6.7.1) DECONTAMINATION
A) Decontamination is not indicated.
6.7.2) TREATMENT
A) MONITORING OF PATIENT 1) HIGH RISK CASES: Testing should be performed on individuals with acute febrile respiratory illness or sepsis-like syndrome, in some cases (e.g., the elderly, infants, and immunocompromised) presentation may be atypical (Centers for Disease Control and Prevention, 2009). Priority testing is indicated for hospitalized patients and those who are at high-risk for severe disease.
2) SUSPECTED CASES: Confirmatory testing is not required for all individuals with suspected novel H1N1. Clinical judgement and state and local recommendations should be considered when testing is being considered (Centers for Disease Control and Prevention, 2009).
3) RT-PCR - Swine influenza real time reverse transcription-polymerase chain reaction (RT-PCR) Detection Panel developed by the CDC has been approved by the FDA to test for the presumptive presence of novel H1N1 influenza. Viral culture may also be used for confirmation, but is unlikely to be available for timely management decisions (Centers for Disease Control and Prevention, 2009; Centers for Disease Control and Prevention, 2009).
4) Negative rapid influenza antigen tests and negative immunofluorescence (DFA or IFA) tests should not be considered final diagnostic tests for H1N1 infections; false negative results may occur (Centers for Disease Control and Prevention, 2009).
5) Monitor respiratory function and fluid balance. Routine laboratory tests are not necessary, unless otherwise indicated. Obtain chest x-ray in symptomatic patients.
B) SUPPORT 1) Individuals with mild to moderate novel H1N1 infection that are being cared for at home should not leave the home or travel unless medically necessary for 7 days after the onset of symptoms or until they are symptom free for 24 hours. Sick persons should avoid close contact (less than 6 feet away) as much as possible, cover coughs and sneezes, and wash hands frequently with soap and water or an alcohol-based hand cleanser. Clinical judgement should guide treatment decisions for patients who are not at high risk or those who are not hospitalized. Treatment is symptomatic and supportive and includes non-aspirin antipyretics for fever or pain, and fluids (oral rehydration or intravenous fluid replacement as necessary). Antiviral therapy may be considered.
2) For patients requiring hospitalization, or patients at high risk for influenza complications who have confirmed, probable, or suspected novel influenza A infection, antiviral therapy (i.e., zanamivir or oseltamivir) should be given. Other treatments should include intravenous or oral rehydration, supplemental oxygen therapy, antibiotics for secondary bacterial infections, non-aspirin antipyretics for pain and fever and nutritional supplementation as necessary. As of the Fall 2009, peramivir, an unapproved agent, has emergency use authorization by the Food and Drug Administration for the treatment of hospitalized adults and pediatric patients with suspected or known H1N1 infection who are not responding to oral or inhaled antiviral therapy.
C) OSELTAMIVIR 1) IMPORTANT NOTE a) As of June 23, 2010, the emergency use authorization allowing the unapproved use of oseltamivir will no longer be in effect for the 2009 H1N1 influenza. Any patient who began treatment prior to June 23, 2010 may be allowed to complete the treatment course if deemed medically necessary (US Food and Drug Administration, 2010).
2) ADULT a) TREATMENT: 75 mg orally twice a day for 5 days (Centers for Disease Control and Prevention, 2009).
b) CHEMOPROPHYLAXIS: 75 mg orally once a day for 10 days after last known exposure to an ill confirmed case (Centers for Disease Control and Prevention, 2009).
3) PREGNANT OR BREASTFEEDING WOMEN a) TREATMENT: Pregnant women with confirmed, probable or suspected H1N1 should receive antiviral treatment, even if more than 48 hours have elapsed since the onset of symptoms; preferably oseltamivir because of its systemic activity (Centers for Disease Control and Prevention, 2009; Centers for Disease Control and Prevention, 2009q).
b) PROPHYLAXIS: Pregnant women who are close contacts with persons with suspected, probable, or confirmed cases H1N1 should receive chemoprophylaxis. The choice of drug for prophylaxis is unclear; either oseltamivir or zanamivir may be used. An advantage of zanamivir is its limited systemic absorption, but respiratory complications and medication delivery system challenges should be considered (Centers for Disease Control and Prevention, 2009).
c) BACKGROUND: The H1N1 infection and accompanying hyperthermia may put the fetus at risk for complications, such as birth defects and preterm delivery (Centers for Disease Control and Prevention, 2009).
d) SAFETY: No adverse effects have been reported among women who used oseltamivir or zanamivir during pregnancy or among infants born to women using these agents (Centers for Disease Control and Prevention, 2009).
e) LACTATION: Women may continue breastfeeding while receiving antivirals (Centers for Disease Control and Prevention, 2009).
4) PEDIATRIC a) TREATMENT: Dosing for infants and children (based on emergency use of oseltamivir) who have been exposed to H1N1 (Centers for Disease Control and Prevention, 2009; US Food and Drug Administration, 2009):I 1) For infants less than one year of age, the recommended treatment dose (for 5 days) is weight-based dosing* (US Food and Drug Administration, 2009): a) Less than 12 months: 3 mg/kg/dose twice a day for 5 days
1) ALTERNATE DOSE: For infants less than one year of age, if weight unknown, the recommended dose is by age*(US Food and Drug Administration, 2009): a) Infants less than 3 months: 12 mg (1 mL) orally twice daily for 5 days
b) Infants 3 to 5 months: 20 mg (1.6 mL) orally twice daily for 5 days
c) Infants 6 to 11 months: 25 mg (2 mL) orally twice daily for 5 days
1) For children older than one year of age, the recommended dosing is as follows (US Food and Drug Administration, 2009): a) Infants 1 to 2 years and 15 kg or less: 60 mg orally per day divided into two doses for 5 days
b) Children 3 to 5 years and 16 to 23 kg: 90 mg orally per day divided into two doses for 5 days
c) Children 6 to 9 years and 24 to 40 kg: 120 mg orally per day divided into two doses for 5 days
d) Children 10 years of age and greater than 40 kg: 150 mg orally per day divided into two doses
1) *Note: Dosing is based on emergency use as approved by the FDA (US Food and Drug Administration, 2009)
b) CHEMOPROPHYLAXIS: Prophylactic dosing for infants and children based on emergency use after last known exposure to an ill confirmed case (US Food and Drug Administration, 2009; Centers for Disease Control and Prevention, 2009; US Food and Drug Administration, 2009): 1) Infants less than 3 months: NOT recommended unless situation is judged critical due to limited data in this age group*(US Food and Drug Administration, 2009) 2) For infants 3 months to less than 12 months, the recommended prophylactic dose (for 10 days) is weight-based dosing* (US Food and Drug Administration, 2009): a) 3 months to less than 12 months: 3 mg/kg/dose once daily for 10 days
1) ALTERNATE DOSE: For infants less than one year of age, if weight unknown, the recommended prophylactic dose is by age* (US Food and Drug Administration, 2009): a) Infants 3 to 5 months: 20 mg (1.6 mL) orally once daily for 10 days
b) Infants 6 to 11 months: 25 mg (2 mL) orally once daily for 10 days
1) For children older than one year of age, the recommended dosing is as follows (US Food and Drug Administration, 2009): a) Infants 1 to 2 years and 15 kg or less: 30 mg orally once daily for 10 days
b) Children 3 to 5 years and 16 to 23 kg: 45 mg orally once daily for 10 days
c) Children 6 to 9 years and 24 to 40 kg: 60 mg orally once daily for 10 days
d) Children greater than 10 years and greater than 40 kg: 75 mg orally once daily for 10 days
c) *Note: Dosing is based on emergency use as approved by the FDA (US Food and Drug Administration, 2009) D) ZANAMIVIR 1) IMPORTANT NOTE a) As of June 23, 2010, the emergency use authorization allowing the unapproved use of zanamivir will no longer be in effect for the 2009 H1N1 influenza. Any patient who began treatment prior to June 23, 2010 may be allowed to complete the treatment course if deemed medically necessary (US Food and Drug Administration, 2010).
2) ADULT a) TREATMENT: Two 5 mg inhalations (10 mg total) twice per day for 5 days(Centers for Disease Control and Prevention, 2009).
b) CHEMOPROPHYLAXIS: Two 5 mg inhalations (10 mg total) once per day for 10 days after last known exposure to confirmed case (Centers for Disease Control and Prevention, 2009).
3) PREGNANT OR BREASTFEEDING WOMEN a) TREATMENT: Pregnant women with confirmed, probable or suspected H1N1 should receive antiviral treatment, even if more than 48 hours have elapsed since the onset of symptoms; preferably oseltamivir because of its systemic activity (Centers for Disease Control and Prevention, 2009; Centers for Disease Control and Prevention, 2009q).
b) PROPHYLAXIS: Pregnant women who are close contacts with persons with suspected, probable, or confirmed cases H1N1 should receive chemoprophylaxis. The choice of drug for prophylaxis is unclear; either oseltamivir or zanamivir may be used. An advantage of zanamivir is its limited systemic absorption, but respiratory complications and medication delivery system challenges should be considered (Centers for Disease Control and Prevention, 2009).
c) BACKGROUND: The H1N1 infection and accompanying hyperthermia may put the fetus at risk for complications, such as birth defects and preterm delivery (Centers for Disease Control and Prevention, 2009).
d) SAFETY: No adverse effects have been reported among women who used oseltamivir or zanamivir during pregnancy or among infants born to women using these agents (Centers for Disease Control and Prevention, 2009).
e) LACTATION: Women may continue breastfeeding while receiving antivirals (Centers for Disease Control and Prevention, 2009).
4) PEDIATRIC a) TREATMENT: Dosing for children 7 years of age or older: 10 mg (2 oral inhalations) twice daily for 5 days (US Food and Drug Administration, 2009).
b) CHEMOPROPHYLAXIS: For children greater than or equal to 5 years: 10 mg (2 oral inhalations) once a day for 10 days after last known exposure to a confirmed case (US Food and Drug Administration, 2009).
E) PERAMIVIR 1) IMPORTANT NOTE: As of June 23, 2010, peramivir is no longer authorized for emergency use by the US Food and Drug Administration for 2009 H1N1 influenza. Any patient who began treatment prior to June 23, 2010 may be allowed to complete the treatment course if deemed medically necessary (US Food and Drug Administration, 2010). 2) TREATMENT: Authorized for emergency use by the Food and Drug Administration for the treatment of certain hospitalized patients with known or suspected 2009 H1N1 influenza. As of the Fall 2009, it remains unapproved and is currently in phase 3 clinical trials (Centers for Disease Control and Prevention, 2009). a) Peramivir is authorized for use for the following patients (Centers for Disease Control and Prevention, 2009): 1) Patient NOT responding to either oral or inhaled antiviral therapy;
2) Drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not possible;
3) Healthcare provider determines IV therapy is appropriate due to other circumstances
b) Peramivir is manufactured for BioCryst Pharmaceuticals, Inc., and it was distributed to the CDC, which then distributed it to hospitals under their direction and guidance (Centers for Disease Control and Prevention, 2009). For further information on FDA-authorized emergency use of peramivir visit the CDC website at: www.cdc.gov/h1n1flu/eua. 3) DOSING a) ADULT 1) STANDARD DOSE: Administer 600 mg once a day intravenously (diluted in 0.9% or 0.45% sodium chloride) over 30 minutes for 5 to 10 days. Do not give as an intramuscular injection. It may be given beyond 10 days based on the patient's condition (e.g., respiratory failure or intensive care admission, continued viral shedding, or unresolved clinical influenza illness) (Centers for Disease Control and Prevention, 2009).
b) PEDIATRIC 1) Dosing is based on modeling only; no pediatric patients have received peramivir during clinical trials. The dose (see below) should be infused over 60 minutes once daily over 5 days or 10 days as clinically indicated. The maximum daily dose should not exceed 600 mg IV daily. Peramivir should be diluted in 0.9% or 0.45% sodium chloride (Centers for Disease Control and Prevention, 2009). a) RECOMMENDED DOSING is based on a mg/kg dose according to the patient's age and given intravenously (Centers for Disease Control and Prevention, 2009) : 1) Birth through 30 days: 6 mg/kg
2) 31 days through 90 days: 8 mg/kg
3) 91 days through 180 days: 10 mg/kg
4) 181 days through 5 years: 12 mg/kg
5) 6 years through 17 years: 10 mg/kg
4) SPECIAL POPULATIONS a) PREGNANT WOMEN: As of the Fall 2009, no adequate and well-controlled studies of peramivir have been conducted in pregnant women. Currently, the use during pregnancy only if the potential benefit justifies the potential risk to the mother and the fetus (Centers for Disease Control and Prevention, 2009).
b) NURSING WOMEN: As of the Fall 2009, peramivir has not been studied in nursing women. In animal studies, it is excreted in milk (Centers for Disease Control and Prevention, 2009).
c) PEDIATRIC: Currently, peramivir has not be given to any pediatric patients during clinical trials. Based on limited use, intravenous therapy has been given under emergency IND procedures (Centers for Disease Control and Prevention, 2009).
F) VACCINE 1) NOVEL H1N1 VACCINE a) Seasonal influenza vaccines are unlikely to elicit a protective antibody response to H1N1. As of the Fall 2009, a novel H1N1 vaccine is available to select individuals. It is anticipated that as the more vaccine is available other individuals will be able to receive the vaccine; likely late in 2009.
b) Five manufacturers (i.e., Sanofi Pasteur, Novartis, ID Biomedical Corp (distributed by Glaxo Smith Kline), Medimmune and CSL) are producing the vaccine for the US, and it is available in an inactivated form in multi-dose vials and single dose syringes (i.e., preservative free) for young children and pregnant women (Centers for Disease Control and Prevention, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine, 2009; Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine IM injection, 2009; Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine intramuscular injection, 2009). A live monovalent influenza A (H1N1) intranasal vaccine is also available (Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine Live Intranasal spray, 2009).
2) CDC GUIDELINES/INITIAL VACCINE DISTRIBUTION 1) Pregnant women
2) Persons who live with or provide care for infants less than 6 months of age, to include parents, siblings, and daycare providers
3) Healthcare and emergency medical services personnel
4) Individuals 6 months to 24 years of age
5) Individuals 25 to 64 years of age with underlying medical conditions that increase their risk of influenza-related complications. These conditions include chronic pulmonary disease; cardiovascular disease (except hypertension); renal, hepatic, cognitive, neurologic, neuromuscular, hematologic, or metabolic disorders (including diabetes); and immunosuppressive conditions
1) Pregnant women
2) Persons who live with or provide care for infants less than 6 months of age, to include parents, siblings, and daycare providers
3) Healthcare and emergency medical services personnel who have direct contact with patients or infectious material
4) Individuals 6 months to 4 years of age
5) Individuals 5 to 18 years of age with underlying medical conditions that increase their risk of influenza-related complications
a) The CDC's Advisory Committee on Immunization Practices (ACIP) is recommending that 5 groups of individuals receive the vaccine initially. These groups were targeted because they are at higher risk of influenza or its complications, they are likely to encounter and potentially transmit the virus because of their occupations in healthcare settings, or they are in close contact with infants under 6 months of age who cannot be vaccinated. The target groups for initial vaccination include, in no particular priority (Centers for Disease Control and Prevention, 2009s):
b) Once the demand for the 5 target groups has been met, vaccination efforts should be expanded to include all individuals 25 to 64 years of age. In the event that insufficient vaccine supply is available to meet the demand for the 5 target groups, the following groups should receive priority for vaccination, in no particular priority (Centers for Disease Control and Prevention, 2009s):
c) NOTE: These guidelines may change as more is understood about individuals at highest risk to develop potential complications (i.e., other age groups) from the H1N1 virus.
d) The H1N1 vaccine will not replace the seasonal influenza vaccine; individuals should receive both vaccines (Centers for Disease Control and Prevention, 2009). Receipt of recent (2005 to 2009) seasonal influenza vaccines is unlikely to elicit a protective antibody response to the novel H1N1 virus (Centers for Disease Control and Prevention, 2009).
e) Simultaneous administration of inactivated seasonal and H1N1 vaccines is acceptable assuming different anatomical sites are used for administration (Centers for Disease Control and Prevention, 2009s).
G) INFLUENZA A VIRUS VACCINE, H1N1, LIVE 1) INDICATION a) As of the Fall 2009, the live Influenza A (H1N1) 2009 Monovalent Vaccine is indicated for active immunization of individuals 2 to 49 years of age against influenza disease caused by the pandemic (H1N1) 2009 virus (Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine Live Intranasal spray, 2009).
2) CHILDREN 2 THROUGH 9 YEARS a) Administer 2 doses (0.2 mL each) intranasally approximately one month apart (Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine Live Intranasal spray, 2009).
3) CHILDREN, ADOLESCENTS AND ADULTS (10 TO 49 YEARS) a) Administer 1 dose of 0.2 mL vaccine intranasally (Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine Live Intranasal spray, 2009).
H) INFLUENZA A VIRUS VACCINE, H1N1, INACTIVATED 1) INDICATION a) As of the Fall 2009, the inactivated Influenza A (H1N1) 2009 Monovalent Vaccine is indicated for active immunization of individuals against influenza disease caused by the pandemic (H1N1) 2009 virus. Three manufacturers currently have vaccine available based on age group: 1) CSL vaccine is indicated for individuals 6 months of age and older (Prod Info AFLURIA(R) intramuscular injection, solution, 2009)
2) Novartis vaccine is indicated for individuals 4 years of age and older (Prod Info Influenza A (H1N1) Monovalent Vaccine, 2009)
3) Sanofi vaccine is indicated for individuals 6 months of age and older (Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009)
2) INFANTS 6 THROUGH 35 MONTHS a) CHILDREN 6 months through 35 months of age: Administer two doses of the 0.25 mL, preservative-free, inactivated influenza A (H1N1) virus vaccine intramuscularly one month apart. At the time of this review, CSL and Sanofi Pasteur have both been approved in children 6 months of age and older (Prod Info AFLURIA(R) intramuscular injection, solution, 2009; Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009).
3) CHILDREN 4 THROUGH 9 YEARS OF AGE a) CHILDREN 36 months through 9 years of age: Administer two doses of the 0.5 mL, inactivated influenza A (H1N1) virus vaccine intramuscularly one month apart. At the time of this review, CSL and Sanofi Pasteur vaccines have been approved in children 6 months of age and older, while the Novartis vaccine is approved in children 4 years of age and older (Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine, 2009; Prod Info AFLURIA(R) intramuscular injection, solution, 2009).
4) CHILDREN 10 THROUGH 17 YEARS OF AGE a) CHILDREN 10 years of age and older: A single 0.5 mL inactivated influenza A (H1N1) virus vaccine administered intramuscularly (Prod Info AFLURIA(R) intramuscular injection, solution, 2009; Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine, 2009).
5) ADULTS 18 YEARS OF AGE AND OLDER a) ADULTS 18 years of age and older: A single 0.5 mL inactivated influenza A (H1N1) virus vaccine administered intramuscularly (Prod Info AFLURIA(R) intramuscular injection, solution, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine IM injection, 2009; Prod Info 499/454 Influenza A (H1N1) Monovalent Vaccine injection, 2009; Prod Info Influenza A (H1N1) 2009 Monovalent Vaccine intramuscular injection, 2009; Prod Info Influenza A (H1N1) Monovalent Vaccine, 2009).
I) AIRWAY MANAGEMENT 1) Monitor respiratory function. Infants and young children may be a greatest risk to develop respiratory effects including apnea. Monitor pulse oximetry and respiratory effort. Oxygen supplementation or mechanical ventilation may be required in severe disease or in patients with significant co-morbidities.
J) PNEUMOCOCCAL VACCINE POLYVALENT 1) GENERAL: Prevention of pneumococcal pneumonia in persons greater than or equal to 65 years of age, high-risk persons aged 2 to 64 years, persons with asthma, and current smokers. a) Primary vaccination: Adult: One 0.5 mL intramuscular dose. Given to all adults 65 years of age and older (Centers for Disease Control and Prevention, 2009; Prod Info PNEUMOVAX(R)23 injection, 2009)
b) Revaccination: Adult: One 0.5 mL intramuscular dose. Given to all adults 65 years of age and older who were vaccinated before the age of 65 and at least 5 years prior (Centers for Disease Control and Prevention, 2009; Prod Info PNEUMOVAX(R)23 injection, 2009)
c) High Risk: Adult: 0.5 mL intramuscularly at one or 2 doses, at least 5 years apart, for adults less than 65 years of age who have medical indications for vaccination or are part of a high risk population (Centers for Disease Control and Prevention, 2009; Prod Info PNEUMOVAX(R)23 injection, 2009).
d) Pediatrics (2 to 18 years): 0.5 mL intramuscularly or subcutaneously as a single dose; may be repeated once after 5 years in selected cases (Centers for Disease Control and Prevention, 2009; Prod Info PNEUMOVAX(R)23 injection, 2009).
K) DIFFERENTIAL DIAGNOSIS 1) Influenza due to other causes (e.g., influenza virus, type A, human; influenza virus, type B or C), respiratory syncytial virus infection, acute bronchitis, and common cold.
L) PREDISPOSING CONDITIONS 1) PERSONS AT HIGH RISK FOR COMPLICATIONS FROM H1N1 a) Data are insufficient to determine what groups may be at increased risk for complications of novel influenza A (H1N1) virus; therefore, the same age and risk groups at high risk for seasonal influenza should be considered at higher risk for H1N1 complications (Centers for Disease Control and Prevention, 2009): 1) Adults 65 years of age and older (Centers for Disease Control and Prevention, 2009) 2) Pregnant women who may be at risk for rapid disease progression complicated by secondary bacterial infections, including pneumonia (Centers for Disease Control and Prevention, 2009; Centers for Disease Control and Prevention, 2009) 3) Persons with the following conditions (Centers for Disease Control and Prevention, 2009): a) Chronic pulmonary diseases, including asthma
b) Cardiovascular diseases, except hypertension
c) Renal conditions
d) Hepatic conditions
e) Hematological conditions, including sickle cell disease
f) Neurologic disease
g) Neuromuscular diseases
h) Metabolic disorders, including diabetes mellitus
4) Nursing home residents or residents of other chronic-care facilities (Centers for Disease Control and Prevention, 2009) 5) Immunosuppressed adults and children, including immunosuppression caused by medications or HIV (Centers for Disease Control and Prevention, 2009) 6) Person less than 19 years old who are receiving long-term aspirin therapy (Centers for Disease Control and Prevention, 2009) may be at risk for Reye syndrome following an influenza virus infection (Centers for Disease Control and Prevention, 2009) 2) CHILDREN AT HIGHER RISK FOR COMPLICATIONS FROM INFLUENZA INFECTION a) The following are based on CDC recommendations (Centers for Disease Control and Prevention, 2009): 1) Children younger than 5 years of age 2) Children younger than 2 years old (highest risk for severe complications from seasonal influenza) 3) Infants less than 6 months old 4) Children with the following medical conditions: a) Immune suppression
b) Pregnancy
c) Chronic kidney disease
d) Heart disease
e) HIV/AIDS
f) Diabetes
g) Asthma and other lung diseases
h) Sickle cell disease
i) Long-term aspirin therapy for chronic disorders (at risk for Reye syndrome)
5) Neurological conditions that affect respiratory function and may hamper the ability to report onset or worsening of symptoms: a) Intellectual and developmental disability
b) Cerebral palsy
c) Spinal cord injuries
d) Seizure disorders
e) Metabolic conditions or other neuromuscular disorders
6) Poor nutritional and fluid intake with prolonged vomiting and diarrhea 7) Metabolic disorders (e.g., medium-chain acyl-CoA dehydrogenase [MCAD] deficiency) causing the inability to tolerate prolonged fasting 8) Person less than 19 years old who are receiving long-term aspirin therapy. |