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About Just out. (Portland, OR) 1983-2013 | View Entire Issue (Nov. 16, 2001)
I . Agouron HnarniaceuDcais, tic. A Pfizer C o m p a n y VIRACEPT® (nelfinavir mesylate) Tablets and Oral Powder Information for Patients about VIRACEPT» (Vl-ra-cept) Generic Name: nelfinavir (nel-FIN-na-veer) mesylate For the Treatment of Human Immunodeficiency Virus (HIV) Infection Please read this information carefully before taking VIRACEPT. Also, please read this leaflet each time you renew the prescription, just in case anything has changed. This is a sum m ary and not a replacement for a careful discussion with your doctor. You and your doctor should d iscuss 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. A lert Find out about m edicines that should NOT be taken with VIRACEPT. Please also read the section “M EDICINES YOU SHOULD NOT TAKE WITH VIRACEPT". WHAT IS VIRACEPT AND HOW DOES IT W ORK? VIRACEPT is used in combination with other antiretroviral drugs in the treatment of people with human immunodeficiency virus (HIV) infection. Infection with HIV leads to the destruction of CD4 T 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 syndrom e (AIDS). VIRACEPT w orks by blocking HIV protease (a protein-cutting enzyme), which is required for HIV to multiply. VIRACEPT has been show n 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), Eptvir® (lamivudine, 3TC), or Zerit® (stavudine. d4T). Taking VIRACEPT in combination 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 A ID S? VIRACEPT is not a cure for HIV infection or AIDS. People taking VIRACEPT may still develop opportunistic infections or other conditions associated with HIV infection. Som e of these conditions are pneumonia, herpes virus infections, Mycobacterium avium complex (MAC) infections, and Kaposi’s sarcoma. There is no proof that VIRACEPT can reduce the risk of transmitting HIV to others through sexual contact or blood contamination. WHO SHOULD OR SHOULD NOT TAKE VIRACEPT? Together with your doctor, you need to decide whether VIRACEPT is appropriate for you. In m aking your decision, the following should be considered: Taking the above drugs with VIRACEPT may cause serious and/or life- threatening adverse events. Rifam pin® (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 will need to take a lower dose of Mycobutin. A change of therapy should be considered if you are taking VIRACEPT with: Phénobarbital Phenytoin (Dilantin® and others) Carbamazepine (Tegretol® and others) D osing 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 a s 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 dam age to your penis Your doctor can explain these sym ptom s to you. The recommended adult dose of VIRACEPT is 1250 mg (five tablets) taken two tim es a day or 750 m g (three tablets) taken three tim es a day. Each dose should be taken with a meal or light snack. 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. 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. 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. Lo ss 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. M evacor® (lovastatin, for cholesterol lowering) Zocor® (simvastatin, for cholesterol lowering) Kg Tablets 7 to < 8 .5 1 5 .5 to < 1 8 .5 4 1 8 5 to < 1 0 .5 1 8 5 to < 2 3 5 1 1/4 — 1 0 .5 to < 1 2 2 3 to < 2 6 .5 6 1 1/2 — 1 2 to < 1 4 2 6 .5 to < 3 1 7 1 3/4 — 1 4 to < 1 6 31 to < 3 5 8 2 — 1 6 to < 1 8 3 5 to < 3 9 .5 9 2 1/4 — 1 8 to < 2 3 3 9 .5 to < 5 0 .5 10 21/2 2 t23 2 5 0 .5 15 3 3/4 3 — Epivir (lamivudine, 3TC) Zerit (stavudine, d4T) Videx® (didanosine, ddl) When VIRACEPT is taken together with: Viram une® (nevirapine) The amount of VIRACEPT in your blood is unchanged. A dose adjustment is not needed when VIRACEPT is used with Viramune. Su stiva ™ (efavirenz) 1 1 level teaspoon contains 200 mg of VIRACEPT. Note: A m easuring teaspoon used for dispensing m edication should be used for m easuring VIRACEPT Oral Powder. A sk your pharm acist to m ake sure you have a medication dispensing teaspoon. How should VIRACEPT Oral Powder be prepared? The oral powder may be mixed with a sm all amount of water, milk, formula, soy formula, soy milk, dietary supplements, or dairy foods such as pudding or ice 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 a s orange or grapefruit juice, apple juice, or apple sauce, because this may create a bitter taste. 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 temperature or refrigerated for up to 6 hours. Do not heat the mixed dose once it has been prepared. Other NNRTIs Do not add water to bottles of oral powder. VIRACEPT has not been studied with other NNRTIs. VIRACEPT powder is supplied with a scoop for measuring. For help in determining the exact dose of powder for your child, please ask your doctor, nurse, or pharmacist. Other protease inhibitors: 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 combination. HOW SHOULD VIRACEPT BE STO RED? N orvir™ (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 SID E 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 m any 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 pharm acist Halcion® (triazolam) N u m b e r ol Level T e a sp oon sf * 1 level scoop contains 50 m g of VIRACEPT. Use only the scoop provided with your VIRACEPT bottle. Ergot derivatives (Cafergot® and others, for migraine headache) Versed® (midazolam) N u m b e r ol Level S c o o p s* Retrovir (zidovudine, AZT) Other side effects that occurred in 2 % or more of patients receiving VIRACEPT include nausea, ga s and rash. Propulsid® (cisapride, for heartburn) N u m b e r of Lb In m easuring oral powder, the scoop or teaspoon should be level. Quinidine (for irregular heartbeat), also known as Quinaglute®. Cardioquin®, Ouinidex®, and others M edicines you should not take with VIRACEPT: 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 im e s D a ily B o d y W e ig h t Nucleoside analogues: No drug interaction problem s were seen when VIRACEPT w as given with: Cordarone® (amiodarone. for irregular heartbeat) VIRACEPT may interact with other drugs, including those you take without a prescnption. You m ust d iscu ss with your doctor any drugs that you are taking or are planning to take before you take VIRACEPT. Dose instructions will be provided by the child’s doctor. The dose wili be given three tim es daily using the m easuring scoop provided, a m easuring 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. Taking VIRACEPT together with 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 medicine, your doctor will direct you on how to take VIRACEPT and other anti-HIV medicines. These drugs should be taken in a certain order or at specific times. This will depend on how many tim es a day each medicine should be taken. It will also depend on whether it should be taken with or without food. Like all medicines, VIRACEPT can cause side effects. M ost of the side effects experienced with VIRACEPT have been mild to moderate. Diarrhea is the m ost com mon side effect in people taking VIRACEPT, and most adult patients had at least mild diarrhea at som e point during treatment. In clinical studies, about 1 5 -2 0 % of patients receiving VIRACEPT 750 mg (three tablets) three tim es daily or 1250 m g (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 without a prescription. CAN VIRACEPT BE TAKEN WITH OTHER M EDICATIO N S? D osing 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 form or, in children unable to take tablets, a s VIRACEPT Oral Powder. HOW SHOULD VIRACEPT BE TAKEN WITH OTHER ANTI-HIV DRUGS? Nonnucleoside reverse transcriptase inhibitors (NNRTIs): Other m edical problem s: Certain medical problems 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 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 and/or frequent urination. Only take medicine that has been prescribed specifically for you. Do not give VIRACEPT to others or take medicine prescribed for som eone else. Special considerations If you are p re gn a n t 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 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. Take VIRACEPT exactly a s 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 time that your doctor has instructed. Do not stop taking VIRACEPT without first consulting with your doctor, even if you are feeling better. 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. Oral contraceptives (“the pill") If you are taking both Videx (ddl) and VIRACEPT: Videx 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 Videx. Children: VIRACEPT is available for the treatment of children 2 through 13 years of age with HIV. There is a powder form 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 d iscusses how VIRACEPT Oral Powder should be prepared VIRACEPT is available only with your doctor's prescription. Ybur doctor may prescribe the light blue VIRACEPT Tablets either a s 1250 mg (five tablets) taken two times a day or a s 750 mg (three tablets) taken three tim es a day. VIRACEPT should alw ays be taken with a meal or a light snack. VIRACEPT tablets are film-coated to help make the tablets easier to swallow. The dosing of VIRACEPT may be different for you than for other patients. Follow the directions from your doctor, exactly a s written on the label. The amount of VIRACEPT in the blood should remain som ewhat consistent over time. M issing doses will 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 a s soon a s possible and then take your next scheduled dose and future doses a s originally scheduled. These agents may reduce the amount of VIRACEPT in your blood and make it less effective. Allergies: If you have had a serious allergic reaction to VIRACEPT, you m ust not take VIRACEPT. You should also inform your doctor, nurse, or pharm acist of any known allergies to substances such as other medicines, foods, preservatives, or dyes. 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? Keep VIRACEPT and all other m edicines out of the reach of children. Keep bottle closed and store at room temperature (between 59°F and 86°F) away from sources of moisture such a s a sink or other damp place. Heat and moisture 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. D iscuss 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.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. Pharmaceuticate, he. A Pfizer C o m p a n y Agouron Pharmaceuticals Inc. La Jolla, California. 92037, USA 1-V01171-BG L203-0001 PPI Rev 01/25/01
