in case of a flu pandemic

What to do in case of a flu pandemic Only for discussion / distribution in connection with pandemic planning

Please note that the following is intended solely to supplement information available from health officials. It is important that you observe the instructions issued by advisors from state and national health departments (such as the Centers for Disease Control and Prevention CDC) during a pandemic situation.

Contents General information 6 What is the flu (influenza)? How can I protect myself from the flu? How can I tell the difference between the flu and a bad cold? What is a flu pandemic? What is bird flu? How can it lead to a flu pandemic? Overview of the WHO pandemic classification system Before a flu pandemic 10 Check and restock your emergency supplies at home During a flu pandemic 11 In the event of emergency: How can I protect myself and others from infection? Non-pharmacologic interventions What should I do if I get sick anyway? What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? 16 What is TAMIFLU? When, how and for how long does TAMIFLU need to be taken? What information is there about the use of TAMIFLU in avian flu? Where can I find more information about this topic? 21 What to do in case of a flu pandemic

General information What is the flu (influenza)? Influenza generally known as the flu is a serious, severe and often unrecognized and underestimated infectious disease. It can result in dangerous complications, even death. The culprit is the highly infectious influenza virus, which usually spreads through coughing or sneezing or contact with contaminated surfaces. Local outbreaks of seasonal flu generally occur every year from October through April. An outbreak of the flu generally lasts six to eight weeks in a community. How can I protect myself from the flu? The annual flu vaccination offers effective protection against the seasonal flu. If a person contracts the flu despite having been vaccinated, he or she can be treated with antiviral flu medicines. The seasonal vaccine will not provide protection against a new/novel influenza strain seen in a pandemic. At the first sign of flu symptoms, consult your personal physician. 6 What to do in case of a flu pandemic

General information How can I tell the difference between the flu and a bad cold? Signs & Symptoms Flu Cold Onset Sudden Gradual Fever* (higher than 100ºF) Common; Lasting 3-4 Days Rare Cough Dry: Can Become Severe Hacking; Mild Headache Prominent Rare Muscle/Joint Aches, Pain Usual; Often Severe Slight Fatigue and Weakness Can Last Up To 2 Weeks Very Mild Extreme Exhaustion Early and Prominent Never Chest Discomfort Common Mild/Moderate Stuffy Nose Sometimes Common Sneezing Sometimes Usually Sore Throat Sometimes Common * For many people aged 65 years or who have chronic illnesses, the risk and severity of influenza infection is magnified; however, flu-induced fever in these individuals may be minimal or even absent. What to do in case of a flu pandemic 7

General information What is a flu pandemic? A flu pandemic is not the same as the seasonal outbreak of flu. An outbreak of the flu can escalate into a full-blown epidemic once it affects an unusually large number of people or occurs over wide areas. A pandemic is a large-scale epidemic that may spread across several countries and continents. A flu pandemic is triggered when a new, aggressive and therefore highly infectious flu virus affects a large number of people worldwide within a short period of time. In the past, pandemics resulted in very high death tolls. What is bird flu? How can it lead to a flu pandemic? Bird flu, caused by the avian influenza virus, is an illness that affects fowl. Only if the virus mutates and develops the ability to bind solidly to human cells will it be effectively transmittable from person to person. Our immune systems would not recognize this new virus and would have trouble combating it, which would allow the virus to spread rapidly throughout the world (a pandemic). 8 What to do in case of a flu pandemic

General information Overview of the WHO pandemic classification system The World Health Organization (WHO) has developed a pandemic classification system that it uses to declare the phases of a flu pandemic in the event of an alert. Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 Interpandemic period Pandemic alert Pandemic (between two pandemics) Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 No new influenza subtypes have been detected in humans. The risk of human infection is considered low. No new influenza subtypes have been detected in humans. The influenza virus circulating in animals (such as birds) poses a higher risk of disease in humans. Human infection(s) with a new subtype but no human-to-human transmission, or only extremely rarely in cases involving close contact. Small cluster(s) involving human-to-human transmission. Only a limited geographic area is affected at this stage. Large cluster(s) involving human-to-human transmission. Affected areas are still localized. Rapidly increasing and sustained transmission in the general population. What to do in case of a flu pandemic 9

Before a flu pandemic Check and restock your emergency supplies at home National authorities have taken extensive precautions to protect their population. In addition, everyone should plan ahead and be prepared for eventual supply bottlenecks. This means that you should keep supplies in stock to last your household for at least three weeks. Supplies should include plenty of non-perishable food, beverages/water and hygiene products. In the event of electrical shortages, select goods that do not require refrigeration. Water allocation should be one gallon per person per day for drinking, food preparation, and sanitation. Don t forget infant formula and pet food. H2O Make sure your medicine chest is also well stocked (including prescription drugs). Local banks and ATMs may shut down, so keep an emergency supply of cash in small denominations. Fuel shortages may occur, so keep your car s fuel tank filled. Detailed lists on what to stock are available on the Internet at www.pandemicflu.gov. 10 What to do in case of a flu pandemic

During a flu pandemic In the event of an emergency: How can I protect myself and others from infection? In the event of a pandemic, the authorities will issue appropriate instructions for the situation at hand. Please follow these instructions and stay informed. As soon as a new vaccine is available, you and your family should be vaccinated. As the new virus must first be identified, however, it can take up to six to nine months to develop a new, optimally effective vaccine. Antiviral flu drugs such as TAMIFLU (oseltamivir phosphate) may provide protection during this time. Generally speaking, everyone can help contain the spread of a pandemic and reduce the risk of becoming infected by taking the precautions listed below. Until a vaccine is available, antiviral drugs such as TAMIFLU are the most important medical interventions to reduce the rate of morbidity and mortality. WHO, January 2005 Non-pharmacologic interventions 1. Avoid contact with people The most effective form of protection because the flu virus is transmitted mainly through coughing and sneezing (droplet infection). 2. Pay attention to personal hygiene Effective supplementary measure if followed consistently. 3. Masks Only suitable as a supplementary measure: masks reduce the risk of droplet infection but do not offer full protection. Correct use and disposal are essential. Please see Important Safety Information for TAMIFLU on page 22. What to do in case of a flu pandemic 11

During a flu pandemic 1. Avoid direct contact with other people Avoid crowds (public transportation, restaurants, meetings, elevators, cinemas, department stores, markets, private visits, etc.). meetings: conduct business by phone, e-mail or videoconferencing instead. shaking hands or hugging as a form of greeting. If you must hold a meeting, keep it as brief as possible and make sure people can be spaced at least 3 feet or more apart and hold the meeting outside, if possible, or in a large room. Postpone business and personal travel, conferences, work shops, training courses, etc. Where feasible, work from home in consultation with your manager. Restrict your shopping to an absolute minimum and shop at uncrowded times. Where feasible, shop online or by phone. People who have been diagnosed with the flu or who have flu symptoms should stay home to protect others from infection. If you have been exposed to a person who has the flu, consult your doctor as soon as possible. Infected people, those who have been exposed to them and those who will be exposed to flu infection may benefit from wearing a mask. 12 What to do in case of a flu pandemic

During a flu pandemic 2. Personal hygiene Bear in mind that the flu virus is not only transmittable from person to person, but also through exposure to contaminated surfaces (such as railings and door handles). It is therefore important to wash your hands frequently and thoroughly with soap and water (or with an alcoholbased disposable tissue or cleaning gel) and equally important to dry them well. Washing your hands is especially important: before you begin preparing food and after eating; after coughing or sneezing, blowing your own or your child s nose, using the toilet or contact with (sick) people (for example, when attending to them). Avoid touching your eyes, nose and mouth. Use disposable tissues only and dispose of them immediately after blowing your nose. Cover your mouth and nose when sneezing or coughing, preferably with a disposable tissue. When you get home: take your shoes and coat off as soon as you enter the doorway and wash your hands or take a shower. Clean the surfaces daily that you touch most often (kitchen and bathroom surfaces, door handles). Do not share your plates, glasses or cutlery with others when eating. Make sure the rooms of your home are well ventilated. What to do in case of a flu pandemic 13

During a flu pandemic 3. Masks You can protect yourself from others more effectively by wearing a mask, but masks do not offer full protection so they should be viewed as a supplementary precaution only. The risk level determines the choice of breathing protection: Simple paper masks are essentially ineffective. Surgical masks offer substantial protection in low-risk situations (even though they are designed to protect the environment and not the persons wearing them). In situations involving higher risk (such as direct exposure to infected persons), only masks with a recognized filter efficiency level (N95, N99 or N100 in the USA) are acceptable. Several health authorities recommend wearing masks in public; others, including the WHO, do not. 14 What to do in case of a flu pandemic

During a flu pandemic What should I do if I get sick anyway? Contact your personal physician immediately (by phone, if necessary). Stay at home to avoid infecting others. Follow hygiene precautions scrupulously. Avoid contact with uninfected persons, particularly infants, small children and persons with chronic health conditions. Use disposable tissues only and dispose of them in plastic bags immediately after use. Wear a mask to protect others from getting infected. Drink plenty of fluids. Avoid physical activity; bed rest is best. As usual, follow the instructions on your doctor s prescription or in the patient information leaflet when taking any medicine, even pain relievers or fever reducers. Take your prescription medicine regularly. What to do in case of a flu pandemic 15

What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? What is TAMIFLU? TAMIFLU (active ingredient: oseltamivir) is a prescription medicine used to treat influenza (flu) types A and B in adults and children over one year of age who have been symptomatic for no more than 2 days. TAMIFLU has also been approved for the prevention of influenza types A and B in adults and children over one year of age. TAMIFLU belongs to a class of drugs called neuraminidase inhibitors. It was developed to attack the influenza virus and stop it from spreading inside the body. Please see Important Safety Information for TAMIFLU on page 22. 16 What to do in case of a flu pandemic

What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? When, how and for how long does TAMIFLU need to be taken? Flu TREATMENT (Seasonal) Begin treatment with TAMIFLU within 48 hours from the first appearance of flu symptoms. TAMIFLU may be taken with or without food. For some patients, however, it may be more tolerable when taken with food. TAMIFLU dosage for flu TREATMENT Dose Adults* and adolescents One 75 mg capsule twice daily 5 days 13 years of age and older Children 1-12 years of age 30 mg or 45 mg capsules and 5 days liquid suspension based on body weight. (Please see accompanying complete Prescribing Information for proper weight-based dosing.) Children under one year of age No experience of use, ---- treatment not recommended * Dosage may vary for patients with renal impairment; please see accompanying complete Prescribing Information. Duration of treatment For further information, please consult the accompanying complete Prescribing Information. TAMIFLU should be used only when medically indicated. What to do in case of a flu pandemic 17

What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? Flu PREVENTION (Seasonal) TAMIFLU has also been approved for the prevention of seasonal flu. If an influenza virus is affecting your immediate environment (for instance, if your partner, your children or other persons in your household have fallen sick with the flu) take TAMIFLU preventively if your doctor has prescribed it. Begin treatment no later than 48 hours after exposure to an infected person. TAMIFLU dosage for flu PREVENTION Dose Duration of preventive Duration of treatment after close preventive contact with infected treatment during person a flu pandemic Adults* and adolescents One 75 mg 10 days Up to 6 weeks 13 years of age or older capsule daily Children 1-12 years 30 mg or 45 mg 10 days of age capsules and liquid suspension based on body weight. (please see accompanying complete Prescribing Information for proper weight based dosing) Children under one No experience of ---- ---- year of age use, treatment not recommended * Dosage may vary for patients with renal impairment; please see accompanying complete Prescribing Information. 18 What to do in case of a flu pandemic

What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? For further information, please consult the patient information leaflet, your doctor or pharmacist. In this situation, too, TAMIFLU should be used only when medically indicated. What information is there about the use of TAMIFLU in avian flu? To date, results from clinical studies in humans are not available. Data from in vitro and animal studies that have been performed are summarized below. Non-human data do not necessarily indicate clinical activity in humans. In vitro activity (i.e. outside an organism) against H5N1 One study compared antiviral actitity of the novel neuraminidase inhibitors zanamivir and oseltamivir against various strains of influenza A and B viruses (including 2 strains of H5N1 avian virus). The analysis demonstrated a high level of viral inhibitory activity by all compounds against the specified H5N1 strains (A/duck/MN/1525/81 and A/gull/ PA/4175/83) of avian influenza. In vivo activity (in mice) against H5N1 and H9N2 One study in ferrets showed that TAMIFLU administered 4 hours after inoculation prevented viral replication in the upper respiratory tract and effectively treated all infected ferrets with no deaths. All ferrets in the control group died. What to do in case of a flu pandemic 19

What do I need to know about the flu medicine TAMIFLU (oseltamivir phosphate)? Another in vivo study in mice tested oseltamivir for protection against avaian strains H5N1 and H9N2. The results showed that oseltamivir provided complete protection against the H5N1 virus strating at a dose of 0.1 mg/kg/day and against the H9N2 virus starting at a dose of 1.0 mg/ kg/day. Additionally, oseltamivir was tested as a treatment regimen from 24 to 60 hours, and oseltamivir was shown to significantly increase the survival rates of mice (65%-90%) as compared with the untreated group (0% survival). The studies described above do not necessarily indicate clinical activity of TAMIFLU in humans with H5N1 avian virus. 20 What to do in case of a flu pandemic

Where can I find more information about this topic? Authorities and institutions World Health Organization: www.who.int U.S. Dept. of Health and Human Services: www.pandemicflu.gov Roche Sites www.pandemictoolkit.com www.tamiflu.com 888-394-2838 What to do in case of a flu pandemic 21

IMPORTANT SAFETY INFORMATION TAMIFLU has not been shown to be effective against any illness other than that caused by influenza types A and B. Efficacy of treatment in patients with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was seen between the treatment and placebo groups in this population. No information is available regarding treatment of influenza in patients at imminent risk of requiring hospitalization. Efficacy of TAMIFLU has not been established in immunocompromised patients. Safety and efficacy of repeated courses of TAMIFLU for treatment or prevention have not been studied. In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported. There have been postmarketing reports (mostly from Japan) of selfinjury and delirium with the use of TAMIFLU in patients with influenza. The reports were primarily among children. The relative contribution of the drug to these events is not known. Patients with influenza should be closely monitored for signs of abnormal behavior throughout the treatment period. In treatment studies in adult patients, the most frequently reported adverse events (incidence 1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking TAMIFLU compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients 1 to 12 years old, the most frequently reported adverse event (incidence 1%) was vomiting (15%). Other events reported more frequently in patients taking TAMIFLU compared with placebo included abdominal pain (5% vs 4%), nosebleed (3% vs 3%), ear disorder (2% vs 1%) and pinkeye (1% vs <1%). In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking TAMIFLU compared with placebo (incidence 1%) were nausea (7% vs 3%), vomiting (2% vs 1%), diarrhea (3% vs 2%), abdominal pain (2% vs 1%), dizziness (1% vs 1%), headache (18% vs 18%) and insomnia (1% vs 1%). In a household prevention trial that included patients 1 to 12 years old, adverse events were similar to those observed in pediatric treatment studies, with GI events being the most common. The concurrent use of TAMIFLU and live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of the possibility for interference between these products, LAIV should not be given within 2 weeks before or 48 hours after taking TAMIFLU, unless it is deemed appropriate by your doctor. Trivalent inactivated influenza vaccine can be administered at any time relative to use of TAMIFLU. 22 What to do in case of a flu pandemic

2007 TAMIFLU is a registered trademark. Hoffmann-La Roche Inc. 340 Kingsland Street Nutley, New Jersey 07110-1199 www.rocheusa.com Plandex 455015 18-002-455-034-0108 MDM R3754-07 11-07