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warnings and cautions
5 WARNINGS AND PRECAUTIONS • 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 ) 5.1 Hypersensitivity 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) ]. 5.2 Hypertension 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. The CGRP antagonist was discontinued in many of the reported cases. Monitor patients treated with ZAVZPRET for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of ZAVZPRET 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. 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. ZAVZPRET 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.
6 ADVERSE REACTIONS 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 . 6.1 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 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. 6.2 Postmarketing 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) ]