any potential adverse effects on the breastfed infant from Qulipta or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk - no human data, animal data suggest presence in milk, potential for adverse effects unknown).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in patients under 18 years of age.
Geriatric Use
No overall differences in effectiveness or safety were observed between patients 65 years of age and older and younger patients. No dose adjustment is required based on age alone, but consider age-related decline in renal function.
Clinical Information
Clinical Pearls
- Qulipta is a daily oral medication for migraine prevention, offering an alternative to injectable CGRP inhibitors.
- It is effective for both episodic and chronic migraine.
- Common side effects include constipation, nausea, and fatigue, which are generally mild to moderate.
- Dose adjustments are necessary for severe renal impairment, moderate hepatic impairment, and with concomitant use of strong CYP3A4 inhibitors or inducers, and OATP inhibitors.
- Patients should be advised on potential drug interactions, especially with certain antifungals, antivirals, and herbal supplements like St. John's Wort.
Alternative Therapies
- Other CGRP receptor antagonists (gepants): Rimegepant (Nurtec ODT), Zavegepant (Zavzpret)
- CGRP monoclonal antibodies (injectables): Erenumab (Aimovig), Fremanezumab (Ajovy), Galcanezumab (Emgality)
- Beta-blockers (e.g., propranolol, metoprolol)
- Antidepressants (e.g., amitriptyline, venlafaxine)
- Anticonvulsants (e.g., topiramate, valproate)
- OnabotulinumtoxinA (Botox) for chronic migraine
Cost & Coverage
Average Cost:
$1000 - $1200 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (Specialty)
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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.