10 - OlTl"l july 2001 rarunmeuricas, g'rnc' A Pfizer Company VI RACEPT° (nelfinavir mesylate) Tablets and Oral Powder lnfonnation for Patients about VIRACEPT‘ (VI-ra-cept) Generic Name: nelfinavir (nel-FIN-na-veer) mesylate For the Treatment of Human Immunodeficiency Virus (HIV) Infection Please read this infonnation carefully before taking VIRACEPT. Also, please read this leaflet each time you renew the 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 doctors 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 SHOUUJ NOT TAKE WITH VlRACEPT". 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 virus (HIV) infection. lnfecbonwilhHNleadstothedesbucbonofCD4Toells,whichareimportam tothe immune system.Atter a large numberof CD4 cells have been destroyed, the infected person develops acquired immune deficiency syndrome (AIDS). VIRACEPT works by blocking HN protease (a protein—cutting enzyme), which is required for HN to multiply. VIRACEPT has been shown to significantly reduce the amount of HN in the blood. Although VIRACEPT is not a cure forgHN orAlDS, VIRACEPT can help reduce your risk for death ‘ and illness associated with Hill. Patients who took VIRACEPT also had significant increases in the number of CD4 cell count VlltACE’T should be taken together with other anltretrmriral drugs such as Relrovir° (zidovudine, AZT), Epivir“ (lamivudine, 3TC), or Zerit° (stavudine, d4T). Taking VIRACEPT in combination with other antiretroviral drugs reduces the amount of HN in the body (viral load) and raises CD4 counts. VlRACEPTmay betaken byadults, adolescents, and children 2 yearsofage oroldecsbrdiesinbrfantsyoungerthanzyearsofagearenuwtaldngplace. noes vrnncaercunenwonnrose VlRN3EFTisnotauuetnrHNinfecfioriorNDS.PeopletaldngVlRACEPTnray sfilldevelopoppmmnisficinfecborisorubrercondifimsassoctatedwimflw uitheseconditionsarepneumonia,herpesvirus infections, Mycobacterium avium complex (MAC) and Kaposi's sarcoma. ThereisnopmoftliatVlRACEPTcanreducethenskoftransmittingHNto others through sexual contact or blood contamination. WHOSHOULDORSl'l0ULDHOTTAKEV|RA0fl7T? Togeberhnbryomdocb)nymrieedtodecidevmeU1erWRACEPTisapprbpriate for you. In making your decision, the following should be considered: Allergies: If you have had a serious allergic reaction to VIRACEPT, you must not take VIRACET. You should also infonn your doctor, nurse, upltanrta:istofarwhnwnallergiestosibstamessud1asoUiermedrdnes, foods, preservatives, or dyes. If you are pregnant: The effects ofVlRACEPT on pregnant women or their unbornbabiesarenotlmown.lfyouarepregnamorplantobecomepregnant 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 Hlll, ttrere is a chance that it can be transmitted through breast-feeding. Women should not breast-feed if they have HIV. Children: VIRACEPT is available for the treatment of children 2 through 13 years of age with HIV. There is a powder fonn of VIRACEPT 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 how VIRACEPT 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 more serious diabetes or high blood sugar. Some people with hemophilia have had increased bleeding. It is not known whether the protease inhibitors caused these problems. Be sure to tell your doctor if you have hemophilia ‘types A and B, diabetes mellitus, or an increase in thirst andlor 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 anns 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 MEDIGATIONS? VIRACEPT may interact with other drugs, including those you take without a prescription. You must discuss with your doctor any drugs that you are taking or are planning to take before you take VIRACEPT Medicines you should M take with VIRACEPT’: Propulsid“ (cisapride, for heartburn) Cordarone° (amiodarone, for inegular heartbeat) Ouinidine (for inegular heartbeat), also known as Ouinaglute°, Cardioquint’, Ouinidexi’, and others Ergot derivatives (Cafergot° and others, for migraine headache) Halciont’ (triazolam) Versed” (midazolam) Mevacori (lovastatin, for cholesterol lowering) Zocor® (simvastatin, for cholesterol lowering) Taking the above drugs with VIRACEPT may cause serious and/or life- threatening adverse events. Rifampin° (for tuberculosis), also known as Rimactane°, Rifadin°, Rifater°, or Ritamatet’ This drug reduces blood levels ofVIRACEPT'. Dose reduction required if you take VIRACET with: Mycobutinf’ (rifabutin, for MAC); you will need to take a lower dose of Mycobutin. A change of therapy should be considered it you are taking VIRACEPT with: Phenobarbital Phenytoin (Dilantin° and others) Carbamazepine (Tegretol° and others) These agents may reduce the amount ofVIHACEPT 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 VTRACEPT, talk to your doctor about possible dnig interactions and side effects. If you take lfiagra and VIRACEPT together, you may be at increased risk of side effects ofifiagra 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 pennanent 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 dnrg interactions between VIRACEPT and l_ipitor° (atorvastatin) and Baycol° (cerivastatin); talk to your doctor before you take either of these cholesterol reducing dmgs 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 John’s wort may decrease VIRACEPT levels and lead to increased viral load and possible resistance to VIRACEPT or cross resistance to other antiretroviral drugs. HOW SHOULD VIRACEPT BE TAKEN Wl'TTt OTHER ANTI-HIV DRUGS? Taking VIRACEPT together with other anti-HN drugs increases their ability to fight the vinrs. It also reduces the opportunity for resistant vimses to grow. Based on your history of taking other anti-HN medicine, your doctor will direct you on how to take VIRACEPT and other anti-HN medicines. These drugs should be taken in a certain order or at specific times. This will depend on how many times a day each medicine should be taken. it will also depend on whether it should be taken with or withoutfood. Nucleoslde analogues: No drug interaction problems were seen when VIRACEPT was given with: _, Retrovir (zidovudine, AZT') Epivir (lamivudine, 3TC) Zerit (stavudine, d4T) index’ (didanosine, ddl) if you are taking both lfidex (ddl) and VIRACEPT: lfidex should be taken without food, on an empty stomach. Therefore, you should take VIRACEPT with food one hour after or more than two hours before you take index. Nonnucteoside reverse transcriptase inhibitors (NNRTls): When VTRACEPT is taken together with: Viramune° (nevirapine) The amount of VIRACEPT in your blood is unchanged. A dose adjustment is not needed when VIRACEPT is used with Vrramune. Sustivam (efavirenz) The amount of VIRACEPT in your blood may be increased. A dose adjusbnent is not needed when VIRACEPT is used with Sustiva. Other NNR'l'Is VIRACEPT has not been studied with other NNFl’lTs. Other protease inhibitors: When VIRACEPT is taken together with: Crixivan° (indinavir) The amount of both drugs in your blood may be increased. Cunentty, there are no safety and efficacy data available from the use of this combination. Norvirm (ritonavir) The amount of VIRACEPT in your blood may be increased. Cunentty, there are no safety and efficacy data available from the use of this combination. |nvirase° (saquinavir) The amount of saquinavir in your blood may be increased. Cunentty, there are no safety and efficacy data available from the use of this combination. WHAT ARE THE SIDE EFFECTS OF VIRACEPT? Like all medicines, VIRACEPT can cause side effects. Most of the side effects experienced with VIRACEPT have been mild to moderate. Dianhea is the most common side effect in people taking VIRACEPT, and most adult patients had at least mild diarrhea at some point during treatment In clinical sbidies, about 15-20% of patients receiving VIRACEPT 750 mg (three tablets) three times daily or 1250 mg (five tablets) two times daily had four or more loose stools a day. In most cases, diarrhea can be controlled using antidianheal medicines, such as lmodium° A-0 (loperamide) and others, which are available without a prescription. Other side effects that occuned in 2% or more of patients receiving VIRACEPT include nausea, gas and rash. There were other side effects noted in clinical studies that occuned in less than 2% of patients receiving VIRACEPT. However, these side effects may have been due to other drugs that patients were taking or to the illness itself. Except for diarrhea, there were not many differences in side effects in patients who took VIRACEPT along with other drugs compared with those who took only the other drugs. For a complete list of side effects, ask your doctor, nurse, or phannacist. HOW SHOULD I TAKE VIRACEPT? VIRACEPT is available only with your doctors prescription. Your doctor may prescribe the light blue VIRACEPT Tablets either as 1250 mg (five tablets) taken two times a day or as 750 mg (three tablets) taken three times a day. VIRACEPT should always be taken with a meal or alight snack. VIRACEPT tablets are film—coated to help make the tablets easier to swallow. Take VIRACEPT exactly as directed by your doctor. Do not increase or decrease any dose orthe number of doses per day. Also, take this medicine for the exact period of time that your doctor has instructed. Do not stop taking VIRACEPT without first consulting with your doctor, even it you are feeling better. Only take medicine that has been prescribed specifically for you. Do not give VIRACEPT to others or take medicine prescribed for someone else. The dosing of VIRACEPT may be different for you than for other patients. Follow the directions from your doctor, exactly as written on the label. The amount of VIRACEPT in the blood should remain somewhat consistent overtime. Missing doses will cause the concentration of VIRACEPT to decrease; therefore, you should not miss any rtoses. However, if you miss a dose, you should take the dose as soon as possible and then take your next scheduled dose and future doses as originally scheduled. _ Dosing in adults (including children 14 years of age and older) The recommended adult dose of VIRACEPT is 1250 mg (five tablets) taken two times a day or 750 mg (three tablets) taken three times a day. Each dose should be taken with a meal or light snack. Dosing in children 2 to 13 years of age The VIRACEPT dose in children depends on their weight The recommended dose is 20 to 30 mg/kg (or 9 to 14 mg/pound) per dose, taken three times daily with a meal or light snack. This can be administered either in tablet fonn or, in children unable to take tablets, as VIRACEPT Oral Powder. Dose instructions will be provided by the child's doctor. The dose will be given three times daily using the measuring scoop provided, a measuring teaspoon, or one or more tablets depending on the weight and age of the child. The amount of oral powder or tablets to be given to a child is described in the chart below. Pediatric Dose to Be Administered Three Times Daily ‘ 1-V01 ‘l 71 -BG Body Weight Number of Number of Number of Kg Lb" Level Smog" Level Teaspoonst Tablets 7 to <8.5 15.5 to