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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (Oct. 19, 2001)
» Taking the above drugs w ith VIRACEPT may cause serious and/or life- threatening adverse events. Rifampin® (for tuberculosis), also known as Rimactane®, Rifadin®, R ifater®, or Rifamate® This drug reduces blood levels of VIRACEPT. A g o u ro n Pharmaceuticals, he. A Pfizer Company Dose reduction required if you take VIRACEPT with: Mycobutin® (rifabutin, for MAC): you w ill need to take a lower dose of Mycobutin. VIRACEPT® (neifinavir mesylate) A change of therapy should be considered if you are taking VIRACEPT with: Tablets and Oral Powder Phénobarbital Information for Patients Phenytoin (Dilantin® and others) about VIRACEPT* (Vl-ra-cept) Generic Name: neifinavir (nel-FIN-na-veer) mesylate For the Treatment of Human Immunodeficiency Virus (HIV) Infection Carbamazepine (Tegretol® and others) These agents may reduce the amount of VIRACEPT in your blood and make it less effective. Please read this Information 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 summary and not a replacement for a careful discussion w ith 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 treatm ent w ithout firs t talking w ith your doctor. Oral contraceptives (“the p ill”) 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. 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 combination w ith other antiretroviral drugs in the treatm ent of people w ith human imm unodeficiency virus (HIV) infection. Infection with HIV leads to the destruction of CD4 T cells, which are important to the immune system. A fter a large number of CD4 cells have been destroyed, the infected person develops acquired immune deficiency syndrome (AIDS). 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 HIV infection or AIDS. People taking VIRACEPT may still develop opportunistic infections or other conditions associated w ith HIV infection. Some of these conditions are pneumonia, herpes virus infections, M ycobacterium avium complex (MAC) infections, and Kaposi's sarcoma. 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? • Other m edical 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 w ith 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 m ellitus, 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 fa t in the upper back and neck (“ buffalo hum p"), 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. N u m b er of N um ber of N um ber of Level Teaspoonsf Tablets 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 vims. It also reduces the opportunity for resistant viruses to grow. Based on your history of taking other anti-HIV medicine, your doctor w ill direct you on how to take VIRACEPT and other anti-HIV medicines. 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 w ithout 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 2 1 /4 — 18 to <23 39 .5 to <50.5 10 2 1 /2 2 *2 3 *5 0 .5 15 3 3/4 3 In measuring 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 (lamivudine, 3TC) Zerit (stavudine, d4T) Nonnucleoside reverse transcriptase inhibitors (NNRTIs): When VIRACEPT is taken together w ith. Viramune® (nevirapine) The amount of VIRACEPT in your blood is unchanged. A dose adjustm ent is not needed when VIRACEPT is used w ith Viramune. Sustiva™ (efavirenz) Do not add water to bottles of oral powder. VIRACEPT has not been studied w ith other NNRTIs. VIRACEPT powder is supplied w ith a scoop for measuring. For help in determ ining the exact dose of powder fo r your child, please ask your doctor, nurse, or pharmacist. Other protease inhibitors: When VIRACEPT is taken together w ith: Crixivan® (indinavir) VIRACEPT Oral Powder contains aspartame, 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 combination. 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 combination. 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 combination. WHAT ARE THE SIDE EFFECTS OF VIRACEPT? 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 w ith other drugs compared w ith those who took only the other drugs. For a com plete list of side effects, ask your doctor, nurse, or pharmacist. Mevacor® (lovastatln, for cholesterol lowering) Zocor® (sim vastatin, for cholesterol lowering) Do not mix the powder w ith any acidic food or juice, such as orange or grapefruit juice, apple juice, or apple sauce, because this may create a bitter taste. Other NNRTIs Ergot derivatives (Cafergot® and others, for migraine headache) Halcion® (triazolam) How should VIRACEPT Oral Powder be prepared? The oral powder may be mixed w ith a sm all amount of water, m ilk, form ula, soy form ula, soy m ilk, dietary supplements, or dairy foods such as pudding or ice cream. Once mixed, the entire amount must be taken to obtain the fu ll dose. 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 side effects that occurred in 2% or more of patients receiving VIRACEPT include nausea, gas and rash. Versed® (midazolam) 1 1 level teaspoon contains 200 mg of VIRACEPT. Note: A measuring teaspoon used for dispensing medication should be used for measuring VIRACEPT Oral Powder. Ask your pharm acist to make sure you have a medication dispensing teaspoon. The amount of VIRACEPT in your blood may be increased. A dose adjustment is not needed when VIRACEPT is used w ith Sustiva. Quinidine (for irregular heartbeat), also known as Quinaglute®, Cardioquin®, Quinidex®, and others Medicines you should not take with VIRACEPT: Propulsid® (cisapride, for heartburn) Body W eight Nucleoside analogues: No drug interaction problem s were seen when VIRACEPT was given w ith: Cordarone® (amiodarone, for irregular heartbeat) VIRACEPT may interact w ith other drugs, including those you take w ithout a prescription. You must discuss w ith your doctor any drugs that you are taking or are planning to take before you take VIRACEPT. P e d ia tric D ose to Be A d m in is te re d T h re e T im e s D a ily Level Scoops* Like all medicines, VIRACEPT can cause side effects. Most of the side effects experienced w ith VIRACEPT have been m ild to moderate. Diarrhea is the most common side effect in people taking VIRACEPT, and most adult patients had at least m ild diarrhea at some 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, dianhea can be controlled using antidiarrheal medicines, such as Imodium® A-D (loperamide) and others, which are available w ithout a prescription. CAN VIRACEPT BE TAKEN WITH OTHER MEDICATIONS? Dose instructions w ill be provided by the child’s doctor. The dose w ill be given three tim es daily using the measuring scoop provided, a measuring 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. Lb If you are taking both Videx (ddl) and VIRACEPT: Videx should be taken w ithout food, on an empty stomach. Therefore, you should take VIRACEPT w ith food one hour after or more than tw o hours before you take Videx. If you have liver disease: VIRACEPT has not been studied in people w ith liver disease. If you have liver disease, you should tell your doctor before taking VIRACEPT. 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 m g/kg (or 9 to 14 mg/pound) per dose, taken three tim es daily w ith 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. Kg Videx® (didanosine, ddl) Children: VIRACEPT is available for the treatm ent of children 2 through 13 years of age with HIV. There is a powder form of VIRACEPT that can be mixed w ith 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 dosing of VIRACEPT may be different for you than fo r 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 over tim e. Missing doses w ill cause the concentration o f VIRACEPT to decrease: therefore, you should not miss any doses. 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) Allergies: If you have had a serious allergic reaction to VIRACEPT, you must not take VIRACEPT. You should also inform your doctor, nurse, or pharmacist of any known allergies to substances such as other medicines, foods, preservatives, or dyes. If you are breast-feeding: You should discuss w ith 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. Only take medicine that has been prescribed specifically for you. Do not give VIRACEPT to others or take medicine prescribed for someone else. The recommended 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 meal or light snack. Together with your doctor, you need to decide whether VIRACEPT is appropriate for you. In making your decision, the follow ing should be considered: If you are pregnant: The effects of VIRACEPT on pregnant women or their unborn babies are not known. If you are pregnant or plan to become pregnant, you should tell your doctor before taking VIRACEPT. 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 medicine for the exact period of tim e that your doctor has instructed. Do not stop taking VIRACEPT without first consulting w ith your doctor, even if you are feeling better. Before you take Viagra® (sildenafil) w ith VIRACEPT, talk to your doctor about possible druginteractions 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 perm anent damage to your penis. Your doctor can explain these symptoms to you. Taking St. John’s w ort (hypericum perforatum), an herbal product sold as a dietary supplement, or products containing St. John’s w ort w ith VIRACEPT is not recommended. Talk w ith your doctor if you are taking or are planning to take St. John’s wort. 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. VIRACEPT should be taken together with other antiretroviral drugs such as Retrovir® (zidovudine, AZT), Epivir® (lamivudine, 3TC), or Zerit® (stavudine, d4T). Taking VIRACEPT in com bination w rth other antiretroviral drugs reduces the amount of HIV in the body (viral load) and raises CD4 counts. VIRACEPT is available only w ith your doctor's 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 tim es a day. VIRACEPT should always be taken w ith a meal or a light snack. VIRACEPT tablets are film -coated to help make the tablets easier to swallow. Special considerations It is not recommended to take VIRACEPT w ith the cholesterol-lowering 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 w ith VIRACEPT. VIRACEPT works by blocking HIV protease (a protein-cutting enzyme), which is required for 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 w ith HIV. Patients who took VIRACEPT also had significant increases in the number of CD4 cell count. HOW SHOULD I TAKE VIRACEPT? Keep VIRACEPT and all other medicines out of the reach of children. Keep bottle closed and store a t 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 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 w ith your doctor. If you have questions about VIRACEPT or any other m edication you are taking, ask your doctor, nurse, or pharmacist. 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 Pharmaceuticals, Inc. Copyright © 2001, Agouron Pharmaceuticals, Inc. All rights reserved. Agouron. Pharmaceuticals, Inc. A Pfizer Company Agouron Pharmaceuticals Inc. La Jolla, California, 92037, USA 1-V01171-BG L203-0001 PPI Rev. 01/25/01
