Use and Important Safety Information You Should Know About NORVIR® (ritonavir)
What is NORVIR?
NORVIR® (ritonavir) is a prescription anti-HIV medicine used with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection.
NORVIR does not cure HIV infection or AIDS, and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using NORVIR.
Important Safety Information
What is the most important information I should know about NORVIR?
NORVIR can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with NORVIR. See the section “Who should not take NORVIR?”
Who should not take NORVIR?
Do not take NORVIR if you are allergic to ritonavir or any of the ingredients in NORVIR. Allergic reactions to NORVIR can sometimes be severe and require treatment in a hospital. You should get medical help right away if you experience symptoms of an allergic reaction (e.g., trouble breathing, rash, fast heartbeat, or swelling of the face, lips, or tongue).
Do not take NORVIR with any of the following medicines because serious problems can happen: alfuzosin (Uroxatral®); amiodarone (Cordarone®, Nexterone®, Pacerone®), flecainide (Tambocor®), propafenone (Rythmol®), or quinidine (Nuedexta®, Quinaglute®, Cardioquin®, Quinidex®, and others); voriconazole (VFend®), if NORVIR dose is 400 mg every 12 hours or greater; dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergotamine (Cafergot®, Ergomar®), or methylergonovine (Methergine®); cisapride (Propulsid®); St. John’s Wort (Hypericum perforatum); lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®); pimozide (Orap®); sildenafil (Revatio®), only when used for the treatment of pulmonary arterial hypertension; and oral midazolam or triazolam (Halcion®).
Serious problems can occur if you or your child takes any of these medicines with NORVIR.
What should I tell my doctor before taking NORVIR?
Before you take NORVIR, you must tell your doctor if you have liver problems, including hepatitis B or hepatitis C, heart problems, high blood sugar (diabetes), bleeding problems or hemophilia, are pregnant or plan to become pregnant, or are breastfeeding.
It is not known if NORVIR will harm your unborn baby. If you take NORVIR during pregnancy, you should talk with your doctor about how you can take part in an Antiretroviral Pregnancy Registry.
Do not breastfeed, as it is not known if NORVIR can be passed to the baby through your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking NORVIR and certain other medicines may affect each other causing serious side effects. NORVIR may affect the way other medicines work and other medicines may affect how NORVIR works. Tell your doctor right away if you are taking:
- Estrogen-based contraceptives (birth control). You should use a different type or an extra form of birth control, since estrogen-based contraceptives may not work as well while you take NORVIR. Talk to your doctor about how to prevent pregnancy while taking NORVIR.
- Medicines used for the treatment of erectile problems, such as avanafil (Stendra®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®). There is an increased risk of certain problems when you take these medicines with NORVIR, such as low blood pressure (dizziness or fainting), vision changes, and/or erections lasting more than 4 hours. Tell your doctor right away if you experience any of these side effects.
NORVIR oral solution contains propylene glycol and a large amount of alcohol.
- If a toddler or young child accidentally drinks more than the recommended dose of NORVIR, it could make them sick from too much alcohol. Contact your local poison control center or emergency room immediately if this happens.
- Talk with your doctor if you are taking or planning to take metronidazole (Flagyl®, Helidac®, MetroCream®) or disulfiram (Antabuse®). Severe nausea and vomiting can occur.
This is not a complete list of medicines about which you should tell your doctor or pharmacist. For more information, refer to the Norvir Patient Information. Ask your doctor or pharmacist if you are not sure what medicines you are taking. Know all the medicines that you take. Keep a list of them to show doctors and pharmacists when you get a new medicine. Do not start any new medicines while you are taking NORVIR without first talking with your doctor.
What are the possible side effects of NORVIR?
Liver disease. Some people taking NORVIR in combination with other anti-HIV medicines have developed liver problems, which may be life-threatening. Your doctor should do regular blood tests during your combination treatment with NORVIR. If you have chronic hepatitis B or C infection, you have an increased chance of developing liver problems. Tell your doctor right away if you have any of the following signs and symptoms: loss of appetite, pain or tenderness on your right side below your ribs, yellowing of your skin or eyes, or itchy skin.
Swelling of your pancreas (pancreatitis). NORVIR can cause serious pancreas problems, which may lead to death. Tell your doctor right away if you have nausea, vomiting, or stomach (abdomen) pain, as these may be signs of pancreatitis.
Changes in the electrical activity of your heart, called PR prolongation, can cause irregular heartbeats. Tell your doctor right away if you have dizziness, lightheadedness, an abnormal heartbeat, or feel faint or pass out.
Increase in cholesterol and triglyceride levels. Treatment with NORVIR may increase your blood levels of cholesterol and triglycerides. Your doctor should do blood tests before you start your treatment with NORVIR and continue them regularly to check for an increase in your cholesterol and triglyceride levels.
New or more serious diabetes and high blood sugar (hyperglycemia) have occurred in some people who take protease inhibitors, including NORVIR. Tell your doctor if you notice an increase in thirst or urinate often while taking NORVIR.
Changes in your immune system (immune reconstitution syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.
Changes in body fat can happen in people who take antiretroviral therapy. The exact cause and long-term health effects are not known.
Increased bleeding has occurred in some people with hemophilia who take protease inhibitors, including NORVIR.
Common side effects of NORVIR include diarrhea, nausea, vomiting, upper and lower stomach (abdomen) pain, tingling feeling or numbness (in hands, feet, or around the lips), rash, and feeling weak or tired.
This is the most important information you should know about NORVIR. For more information, talk to your doctor.
Reference: NORVIR [package insert].
If you cannot afford your medication, contact: www.pparx.org for assistance.
Please see the full Prescribing Information for NORVIR Capsules.
Please see the full Prescribing Information for NORVIR Tablets.