Adenovirus Type 4 and Type 7 Vaccine Live Oral and Sirturo Tablets

• Generic Name: adenovirus vaccine
• Dosage Forms: n.a.
• Other Brand Names: Adenovirus Type 4 and Type 7 Vaccine Live Oral

Prevention of febrile acute respiratory disease caused by adenovirus type 4 and type 7. Labeled by FDA for use in military populations 17 through 50 years of age; not commercially available for use in other individuals. (See Restricted Distribution under Dosage and Administration.)

Adenoviruses, especially adenovirus type 4 and type 7, commonly cause acute respiratory disease (e.g., runny nose, fever, sore throat, breathing problems, cough, headache, croup, bronchitis). Certain adenovirus serotypes cause other illnesses (e.g., conjunctivitis, keratoconjunctivitis, otitis media, gastroenteritis, cystitis). Disseminated or life-threatening infections can occur (e.g., severe pneumonia, hepatitis, meningitis, encephalitis). Adenoviruses spread person to person via direct contact, respiratory droplet transmission, or food and/or water contaminated with feces. Fomites also may be involved in transmission since adenoviruses survive for long periods outside of the body, including on environmental surfaces, and are unusually stable when exposed to chemical and physical agents or adverse pH conditions.

Military recruits are at increased risk of acute respiratory illnesses during basic training because of several factors, including close sleeping and training environments where transmission of respiratory pathogens is facilitated, congregation of young adults arriving from wide geographic distributions who may enter basic training carrying pathogens capable of being spread to others who are immunologically susceptible, and stressful nature of basic training and military operations. Adenoviruses, especially adenovirus type 4 and type 7, are a well documented cause of acute respiratory illness in military recruits; adenoviruses reportedly cause 50–80% of cases of acute respiratory disease in this population. Outbreaks of adenovirus-associated disease also occur in other populations (e.g., healthcare-associated outbreaks), but the combination of sustained transmission and relatively high and predictable attack rates of adenovirus-associated respiratory disease appears to be unique to military basic trainees.

US Department of Defense (DOD) requires that all enlisted US military recruits 17 through 50 years of age receive a single dose of adenovirus type 4 and type 7 vaccine live oral at the earliest opportunity upon arrival at initial entry training (basic military training), unless contraindicated (see Contraindications under Cautions). May also be recommended for other military personnel at high risk for adenovirus infection, but not required for cadre working at enlisted basic training sites.

• Generic Name: bedaquiline
• Dosage Forms: tablet
• Other Brand Names: Sirturo

Treatment of pulmonary multidrug-resistant tuberculosis (i.e., caused by Mycobacterium tuberculosis resistant to isoniazid and rifampin) in conjunction with other antituberculosis agents.

Designated an orphan drug by FDA for use in treatment of active tuberculosis.

Use only when an effective treatment regimen for multidrug-resistant tuberculosis cannot otherwise be provided.

Safety and efficacy for treatment of drug-susceptible tuberculosis, extrapulmonary (e.g., CNS) tuberculosis, or latent tuberculosis infection not established; use not recommended.

Safety and efficacy for treatment of infections caused by nontuberculous mycobacteria (NTM) not established; use not recommended.

Patients with multidrug-resistant tuberculosis are at high risk for treatment failure and acquisition of further drug resistance. ATS, CDC, and IDSA recommend that such patients be referred to or that consultation be obtained from a specialized treatment center as identified by local or state health departments or the CDC.