Qulipta Tablet
These highlights do not include all the information needed to use QULIPTA safely and effectively. See full prescribing information for QULIPTA. QULIPTA ® (atogepant) tablets, for oral use Initial U.S. Approval: 2021: …
Uses and indications
QULIPTA is indicated for the preventive treatment of migraine in adults.
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 )].
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see Warnings and Precautions (
5.1
)]
- Hypertension [see Warnings and Precautions (
5.2
)]
- Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )]
Precautions
• Hypersensitivity Reactions: If a hypersensitivity reaction occurs, discontinue QULIPTA and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur days after administration. (5.1)
• Hypertension: New-onset or worsening of pre-existing hypertension may occur. (5.2)
• Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. (5.3) 5.1
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA [see Adverse Reactions (6.2)]. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy [see Contraindications (4)]. 5.
2
Hyper
tension
Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including QULIPTA, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. QULIPTA was discontinued in many of the reported cases.
Monitor patients treated with QULIPTA for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5.
3
Raynaud’s Phenomenon
Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including QULIPTA. In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.
QULIPTA should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.
Dosage
QULIPTA is taken orally with or without food.
Episodic Migraine
The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily.
Chronic Migraine
The recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily.
Dosage modifications and usage recommendations for episodic and chronic migraine with concomitant use of specific drugs and for patients with renal impairment are provided in Table 1.
Table 1: Dosage Modifications for Drug Interactions and for Specific Populations
| Dosage Modifications | Recommended Once Daily Dosage for Episodic Migraine | Usage and Recommended Once Daily Dosage for Chronic Migraine |
| Concomitant Drug [see Drug Interactions (7)] | ||
| Strong CYP3A4 Inhibitors ( 7.1 ) | 10 mg | 10 mg |
| Strong CYP3A4 Inducers ( 7.2 ) | 60 mga | Not recommended |
| Moderate CYP3A4 Inducers ( 7.2 ) | 60 mg | Not recommended |
| Weak CYP3A4 Inducers ( 7.2 ) | 30 mg or 60 mg | 60 mga |
| OATP Inhibitors ( 7.3 ) | 10 mg or 30 mg | 30 mg |
| Renal Impairment [see Use in Specific Populations (8)] | ||
| Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min) ( 8.6 ) | 10 mg | Not recommended |
a Coadministration decreases atogepant exposure. Monitor for reduced efficacy.
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.
Drug interactions
Recommended dosage modifications: • Strong CYP3A4 Inhibitors (2.2, 7.1): • Episodic or chronic migraine: 10 mg once daily
• Strong CYP3A4 Inducers (2.2, 7.2): • Episodic migraine: 60 mg once daily (monitor for reduced efficacy).
• Chronic migraine: Not recommended.
• Moderate CYP3A4 Inducers (2.2, 7.2): • Episodic migraine: 60 mg once daily.
• Chronic migraine: Not recommended.
• Weak CYP3A4 Inducers (2.2, 7.2): • Episodic migraine: 30 mg or 60 mg once daily.
• Chronic migraine: 60 mg once daily.
• OATP Inhibitors (2.2, 7.3): • Episodic migraine: 10 mg or 30 mg once daily.
• Chronic migraine: 30 mg once daily. 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)]. The recommended dosage of QULIPTA with concomitant use of strong CYP3A4 inhibitors is 10 mg once daily
[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 and OATP1B1 and OATP1B3 inhibitor, 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 Phar
macology (12.3)].
For episodic migraine, the recommended dosage of QULIPTA with concomitant use of strong or moderate CYP3A4 inducers is 60 mg once daily. During concomitant use of QULIPTA with strong CYP3A4 inducers, monitor monthly for signs of reduced efficacy, and consider alternative therapies if a reduction in efficacy is observed. The recommended dosage of QULIPTA with concomitant use of weak CYP3A4 inducers is 30 mg or 60 mg once daily
[see Dosage and Administration
(2.2)
].
For chronic migraine, concomitant use of strong or moderate CYP3A4 inducers with QULIPTA is not recommended. The recommended dosage of QULIPTA with concomitant use of weak CYP3A4 inducers is 60 mg once daily. Monitor monthly for signs of reduced efficacy, and consider alternative therapies if a reduction in efficacy is observed
[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)
].