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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (June 1, 2001)
Taking the above drugs w ith VIRACEPT may cause serious and/or life- threatening adverse events. A gouron. ■ — »• » *- marmaceuucan,nc. A P f i z • r C o m p a n y VIRACEPT* (netfinavir m esylate) Tablets and Oral Powder Information for Patients about VMACEPT* (Vl-ra-cept) Generic Name: netfinavir (nel-RN-na-veer) mesylate For the Treatment of 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 with your doctor. You and your doctor should discu ss VIRACEPT when you start taking this m edication and at regular checkups. You should remain under a doctor’s care when taking VIRACEPT and should not change or stop treatm ent 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 com bination with other antiretroviral drugs in the treatm ent of people with human im m unodeficiency virus (HIV) infection. Infection with HIV leads to the destruction of C 0 4T cells, which are important to the immune system . After a large number of CD4 ce lls have been destroyed, the infected person develops acquired immune deficiency syndrom e (AIDS). VIRACEPT works by blocking HIV protease (a protein-cutting enzyme), which is required tor HIV to m ultiply. 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® (stavudme, d4T). Taking VIRACEPT in com bination with other antiretroviral drugs 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 VIRACEPT CURE HIV OR AIDS? VIRACEPT is not a cure for HfV infection or AIDS. People taking VIRACEPT may still develop opportunistic infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, M ycobacterium 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 V H A C B T is appropriate for you. In m aking your decision, the follow 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 it you take VIRACEPT with: Mycobutin® (rifabutin, for MAC); you w ill need to take a low er dose of Mycobutin A change of therapy should be considered if you are taking VIRACEPT with: Phénobarbital Phenytoin (Dilantin® and others) Carbam azepine (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. VIRACEPT is available only with your doctor's prescnption. Your doctor may prescribe the light blue VIRACEPT Tablets either as 125B 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 w ith a meal or a light snack. VIRACEPT tablets are film -coated to help m ake the tablets easier to swallow. Take VIRACEPT exactly as directed by your doctor. Do not Increase or decrease any dose or the number of doses per day. Also, take this m edicine for the exact period of 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 tor other patients. Follow the directions from your doctor, exactly as written on the label. The amount of VIRACEPT in the blood should rem ain som ewhat consistent over time. M issing doses w ill cause the concentration of VIRACEPT to decrease; therefore, you should not miss 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. Special considerations 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 permanent dam age to your penis. Your doctor can explain these sym ptom s to you. The recomm 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 with a m eal or light snack. It is not recommended to take VIRACEPT with 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 Lipitoc® (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 S I 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 weight. The recommended dose is 20 to 30 mg/kg (or 9 to 14 mg/pound) per dose, taken three tim es daily with a meal 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 easunng 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. P e d ia t r ic D o s e to B e A d m in is t e r e d T h r e e T i m e s D a i l y N u m b e r of N u m b e r of N u m b e r of Kg Lb Leve l Scoops’ Leve l Teaspoonsf T a b le ts 7 to <8.5 15.5 to <18.5 4 1 — HOW SHOULD VIRACEPT BE TAKEN WITH 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 viruses to grow. Based on your history of taking other anti-HIV m edicine, your doc v 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 specific 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 whether it should be taken w ith or without food. 10.5 to <12 23 to <26 5 6 1 1/2 — 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 *50.5 15 3 3/4 3 B o d y W e ig h t Nucleoside analogues: No drug interacbon problem s were 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 with your VIRACEPT bottle. Epivir (lam ivudine, 3TC) Zerit (stavudme, d4T) Videx® (didanosine, ddl) Allergies: If you have had a serious allergic reaction to VIRACEPT, 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 taking both Videx (ddl) and VIRACEPT: Videx should be taken w ithout food, on an empty stom ach Therefore, you should take VIRACEPT with food one hour after or more than two hours before you take Videx. If you are pregnant The effects of VIRACEPT on pregnant women or their unborn babies are not known, tf you are pregnant or plan to become pregnant, you should tell your doctor before taking VIRACEPT. Nonnucleoside reverse transcriptase inhibitors (NNRTIs): 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 if they have HIV. HOW SHOULD I TAKE VIRACEPT? When VIRACEPT 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 w ith Viramune. 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 powder m ay be mixed 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 ust be taken to obtain the full dose. Do not mix the pow der with any acidic food or juice, such as orange or grapefruit juice, apple juice, or apple sauce, because this may create a bitter taste Children: VIRACEPT is available for the treatm ent of children 2 through 13 years of age with HIV There is a powder to rn 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 Powder should be prepared The amount of VIRACEPT in your blood may be Increased . A dose adjustment is not needed when VIRACEPT is used with Sustiva. Once the powder is mixed, it may be stored at room tem perature or refrigerated for up to 6 hours. Do not heat the mixed dose once it has been prepared. Other NNRTIs Do not add w ater to bottles of oral powder VIRACEPT has not been studied w ith other NNRTIs. 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. inner protease innioftors. VIRACEPT powder 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 Other medical problems: Certain m edical problem s 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 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. 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 hump"), breast, and around the trunk. Loss of fat from the face, legs and arm s may also happen. The cause and long-term health effects of these conditions are not known at this time. When VIRACEPT is taken together with: Crixivan® (indinavir) VIRACEPT Oral Powder contains aspartame, a low -calorie sweetener, and therefore should not be taken by children with 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? Norvir™ (ritonavir) The amount of VIRACEPT in your blood may be increased Currently, there are no safety and efficacy data available from the use of this com bination. Invirase® (saquinavir) The amount of saquinavir in your blood may 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? Cordarone® (amiodarone, for irregular heartbeat) Like a ll m edicines, VIRACEPT can cause side effects. Most 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 treatment. In clin ica l 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, dianhea can be controlled using antidiarrheal m edicines, such as Imodium® A-D (loperamide) and others, w hich are available without a prescription. Quinidine (for irregular heartbeat), also known as Qumaglute®, Cardioquin®. Quinidex®, and others Other side effects that occurred in 2% or more 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 clinical studies that occurred 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 com plete list of side effects, ask your doctor, nurse, or pharm acist CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS? VIRACEPT may interact with 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: Propulsid® (cisapride, for heartburn) Halcion® (triazolam) Versed® (midazolam) Mevacor® (lovastatin, for cholesterol lowering) Zocor® (sim vastatin, for cholesterol lowering) Keep VIRACEPT and all other m edicines out of the reach of children Keep bottle closed and store at room tem perature (between 59°F and 86°F) away from sources of m oisture such as a sink or other damp place Heat and m oisture may 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 all questions about your health with 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 © 2001, Agouron Pharm aceuticals, Inc. A ll rights reserved Agouron« marmaceuocaB, nc. A Pfiz er C o m p a n y Agouron Pharm aceuticals Inc. La Jolla, California, 92037, USA 1-V01171-BG L203-0001 PPI Rev. 01/25/01
