Microsoft word - hiv community letter draft 3.11.11.doc
Dear Community Friend: Last year was economically difficult for so many people, and 2011 promises to bring more financial challenges. In response to even greater need, Abbott is increasing access to our HIV medications, Kaletra® (lopinavir/ritonavir) and Norvir® (ritonavir). Working with community leaders in the United States, Abbott is making some important changes and expanding several existing programs.
• The Norvir co-pay card will begin paying private insurance co-pays at the first dollar up
to $50.00. The previous co-pay card paid from $25.00 through $50.00. Abbott will continue to provide the Kaletra Co-Pay Plus card, which covers up to $50.00 of co-pay costs for Kaletra and up to $50.00 each for two additional HIV medications in the Kaletra regimen. Both co-pay cards are available in physician offices.
• Abbott has increased donations to the Abbott Patient Assistance Foundation, to expand
eligibility for uninsured patients prescribed Kaletra from 400% of Federal Poverty Level (FPL) to 500% of FPL. This will match or exceed all state AIDS Drugs Assistance Program (ADAP) qualifications and will allow the Foundation to help even more patients. More information about the Abbott Patient Assistance Foundation may be found at www.abbottpatientassistancefoundation.org or by calling 1-800-222-6885.
• Abbott is also extending our support of Welvista and the Heinz Family Philanthropies to
enable more patients on State ADAP waiting lists to get their medications quickly and easily with one application. Please visit www.welvista.org or call 1-877-258-1556 for additional information.
Abbott is committed to expanding access to Kaletra and Norvir for those living with HIV. As we move through 2011, we will continue to communicate with community leaders to monitor the success of these programs and will look forward to your feedback. Thank you for all of the hard work you do for patients in the HIV community. Yours in the cause, Jim Howley Director, Advocacy and Policy Abbott Labs a Use and Important Safety Information
mportant Safety Information ation http://rxabbott.com/pdf/norvirtab_pi.pdf
Kaletra® (lopinavir/ritonavir) is a prescription anti-HIV-1 medicine called a protease inhibitor that contains lopinavir and ritonavir. Kaletra is used with other anti-HIV-1 medicines to increase the chance of treatment response in people with human immunodeficiency virus (HIV-1) infection. It is not known if Kaletra is safe and effective in children under 14 days old.
Kaletra does not cure HIV-1 infection or AIDS and does not stop people from passing HIV-1 to others. People taking Kaletra may still get opportunistic infections or other conditions that happen with HIV-1.
Kaletra Important Safety Information
Kaletra should not be taken by people who are allergic to Kaletra or any of its ingredients, including lopinavir or ritonavir. Skin rashes, some of them severe, can occur in people who take Kaletra. People should tell their doctor if they had a rash when they took another medicine for HIV or if they notice any skin rash when they take Kaletra.
The list of drug interactions below is not complete. People must tell their doctor about all medicines they are taking or planning to take, including those without a prescription, vitamins, and herbal products.
Serious problems or death can happen when taking these medicines with Kaletra: ergot- containing medicines, including ergotamine (Cafergot® and others), dihydroergotamine (D.H.E. 45® and others), ergonovine (Ergotrate®), and methylergonovine (Methergine®); triazolam (Halcion®); midazolam oral syrup; pimozide (Orap®); lovastatin (Mevacor®); simvastatin (Zocor®); rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®); sildenafil (Revatio®) only when used to treat pulmonary arterial hypertension; alfuzosin (Uroxatral®); or products containing St. John's wort (Hypericum perforatum). The following medicines may need changes when taken with Kaletra: birth control pills that contain estrogen ("the pill"), birth control (contraceptive) patches, nilotinib (Tasigna®), dasatinib (Sprycel®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), fosamprenavir (Lexiva®), nelfinavir (Viracept®), phenytoin (Dilantin®), carbamazepine (Tegretol®), phenobarbital, sildenafil (Viagra®), tadalafil (Cialis®, Adcirca®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®), colchicine (Colcrys®), bosentan (Tracleer®), fentanyl (Duragesic®, IonsysTM, Fentora®) and methadone.
Kaletra should not be administered once daily in combination with carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminal®), or phenytoin (Dilantin®).
There is an increased risk of certain problems when taking medicines used for the treatment of erectile problems such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) with Kaletra, because the interaction with these medicines may result in an increase in their side effects, such as low blood pressure (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. People should tell their doctor right away if they experience any of these side effects.
Kaletra oral solution contains propylene glycol and a large amount of alcohol.
• Kaletra oral solution should not be given to babies younger than 14 days of age unless a
doctor thinks it is right for the baby. Babies taking Kaletra oral solution may have side effects. People should call their doctor right away if their baby appears too sleepy or their breathing has changed.
• People should talk with their doctor if they take or plan to take metronidazole (Flagyl®) or
disulfiram (Antabuse®). They can have severe nausea and vomiting if they take these medicines with Kaletra.
Kaletra may not be right for everyone. People should tell their doctor about all their medicalconditions. Changes in heart rhythm and electrical activity of the heart can occur when taking Kaletra. These changes can lead to serious heart problems. The risk for these problems may be higher for people who already have a history of abnormal heart rhythm or other types of heart disease, or if they take other medicines that can affect their heart rhythm while taking Kaletra. People should tell their doctor right away if they experience dizziness, lightheadedness, fainting, and/or a sensation of abnormal heartbeats. Liver problems, including death, can happen in people who take Kaletra. Blood tests in people who take Kaletra may show possible liver problems. People with liver disease such as hepatitis B or C who take Kaletra may have worsening liver disease. People should tell their doctor right away if they have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin, and/or stomach area (abdominal) pain. Inflammation of the pancreas (pancreatitis), which may be serious and cause death, has occurred in some people who take Kaletra. People have a higher chance of having pancreatitis if they have had it before. People should tell their doctor if they have nausea, vomiting, and/or abdominal pain, as these may be signs of pancreatitis. Immune reconstitution syndrome may occur after starting anti-HIV medicines, including Kaletra. This happens when people develop signs and symptoms of serious infections they already have, which may require additional treatment. Large increases in certain fat (triglycerides and cholesterol) levels in the blood have occurred in some people receiving Kaletra. The long-term chance of getting complications such as heart attacks or strokes due to these increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time. New or more serious diabetes and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including Kaletra. People should tell their doctor if they notice an increase in thirst or urinate often while taking Kaletra. Changes in body fat have been seen in some people who take anti-HIV therapy. The cause and long-term health effects of these conditions are not known at this time. Increased bleeding has occurred in some people with hemophilia who take protease inhibitors, including Kaletra.
Women taking birth control pills or using patches to prevent pregnancy should use an extra form or a different type of birth control since birth control pills or patches may not work as well while taking Kaletra. Women should talk to their doctor about how to prevent pregnancy while taking Kaletra.
It is not known if Kaletra will harm unborn babies. Women who are pregnant or planning to become pregnant should tell their doctor.
Women taking Kaletra during pregnancy should talk with their doctor about how they can take part in an Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to follow the health of the mother and their baby.
Women should not breast-feed while taking Kaletra. There is a chance that HIV can be passed to the baby through breast milk and their baby may have serious side effects from Kaletra.
Common side effects of Kaletra include diarrhea, nausea, stomach area (abdominal) pain, feeling weak, vomiting, headache, and upset stomach. These are not all of the possible side effects of Kaletra.
The long-term effects of Kaletra are not known at this time.
a full Prescribing Information. http://rxabbott.com/pdf/kaletratabpi.pdf Norvir® (ritonavir) Use Norvir® (ritonavir) is in a class of medicines called the HIV protease (PRO-tee-ase) inhibitors. Norvir is used in combination with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. Norvir is for adults and for children age greater than 1 month and older. Norvir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking Norvir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. Norvir Important Safety Information People who have had a serious allergic reaction to Norvir or any of its ingredients should not take Norvir. Allergic reactions ranging from hives, asthma, severe breathing issues and mild to severe skin reactions have occurred. Drug Interactions: The below list of drug interactions is not complete. Before people take Norvir, they must tell their doctor about all the medicines they are taking or are planning to take. These include other prescription and non-prescription medicines, and herbal supplements. People should not take the following medicines with Norvir because they can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties or excessive sleepiness: Cordarone® (amiodarone); ergotamine, ergonovine, methylergonovine, and dihydroergotamine such as Cafergot®, Migranal®, D.H.E. 45® and others; Halcion® (triazolam); Orap® (pimozide); Propulsid® (cisapride); quinidine, also known as Quinaglute®, Cardioquin®, Quinidex® and others; Revatio® (sildenafil) only when used for the treatment of pulmonary arterial hypertension; Rythmol® (propafenone); Tambocor® (flecainide); Uroxatral® (alfuzosin hydrochloride); Vascor® (bepridil); Versed® (oral midazolam); and Vfend® (voriconazole).
People should not take Norvir with St. John's wort (Hypericum perforatum) as this may decrease Norvir levels and lead to increased viral load and possible resistance to NORVIR or other antiretroviral medicines. People should not take Norvir with Mevacor® (lovastatin) or Zocor® (simvastatin) because of possible serious reactions. There is an increased risk of drug interactions between Norvir and Lipitor® (atorvastatin) and Crestor® (rosuvastatin); people should talk to their doctor before they take any of these cholesterol-lowering medicines with Norvir. For people taking Viagra® (sildenafil), Cialis® (tadalafil), or Levitra® (vardenafil) with Norvir, their doctor may lower their dose of these medicines because they may be at risk of side effects such as low blood pressure, visual changes, and penile erection lasting more than 4 hours. People should tell their doctor right away if they experience any of these side effects. If people are taking Adcirca® (tadalafil) for pulmonary arterial hypertension, their doctor may change their dose of this medicine. Women taking oral contraceptives ("the pill") or using the contraceptive patch to prevent pregnancy should use a different type of contraception since Norvir may reduce the effectiveness of oral or patch contraceptives. For people taking Mycobutin® (rifabutin), their doctor will lower the dose of Mycobutin. For people taking Colcrys® (colchicine) or Tracleer® (bosentan), their doctor will tell them what dose to use. Norvir oral solution contains alcohol. People should talk with their doctor if they are taking or planning to take Flagyl® (metronidazole) or Antabuse® (disulfiram). Severe nausea and vomiting can occur. Rifampin, also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®, may reduce blood levels of Norvir. People should tell their doctor if they are taking rifampin. Rifampin and saquinavir should not be taken together with Norvir. People should tell their doctor if they are taking rifampin and saquinavir. People taking or about to begin using inhaled Flonase® (fluticasone propionate), Serevent® (salmeterol), or Advair® (salmeterol in combination with fluticasone propionate) should talk to their doctor about problems these medicines may cause when taken with Norvir. Their doctor may choose not to keep them on inhaled Flonase, Serevent, or Advair. Side Effects (This list is not complete): Blood tests in patients taking Norvir may show possible liver problems. People with liver disease such as hepatitis B and C who take Norvir may have worsening liver disease. Liver problems, including death, have occurred in people who take Norvir and in people taking Aptivus® (tipranavir) with Norvir. People should tell their doctor right away if they have any of the following signs and symptoms: loss of appetite, yellowing of skin or eyes (jaundice), dark-colored urine, pale-colored stools, itchy skin and/or stomach area (abdominal) pain.
Pancreas problems (pancreatitis), which may cause death, have been reported in some people taking Norvir. People should tell their doctor if they have nausea, vomiting or abdominal pain as these may be signs of pancreatitis. Large increases in triglycerides and cholesterol have occurred in some people taking Norvir. The long-term chance of getting complications such as heart attacks or stroke due to increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time. Diabetes and high blood sugar (hyperglycemia), changes in body fat, and increased bleeding in people with hemophilia have occurred in some people taking protease inhibitors including Norvir. People should tell their doctor if they have diabetes or an increase in thirst or urinate often. The cause and long-term effects of body fat changes are not known at this time. Changes in the electrocardiogram (EKG) can occur when taking Norvir. People should consult their physician if they experience dizziness, lightheadedness, fainting spells or abnormal heartbeat. People with heart defects or conduction defects should avoid Norvir. Immune reconstitution syndrome may occur after starting anti-HIV medicines, including Norvir. This happens when people develop signs and symptoms of serious infections they already have or had, which may require additional treatment. The most commonly reported side effects are feeling weak/tired, nausea, vomiting, diarrhea, loss of appetite, abdominal pain, changes in taste, tingling feeling or numbness (in hands, feet or around the lips), headache, and dizziness. For women who are pregnant or planning to become pregnant, it is not known if Norvir can harm their unborn baby. Women taking Norvir while they are pregnant should talk to their healthcare professional about how they can take part in the Antiretroviral Pregnancy Registry. Mothers taking Norvir should not breast-feed because they may pass HIV on to their baby, or their baby could experience side effects from Norvir. The long-term effects of Norvir are not known at this time. ation. http://www.norvir.com
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Important Safety Updates to the Patient Package Inserts for NORVIR® (ritonavir) Soft Gelatin Capsules and NORVIR® (ritonavir) Tablet and Oral Solution In November 2013, the following safety update was added to the Patient Package Inserts for NORVIR: The following safety information was added to the section “What are the possible side effects of NORVIR?” Talk to your d