Learn more about the Use and Important Safety Information for NORVIR.
Your safety is important to us.
What is NORVIR?1
NORVIR® (ritonavir) tablets and oral solution are prescription medicines each used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection.
NORVIR® (ritonavir) oral powder is a prescription medicine that is used with other antiviral medicines to treat children with HIV-1 infection.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
Important Safety Information1
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 or your child are allergic to ritonavir or any of the ingredients in NORVIR.
Drug Interactions
Do not take NORVIR if you or your child take any of the following medicines: alfuzosin; apalutamide; ranolazine;
dronedarone; colchicine, if you have kidney or liver problems; lurasidone; pimozide; amiodarone; ergot-containing
medicines, including dihydroergotamine mesylate, ergotamine tartrate, methylergonovine maleate; cisapride;
flecainide; lovastatin; simvastatin; lomitapide; sildenafil (REVATIO®), only when used for treating the lung problem
pulmonary arterial hypertension (PAH); triazolam; midazolam, when taken by mouth; propafenone; quinidine; St.
John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort; voriconazole, if your NORVIR dose
is 400 mg every 12 hours or greater.
Serious problems can happen if you or your child takes any of these medicines with NORVIR.
What should I tell my healthcare provider before taking NORVIR?
Before you take NORVIR, tell your healthcare provider if you or your child have liver problems, including hepatitis B or hepatitis C; heart problems; high blood sugar (diabetes); or bleeding problems or hemophilia.
Before you take NORVIR, tell your healthcare provider if you are pregnant or plan to become pregnant, are taking hormonal birth control, or are breastfeeding.
Tell your healthcare provider if you become pregnant during treatment with NORVIR.
NORVIR oral solution contains alcohol. Do not take NORVIR oral solution during pregnancy, as there is no known safe level of alcohol exposure during pregnancy.
If you take a hormonal birth control, use another effective form of birth control or an additional barrier method of birth control during treatment with NORVIR. NORVIR may reduce how well hormonal birth control works.
Do not breastfeed. NORVIR can be passed to the baby through your breast milk. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Talk to your healthcare provider about the best way to feed your baby.
If you take NORVIR during pregnancy, you should talk with your healthcare provider about how you can take part in an Antiretroviral Pregnancy Registry.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with NORVIR. Keep a list of your medicines to show your healthcare provider and pharmacist.
Ask your healthcare provider or pharmacist for a list of medicines that interact with NORVIR.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take NORVIR with other medicines.
NORVIR oral solution contains a large amount of alcohol. If a toddler or young child accidentally drinks more than the recommended dose of NORVIR, it could make him/her sick from too much alcohol. Go to the nearest emergency room right away if this happens.
What are the possible side effects of NORVIR?
Liver problems. Some people taking NORVIR in combination with other anti-HIV medicines have developed liver problems, which may be life-threatening. Your healthcare provider 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 healthcare provider 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.
Inflammation of your pancreas (pancreatitis). NORVIR can cause serious pancreas problems, which may lead to death. Tell your healthcare provider right away if you have nausea, stomach (abdomen) pain, or vomiting, as these may be signs of pancreatitis.
Allergic reactions. Allergic reactions can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking NORVIR and get medical help right away if you have any of the following symptoms of a severe allergic reaction: trouble breathing; wheezing; dizziness or fainting; throat tightness or hoarseness; fast heartbeat or pounding in your chest (tachycardia); sweating; swelling of your face, lips, or tongue; muscle or joint pain; blisters or skin lesions; or mouth sores or ulcers.
Changes in the electrical activity of your heart called PR prolongation. PR prolongation can cause irregular heartbeats. Tell your healthcare provider right away if you have symptoms such as: dizziness, lightheadedness, feel faint or pass out, or abnormal heartbeat.
Increase in cholesterol and triglyceride levels. Treatment with NORVIR may increase your blood levels of cholesterol and triglycerides. Your healthcare provider 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.
Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors, including NORVIR, can get high blood sugar (diabetes), or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often during treatment with NORVIR.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
Change in body fat can happen in some people who take HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors, including NORVIR.
Kidney stones have been reported in patients taking NORVIR.
The most common side effects of NORVIR include: diarrhea, nausea, vomiting, upper and lower stomach (abdominal) pain, tingling feeling or numbness in hands or feet or around the lips, rash, and feeling weak or tired.
These are not all of the possible side effects of NORVIR. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
