Qulipta
- Generic Name: atogepant tablets
- Brand Name: Qulipta
Qulipta (Atogepant Tablets) side effects drug center
Qulipta Side Effects Center
What Is Qulipta?
Qulipta (atogepant) is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of episodic migraine in adults.
What Are Side Effects of Qulipta?
Side effects of Qulipta include:
- nausea,
- constipation,
- fatigue, and
- decreased appetite.
Dosage for Qulipta
The recommended dosage of Qulipta is 10 mg, 30 mg, or 60 mg taken orally once daily with or without food.
Qulipta In Children
Safety and effectiveness of Qulipta in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Qulipta?
Qulipta may interact with other medicines such as:
- strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin),
- strong and moderate CYP3A4 inducers (e.g., rifampin, carbamazepine,
- phenytoin, St. John’s wort, efavirenz, etravirine), and
- OATP inhibitors (e.g., cyclosporine).
Tell your doctor all medications and supplements you use.
Qulipta During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Qulipta; it may harm a fetus. It is unknown if Qulipta passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Qulipta (atogepant) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Qulipta and how is it used?
QULIPTA is a prescription medicine used for the preventive treatment of episodic migraine in adults.
It is not known if QULIPTA is safe and effective in children.
What are the possible side effects of QULIPTA?
The most common side effects of QULIPTA include:
- nausea,
- constipation, and
- fatigue.
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.
Qulipta Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of QULIPTA was evaluated in 1958 patients with migraine who received at least one dose of QULIPTA. Of these, 839 patients were exposed to QULIPTA once daily for at least 6 months, and 487 patients were exposed for 12 months.
In the 12-week, placebo-controlled clinical studies (Study 1 and Study 2), 314 patients received at least one dose of QULIPTA 10 mg once daily, 411 patients received at least one dose of QULIPTA 30 mg once daily, 417 patients received at least one dose of QULIPTA 60 mg once daily, and 408 patients received placebo [see Clinical Studies]. Approximately 88% were female, 80% were White, 17% were Black, and 12% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range 18 to 74 years).
The most common adverse reactions (incidence at least 4% and greater than placebo) are nausea, constipation, and fatigue.
Table 2 summarizes the adverse reactions that occurred during Study 1 and Study 2.
Table 2: Adverse Reactions Occurring with an Incidence of At Least 2% for QULIPTA and Greater than Placebo in Studies 1 and 2
| Placebo (N= 408) % |
QULIPTA 10 mg (N=314) % |
QULIPTA 30 mg (N=411) % |
QULIPTA 60 mg (N=417) % |
|
| Nausea | 3 | 5 | 6 | 9 |
| Constipation | 1 | 6 | 6 | 6 |
| F atigue/ Somnolence | 3 | 4 | 4 | 6 |
| Decreased Appetite | <1 | 2 | 1 | 2 |
The adverse reactions that most commonly led to discontinuation in Studies 1 and 2 were constipation (0.5%), nausea (0.5%), and fatigue/somnolence (0.5%).
Liver Enzyme Elevations
In Study 1 and Study 2, the rate of transaminase elevations over 3 times the upper limit of normal was similar between patients treated with QULIPTA (1.0%) and those treated with placebo (1.8%). However, there were cases with transaminase elevations over 3 times the upper limit of normal that were temporally associated with QULIPTA treatment; these were asymptomatic, and resolved within 8 weeks of discontinuation. There were no cases of severe liver injury or jaundice.
Decreases In Body Weight
In Studies 1 and 2, the proportion of patients with a weight decrease of at least 7% at any point was 2.8% for placebo, 3.8% for QULIPTA 10 mg, 3.2% for QULIPTA 30 mg, and 4.9% for QULIPTA 60 mg.
DRUG INTERACTIONS
CYP3A4 Inhibitors
Coadministration of QULIPTA with itraconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see CLINICAL PHARMACOLOGY]. The recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) is 10 mg once daily [see DOSAGE AND ADMINISTRATION]. No dosage adjustment of QULIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors.
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 [see CLINICAL PHARMACOLOGY]. Concomitant administration of QULIPTA with moderate inducers of CYP3A4 can also result in decreased exposure of atogepant. The recommended dosage of QULIPTA with concomitant use of strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort, efavirenz, etravirine) is 30 mg or 60 mg once daily [see DOSAGE AND ADMINISTRATION]. No dosage adjustment of QULIPTA is needed with concomitant use of weak CYP3A4 inducers.
OATP Inhibitors
Coadministration of QULIPTA with single dose rifampin, an OATP inhibitor, resulted in a significant increase in exposure of atogepant in healthy subjects [see CLINICAL PHARMACOLOGY]. The recommended dosage of QULIPTA with concomitant use of OATP inhibitors (e.g., cyclosporine) is 10 mg or 30 mg once daily [see DOSAGE AND ADMINISTRATION].
Read the entire FDA prescribing information for Qulipta (Atogepant Tablets)
&Copy; Qulipta Patient Information is supplied by Cerner Multum, Inc. and Qulipta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.