Qulipta 60mg Tablets
It is used to prevent migraine headaches.
Drug Class
Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
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 substance in your body called CGRP, which is involved in causing migraine pain. By blocking CGRP, Qulipta helps reduce the number of migraine days you experience.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If you're undergoing dialysis, take your medication after your dialysis treatment on the day of treatment. If you have any questions or concerns, be sure to discuss them with your doctor.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally friendly way to dispose of your medication.
What to Do If You Miss 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 get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If you're undergoing dialysis, take your medication after your dialysis treatment on the day of treatment. If you have any questions or concerns, be sure to discuss them with your doctor.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally friendly way to dispose of your medication.
What to Do If You Miss 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
- Take Qulipta exactly as prescribed, usually once daily, with or without food.
- Qulipta is for migraine prevention, not for treating a migraine attack once it has started.
- Continue to identify and avoid migraine triggers (e.g., certain foods, stress, lack of sleep).
- Maintain a regular sleep schedule.
- Stay hydrated.
- Engage in regular, moderate exercise.
- Manage stress through relaxation techniques.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg orally once daily
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
episodic migraine prevention:
10 mg, 30 mg, or 60 mg orally once daily
chronic migraine prevention:
60 mg orally once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 60-89 mL/min)
Moderate:
No dosage adjustment needed (CrCl 30-59 mL/min)
Severe:
10 mg orally once daily (CrCl 15-29 mL/min)
Dialysis:
Avoid use in patients with end-stage renal disease (CrCl <15 mL/min) or on dialysis
Hepatic Impairment:
Mild:
No dosage adjustment needed (Child-Pugh A)
Moderate:
No dosage adjustment needed (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 CGRP-mediated signaling. CGRP is a neuropeptide that is involved in nociceptive transmission and is released during migraine attacks.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 9%
Tmax:
1-2 hours
FoodEffect:
A high-fat meal reduces Cmax by 22% and AUC by 9%, but this is not considered clinically significant. Can be taken with or without food.
Distribution:
Vd:
29-39 L
ProteinBinding:
Approximately 96%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 11 hours
Clearance:
Not available
ExcretionRoute:
Primarily fecal (79%), with a minor renal component (9%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Not applicable for preventive treatment; clinical efficacy observed over weeks.
PeakEffect:
Not applicable for preventive treatment; sustained effect with daily dosing.
DurationOfAction:
24 hours (due to once-daily dosing)
Confidence:
Medium
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, 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
- Constipation
- Feeling sleepy
- Feeling tired or weak
Additional Information
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.
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, 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
- Constipation
- Feeling sleepy
- Feeling tired or weak
Additional Information
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 or persistent constipation
- Severe nausea or vomiting
- Unusual fatigue or weakness
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing) - seek immediate medical attention.
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.
If you have a history of kidney disease or liver disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or modify 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.
If you have a history of kidney disease or liver disease.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.
Remember, do not start, stop, or modify 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. Some medications should not be taken concurrently with this drug, and your healthcare team needs to be aware of your full medication regimen. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Limited information on overdose symptoms. In clinical trials, doses up to 300 mg once daily for 5 days were well-tolerated.
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Provide supportive care as clinically indicated.
Drug Interactions
Major Interactions
- Strong/Moderate CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Avoid co-administration due to potential for significant decrease in atogepant exposure and loss of efficacy.
Moderate Interactions
- Strong CYP3A4 Inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir): Reduce Qulipta dose to 10 mg or 30 mg once daily.
- OATP Inhibitors (e.g., cyclosporine, rifampin): Reduce Qulipta dose to 10 mg or 30 mg once daily.
Monitoring
Routine Monitoring
Migraine frequency and severity
Frequency: Monthly or as clinically indicated
Target: Reduction in migraine days
Action Threshold: Lack of significant improvement after 3 months of treatment may warrant re-evaluation or dose adjustment.
Adverse effects (e.g., constipation, nausea, fatigue)
Frequency: Regularly, especially during initial treatment
Target: Tolerable levels
Action Threshold: Persistent or severe adverse effects may require dose adjustment or discontinuation.
Symptom Monitoring
- Constipation
- Nausea
- Fatigue
- Somnolence
- Abdominal pain
- Weight changes
Special Patient Groups
Pregnancy
Available data on QULIPTA use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Consider the benefits and risks of QULIPTA for the mother and the potential risks to the fetus.
Trimester-Specific Risks:
First Trimester:
Insufficient data
Second Trimester:
Insufficient data
Third Trimester:
Insufficient data
Lactation
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:
Unknown
Pediatric Use
The safety and effectiveness of QULIPTA in pediatric patients have not been established. Not indicated for use in patients younger than 18 years of age.
Geriatric Use
No overall differences in effectiveness or safety were observed between elderly patients (65 years and older) and younger adult patients. No dosage adjustment is required based on age alone.
Clinical Information
Clinical Pearls
- Qulipta is the first and only oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention.
- It offers an oral alternative for patients who prefer not to use injectable CGRP monoclonal antibodies.
- Patients should be counseled on potential drug interactions, especially with strong CYP3A4 inducers/inhibitors and OATP inhibitors.
- Constipation is a common side effect; advise patients on adequate hydration and fiber intake.
- Efficacy for migraine prevention is typically assessed after 2-3 months of consistent daily use.
Alternative Therapies
- Other oral CGRP receptor antagonists (e.g., rimegepant, zavegepant - though rimegepant is also approved for acute treatment, zavegepant is acute only)
- Injectable CGRP monoclonal antibodies (e.g., erenumab, fremanezumab, galcanezumab)
- Beta-blockers (e.g., propranolol, metoprolol)
- Anticonvulsants (e.g., topiramate, valproate)
- Tricyclic antidepressants (e.g., amitriptyline)
- OnabotulinumtoxinA (Botox) for chronic migraine
Cost & Coverage
Average Cost:
$900 - $1200 per 30 tablets
Insurance Coverage:
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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.