Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Qulipta
Product Details
Qulipta
Product Details
Qulipta
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
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Indications and Usage (1) |
4/2023 |
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Dosage and Administration (2.1, 2.2) |
4/2023 |
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Contraindications (4) |
4/2023 |
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Warnings and Precautions (5.1) |
4/2023 |
INDICATIONS & USAGE SECTION
Highlight: QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. (1)
1****INDICATIONS AND USAGE
QULIPTA is indicated for the preventive treatment of migraine in adults.
DOSAGE FORMS & STRENGTHS SECTION
Highlight: Tablets: 10 mg, 30 mg, and 60 mg. (3)
3****DOSAGE FORMS AND STRENGTHS
QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side.
QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side.
QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side.
CONTRAINDICATIONS SECTION
Highlight: Patients with a history of hypersensitivity to atogepant or to any of the components of QULIPTA. (4)
4****CONTRAINDICATIONS
QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA. Reactions have included anaphylaxis and dyspnea [see Warnings and Precautions (5.1)].
DRUG INTERACTIONS SECTION
Highlight: Recommended dosage modifications:
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Strong CYP3A4 Inhibitor (2.2, 7.1):
○ Episodic migraine: 10 mg once daily.
○ Chronic migraine: avoid use. -
Strong, Moderate, or Weak CYP3A4 Inducers (2.2, 7.2):
○ Episodic migraine: 30 mg or 60 mg once daily.
○ Chronic migraine: avoid use. -
OATP Inhibitors (2.2, 7.3):
○ Episodic migraine: 10 mg or 30 mg once daily.
○ Chronic migraine: 30 mg once daily.
7** DRUG INTERACTIONS**
7.1****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 (12.3)]. For episodic migraine, the recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once daily. For chronic migraine, avoid concomitant use of strong CYP3A4 inhibitors with QULIPTA [see Dosage and Administration (2.2)]. No dosage adjustment of QULIPTA is needed with concomitant use of moderate or weak CYP3A4 inhibitors.
7.2****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 [see Clinical Pharmacology (12.3)]. 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 [see Clinical Pharmacology (12.3)].
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 Dosage and Administration (2.2)].
For chronic migraine, avoid concomitant use of strong, moderate, or weak CYP3A4 inducers with QULIPTA [see Dosage and Administration (2.2)].
7**.3****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 (12.3)]. 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 Dosage and Administration (2.2)].
SPL PATIENT PACKAGE INSERT SECTION
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PATIENT INFORMATION | |
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What isQULIPTA?
It is not known if QULIPTA is safe and effective in children. | |
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Do not take QULIPTA if you:
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Before you takeQULIPTA tell your healthcare provider about all of your medical conditions, including if you:
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. | |
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Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine. | |
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How should I takeQULIPTA?
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What are the possible side effects ofQULIPTA? | |
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The most common side effects of****QULIPTA****include**:** nausea,
constipation, and fatigue/sleepiness. | |
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How should I storeQULIPTA?
KeepQULIPTA and all medicines out of the reach of children. | |
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General information about the safe and effective use ofQULIPTA. | |
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What are the ingredients inQULIPTA? Manufactured for: |
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 6/2023
20078877