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Taking the above drugs with VIRACEPT may cause serious and/or life- threatening adverse events. Pharm aceutical, k ia A P fi z e r C o m p a n y VIRACEPT® (neifinavir mesylate) Tablets and Oral Pow der Information for Patients abort VIRACEPT* (Vl-ra-cept) Generic Nam e: neifinavir (nel-FIN-na-veer) mesylate u T».I Iilninnl nl lii.mon ror U me ireauueni oi Human Immunodeficiency Virus (HIV) Infection Please read this inform ation carefully before taking VIRACEPT. Also, please read this leaflet each tim e you renew the prescription, just in case anything has changed. This is a sum m ary and not a replacem ent for a careful discussion w ith your doctor. You and your doctor should discu ss VIRACEPT when you start taking this m edication and at regular checkups. You should rem ain under a doctor's care when taking VIRACEPT and should not change or stop treatm ent without first talking with your doctor. A lert 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 com bination w ith other antiretroviral drugs In the treatm ent of people w ith human im m unodeficiency virus (HIV) Infection. Infection with HIV leads to the destruction of CD4 T cells, which are important to the im m une system . After a large num ber of CD4 ce lls have been destroyed, the infected person develops acquired Immune deficiency syndrom e (AIDS). VIRACEPT w orks by blocking HIV protease (a protein-cutting enzyme), which is required for HIV to m ultiply. VIRACEPT has been shown to significantly reduce the am ount of HIV in the blood. Although VIRACEPT is not a cure tor HIV or AIDS, VIRACEPT can help reduce your risk for death and illness associated w ith HIV. Patients who took VIRACEPT also had significant increases in the num ber of CD4 ce ll count. VRACEPT should be taken togedwr with other antiretroviral drugs such as Retrow® (zidovudine, AZT), Epivir® (lamivudine, 3TC), or Zerit® (stavudine, d4T). Taking VIRACEPT in com bination w ith other antiretroviral drugs reduces the am ount ot HIV in the body (viral load) and raises CD4 counts. VIRACEPT may be taken by adults, adolescents, and children 2 years of age v older. Studies in infants younger than 2 years ot age are now taking place. DOES VIRACEPT CURE WV OR AIDS? VIRACEPT is not a cure tor HW infection or AIDS. People taking VIRACEPT may still develop opportunistic infections or other conditions associated w ith HIV infection. Som e of these conditions are pneumonia, herpes virus infections, Mycobacterium avium com plex (MAC) infections, and Kaposi's sarcom a. There is no proof that VIRACEPT can reduce the risk of transm itting HIV to others through sexual contact or blood contam ination. WHO SHOULD OR SHOULD NOT TAKE VIRACEPT? Together with your doctor, you need to decide whether VRACEPT is appropriate tor you. In m aking your decision, the foliow ing should be considered: Rifampin® (for tuberculosis), also known as Rimactane® , Rifadin®, Rifater® , or Rifamate® This drug reduces blood levels of VIRACEPT. Dose reduction required if you take VIRACEPT with: Mycobutin® (rifabutin, for MAC); you w ill need to take a low er dose of M ycobutin. A change of therapy should be considered if you are taking VIRACEPT with: Phénobarbital Phenytoln (Dilantin® and others) Carbam azepine (Tegretol® and others) These agents may reduce the am ount of VIRACEPT in your blood and m ake it less effective. Oral contraceptives (“the pill") If you are taking the p ill to prevent pregnancy, you should use a different type of contraception since VIRACEPT m ay reduce the effectiveness of oral contraceptives. Take VIRACEPT exactly as directed by your doctor. Do not increase or decrease any dose or the number ot doses per day. Also, take this m edicine for the exact period ot tim e that your doctor has instructed. Do not stop taking VIRACEPT without first consulting with your doctor, even if you are feeling better. Only take m edicine that has been prescribed specifically for you. Do not give VIRACEPT to others or take m edicine prescribed for som eone 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 am ount of VIRACEPT in the blood should rem ain som ew hat consistent over time. M issing doses w ill cause the concentration of VIRACEPT to decrease; therefore, you should not m iss any doses. However, if you m iss 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) Before you take Viagra® (sildenafil) with VIRACEPT, talk to your doctor about possible drug 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 im m ediate m edical assistance to avoid perm anent dam age to your penis. Your doctor can explain these sym ptom s to you. The recom m ended adult dose of VIRACEPT is 1250 mg (five tablets) taken two tim es a day or 750 mg (three tablets) taken three tim es a day. Each dose should be taken w ith a m eal or light snack. It is not recomm ended to take VIRACEPT w ith the cholesterol-low ering drugs Mevacor® (lovastatin) or Zocor® (sim vastatin) 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 S t John's w ort with VIRACEPT is not recommended. Talk w ith your doctor if you are taking or are planning to take S t John's w ort Taking S t 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. Dosing in children 2 to 13 years of age The VIRACEPT dose in children depends on their w eight The recommended dose is 20 to 30 mg/kg (or 9 to 14 mg/pound) per dose, taken three tim es daily with a m eal or light snack. This can be adm inistered either in tablet form or, in children unable to take tablets, as VIRACEPT Oral Powder. Dose instructions w ill be provided by the ch ild 's doctor The dose w ill be given three tim es daily using the m easuring scoop provided, a m easuring teaspoon, or one or more tablets depending on the w eight and age of the child. The am ount 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 Number of Body Weight Kg LB 7 to <8.5 15.5 to <18.5 Numoer oi Number of Level Scoops* Level Teaspoons! Tablets 4 1 — HOW SHOULD VIRACEPT BE TAKEN WfTH OTHER ANTI-HIV DRUGS? 8.5 to <10.5 18.5 to <23 5 1 1/4 — Taking VIRACEPT together w ith other anti-HIV drugs increases their ability to fight the virus. It also reduces the opportunity for resistant virase.' to grow. Based on your history ot taking other anti-HIV m edicine, your doctor w ill direct you on how to take VIRACEPT and other anti-HIV m edicines. These drugs should be taken in a certain order or at sp e cific tim es. This w ill depend on how many tim es a day each m edicine should be taken. It w ill also depend on w hether it should be taken w ith or w ithout food. 10.5 to <12 23 to <26.5 6 11/2 — 12 to <14 26.5 to <31 7 1 3/4 — 14 to <16 31 to <35 8 2 — 16 to <18 35 to <39.5 9 21/4 — 18 to <23 39.5 to <50.5 10 21/2 2 »23 *505 15 3 3/4 3 Nucleoside analogues: No drug interaction problem s w ere seen when VIRACEPT w as given with: In m easuring oral powder, the scoop or teaspoon should be level. Retrovir (zidovudine, AZT) * 1 level scoop contains 50 mg of VIRACEPT. Use only the scoop provided w ith your VIRACEPT bottle. Epivir (lam ivudine, 3TC) Zerit (stavudine, d4T) Videx® (didanosine, ddl) If you are taking both VMex (ddl) and VIRACEPT: Videx should be taken w ithout food, on an em pty stom ach. Therefore, you should take VIRACEPT w ith food one hour after or m ore than two hours before you take Videx. If you are pregnant The effects of VIRACEPT on pregnant wom en or their unborn babies are not known. If you are pregnant or plan to become pregnant, you should tell your doctor before taking VIRACEPT. Nonnudeoside reverse transcriptase inhibitors (NNRTIs): Children: VIRACEPT is available for the treatm ent of children 2 through 13 years of age w ith HIV. There is a powder form of VIRACEPT that can be mixed with m ilk, baby form ula, or foods like pudding. Instructions on how to take VIRACEPT powder can be found in a later section that discusses how VIRACEPT Oral Pow der should be prepared. VIRACEPT is available only with your doctor's prescription. Your doctor may prescribe the light blue VIRACEPT Tablets either as 1250 mg (five tablets) taken two tim es a day or as 750 mg (three tablets) taken three tim es a day VIRACEPT should alw ays be taken with a m eal or a light snack. VIRACEPT tablets are film -coated to help m ake the tablets easier to sw allow . Special considerations Allergies: If you have had a serious atlergic reaction to VtRACS’T, you must not take VIRACEPT. You should also inform your doctor, nurse, or pharm acist of any known allergies to substances such as other m edicines, foods, preservatives, or dyes. If you are brrist-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 transm itted through breast-feeding. Women should not breast-feed if they have HIV. HOW SHOULD I TAKE VWACEPT? When VIRACEPT is taken together with: Viramune® (nevirapine) The am ount of VIRACEPT in your blood is unchanged. A dose adjustm ent is not needed when VIRACEPT is used w ith Viram une. Sustiva™ (efavirenz) 1 1 level teaspoon contains 200 mg of VIRACEPT. Note; A measuring teaspoon used for dispensing medication should be used for m easuring VIRACEPT Oral Powder. A sk your pharm acist to m ake sure you have a m edication dispensing teaspoon. How should VIRACEPT Oral Powder be prepared? The oral pow der may be m ixed with a sm all am ount of water, m ilk, form ula, soy form ula, soy m ilk, dietary supplem ents, or dairy foods such as pudding or ice cream . Once m ixed, the entire amount m ifet be taken to obtain the fu ll dose. Do not m ix the pow der with any acidic food or juice, such as orange or grapefruit juice, apple juice, or apple sauce, because this m ay create a bitter taste. The amount of VIRACEPT In your blood m ay be increased. A dose adjustment is not needed when VIRACEPT is used w ith Sustiva. Once the pow der is m ixed, it may be stored at room tem perature or refrigerated for up to 6 hours. Do not heat the m ixed dose once it has been prepared. Other NNRTIs Do not add w ater to bottles ot oral powder. VIRACEPT has not been studied w ith other NNRTIs. VIRACEPT pow der is supplied with a scoop for m easuring. For help in determ ining the exact dose of powder for your child, please ask your doctor, nurse, or pharm acist. 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 protease inhibitors: Other medical problems: Certain m edical problem s may affect the use of VIRACEPT. Som e people taking protease inhibitors have developed new or more serious diabetes or high blood sugar. Som e people with hem ophilia have had increased bleeding. It is not known whether the protease inhibitors caused these problem s. Be sure to tell your doctor if you have hem ophilia types A and B, diabetes m ellitus, or an increase in thirst and/or frequent urination. Crixivan® (indinavir) VIRACEPT Oral Pow der contains aspartam e, a low -calorie sweetener, and therefore should not be taken by children w ith phenylketonuria (PKU) The amount of both drugs in your blood may be increased. Currently, there are no safety and efficacy data available from the use of this com bination HOW SHOULD VIRACEPT BE STORED? When VIRACEPT is taken together with: Norvir™ (ritonavir) The am ount of VIRACEPT in your blood m ay be increased. Currently, there are no safety and efficacy data available from the use of this com bination Changes in body fat have been seen in som e patients taking protease inhibitors. These changes may include increased amount of fat in the upper back and neck ("buffalo hum p”), breast, and around the trunk. Loss of fat from the face, legs and arm s m ay also happen. The cause and long-term health effects of these conditions are not known at this tim e Invirase® (saquinavir) CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS? Cordarone® (am iodarone, for irregular heartbeat) Like all m edicines, VIRACEPT can cause side effects. M ost of the side effects experienced with VIRACEPT have been m ild to m oderate. Diarrhea is the m ost common side effect in people taking VIRACEPT, and most adult patients had at least m ild diarrhea at som e point during treatm ent. In clinical studies, about 15-20% of patients receiving VIRACEPT 750 mg (three tablets) three tim es daily or 1250 mg (five tablets) two tim es daily had four or more loose stools a day. In most cases, diarrhea can be controlled using antidiarrheal m edicines, such as Imodium® A-D (loperam ide) and others, w hich are available without a prescription. Quinidine (for irregular heartbeat), also known as Quinaglute®, Cardioquin® , Quinidex®, and others Other side effects that occurred in 2% or m ore of patients receiving VIRACEPT include nausea, gas and rash Ergot derivatives (Cafergot® and others, for m igraine headache) There were other side effects noted in clin ica l studies that occurred in less than 2% of patients receiving VIRACEPT. However, these side effects may have been due to other drags that patients were taking or to the Illness itself. Except for diarrhea, there w ere not m any differences in side effects in patients who took VIRACEPT along with other drags com pared w ith those who took only the other drags. For a com plete list of side effects, ask your doctor, nurse, or pharm acist. VIRACEPT may interact w ith other drugs, including those you take without a prescription. You m ust discuss with your doctor any drugs that you are taking or are planning to take before you take VIRACEPT Medicines you should not take with VIRACEPT: Proputsid® (cisapride, for heartburn) Halcion® (triazolam ) Versed® (midazolam) Mevacor® (lovastatin, for cholesterol lowering) Zocor® (sim vastatin, for cholesterol lowering) The am ount of saquinavir In your blood m ay be increased. Currently, there are no safety and efficacy data available from the use of this com bination. WHAT ARE THE SIDE EFFECTS OF VIRACEPT? Keep VIRACEPT and all other m edicines out of the reach of children. Keep bottle dosed and store at room tem perature (between 59°F and 86°F) away from sources of m oisture such as a sin k or other dam p place. Heat and m oisture m ay reduce the effectiveness of VIRACEPT. Do not keep m edicine that is out of date or that you no longer need Be sure that if you throw any m edicine away, it is out of the reach of children. D iscuss a ll questions about your health w ith your doctor. If you have questions about VIRACEPT or any other m edication you are taking, ask your doctor, nurse, or pharm acist. You can also call 1.888.VIRACEPT (1.888.847.2237) toll free. Call 1.888. VIRACEPT VIRACEPT and Agouron are registered tradem arks of Agouron Pharm aceuticals, Inc. Copyright 0 2 0 0 1 , Agouron Pharm aceuticals, Inc. All rights reserved. Agouoru _ - - — ■ ■ ■ - n w T T W lU lw ^ iiC . A P f I z •r Company Agouron Pharm aceuticals Inc. La Jolla, California, 92037, USA 1-V01171-BG L203-0001 PPI Rev. 01/25/01
