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Package Insert Individuals using assistive technology may not be able to fully access the information contained in this file. For assistance, please send an e-mail to: [email protected] and include 508 Accommodation and the title of the document in the subject line of your e-mail. HIGHLIGHTS OF PRESCRIBING INFORMATION ___________________ CONTRAINDICATIONS ___________________ These highlights do not include all the information needed to use • Pregnancy (4.1, 8.1). Adenovirus Type 4 and Type 7 Vaccine, Live, Oral safely and effectively. • Severe allergic reaction (e.g., anaphylaxis) to any component of See full prescribing information for Adenovirus Type 4 and Type 7 Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a Contraindication. Vaccine, Live, Oral. (4.2, 11) • Inability to swallow the tablets whole without chewing. (4.3) Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Enteric Coated Tablets for Oral Administration _______________ WARNINGS AND PRECAUTIONS _______________ Initial U.S. Approval: 2011 • Safety and effectiveness have not been evaluated in persons with primary _________________ _________________ or acquired immunodeficiency states. (5.1) RECENT MAJOR CHANGES • Vaccinees and individuals who come in close contact with vaccinees may Warnings and Precautions, Planning for Pregnancy (5.3) 10/2019 be exposed to the vaccine viruses shed in the stool for up to 28 days. Proper __________________ _________________ personal hygiene can minimize this risk. (5.2) INDICATIONS AND USAGE • Vaccinees should exercise caution when in close contact with children less Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for than 7 years of age, immunocompromised individuals and pregnant women active immunization for the prevention of febrile acute respiratory disease during the 28 days following vaccination. (5.2) caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 • Use effective contraception for 6 weeks after vaccination to avoid Vaccine, Live, Oral is approved for use in military populations 17 through 50 pregnancy. (5.3) years of age. (1) ___________________ ___________________ _______________ ______________ ADVERSE REACTIONS DOSAGE AND ADMINISTRATION The most common (≥ 5%) systemic adverse reactions observed in clinical • A single vaccine dose is administered orally as two tablets: one tablet of trials were upper respiratory tract infections, headache, nasal congestion, Adenovirus Type 4 and one tablet of Adenovirus Type 7. (2) pharyngolaryngeal pain, cough, arthralgia, nausea, abdominal pain, diarrhea, • Each of the two tablets should be swallowed whole. The tablets should not and vomiting. (6) be chewed or crushed to avoid releasing the live adenovirus in the upper respiratory tract. To report SUSPECTED ADVERSE REACTIONS, contact Teva • Postpone administration in vaccinees with vomiting and/or diarrhea. Pharmaceuticals at 1-8888-483-8279 or VAERS at 1-800-822-7967 or ______________ _____________ http://vaers.hhs.gov. DOSAGE FORMS AND STRENGTHS A single oral dose consists of one Adenovirus Type 4 tablet and one ______________ USE IN SPECIFIC POPULATIONS _______________ Adenovirus Type 7 tablet. (3) Administration during pregnancy is contraindicated (4.1). See 17 for PATIENT COUNSELING INFORMATION Revised: 10/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 8.1 Pregnancy 8.2 Lactation 1 INDICATIONS AND USAGE 8.3 Females and Males of Reproductive Potential 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 3 DOSAGE FORMS AND STRENGTHS 8.5 Geriatric Use 4 CONTRAINDICATIONS 11 DESCRIPTION 4.1 Pregnancy 12 CLINICAL PHARMACOLOGY 4.2 Severe Allergic Reaction 12.1 Mechanism of Action 4.3 Inability to Swallow 12.2 Pharmacodynamics 5 WARNINGS AND PRECAUTIONS 13 NONCLINICAL PHARMACOLOGY 5.1 Altered Immunocompetence 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.2 Shedding and Transmission 14 CLINICAL STUDIES 5.3 Planning for Pregnancy 14.1 Multicenter Safety and Efficacy Trial 5.4 Human Serum Albumin 15 REFERENCES 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Trials Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience 7 DRUG INTERACTIONS *Sections or subsections omitted from the full prescribing information 7.1 Concomitant Vaccine Administration are not listed. 7.2 Immunosuppressive Therapies 8 USE IN SPECIFIC POPULATIONS 1 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a vaccine indicated for active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age. 2 DOSAGE AND ADMINISTRATION A single vaccine dose is administered orally as two tablets: one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7. (2) The tablets should be swallowed whole, without chewing, to avoid releasing the virus in the upper respiratory tract [See Mechanism of Action (12.1)]. Postpone administration to individuals with vomiting and/or diarrhea because the effectiveness of the vaccine depends upon the multiplication of orally administered live adenovirus within the intestinal tract [See Mechanism of Action (12.1)]. 3 DOSAGE FORMS AND STRENGTHS A single vaccine dose consists of two tablets: one tablet of Adenovirus Type 4 and one tablet of Adenovirus Type 7. 4 CONTRAINDICATIONS 4.1 Pregnancy Adenovirus Type 4 and Type 7 Vaccine, Live, Oral should not be administered to pregnant females [See Pregnancy (8.1)]. It is not known whether Adenovirus Type 4 and Type 7 Vaccine, Live, Oral can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naturally occurring infection with adenoviruses has been associated with fetal harm. Pregnancy should be avoided for 6 weeks following receipt of vaccine. 4.2 Severe Allergic Reaction Severe allergic reaction (e.g., anaphylaxis) to any component of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is a Contraindication [See Description (11)]. 4.3 Inability to Swallow Adenovirus Type 4 and Type 7 Vaccine, Live, Oral should not be administered to individuals incapable of swallowing each entire tablet, whole, without chewing. Chewing a tablet could 2 expose the upper respiratory tract to live adenovirus leading to disease [See Mechanism of Action (12.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Altered Immunocompetence The safety and effectiveness of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral in immunocompromised individuals has not been evaluated. 5.2 Shedding and Transmission Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains live viruses that are shed in the stool and can cause disease if transmitted. People who come in close contact with those who were vaccinated, including other vaccinees, may be exposed to the virus present in the stool and may develop disease [See Pharmacodynamics (12.2)]. Persons vaccinated with Adenovirus Type 4 and Type 7 Vaccine, Live, Oral should exercise caution when in close contact with children less than 7 years of age and immunocompromised individuals such as those with HIV infection and cancer, or those receiving immunosuppressive therapy during the 28 day period of viral shedding following the vaccination [See Use in Specific Populations (8.3) and Pharmacodynamics (12.2)]. Vaccinees should exercise caution when in close contact with pregnant women during the 28 day period of shedding because fetal harm may result if pregnant women are exposed to adenovirus [See Pregnancy (8.1) and Pharmacodynamics (12.2)]. 5.3 Planning for Pregnancy Use effective contraception for 6 weeks after vaccination to avoid pregnancy [See Pregnancy (8.1)]. 5.4 Human Serum Albumin Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains albumin, a derivative of human blood. It is present at concentrations of <0.3 mg/tablet. Based on effective donor screening, and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmissions of viral diseases or CJD have ever been identified for human albumin. 3 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to the rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. Multicenter Safety and Efficacy Trial Safety of Adenovirus Type 4 and Type 7 Vaccine, Live, Oral was evaluated in a multicenter, double-blind, randomized, placebo-controlled study that enrolled 3031 subjects who received vaccine and 1009 subjects who received placebo (lactose tablets). The study was conducted in healthy male (63%) and female (37%) active duty US Army and Navy military recruits during their basic training. The population had a mean age of 21 years, with an age range of 17 to 42 years. Race was 62% Caucasian, 18% African-American, 11% Hispanic, 3% Asian and 6% other. Subjects in both groups were administered other vaccines concomitantly with Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. The specific vaccines that each subject received varied and were dependent on their immunization history. The vaccines that were co-administered included Hepatitis A Vaccine, Inactivated (Merck & Co., Inc.), Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine (GlaxoSmithKline
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