Use and Important Safety Information You Should Know About NORVIR® (ritonavir)

Use/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).

Drug Interactions:

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®), ergonovine, 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®).

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), have bleeding problems or hemophilia, are pregnant or plan to become pregnant, or are breast-feeding.

Tell your doctor about all the medicines you are taking or are planning to take. These include other prescription and non-prescription medicines, vitamins, and herbal supplements. NORVIR may affect the way other medicines work and other medicines may affect how NORVIR works, which may cause serious side effects.

The list of drug interactions below is not complete.

Tell your doctor especially if you take the following medicines, as they may cause an increase in side effects if you take them with NORVIR: meperidine, nilotinib (Tasigna®) and dasatinib (Sprycel®), colchicine (Colcrys®, Col-Probenecid®, Colchine®), trazodone, sildenafil (Viagra®), tadalafil (Cialis®, Adcirca®), avanafil (Stendra™), vardenafil (Levitra®, Staxyn®), fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®), budesonide (Pulmicort®, Symbicort®, Rhinocort Aqua®, Entocort® EC), dexamethasone, prednisone (Rayos®), salmeterol (Serevent®), fentanyl (Abstral®, Actiq®, Lazanda®, Onsolis®, Duragesic®, Fentora®), and rivaroxaban (Xarelto®).

If you are taking sildenafil (Viagra), tadalafil (Cialis, Adcirca), avanafil (Stendra), or vardenafil (Levitra, Staxyn) with NORVIR, you may be at risk of side effects such as low blood pressure, visual changes, and penile erection lasting more than 4 hours. Tell your doctor right away if you experience any of these side effects.

Tell your doctor if you are taking estrogen-based contraceptives (birth control). NORVIR might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as a condom.

Rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®) may reduce blood levels of NORVIR. Be sure to tell your doctor if you are taking rifampin.

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. Ask your doctor or pharmacist if you are not sure what medicines you are taking or refer to the NORVIR patient information leaflet. Know the medicines you take. Keep a list of them to show your doctor or pharmacist 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 (abdominal) 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 in people with hemophilia has occurred in some people taking protease inhibitors, including NORVIR.

If you are pregnant or planning to become pregnant, it is not known if NORVIR can harm your unborn baby. Do not breast-feed because of the chance of passing HIV to your baby.

If you take NORVIR while you are pregnant, talk to your doctor about how you can take part in the Antiretroviral Pregnancy Registry.

Common side effects of NORVIR include 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.

This is the most important information you should know about NORVIR. For more information, talk to your doctor.

Reference: NORVIR [package insert].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

Please see the full Prescribing Information for NORVIR Capsules.

Please see the full Prescribing Information for NORVIR Tablets.

1440485-1340501