Is ISENTRESS right for you?

Transcription

1 Is ISENTRESS right for you? Models ISENTRESS.com Provided as an educational resource by Merck

2 INDICATION ISENTRESS is a prescription HIV-1 medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV-1) infection in people 4 weeks of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age. The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV. ISENTRESS does not cure HIV-1 infection or AIDS. You must stay on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illnesses. Use this brochure as a helpful guide to work with your healthcare team to find an HIV therapy that fits your needs and lifestyle. Important Risk Information Some people who take ISENTRESS develop serious skin reactions and allergic reactions that can be severe, and may be life-threatening or lead to death. If you develop a rash with any of the following symptoms, stop using ISENTRESS and call your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of your skin or whites of your eyes, dark or tea-colored urine, pale-colored stools (bowel movements), nausea or vomiting, loss of appetite, pain, aching or tenderness on the right side of your stomach area.

3 Table of contents Before you start treatment Your healthcare team will want to know... 1 My health history...2 Thinking about taking ISENTRESS (raltegravir) What is ISENTRESS?...4 Common side effects...5 Information about cholesterol, Hep B, and Hep C...6 Now that you are taking ISENTRESS How ISENTRESS works...7 ISENTRESS and other medications...8 Talk to your doctor about other medications...9 Your healthcare team will want to know: Any health conditions you may be dealing with, like: Heart issues Drug or alcohol abuse Liver disease Pregnant or thinking about becoming pregnant Mental health issues Kidney disease Lung/breathing issues What s next after choosing ISENTRESS? How to take ISENTRESS Take your medicines as prescribed Make a plan and follow it through Tools and resources Patient resources Glossary Savings coupon And your healthcare team will want to know: If you re taking over-the-counter medicines (such as antacids or cold/allergy medicine), vitamins, or herbal supplements (that might change how your HIV medicine works) If you have any allergies or reactions to any medicines [1]

4 My health history NAME DATE / / If certain health conditions run in your family, your healthcare team will want to know about them. Write down as many as you can think of. Different things can affect how well you take your medicine. How much do you think each item below will affect how well you take yours? 1 = not at all 2 = a little 3 = a decent amount 4 = a whole lot 5 = more than I can handle Work Relationships Now list other medicines you may be taking, such as prescription meds, over-the-counter meds, vitamins, antacids, or herbal supplements. Do you have any allergies? Are you allergic to any medicine? If you answered 4 or 5 to any of these items, make a note of it so you remember to bring it up with your healthcare team. Remember to take this completed tracker to your next check up. It s important to talk to your healthcare team about any side effects you may be experiencing. Your healthcare team may be able to help. Travel Family Community Forgetting to take my meds at the right time Side effects [2] [3]

5 What is ISENTRESS? HIV Positive Model Read everything there is to know about your HIV treatment options. Work with your healthcare team to find a treatment option that is right for you. ISENTRESS is a prescription HIV-1 medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV-1) infection in people 4 weeks of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age. The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV. ISENTRESS does not cure HIV-1 infection or AIDS. You must stay on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illnesses. Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine. People taking ISENTRESS may still develop infections or other conditions associated with HIV infections. You have been thinking about starting treatment. Now is the time to talk to your healthcare team about ISENTRESS (raltegravir), as part of a regimen that fits your needs and lifestyle. [4]

6 It is important to talk to your healthcare team about any side effects you may be experiencing. Common side effects ISENTRESS has been shown to have a low rate of side effects. In a long-term clinical study lasting more than 4 years (240 weeks) of patients being treated with HIV medicine for the first time, it was found that: The side effects of ISENTRESS plus Truvada that interfered with the daily activities of 2% or more of those who participated in the study were: Trouble sleeping (4% of participants) Headache (4% of participants) Nausea (3% of participants) Dizziness (2% of participants) Tiredness (2% of participants) The most common side effects of ISENTRESS include: trouble sleeping, headache, dizziness, nausea, and tiredness. Less common side effects include: depression, hepatitis, genital herpes, herpes zoster including shingles, kidney failure, kidney stones, indigestion or stomach area pain, vomiting, suicidal thoughts and actions, and weakness. Tell your doctor before you take ISENTRESS if you have a history of a muscle disorder called rhabdomyolysis or myopathy or increased levels of creatine kinase in your blood. [5] HIV positive people are at higher risk of contracting Hep C. To reduce that risk, make sure you do not share needles; and use latex condoms. Information about cholesterol, Hepatitis B, and Hepatitis C In a long-term clinical study lasting more than 4 years (240 weeks) of patients being treated with HIV medicine for the first time, it was found that: ISENTRESS plus Truvada increased LDL (bad) cholesterol less (10 mg/dl) than Sustiva plus Truvada (25 mg/dl) When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 96 mg/dl versus 93 mg/dl for those on Sustiva plus Truvada ISENTRESS plus Truvada may be used by people with chronic Hepatitis B and C In clinical studies with ISENTRESS, higher levels of liver enzymes occurred more often in patients with Hepatitis B and C ISENTRESS has not been studied in patients with severe liver impairment ISENTRESS will not cure HIV Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. These may be signs of a rare serious muscle problem that can lead to kidney problems. [6]

7 How ISENTRESS works HIV Positive Models An HIV drug is more likely to be effective when it works with other HIV drugs. ISENTRESS may help control HIV for over 4 years. A long-term clinical study lasting more than 4 years (240 weeks) of patients being treated with HIV medicine for the first time showed that ISENTRESS plus Truvada may help: Lower viral load to undetectable Raise CD4 cell counts ISENTRESS may not have these effects in all patients. For your HIV treatment to work, you should take your medicine as instructed. Work with your healthcare team to find a treatment plan that fits your needs and lifestyle. Ask if ISENTRESS may be right for you as part of your HIV regimen. These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacists. Tell your doctor if you have any side effect that bothers you or that does not go away. Now that you are ready to start HIV therapy, there are certain things you should know. Talk to your healthcare team about any questions you may have. [7]

8 ISENTRESS and other medications Talk to your doctor about other medications Some HIV therapies may increase cholesterol and triglyceride levels (fatty substance in blood). If high cholesterol runs in your family, or you d like tips on how to manage it, talk to your healthcare team. ISENTRESS can be used with a wide range of non-hiv medications. Do not start any new medicines while you are taking ISENTRESS without first talking with your doctor. ISENTRESS may be used with a wide range of non-hiv medications, either prescribed or over-the-counter. For example: Cholesterol medications (statins) Pain medications (opioid analgesics) Birth control medications (hormonal contraceptives) Anti-fungal medications (azole antifungals) Start planning for tomorrow today. Work with your healthcare team to find a treatment option that fits your needs and lifestyle. Working with your healthcare team is an important part of managing your HIV now and up ahead. Be open, and talk to your healthcare team about any questions you have. Tell your doctor about all the medicines you take, including, prescription and over-the-counter medicines, vitamins, and herbal supplements Tell your doctor about any allergies or reactions you have to any medicines Some medicines interact with ISENTRESS. Keep a list of your medicines to show your doctor and pharmacist Heartburn medications (proton pump inhibitors) Antacids that contain calcium Tell your doctor about all your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. ISENTRESS is not recommended for use during pregnancy. Do not breastfeed if you take ISENTRESS. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk. Tell your doctor about all the medicines you take, including, prescription and overthe-counter medicines, vitamins, and herbal supplements. Some medicines interact with ISENTRESS. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ISENTRESS with those other medicines. [8] [9]

9 How to take ISENTRESS HIV Positive Model 400 mg Film-Coated Tablet Some HIV medicines have to be refrigerated or taken with food. ISENTRESS does not. Take ISENTRESS exactly as your healthcare professional prescribes. Remember to: Take it twice a day with or without food If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do NOT take 2 tablets of ISENTRESS at the same time Take it by mouth and swallow film-coated tablets whole Get your ISENTRESS refilled from your healthcare professional or pharmacy before you run out Store it at room temperature (68 to 77 F). ISENTRESS does not require refrigeration Stay under the care of your doctor while taking ISENTRESS Some people who take ISENTRESS develop serious skin reactions and allergic reactions that can be severe, and may be life-threatening or lead to death. If you develop a rash with any of the following symptoms, stop using ISENTRESS and call your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. What s next comes sooner than you think so work with your healthcare team today. [10]

10 Take your medicines as prescribed Make a plan and follow it through You may have so much going on in your life, remembering to take your medicines can be a challenge. Try these simple reminders: Organize pills by day and time Keep a note pad near your dresser Put sticky notes on your mirror Write it down on a calendar Make taking your medicine part of your daily routine (eg, when brushing your teeth or at meal time) Ask your healthcare team if ISENTRESS fits your future treatment plans and is right for you. ISENTRESS has been available to help people manage their HIV since 2007 and has been tested in long-term clinical trials. ISENTRESS has been available for previously treated patients since 2007 and for first-time patients since 2009 A long-term clinical study lasting more than 4 years (240 weeks) of patients being treated with HIV medicine for the first time showed that ISENTRESS plus Truvada may help: Lower viral load to undetectable Join a program that sends reminders to your cell phone or computer Raise CD4 cell counts ISENTRESS may not have these effects in all patients. Ask friends/family for help Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of your skin or whites of your eyes, dark or tea-colored urine, pale-colored stools (bowel movements), nausea or vomiting, loss of appetite, pain, aching or tenderness on the right side of your stomach area. [11] Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine. [12]

11 Patient resources Model Taking ISENTRESS? Thinking about talking to your healthcare team about it? Check out these resources to help you manage your treatment. If you are already taking ISENTRESS or are working with your healthcare team Register now to get treatment info, financial assistance info, and treatment management tools. ISENTRESS.com/stepbystep Online Resources Visit our Web site for more information about ISENTRESS and tools that can help you take note of important topics to share with your healthcare team. ISENTRESS.com to find a therapy that fits your needs, here are some tools & resources that can help you manage your treatment. [13]

12 Glossary Before your next check up, get familiar with these terms: CD4/T-cell count CD4 cells (also known as T cells) are white blood cells that fight infection. The number of T cells in a sample of blood is your T-cell count. cholesterol An important soft, waxy substance found in your blood. Cholesterol comes in 2 forms: good (HDL) and bad (LDL). chronic When a disease or weakness has been with you for a long time. hepatic impairment When the condition of your liver gets worse. You cannot live without your liver. It removes harmful chemicals from your blood; fights infection; helps you digest food; and stores nutrients, vitamins, and energy. Hepatitis B A form of liver disease caused by the hepatitis B virus. You get it by coming in contact with body fluids, like the blood, semen, and vaginal fluids of an infected person. It can lead to permanent liver damage and even liver cancer. Hepatitis C A form of liver disease caused by the hepatitis C virus. You can get it by sharing needles or having unprotected sex with an infected person. It can lead to permanent liver damage and even liver cancer. opportunistic infections When HIV makes your immune system so weak, it has trouble fighting common infections. over-the-counter meds Drugs you can buy without a prescription. side effects When a medicine has a different effect on you than it was meant to have. Side effects can be unpleasant and can make it difficult for you to do your daily activities. undetectable viral load When the amount of HIV in your blood is so small, the lab test can hardly tell it s there. This does not mean that your HIV is cured. And it is still possible to pass the virus on to someone even if it is undetectable. For eligible privately insured patients. Certain restrictions apply. Please see terms and conditions. The savings coupon for ISENTRESS Privately insured eligible patients may save on ISENTRESS. Not all patients are eligible. Certain restrictions apply. Please see Terms and Conditions. To find out more or print your coupon, visit ISENTRESS.com. Please see full terms and conditions on ISENTRESS.com [14] [15]

13 Your Healthcare Professional s info: HIV Positive Models Please read the accompanying Patient Information and Instructions for Use for ISENTRESS and discuss them with your doctor. The physician Prescribing Information also is available. Brands mentioned are the trademarks of their respective owners. Copyright 2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC /15