STANDING ORDERS FOR ANTIVIRAL THERAPY AND POST-ExPOSURE PROPHYLAXIS TO INFLUENZA A AND B: OSELTAMIVIR, RIMANTADINE, AND ZANAMIVIR

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1 STANDING ORDERS FOR ANTIVIRAL THERAPY AND POST-ExPOSURE PROPHYLAXIS TO INFLUENZA A AND B: OSELTAMIVIR, RIMANTADINE, AND ZANAMIVIR Purpose: To reduce the morbidity and mortality from influenza infection by providing treatment and post-exposure prophylaxis with oseltamivir, rimantadine, and zanamivir. Policy: These standing orders allow eligible healthcare providers to treat persons exposed to. Indications, Contraindications, Precautions, Special Populations, and Side Effects: The dose and safety precautions for these drugs can change over time. Clinicians should seek the most current and comprehensive product information before using these drugs as treatment or prophylaxis for influenza. Current information may be found at: Persolfs infected or exposed to wi/penza A and B vitus. Hypersensitivity to any of the components of the oseltamivit. adjustment is recommended for patients with a serum creatinine clearatfce <30 ml/min. For patients with hereditary fructose intolerance, drug contents are above the daily maximum limit of sorbitol and may cause dyspepsia and diarrhea. LAIV should not be administered within 2 weeks before or 48 hours after administration of oseltamivir, unless medically indicated. Pregnant and Nursing Women: Do not use unless potential benefit is greater than risks to fetus and Persons infected or exposed to in11uenza A and B vitus. Hypersensitivity to any of the components of the zanamivir or persons with underlying "'1,.,"""'~r" disease. Advise patients of risks of bronchospasms. Pateints should stop use and contact physician ifincreased respiratory symptoms occur. Patients who use bronchodiiators should use dilator prior to zanamivir use. Patient instructions and, if possible, demonstration should be provided prior to use. LAIV should not be administered within 2 weeks before or 48 hours ofuse. Pregnant and Nursing Women: Do not use unless potential benefit is greater than risks to fetus and infant. Persons infected or exposed to influenza A virus.". Hypersensitivity to any ofthe coniponents of the. '. adamantane 'class. of drugs (e.g., rimantadine and '.'.' Due to increased. resistance, the CDC and.acip has rec~m.mendedthat the adamantine da~s'.no longer be.used for the.tteatnlent or llrpphylaxis ()(il::lfluenza A untilsusteptibilityhas.been re~estabiisiled.usewith cauti~n 'in Plltients.with hepatic atldre.nali1npairment,, prirchqsis, and seizw:es, LAN sh()uld not be administered within:2 weeks,before or,48 hours oflls,e.. <Cimetldine; '.. acetamk~phen.an<i aspirin inay reduceplasro3'.,.;' ~'" ~...., Pregnan(andNursfug Women: Do not llse, unless potential 'bell~fi.i is greater than riskst:o fetusandinfallt.anird.al October 11,2011 Page 1 of6 Version 3.1

2 Children: Oseltamivir is not indicated for either treatment or prophylaxis of influenza in pediatric patients younger than 1 year of Nausea, vomiting, diarrhea, fatigue, dizziness, headache, pain in anns or legs, vision changes, resciessness, ringing of ears, mental changes,or photosensitivity / phototoxic ity. Children: Zanamivir is not indicated for either treatment or prophylaxis ofinfluenza in pediatric patients younger than 7 years of age. Cough, diarrhea, dizziness, headache, nausea, s.inus jnflammation, sore throat, stuffy nose, vomiting, bronchitis, ENT infections, oropharyngeal edema, rash, seizures, hallucinations, delirium, and abnonnal behavior. Serious cases of bronchospasm, including. have been...'n..t"pr; studies.ha;ve documented adverse. events to fetus and infants. Elderly: Higher risk for CNS an~.gastrointestinal adverse events so dosage lldjustment is. recomme..:{ded \iausea,anorexia,. vomiting; qian:hea, xerostomia,. insoinnia, dizz.iness, headache,.. nervousness, fatigue. Influenza Infection (fable 1 and 2): Clinicians should monitor local, state, and national recommendations during the influenza season to determine the most appropriate treatment practices and receive updates on antiviral resistance profiles of the circulating viruses. Successful medical management is related to early use of antiviral and aggressive use of supportive care. The recommendation for treatment of influenza is dependent on the class of antiviral used and strain ofinfluenza virus. Zanamivir or oseltamivir may reduce the duration ofuncomplicated influenza A and B illness and viral shedding when administered within 48 hours ofillness onset. Because oftesistance.in circulating influenza A virus strains, rirnantadine is not recommended for antiviral treatment of influenza A. Persons at higher risk for influenza complications recommended for antiviral treatment include:.:. Children aged <2 years -:. Adults aged ;:::65 years (. Persons with chronic pulmonary (mc1uding asthma), cardiovascular (except hypertension alone), renal, hepatic, hematological (mcluding sickle cell disease), metabolic disorders (including diabetes mellitus), or neurologic and neurodevclopment conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability [mental retardation], moderate to severe developmental delay, muscular dystrophy, or spinal cord injury).:. Persons with immunosuppression, including that caused by medications or by HIV infection.) Women who are pregnant or postpartum (within 2 weeks after delivery).,. Persons aged <19 years who are receiving long-term aspirin therapy.,. American Indians/Alaska Natives October 11, 2011 Page 2 of6 Version 3.1

3 .:. Persons who are morbidly obese (ie., body-mass index 2::40).:- Residents ofnursing homes and other chronic-care facilities Longer treatment regimens might be necessary in severely ill hospitalized patients or persons with immunosuppression. Antibacterial therapy plus antiviral treatment are recommended for patients with community-acquired pneumonia when influenza also is suspected. Aspirin or aspirin-containing products should not be administered to any person aged :518 years because of the risk for Reye's syndrome. Children aged <4 years should not receive over-the-counter cold medications without a health-care provider being consulted first. InlIuenza Post-Exposure Prophylaxis (PEP) Criteria (fable 1 and 2): Because of resistance in circulating influenza A virus strains, rimantadine is not recommended for chemoprophylaxis of influenza A. Persons who can be considered for antiviral chemoprophylaxis include family or other close contacts of a person with a suspected or confirmed case who are at higher risk for influenza complications but have not been vaccinated against the influenza virus strains circulating at the time of exposure. PEP is not indicated for health care and mortuary workers ifthey use standard precautions (airborne ifindicated). Unvaccinated health-care workers who have occupational exposures and who did not use adequate personal protective equipment at the time of exposure are potential candidates for chemoprophylaxis. Persons who receive an antiviral medication for chemoprophylaxis might still acquire influenza virus infection and be potentially able to transmit influenza virus, even if clinical illness is prevented. Decisions on whether to administer antivirals for chemoprophylaxis should take into account the exposed person's risk for influenza complications, the type and duration of contact, recommendations from local or public health authorities, and clinical judgment. Chemoprophylaxis with antiviral medications is not a substitute for influenza vaccination. InlIuenza Pre-Exposure Prophylaxis Criteria: In community and institutional studies of adults administered antiviral medications during influenza virus activity, both oseltamivir and zanamivir had similar efficacy in preventing febrile, laboratory-confirmed influenza illness. When used, preexposure chemoprophylaxis must be administered for the duration of time when exposure might occur. The duration of pre-exposure chemoprophylaxis based on potential exposure in the community depends on the duration of community influenza activity. The adverse events associated with long-term use are uncertain and prolonged use of antivirals might select for resistance to antiviral medications. Therefore, pre exposure antiviral chemoprophylaxis should be used only for persons who are at very high risk (e.g., severely immunosuppressed patients) for influenza-related complications who cannot otherwise be protected during times when a high risk for exposure exists. October 11, 2011 Page 3 of6 Version 3.1

4 During widespread illness or a pandemic, demand for anti-vitals might exceed available supplies and prioritization of who should receive antivirus may occur. Medical Emergency or Anaphylaxis: Written emergency medical protocols, as well as equipment and medications, must be available at administration site. Anaphylaxis includes rash, difficulty breathing, swollen tongue or throat, itchiness of throat, and collapse. Dosage Information: See Table 1 for recommended therapy and post-exposure prophylaxis for influenzf1 vi1'1ls. Table 2 provides simplified oseltamivir dosing by weight for children <1 year of age. This protocol shall remain in effect for all persons infected or exposed to influenza A and B until rescinded Approved by: ~. ~ \ "Chief Medical Executive Michigan D f (J>1lJa1:qDi' ty Health Date Date October 11, 2011 Page 4 of6 Version 3.1

5 Table 1. Recommended dosage and schedule of influenza antiviral medications' for treatment t and chemoprophylaxis s. Zanamivir Oseltamivir' Antiviral agent Treatment, for 5 days Chemoprophylaxis, for 10 days Treatment,** for 5 days Age group (yrs) :65 NA NAfor ages 1-4 weight** Ages 5--9 weight** weight** 75mg 75mg Chemoprophylaxis, for 10 days weighttt weighttt >40 kg = adult dose weighttt 75mg 7Smg >40 kg = adult dose Abbreviation: N.-\ =not approved * Zanamivir is manufactured by GlaxoSmithKline (Relenza - inhaled powder). Zanamivir is approved for treatment of persons aged 27 years and approved for chemoprophylaxis of persons aged 25 years. Zanamivir is administered through oral inhalation by using a plastic device included in the medication package. Patients will benefit from instruction and demonstration of the correct use of the device. Zanamivir is not recommended for those persons with underlying airway disease. Oseltamivir is manufactured by Roche Pharmaceuticals (Tamiflu --- tablet). Oseltamivir is approved for treatment or chemoprophylaxis of persons aged 21 year. Oseltamivir is available for oral administration in 30 mg, 45 mg, and 75 mg capsules and liquid suspension. No antiviral medications are approved for treatment or chemoprophylaxis of influenza among children aged <1 year. This information is based on data published by the Food and Drug.'\dministration.(EQA)~. t Recommended duration for antiviral treatment is 5 days. Longer treatment courses can be considered for patients who remain severely ill after 5 days of treatment. Recommended duration is 10 days when administered after a household exposure and 7 days after the most recent known exposure in other situations. For control of outbreaks in long-term care facilities and hospitals, CDC recommends antiviral chemoprophylaxis for a minlmum of 2 weeks and up to 1 week after the most recent known case was identified ~ See Table 4 for information about use of oseltamivir for infants aged <1 year. A reduction in the dose of oseltamivir is recommended for persons with creatinine clearance <30 ml/min. ** The treatment dosing recommendation for oseltamivir for children aged 21 year who weigh ~15 kg is 30 mg twice a day. For children who weigh >15 kg and up to 23 kg, the dose is 45 mg twice a day. For children who weigh >23 kg and up to 40 kg, the dose is 60 mg twice a day. For children who weigh >40 kg, the dose i's 75 mg twice a day. tt The chemoprophylaxis dosing recommendation for oseltamivir for children aged 21 year who weigh ~15 kg is 30 mg once a day. For children who weigh >15 kg and up to 23 kg, the dose is 45 mg once a day. For children who weigh >23 kg and up to 40 kg, the dose is 60 mg once a day. For children who weigh >40 kg, the dose is 75 mg once a day. October 11, 2011 Page 5 of6 Version 3.1

6 Table 2. Dosing recommendations for treatment or chemoprophyla..-cis of children aged < 1 year using oseltamivir*. Age Recommended treatment dose Recommended chemoprophylaxis dose for 10 dayst for 5 dayst <3mos 3 mg/kg/dose Not recommended unless situation judged critical because of limited data on use in this age group mos 3 mg/kg/dose 3 mg/kg/dose * Oseltamivir is not approved by the Food and Drug Adminiswtion (FDA) for use in children aged <1 year. i\n Emergenc.y Use L\uthorization <;EUA) was issued by the FDA on.:\pril ~I I, and expired on June 23,2010. TIlls EUA allowed use of oseltamivir for treatment or chemoprophylaxis of 2009 pandemic influenza A (H1N1) virus infection during the pandemic in infants aged <1 year. Currently circulating 2009 H1N1, seasonal influenza A (H3N2), and B viruses have similar sensitivity to oseltamivir. t Current weight-based dosing recommendations are not appropriate for premature infants. Premature infants might have slower clearance of oseltamivir because of immature renal function, and doses recommended for full-term infants might lead to very high drug concentrations in this age group. Very limited data from a small cohort of premature infants suggested that oseltamivir concentrations among premature infants administered oseltamivir 1 mg/kg would be similar to those observed with the recommended treatment dose in term infants (3 mg/kg ). Observed drug concentrations were highly variable among premature infants. These data are insufficient to recommend a specific dose of oseltamivir for premature infants. October 11, 2011 Page 6 of 6 Version 3.1