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Drug Safety-related Labeling Changes (SrLC)

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QULIPTA (NDA-215206)

(ATOGEPANT)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/17/2023 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

Newly added information:

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)].

5 Warnings and Precautions

Newly added section:

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)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

6.2 Postmarketing Experience

Newly added subsection

The following adverse reactions have been identified during post approval use of QULIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, rash, pruritus, urticaria, facial edema) [see Contraindications (4) and Warnings and Precautions (5.1)]

7 Drug Interactions

7.1 CYP3A4 Inhibitors

Additions and/or revisions underlined:

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

Newly added information:

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

Additions and/or revisions underlined:

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)].

8 Use in Specific Populations

8.6 Renal Impairment

Additions and/or revisions underlined:

The renal route of elimination plays a minor role in the clearance of atogepant [see Clinical Pharmacology (12.3)]. For episodic migraine, in patients with severe renal impairment

(CLcr 15-29 mL/min) and in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min), the recommended dosage of QULIPTA is 10 mg once daily; in patients with ESRD undergoing intermittent dialysis, QULIPTA should preferably be taken after dialysis [see Dosage and Administration (2.2)]. For chronic migraine, avoid use of QULIPTA in patients with severe renal impairment and in patients with ESRD. No dose adjustment is recommended for patients with mild or moderate renal impairment.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Hypersensitivity Reactions

Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with QULIPTA. Advise patients to discontinue QULIPTA and seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.1)].

PATIENT INFORMATION

Additions and/or revisions underlined:

Do not take QULIPTA if you:

have had an allergic reaction to atogepant or any ingredients in QULIPTA. See the end of this Patient Information leaflet for a complete list of ingredients in QULIPTA.

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

The most common side effects of QULIPTA include: nausea, constipation, and fatigue/sleepiness.