Do you have severe diarrhea? It could be a potentially serious infection known as C diff, caused by the bacteria Clostridium difficile. In some people, C diff can come back. Not an actual patient. ZINPLAVA is a medicine that helps reduce the risk that your C diff will come back. Indication ZINPLAVA is a prescription medicine used to help decrease the risk of C diff (Clostridium difficile infection) from coming back in people aged 18 years or older who are taking an antibiotic for C diff and who have a high risk of C diff coming back. ZINPLAVA is not an antibiotic and does not replace the antibiotic. Make sure to tell your doctor if you have or have had congestive heart failure (CHF). Heart failure may happen in people who receive ZINPLAVA and can be serious. People with a history of CHF who received ZINPLAVA had a higher rate of heart failure and death than those who did not receive ZINPLAVA. Talk to your doctor today to see if ZINPLAVA is right for you.
What s inside? What is C diff? 1 2 3 4 5 6 What is C diff? A C diff infection can come back, even when treated with an antibiotic Who is more likely to get a C diff infection again? What is ZINPLAVA? How does ZINPLAVA work? How will I get ZINPLAVA? Things to discuss with your doctor about getting ZINPLAVA C diff is short for Clostridium difficile (klo-stri-dee-um dif-uh-seel). It is a bacteria that can cause an infection in your colon. Chemicals (toxins) released by C diff bacteria cause symptoms that may include Watery diarrhea 3 or more times a day Feeling sick to your stomach Fever Loss of appetite Pain or tenderness in your belly If you think you may have C diff, talk with your doctor. 7 8 10 Possible side effects of ZINPLAVA Are there things I can do to prevent C diff from spreading? Get help with your questions about access and support for ZINPLAVA C diff releases TOXINS in your colon that can give you diarrhea Indication ZINPLAVA is a prescription medicine used to help decrease the risk of C diff (Clostridium difficile infection) from coming back in people aged 18 years or older who are taking an antibiotic for C diff and who have a high risk of C diff coming back. ZINPLAVA is not an antibiotic and does not replace the antibiotic. The most common side effects that may happen on the day of or the day after receiving ZINPLAVA are nausea, headache, fever, feeling tired, shortness of breath, feeling dizzy, and high blood pressure. In some cases, C diff diarrhea can be severe enough that you need to go to the hospital. In the worst cases, people die from C diff. How do you get C diff? C diff spreads easily from person to person. You can get C diff by touching a surface with C diff bacteria on it, and then touching your mouth. You can catch it both in and out of the hospital. You are at greater risk for getting C diff if you are taking or have just finished taking antibiotics. You are also at greater risk if you are a patient in a hospital or live in a nursing home. 1
A C diff infection can come back, even when treated with an antibiotic When people get C diff, they often take an antibiotic to get rid of the infection. Even when treated with an antibiotic, C diff can come back within weeks to months. Who is more likely to get a C diff infection again? A C diff infection is more likely to come back if You are 65 years or older. You had C diff before. C diff comes back in 1 in 4 people. If you have had C diff 2 or more times, there is an even greater chance it will come back again. Not actual patients. You are taking, or have recently taken, antibiotics. You have a weakened immune system due to a major, ongoing illness, such as cancer or AIDS. 2 3
What is ZINPLAVA? ZINPLAVA is an intravenous (IV) medicine that helps reduce the risk that your C diff will come back. It is given to adults already taking antibiotics for C diff, who are at high risk for C diff coming back. How does ZINPLAVA work? How will I get ZINPLAVA? You will get ZINPLAVA through an IV ZINPLAVA is not an antibiotic. It is an IV medicine that works with the antibiotic that you are taking for C diff. ZINPLAVA does not replace your antibiotic. ZINPLAVA blocks toxin B, one of the C diff toxins in your colon, and helps reduce the risk that your C diff will come back. 1visit 1dose 1hour for administration The most common side effects that may happen up to four weeks after receiving ZINPLAVA are nausea, fever, and headache. Make sure to tell your doctor if you have or have had congestive heart failure (CHF). Heart failure may happen in people who receive ZINPLAVA and can be serious. People with a history of CHF who received ZINPLAVA had a higher rate of heart failure and death than those who did not receive ZINPLAVA. Where do I go to get ZINPLAVA? Your doctor will help you find a hospital or clinic where you can get ZINPLAVA. You may need to make an appointment to get it. What if I miss my appointment? If you miss your appointment to get ZINPLAVA, call your doctor right away to reschedule it. ZINPLAVA can only be given while you are taking a C diff antibiotic. The most common side effects that may happen on the day of or the day after receiving ZINPLAVA are nausea, headache, fever, feeling tired, shortness of breath, feeling dizzy, and high blood pressure. Talk to your doctor today to see if ZINPLAVA is right for you. ZINPLAVA is given while you are taking an antibiotic to treat C diff. ZINPLAVA does not replace your antibiotic. Remember to finish your C diff antibiotic, even if you start to feel better. 4 5
Things to discuss with your doctor about getting ZINPLAVA Possible side effects of ZINPLAVA Are you under 18? It is not known if ZINPLAVA works or is safe for people under 18 years old. Are you pregnant or trying to get pregnant? If so, tell your doctor. We don t know if ZINPLAVA will harm your baby while you are pregnant. Are you breastfeeding or planning to breastfeed? If so, check with your doctor first. We don t know if ZINPLAVA will pass to your baby through your breast milk. Do you have any other medical conditions? Tell your doctor about any medical conditions you have now or have had in the past. Make sure to tell your doctor if you have or have had congestive heart failure (CHF). Are you taking other medicines? Tell your doctor about all of the medicines you take. Some examples are Prescription medicine Over-the-counter medicine You and your doctor should decide together if you will get ZINPLAVA. Vitamins Herbal supplements ZINPLAVA may cause serious side effects, including Heart failure. Heart failure may happen in people who receive ZINPLAVA and can be serious. People with a history of congestive heart failure (CHF) who received ZINPLAVA had a higher rate of heart failure and death than those who did not receive ZINPLAVA. Some common side effects you may notice within 24 hours of getting ZINPLAVA Feeling tired Headache Fever Nausea Short of breath Dizzy High blood pressure The most common side effects that may happen up to 4 weeks later Nausea Fever Headache If you have any side effect that bothers you or does not go away, tell your doctor. There may be other side effects of ZINPLAVA that are not listed above. For more information, ask your doctor. You can also report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088 (1-800-332-1088). 6 7
Are there things I can do to prevent C diff from spreading? Cleaning C diff spreads easily and can be picked up by other people. Washing your hands often with soap and water and cleaning your house with a bleach solution can prevent other people from getting it. Be sure to wash your hands again after cleaning your house. Fact: Hand sanitizers DO NOT kill C diff germs. Do not use them instead of washing your hands. Clean all surfaces that you may have touched with a bleach solution. + Handwashing Be sure to wash your hands often with soap and water. Always wash them before eating and after using the bathroom. Your family and/or caregivers should also wash their hands. CUP BLEACH CUPS WATER 1 2 3 Clean bathroom and kitchen surfaces. Also remember to clean surfaces that are touched often Toilet seats/handles Sinks/faucets Light switches Doorknobs/handles Telephones Remotes Wet your hands Apply soap Lather and scrub for 20 seconds 9 4 5 6 Rinse thoroughly Turn off faucet with a paper towel Don t forget to wash Dry your hands with a new paper towel Between your fingers Under your nails The backs of your hands For more information about accessing ZINPLAVA, visit merckaccessprogram-zinplava.com or call 1-877-709-4455. A dedicated representative may be able to Research insurance benefits Obtain information about out-of-pocket costs Provide information about co-pay assistance options Refer you to the Merck Patient Assistance Program Answer any questions about filling out the enrollment form 8
Get help with your questions about access and support for ZINPLAVA The Merck Access Program Go to merckaccessprogram-zinplava.com for help answering questions like Does my insurance cover ZINPLAVA? What options may be available for co-pay assistance? Should I be referred to the Merck Patient Assistance Program? More information about the Merck Access Program can be found at merckaccessprogram-zinplava.com. You can also call 1-877-709-4455 to speak with a representative. Please read the accompanying Patient Information for ZINPLAVA and discuss it with your doctor. The Physician Prescribing Information also is available. Copyright 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. AINF-1183470-0001 09/17 You have an appointment to get ZINPLAVA. Date: Time: Facility Name: Facility Address: If you have any questions about your appointment, call the facility. Facility Phone: Copyright 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. AINF-1183470-0001 09/17