Zavegepant

Zavzpret

10MG BASE/SPRAY spray, meteredÉtats-UnisCommercialiséAutorisé le 9 mars 2023

Contenu en anglais

Indications

ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ZAVZPRET is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ZAVZPRET is not indicated for the preventive treatment of migraine. ( 1 )

Contre-indications

ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. ( 4 )

Mises en garde et précautions d’emploi

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity reactions including anaphylaxis, facial swelling, and urticaria, have occurred with ZAVZPRET. ( 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 )

5.1Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, facial swelling, and urticaria, have occurred in patients treated with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy [see Contraindications (4) and Adverse Reactions (6.1 , 6.2) ].

5.2Hypertension Development

of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists in the postmarketing setting. Some of the patients receiving a CGRP antagonist 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.

Indications

Contre-indications

Mises en garde et précautions d’emploi

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity reactions including anaphylaxis, facial swelling, and urticaria, have occurred with ZAVZPRET. ( 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 )

5.1Hypersensitivity Reactions

5.2Hypertension Development

Effets indésirables

The following clinically significant adverse reactions are discussed in greater detail in other sections of 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) ] Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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 clinical practice. The safety of ZAVZPRET for the acute treatment of migraine in adults has been evaluated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2) in patients with migraine who received one 10 mg dose of ZAVZPRET nasal spray (N=1023) or placebo (N=1056) [see Clinical Studies (14) ] .

Approximately 83% were female, 81% were White, 20% were Hispanic or Latino, and 15% were Black. The mean age at study entry was 41 years (range 18-79 years of age). Adverse reactions in Study 1 and 2 are shown in Table 1. Table 1: Adverse Reactions Occurring in At Least 2% of Patients Treated with ZAVZPRET and at a Frequency Greater than Placebo in Study 1 and 2 Adverse Reaction ZAVZPRET N=1023 % Placebo N=1056 % Taste Disorders Taste disorders includes dysgeusia and ageusia 18 4 Nausea 4 1 Nasal Discomfort 3 1 Vomiting 2 <1 Hypersensitivity, including facial swelling and urticaria, occurred in less than 1% of patients treated with ZAVZPRET [see Contraindications (4) and Warnings and Precautions (5.1) ].

Long-term safety was assessed in an open-label extension study. That study evaluated 603 patients, dosing intermittently for up to one year, including 360 patients who were exposed to ZAVZPRET 10 mg for at least 6 months, and 298 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month.

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ZAVZPRET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity (e.g., anaphylaxis) [see Contraindications (4) and Warnings and Precautions (5.1) ] Vascular Disorders : Hypertension [see Warnings and Precautions (5.2) ] , Raynaud’s phenomenon [see Warnings and Precautions (5.3) ]

Zavzpret

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Hypersensitivity Reactions

5.2Hypertension Development

Deux médicaments dans une même question ?

Zavzpret

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Hypersensitivity Reactions

5.2Hypertension Development

Deux médicaments dans une même question ?

Interactions

7.1OATP1B3 or NTCP Inhibitors

7.2OATP1B3 or NTCP Inducers

7.3Intranasal Decongestants

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

6.1Clinical Trials Experience

6.2Postmarketing Experience

Conditionnements

Documents

Sources et licences

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