Abbott Receives U.S. FDA Approval for Heat-Stable Norvir(R) (ritonavir) Tablets

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Feb 11, 2010, 03:11 ET

ABBOTT PARK, Ill., Feb. 11 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir ® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.

"Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV," said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."

Abbott scientists evaluated several candidate formulations before developing the final Norvir tablet formulation. The Norvir tablet was developed using Abbott's Meltrex® technology, a proprietary melt-extrusion process, making it more heat-stable. This is the same technology used to develop Abbott's Kaletra® (lopinavir/ritonavir) tablet, which combines lopinavir and ritonavir.

"Approximately one-third of all HIV-positive patients in treatment use Norvir in combination with other antiretroviral medicines. The heat-stable tablet formulation may allow these patients greater flexibility to store and carry their medication with them," said Renslow Sherer, M.D., professor of medicine, section of infectious diseases and global health and director, International HIV Training Center, University of Chicago Hospitals. "For patients who may not have access to refrigeration, this new formulation is also important."

Important Information About Norvir

Do not take Norvir with certain medicines, as these can cause serious or life-threatening problems such as irregular heartbeat, breathing difficulties, or excessive sleepiness. Do not take Norvir if you have had a serious allergic reaction to any of its ingredients. Some patients taking Norvir may develop liver and pancreas problems, which can cause death. Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. You may develop signs and symptoms of infections that you already have after starting anti-HIV medicines. Please see the Important Safety Information for more details.

Important Information About Kaletra

Do not take Kaletra if you are allergic to any of its ingredients, including lopinavir or ritonavir. Do not take Kaletra with certain medicines, as they can cause serious problems, death, or make Kaletra less effective against HIV. Some patients taking Kaletra can develop inflammation of the pancreas and liver problems, which can cause death. Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia. Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines. Please see the Important Safety Information for more details.

The European Commission granted approval of the Norvir tablet in January. Abbott intends to register the new Norvir tablet as broadly worldwide as the Kaletra/Aluvia® (lopinavir/ritonavir) tablet. The Kaletra/Aluvia tablet is approved for sale, available (in countries where no regulatory approval is needed) or has been submitted for registration in 170 countries around the world, making it the most widely registered antiretroviral medicine available for patients across the globe.

HIV Access Programs in the United States

To help patients access this important new formulation of Norvir, Abbott is launching a Norvir co-pay support program which will be available in 2010 for all formulations of Norvir. Once a patient has paid $25 in co-pays, this program will cover up to $75 each month in patient co-pays within the first 12 months. Certain restrictions may apply.

Abbott also offers several patient assistance programs to help patients on Kaletra and Norvir access their medications. More information about other access programs can be found online by visiting Abbott's Patient Assistance Programs overview or by calling Abbott's patient access toll-free number at 1-800-222-6885.

Abbott and HIV

For more than 20 years, Abbott has made a significant contribution to the fight against HIV/AIDS through the development of innovative tests and medicines.

In 1985, Abbott developed the first licensed test to detect HIV antibodies in the blood. The company remains a leader in HIV diagnostics today
In 1992, Abbott was the first company to receive FDA approval for an HIV diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply
In 1996, Norvir was approved for the treatment of HIV in the United States. Norvir was one of the first protease inhibitors on the market and remains one of the most commonly prescribed medicines as part of combination therapy
In 1997, Norvir became one of the first protease inhibitors to receive FDA clearance for use in children
In 2000, Abbott received FDA accelerated approval for Kaletra
In 2005, the tablet form of Kaletra received FDA approval
In 2006, Kaletra tablets received EMEA approval
In 2007, Abbott received FDA approval for a new lower-strength Kaletra tablet suitable for pediatric use
In 2007, Abbott's RealTime HIV-1 Viral Load test was approved by the FDA for use on the m2000™ molecular diagnostics instruments
In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully-automated blood screening test for HIV-1/HIV-2
In 2010, the FDA approved the new Norvir tablet

More information may also be found on Abbott.com/HIV.

About Norvir

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 one 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.

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 four hours. People should tell their doctor right away if they experience any of these side effects.

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.

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 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® (ritonavir) 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 notice 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.

Please click here for Norvir full Prescribing Information.

About Kaletra

Use

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 reduce the risk of passing HIV-1 to others. People taking Kaletra may still get opportunistic infections or other conditions that happen with HIV-1.

Important Safety Information

Kaletra should not be taken by people who are allergic to Kaletra or any of its ingredients, including lopinavir or ritonavir.

Drug Interactions:

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 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 for the treatment of pulmonary arterial hypertension; 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, 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®), vardenafil (Levitra®), rifabutin (Mycobutin®), inhaled fluticasone (Flonase®), salmeterol (Serevent®) and salmeterol in combination with fluticasone propionate (Advair®).

There is an increased risk of certain problems when taking medicines 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 a large amount of alcohol. 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 can cause serious side effects:

Kaletra may not be right for everyone. People should tell their doctor about all their medical conditions.

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.

Please click here for Kaletra full Prescribing Information.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott