WARNINGS
Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. See the section ADDITIONAL INFORMATION below, for a complete list of ingredients in QULIPTA.
USES
QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults.
It is not known if QULIPTA is safe and effective in children.
HOW TO USE
How should I take QULIPTA?
Take QULIPTA by mouth with or without food.
Take QULIPTA exactly as your healthcare provider tells you to take it.
QULIPTA can cause serious side effects, including:
Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction:
swelling of the face, lips, or tongue
itching
trouble breathing
hives
rash
High blood pressure: High blood pressure or worsening of high blood pressure can happen when you take QULIPTA. Contact your healthcare provider if you have an increase in blood pressure.
Raynaud’s phenomenon: A type of circulation problem can worsen or happen when you take QULIPTA. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.
The most common side effects of QULIPTA include: nausea, constipation, and fatigue/sleepiness.
These are not all of the possible side effects of QULIPTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QULIPTA for a condition for which it was not prescribed. Do not give QULIPTA to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about QULIPTA that is written for health professionals.
What are the ingredients in QULIPTA?
Active ingredient: atogepant
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store QULIPTA at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
Keep QULIPTA and all medicines out of the reach of children
NOTES
Medication Guide: revision date 06/2025
Prescribing Information: revision date 06/2025
1.) CYP3A4 Inhibitors
Coadministration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a
significant increase in exposure of atogepant in healthy subjects. The recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once daily (see the section USES above. No dosage adjustment of QULIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors.
2.) CYP3A4 Inducers
Coadministration of QULIPTA with steady state rifampin, a strong CYP3A4 inducer, resulted in a significant decrease in exposure of atogepant in healthy subjects.. Concomitant administration of QULIPTA with moderate inducers of CYP3A4 can also result in decreased exposure of atogepant. Coadministration of QULIPTA with steady-state topiramate, a weak CYP3A4 inducer, resulted in decreased exposure of atogepant in healthy subjects.
For episodic migraine, the recommended dosage of QULIPTA with concomitant use of strong,
moderate, or weak CYP3A4 inducers is 30 mg or 60 mg once daily [see the section USES above].
For chronic migraine, avoid concomitant use of strong, moderate, or weak CYP3A4 inducers
with QULIPTA [see the section USES above].
3.) OATP Inhibitors
Coadministration of QULIPTA with single dose rifampin, an OATP inhibitor, resulted in asignificant increase in exposure of atogepant in healthy subjects. For episodic migraine, the recommended dosage of QULIPTA with concomitant use of OATP inhibitors is 10 mg or 30 mg once daily. For chronic migraine, the recommended dosage of QULIPTA with concomitant use of OATP inhibitors is 30 mg once daily [see the section USES above].
Before you take QULIPTA tell your healthcare provider about all of your medical conditions, including if you:
have high blood pressure.
have circulation problems in your fingers and toes.
have kidney problems or are on dialysis.
have liver problems.
are pregnant or plan to become pregnant. It is not known if QULIPTA will harm your unborn baby.
Pregnancy Registry: There is a pregnancy registry for women who take QULIPTA. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-833-277-0206 to enroll in this registry. You can also visit http://empresspregnancyregistry.com.
are breastfeeding or plan to breastfeed. Very small amounts of QULIPTA pass into breast milk. Talk to your healthcare provider if you plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines.
Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine.
