12 - OITN november 2001 i ...i..i..i.*!l!...;“E..‘3t‘..- A Pfizer Company VIRACEPTP (nelfinavir mesylate) Tablets and Oral Powder Information for Patients about VlHIlcEPT° (VI-ra-cept) Generic Name: neliinavir (nel-FIN-na-veer) mesylate For the Treatment of ltuman Immunodeficiency lfirus (HIV) Infection Please read this infonnation carefully before taking VIRACEPT. Also, please read this leaflet each time you renew the prescription, just in case anything has changed. This is a summary and not a replacement for a careful discussion with your doctor. You and your doctor should discuss VIRACEPT when you start taking this medication and at regular checkups. You should remain under a doctor's care when taking VIRACEPT and should not change or stop treatment without first talking with your doctor. Alert: Find out about medicines that should NOT be taken with VIRACEPT. Please also read the section “MEDICINES YOU SHOULD NOT’ TAKE WITH VIRACEPT". , WHAT IS VIRACEPT AND HOW DOES IT WORK? VIRACEPT is used in combination with other antiretroviral drugs in the treatment of people with human immunodeficiency vinis (HIV) infection. Infection with HN leads to the destruction of CD4T cells, which are important to the immune system.After a large number of CD4 cells have been destroyed, the infected person develops acquired immune deficiency syndrome (AIDS). VIRACEPT works by blocking HIV protease (a protein-cutting enzyme), which is required for HIV to multiply. VIRACEPT has been shown to significantly reduce the amount of HIV in the blood. Although VIRACEPT is not a cure for HIV or AIDS, VIRACEPT can help reduce your risk for death and Illness associated with HIV. Patients who took VIRACEPT also had significant increases in the number of CD4 cell count. VIRACEPT should be taken together with other antiretroviral drugs such as Retrovir” (zidovudine,AZT), Epivir” (lamivudine, 3TC), or Zerit“ (stavudine, d4T). Taking VIRACEPT in combination with other antiretroviral dnigs reduces the amount of HIV in the body (viral load) and raises CD4 counts. VIRACEPT may be taken by adults, adolescents, and children 2 years of age or older. Studies in infants younger than 2 years of age are now taking place. DOES VIHAGEPT CURE HIV OR AIDS? VIRACEPT is not a cure for HN infection orAlDS. People taking VIRACB’T may still develop opportunistic infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, Mycabacferium avium complex (MAC) infections, and Kaposi's sarcoma. There is no proof thatVlRACEPT can reduce the risk of transmitting HN to others through sexual contact or blood contamination. WHO SHOULD OR SHOULD NOT TAKE VIRACEPT? TogeHierwimyourdocmnywneedtodecidewheflierVlRACEPTisappmpnate for you. In making your decision, the following should be considered; Allergies: If you have had a serious allergic reaction to VIRACEPT, you must nottake VIRACEPT. You should also infonn your doctor, nurse, mpliamtacistofanylunwnallergiesbisubslamessrdiasofliermedicines, foods, preservatives, or dyes. lfyouarepregnanl:The efiec1sofVlHACEPTon pregnantwomen ortheir uIiornbabiesareriotioiown.lfyouarepregnamorplanh)beoomepregnant you should tell your doctor before taking VIRACEPT. If you are breast-feeding: You should discuss with your doctor the best way to feed your baby. You should be aware that if your baby does not already have HIV, there is a chance that it can be transmitted through breast-feeding. Women should not breast-feed Ifthey have HIV. children: VIRACEPT is available for the treatment of children 2 through 13 years of age with HN.There is a powderfonn ofVlRACEPT that can be mixed with milk, baby formula, or foods like pudding. Instructions on how to take VIRACEPT powder can be found in a later section that discusses howVlRACEPT Oral Powder should be prepared. If you have liver disease: VIRACEPT has not been studied in people with liver disease. If you have liver disease, you should tell your doctor before taking VIRACEPT. Other medical problems: Certain medical problems may affect the use of- VIRACEPT. Some people taking protease inhibitors have developed new or niaeserimsdiabetesorhighbbodaigansomepeoplewimtentopliiliatiave had increased bleeding. It is not known whether the protease inhibitors caused these problems. Be sure to tell your doctor if you have hemophilia typesA and B, diabetes mellitus, or an increase in thirst and/or frequent urination. ' Changes in body fat have been seen in some patients taking protease inhibitors. These changes may include increased amount of fat in the upper back and neck (“buffalo hump"), breast, and around the trunk - Loss of fat from the face, legs and arms may also happen. The cause and long-term health effects of these conditions are not known at this time. CAN VIRACEPT BE TAKEN WITH OTHER MEDIOATIONS? VIRACEPT may ihteract with other drugs, including those you take without a prescription. You must discuss with your doctor any drugs thatyou are taking or are planning to take before you take VIRACEPT. Medicines you should not take with VIRACEPT: Propulsid° (cisapride, for heartbum) Cordarone° (amiodarone, for irregular heartbeat) Ouinidine (for irregular heartbeat), also known as Ouinaglutef’, Cardioquin°, Quinidexf’, and others Ergot derivatives (Cafergot° and others, for migraine headache) Halcion° (triazolam) Versed° (midazolam) Mevacor° (lovastatin, forcholesterol lowering) Taking the above drugs with VIRACEPT may cause serious and/or life- threatening adverse events. R'rfampin° (for tuberculosis), also known as Rimactanet, Rifadin“, Hifater°, or Rifamate° This drug reduces blood levels of VIRACEPT. Dose reduction required if you take VIRACEPT with: Mycobutiné (rifabutin, for MAC); you will need to take a lower dose of Mycobutin. A change of therapy should be considered if you are taking VIRACEPT with: ' Phenobarbital Phenytoin (Dilantin" and others) Carbamazepine (Tegretol° and others) These agents may reduce the amount of VIRACEPT in your blood and make it less effective. Oral contraceptives (“the pill") If you are taking the pill to prevent pregnancy, you should use a different type of contraception since VIRACEPT may reduce the effectiveness of oral contraceptives. Special considerations Before you take Viagra“ (sildenafil) with VIRACEPT, talk to your doctor about possible dmg interactions and side effects. If you take Viagra and VIRACEPT together, you may be at increased risk of side effects of Viagra such as low blood pressure, visual changes, and penile erection lasting more than 4 hours. If an erection lasts longer than 4 hours, you should seek immediate medical assistance to avoid permanent damage to your . penis. Your doctor can explain these symptoms to you. It is not recommended to take VIRACEPT with the cholesterol-lowering drugs Mevacor” (lovastatin) or Zocor” (simvastatin) because of possible drug interactions. There is also an increased risk of drug interactions between VIRACEPT and Lipitor® (atorvastatin) and Baycol” (cerivastatin); talk to your doctor before you take either of these cholesterol reducing drugs with VIRACEPT Taking St. John's wort (hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John’s wort with VIRACEPT is not recommended. Talk with your doctor if you are taking or are planning to take St. John's wort. Taking St._23 250.5 ' 15 3 3/4 In measuring oral powder, the scoop or teaspoon should be level. * 1 level scoop contains 50 mg of VIRACEPT Use only the scoop provided with your VIRACEPT bottle. t 1 level teaspoon contains 200 mg of VIRACEPT. Note: A measuring teaspoon used for dispensing rnedicatlon should be used for measuring _ VIRACEPT Oral Powder. Ask your pharmacist to make sure you have a medication dispensing teaspoon. How should VIRACEPT Oral Powder be prepared? Theoralpowderniaybembredwidiasniallarnoumofwatecmilkformulasoy fumula,soymIlkdietaryaippIements,ordairyfoodssuchaspuddingorioe cream. Once mixed, the entire amount must be taken to obtain the full dose. Do not mix the powder with any acidic food or juice, such as orange or grapefnritiuice, apple juice, or apple sauce, because this may create a bitter taste. - Once the powder is mixed, it may be stored at room temperature or refrigerated for up to 6 hours. Do not heat the mixed dose once it has been prepared. Do notadd waterto bottles of oral powder. VIRACEPT powder is supplied with a scoop for measuring. For help in detennining the exact dose of powder for your child, please ask your doctor, nurse, or pharmacist. I VIRACEPT Oral Powder contains aspartame, a low-calorie sweetener, and therefore should not be taken by children with phenylketonuria (PKU). HOW SHOULD VIl1AOB"l’ BE STORED? Keep VIRACEPT and all other medicines out of the reach of children. Keep bottle closed andstore at room temperature (between 59"F and 86°F) away from sources of moisture such as a sink or other damp place. Heat and moisture may reduce the effectiveness ofVlRACEPT. Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children. Discuss all questions about your health with your doctor. If you have questions about VIRACEPT or any other medication you are taking, ask your doctor, nurse, or pharmacist. You can also call 1.888.VlRACEPT (1 .888.847.2237) toll free. CalI1.888.VlllAcEPT . VIRACEPT and Agouron are registered trademarks of Agouron Pharmaceuticals, Inc. Copyright ©2001 , Agouron Pharmaceuticals, Inc. All rights reserved. :51‘- m A Pfizer Company AQOUTOTI Pharmaceuticals |l'lC. ' I 2 .lnIIa Califnmia, 99037, USA |_2()3_g001 pp)