Norvir

Norvir tablets are prescription medicines that are used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection. Norvir 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). Norvir is not a cure for HIV-1 or acquired immunodeficiency syndrome (AIDS).

Norvir (ritonavir) has two ways of working. The first way is by blocking HIV-1 protease, an enzyme the virus needs to mature. Normally, this enzyme cuts a long viral protein into the working parts required to build infectious virus. With it blocked, the new HIV particles remain immature and non-infectious, so they cannot go on to infect other cells. At low doses, ritonavir also acts as a "booster." It slows down a liver enzyme (CYP3A4) that breaks down many medicines. By slowing this breakdown, ritonavir keeps blood levels of certain other HIV medicines higher for longer, allowing lower or less frequent doses, which is also the reason it interacts with so many drugs.

Norvir (ritonavir) received FDA approval on March 1, 1996. Generic versions are available.

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?”

See the detailed Instructions for Use for information about how to give or take a dose of Norvir oral powder.

• Take Norvir exactly as your healthcare provider tells you to take it.
• You should stay under a healthcare provider’s care during treatment with Norvir. Do not change your dose of Norvir or stop your treatment without talking with your healthcare provider first.
• If your child takes Norvir, your child’s healthcare provider will decide the right dose based on your child’s height and weight. Tell your healthcare provider if your child’s weight changes. If your child does not tolerate Norvir oral powder, ask your child’s healthcare provider for advice.
• Swallow Norvir tablets whole. Do not chew, break, or crush tablets before swallowing. If you cannot swallow Norvir tablets whole, tell your healthcare provider. You may need a different medicine.
• Take Norvir with meals.
• Do not run out of Norvir. Get your Norvir prescription refilled from your healthcare provider or pharmacy before you run out.
• If you miss a dose of Norvir, take it as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not double the next dose.
• If you take too much Norvir, call your local poison control center or go to the nearest hospital emergency room right away.

Do not take Norvir if you or your child:

• are allergic to ritonavir or any of the ingredients in Norvir. See the end of this leaflet for a complete list of ingredients in Norvir.
• take any of the following medicines:
• alfuzosin suzetrigine 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. This is not a complete list of medicines. Tell your healthcare provider about all of the medicines you or your child take.

Before taking Norvir, tell your healthcare provider about all of your medical conditions, including if you or your child:

• have liver problems, including Hepatitis B or Hepatitis C
• have heart problems
• have high blood sugar (diabetes)
• have bleeding problems or hemophilia
• are pregnant or plan to become pregnant. Norvir may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with Norvir. Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take Norvir.Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with Norvir: The HIV-1 virus may pass to your baby if your baby does not have HIV-1. The HIV-1 virus may become harder to treat if your baby has HIV-1. Your baby may get side effects from Norvir. Talk to your healthcare provider about the best way to feed your baby.

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.
• You can 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.

Serious side effects

Norvir can cause serious side effects including:

• See “What is the most important information I should know about Norvir?”
• Liver problems. Some people taking Norvir in combination with other antiviral 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, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems: loss of appetite pain or tenderness on your right side below your ribs yellowing of your skin or whites of your eyes 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 signs or symptoms of pancreatitis such as: nausea stomach (abdomen) pain vomiting
• Allergic reactions. Sometimes these 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 mouth sores or ulcers
• Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram). Your risk for these problems may be higher if you have a history of abnormal heart rhythm or certain types of heart problems. Tell your healthcare provider right away if you get any of these symptoms: dizziness lightheadedness fainting sensation of abnormal heartbeats
• 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 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, develop 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 are taking 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.

Common side effects

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
• feeling weak or tired.

These are not all of the possible side effects of Norvir. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norvir tablets:

• Store below 30°C (86°F). You may store Norvir tablets up to 50°C (122°F) for seven days.
• Store Norvir tablets in the original container given to you by the pharmacist.
• Exposure to high humidity outside the original container for longer than 2 weeks is not recommended.

Norvir oral powder:

• Store at or below 30°C (86°F).
• Norvir oral powder comes in child-resistant packets.

Throw away Norvir that is expired or no longer needed.

Keep Norvir and all medicines out of the reach of children.

Active ingredient: ritonavir

Inactive ingredients:

Norvir tablet: copovidone, anhydrous dibasic calcium phosphate, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, polyethylene glycol 3350, colloidal silicon dioxide, and polysorbate 80.

Norvir oral powder: copovidone, sorbitan monolaurate, and colloidal silicon dioxide.

Norvir tablets are manufactured by: AbbVie Inc., North Chicago, IL 60064 USA. Norvir oral powder is manufactured for: AbbVie Inc., North Chicago, IL 60064 USA.