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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Anaphylactic reactions have been reported in patients receiving miconazole. Discontinue ORAVIG immediately at the first sign of hypersensitivity (5.1). 5.1 Hypersensitivity Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. Discontinue ORAVIG immediately at the first sign of hypersensitivity. There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC Marietta, GA 30067 at 1-833-757-0904 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects. HIV Infected Patients Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25). In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are presented in Table 1. Table 1 Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 290 (%) Clotrimazole troches N = 287 (%) Patients with any adverse reaction during the study 158 (54.5) 146 (50.9) Gastrointestinal disorders Diarrhea Nausea Vomiting Dry mouth Abdominal pain upper 25.9 9.0 6.6 3.8 2.8 1.7 23.7 8.0 7.7 3.1 1.7 2.8 Infections and infestations Upper respiratory infection Gastroenteritis 15.9 2.1 1.4 17.1 2.4 2.8 Nervous system disorders Headache Ageusia 13.1 7.6 2.4 8.4 6.6 0.3 Blood and lymphatic disorders Anemia Lymphopenia Neutropenia 6.9 2.8 1.7 0.7 8.4 1.7 2.1 2.1 General disorders and administration site conditions Fatigue Pain 6.6 2.8 1.0 8.0 2.1 2.8 Respiratory/thoracic Cough Pharyngeal pain 5.2 2.8 0.7 7.7 1.7 2.4 Investigations Increased GGT 5.5 1.0 6.3 2.8 Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches. Head and Neck Cancer Patients In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used ORAVIG once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥2% of patients in either arm are listed in Table 2. Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial) Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 147 (%) Miconazole gel N = 147 (%) Patients with at least one adverse reaction 30 (20.4) 32 (21.8) Gastrointestinal disorders Abdominal pain, upper Oral discomfort Nausea Vomiting Glossodynia 8.8 1.4 2.7 0.7 0.7 0 13.6 2.0 2.7 2.7 2.0 2.0 Nervous system disorders Dysgeusia 5.4 4.1 1.4 0 Skin and subcutaneous Pruritus 3.4 2.0 0.7 0.7 Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain, were experienced by 14 (9.5%) patients who used ORAVIG compared to 16 (10.9%) patients who used miconazole gel. Overall ORAVIG Safety Experience In Patients and Healthy Subjects Adverse reactions reported in the overall safety database of 480 subjects who received miconazole buccal tablet is listed in Table 3. Table 3 Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received ORAVIG in Clinical Trials Adverse reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 480 (%) Patients with at least one AE 209 (43.5) Gastrointestinal disorders Diarrhea Nausea Abdominal pain upper Vomiting 20.6 6.0 4.6 2.5 2.5 Infections and infestations 11.9 Nervous system disorders Headache Dysgeusia 10.6 5.0 2.9 Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.