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Ng Treatment STARTING TREATMENT In this Patient Information Brochure, you will learn: • About the serious health concerns of toxoplasmosis • The importance of working with your doctor during your toxoplasmosis treatment • About getting started and the support available to you Your doctor has prescribed DARAPRIM. DARAPRIM Read more about what you can expect What you need to know during treatment. Let’s get started! DAR2016004, © May 2016 Turing Pharmaceuticals LLC. 1 01 ABOUT TOXOPLASMOSIS What is it and how is it contracted? • A serious infection caused by a parasite found in cat stool, raw meats, unwashed vegetables, water, and soil. • A parasite is an organism that lives on or in another (the “host”). Parasites survive by living off of their host. • Most people who have the parasite will not get seriously ill. However, in some people who have weakened immune systems, the parasite can cause serious illness. • The parasite most often affects the brain and eyes, but other organs such as the heart and the lungs can also be affected. • Toxoplasmosis can make you very sick and may even cause death. INDICATION DARAPRIM is a prescription medication that contains Not an actual patient pyrimethamine, indicated for the treatment of toxoplasmosis when used with a sulfonamide. NOTE: Do not use DARAPRIM if you: • are allergic to pyrimethamine or any component of DARAPRIM • have megaloblastic anemia due to folate deficiency What you need to know: Toxoplasmosis is an infection caused by a parasite that most commonly causes a serious brain disease called encephalitis. 2 3 02 STARTING TOXOPLASMOSIS TREATMENT What is DARAPRIM (pyrimethamine)? How can I get DARAPRIM? DARAPRIM is a pill for the treatment of toxoplasmosis Your doctor will fax your DON’T FORGET to: that is used in combination with a sulfonamide (antibiotic). prescription to DARAPRIM • Provide a reliable phone DARAPRIM can cause a side effect (folate deficiency) so Direct’s Specialty number to reach you. your doctor may prescribe another medication (folinic Mail Order Pharmacy. acid) for this purpose. • Answer the phone when A Case Manager will call a Case Manager calls. USUALLY you about available financial DARAPRIM SULFONAMIDE • Be available at the FOLINIC assistance programs and to ACID appropriate location schedule your DARAPRIM to sign for the delivery delivery. Your doctor will prescribe the medication that is right of your DARAPRIM for you. It is very important to follow your doctor’s DARAPRIM will be medication. treatment plan. delivered to a convenient location for you. Please make sure INDICATION to answer the phone when DARAPRIM DARAPRIM is a prescription medication that contains Direct’s Specialty Mail pyrimethamine, indicated for the treatment of Order Pharmacy calls. toxoplasmosis when used with a sulfonamide. Not an actual patient NOTE: DARAPRIM is not for everyone. Do not take DARAPRIM if you are allergic to pyrimethamine or have anemia due to folate deficiency. At the first appearance of a skin rash you should stop use of DARAPRIM and seek medical attention immediately. Other symptoms that may be early indications of serious disorders include sore throat, paleness, and purple spots on skin or swollen tongue. See pages 8-9 for Important Safety Information 4 5 03 STAYING ON YOUR TREATMENT PLAN Stick to your treatment plan as prescribed by your doctor. What happens if you don’t take your medicine as prescribed? It is important to make sure you take your medication as prescribed. If you do not take your medication as directed, your health may worsen. Life gets busy and routines change, so let your doctor know if you’re having trouble taking your medication regularly. Here are a few tips that can help you stay on top of your treatment: • Let your medication become part of your daily routines so you’ll be less likely to forget it. • Set an alarm on your phone, or put a sticky note on your door, to remind you to take your medication with you when you’ll be away from home. • Answer calls from the Specialty Mail Order Not an actual patient Pharmacy and respond to their refill reminders so you don’t run out of pills. • Financial help may be available so that cost does not prevent you from taking your medication. • Stay engaged. If you’re taking multiple medications, don’t let it become overwhelming. Speak with your doctor about your concerns. 6 7 04 IMPORTANT SAFETY INFORMATION INDICATION Tell your healthcare provider if you have any side effects while DARAPRIM is a prescription medication that contains taking DARAPRIM. pyrimethamine for the treatment of: Notify your healthcare provider if you become pregnant or • Toxoplasmosis or acute malaria when used with a sulfonamide intend to become pregnant during therapy or if you intend to (e.g., sulfadoxine) breast-feed or are breast-feeding an infant. • DARAPRIM is not for use by itself to treat acute malaria Tell your healthcare provider if you have problems with your and only for patients infected in areas where susceptible kidney or liver, decreased intestinal absorption problems, plasmodia (the parasite that causes malaria) exist. Other alcoholism, or any other medical conditions. medicines such as chloroquine or quinine are preferred for Make sure you tell your healthcare provider about all of the the treatment of acute malaria prescription and non-prescription medications you take, • For prevention of malaria when the plasmodia is susceptible. including supplements, and especially sulfonamides or It is not suitable as a prophylactic agent for travelers trimethoprim-sulfamethoxazole combination, proguanil (another to most areas since resistance to pyrimethamine is prevalent antimalarial medicine), zidovudine (a medicine to treat Human worldwide Immunodeficiency Virus, HIV), or cytostatic agents (medicines that block cell division e.g., methotrexate, a medicine used for IMPORTANT SAFETY INFORMATION cancer or rheumatoid arthritis), phenytoin (a medicine to treat Do not use DARAPRIM if you: seizures), or lorazepam (a medicine to treat anxiety). • are allergic to pyrimethamine or any component of DARAPRIM Be sure to take your medicine as instructed. Do not exceed the recommended dosage. You may take DARAPRIM with • have megaloblastic anemia due to folate deficiency or without food. However, taking DARAPRIM with food may Taking DARAPRIM may result in allergic reactions that can be minimize associated anorexia and vomiting. severe (such as Stevens-Johnson syndrome, toxic epidermal Keep out of the reach of infants and children: necrolysis, erythema multiforme, and anaphylaxis). Symptoms Deaths in pediatric patients have been reported after of an allergic reaction or the severe reactions may include: accidental ingestion. fever, body aches, facial or tongue swelling, skin pain, peeling of skin, blisters on your skin and mucous membranes, itching, Note: The above information for patients being treated with rash, red itchy welts, wheezing, asthma symptoms, or dizziness DARAPRIM is intended to aid in the safe and effective use of or feeling faint. At the first appearance of a skin rash or any of this medication. It is not a disclosure of all possible adverse or the above symptoms, stop the medication and immediately intended effects. Please read the accompanying Full Prescribing seek medical attention. Other signs and symptoms of serious Information and talk to your healthcare provider for more disorders may include sore throat, paleness, tongue changes, information concerning your treatment if you have questions. and purple skin color. You are encouraged to report negative side effects of Make sure to tell your healthcare provider if you have any heart prescription drugs to the FDA. Visit www.fda.gov/medwatch conditions, especially if you experience irregular heartbeat. or call 1-800-FDA-1088. To report SUSPECTED ADVERSE The most common side effects that may occur with DARAPRIM REACTIONS contact Turing Pharmaceuticals at 1-877-258-2033. include allergic reactions (see above), blood disorders (including neutropenia or a low level of neutrophils, a white blood cell Please See Accompanying Full Prescribing Information important to fight off infections), tongue changes, blood in the DARAPRIM is a licensed trademark urine, heart rhythm disorders, anorexia, and vomiting. of Turing Pharmaceuticals AG. 8 9 05 DARAPRIM DIRECT—A TRUSTED RESOURCE The DARAPRIM Direct Program was created to help you obtain quick and affordable access to DARAPRIM. Not actual patients Through enrollment in the DARAPRIM Direct program, you may be able to benefit from a range of financial assistance programs.1 • Uninsured patients have access to DARAPRIM for no out-of-pocket cost through the patient assistance program. • Through co-pay assistance, patients with commercial insurance are not obligated to pay more than $10 out-of-pocket for their DARAPRIM prescription. • Patients with Medicare Part D insurance coverage have access to an independent charitable foundation that may assist with affordability of their disease treatment. Be sure to sign the patient authorization on the DARAPRIM Enrollment Form (HIPAA form) to allow a Case Manager to assess your eligibility. 1Financial assistance programs are subject to terms and conditions and patient eligibility requirements. Restrictions, including where prohibited by law, may apply. Offers are subject to change or discontinuance without notice. Financial assistance programs are not insurance nor are they intended to be a substitute for insurance. 10 11 06 ADDITIONAL TOXOPLASMOSIS INFORMATION CDC http://www.cdc.gov/parasites/toxoplasmosis/
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