An Overview of Norvir (Ritonavir)

Brand Name: Norvir
Other Name(s): RTV
Drug Class: Protease Inhibitors

WARNING:

Ritonavir can cause serious, life-threatening side effects. These include inflammation of the pancreas (pancreatitis), heart rhythm problems, severe allergic reactions, liver problems, and life-threatening drug interactions.

Contact your health care provider right away if you have any of the following symptoms that may be a sign of pancreatitis:

• Nausea
• Vomiting
• Pain in the stomach area (abdominal pain)

Contact your health care provider right away if you have any of the following symptoms that may be a sign of heart rhythm problems:

• Feeling dizzy or fainting
• Feeling lightheaded
• Abnormal heartbeat

Contact your health care provider right away if you develop a rash. Stop taking ritonavir and get medical help right away if you have any of the following symptoms that may be a sign of a severe allergic reaction:

• Trouble breathing
• Wheezing
• Feeling dizzy or fainting
• Throat tightness or hoarseness
• Fast heartbeat or pounding in your chest
• Sweating
• Swelling of your face, lips, or tongue
• Muscle or joint pain
• Blisters or skin lesions
• Mouth sores or ulcers

Some people taking ritonavir have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking ritonavir. Liver function tests may be done before and during treatment with ritonavir. Contact your health care provider right away if you have any of the following symptoms that may be a sign of liver problems:

• Loss of appetite
• Pain or tenderness on your right side below your ribs
• Yellowing of your skin or the whites of your eyes (jaundice)
• Itchy skin

Taking ritonavir with certain other medicines (including sedatives or sleeping pills, medicines for irregular heartbeat, or ergot medicines) may result in serious, life-threatening drug interactions. Before taking ritonavir, tell your health care provider about all medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Ritonavir oral solution contains a large amount of alcohol. Accidentally drinking more than the recommended dose of ritonavir could make a toddler or young child sick from too much alcohol. If this happens, call your local poison control center (1-800-222-1222) or hospital emergency room immediately.

While taking ritonavir, it is important to keep all of your appointments with your health care provider.

What Is Ritonavir?

Ritonavir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children older than 1 month. Ritonavir is always used in combination with other HIV medicines.

Although ritonavir is a protease inhibitor, it is generally used as a pharmacokinetic enhancer as recommended in the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Pharmacokinetic enhancers are used in HIV treatment to increase the amount of other HIV medicines in the blood, making them more effective. The guidelines include recommendations on using ritonavir as a pharmacokinetic enhancer of other HIV protease inhibitors.

HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

What Should I Tell My Health Care Provider Before Taking Ritonavir?

Before taking ritonavir, tell your health care provider:

• If you are allergic to ritonavir or any other medicines.
• If you have or have ever had liver problems, including hepatitis B virus (HBV) infection or hepatitis c virus (HCV) infection.
• If you have or have ever had heart problems.
• If you have or have ever had diabetes or high blood sugar (hyperglycemia).
• If you have or have ever had bleeding problems or hemophilia.
• If you have or have ever had any other medical conditions.
• If you are pregnant or plan to become pregnant. You should not take ritonavir oral solution while pregnant. Whether other formulations of ritonavir can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking ritonavir when pregnant.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking ritonavir.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Ritonavir may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking ritonavir. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
• If you are using an estrogen-based medicine for hormone replacement.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John's wort) you are taking or plan to take. Ritonavir may affect the way other medicines or products work, and other medicines or products may affect how ritonavir works. Taking ritonavir with certain medicines or products may cause serious, life-threatening side effects.

How Should I Take Ritonavir?

Ritonavir (brand name: Norvir) comes in the following forms and strengths:

• 100-mg tablets.
• 100-mg soft gelatin capsules.
• 80-mg/mL oral solution. (An oral solution is a mixture of a medicine and a liquid that can be taken by mouth.)
• 100-mg of oral powder (The oral powder is mixed with soft foods or liquid and then can be taken by mouth.)

Take ritonavir according to your health care provider's instructions.

Take ritonavir with meals.

Swallow ritonavir tablets whole. Do not chew, break, or crush the tablets before swallowing.

Ritonavir oral solution is a peppermint- or caramel-flavored liquid that can be taken alone or mixed with 8 ounces of chocolate milk, Ensure®, or Advera® to improve the taste. (When mixed with these fluids, ritonavir oral solution should be taken within 1 hour of mixing.) Always shake the oral solution well before each use.

Ritonavir oral solution contains a large amount of alcohol. Accidentally drinking more than the recommended dose of ritonavir could make a toddler or young child sick from too much alcohol. If this happens, call your local poison control center (1-800-222-1222) or hospital emergency room immediately.

Ritonavir oral powder comes in individual packets and is an option for children. The oral powder is mixed into a spoonful or more of soft food (such as applesauce or pudding) or liquid (such as water, milk, or infant formula). The bitter aftertaste of ritonavir oral powder may be lessened if it's given with food. All of the mixture should be taken. The mixture must be given within 2 hours of mixing with the food or liquid. If it's not given within 2 hours of mixing, throw away the mixture and prepare a new dose.

Always take ritonavir in combination with other HIV medicines.

If you take too much ritonavir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take ritonavir, see the FDA drug labels for ritonavir tablets, capsules, oral solution, and oral powder from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What Should I Do if I Forget a Dose?

If you miss a dose of ritonavir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose.

What Side Effects Can Ritonavir Cause?

Ritonavir may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of ritonavir can be serious. Serious side effects of ritonavir include inflammation of the pancreas (pancreatitis), heart rhythm problems, severe allergic reactions, liver problems, and life-threatening drug interactions. (See the WARNING box above.)

Other possible side effects of ritonavir include:

• Increase in levels of certain fats (cholesterol and triglycerides) in the blood (hyperlipidemia).
• Diabetes and high blood sugar (hyperglycemia).
• Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Changes in body fat (including gain or loss of fat).
• Increased bleeding in people with hemophilia.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ritonavir. To learn more about possible side effects of ritonavir, read the drug label (tablet, capsule, oral solution, or oral powder) or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.

How Should Ritonavir Be Stored?

Store ritonavir in the container that it came in and keep the container tightly closed. Do not use ritonavir if the original seal over the container opening is broken or missing.

Follow specific storage instructions for ritonavir tablets, capsules, oral solution, and oral powder.

Ritonavir tablets:

• Store ritonavir tablets below 86°F (30°C). Ritonavir tablets can be exposed to temperatures up to 122°F (50°C) for up to 7 days.
• If ritonavir tablets are not stored in their original container, don't expose the tablets to high humidity for longer than 2 weeks.

Ritonavir capsules:

• Store ritonavir capsules in the refrigerator, 36°F to 46°F (2°C to 8°C). If the capsules are used within 30 days, they don't need to be refrigerated but do need to be stored below 77°F (25°C).
• Protect the capsules from light and excessive heat.

Ritonavir oral solution:

• Store ritonavir oral solution at room temperature, 68°F to 77°F (20°C to 25°C).
• Don't refrigerate ritonavir oral solution and keep it away from heat.

Ritonavir oral powder:

• Store ritonavir oral powder at or below 86°F (30°C).

Throw away ritonavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine. Keep ritonavir and all medicines out of reach of children.

Where Can I Find More Information About Ritonavir?

More information about ritonavir is available:

• Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents: Characteristics of Protease Inhibitors
• Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection: Ritonavir
• The FDA drug labels for ritonavir tablets, capsules, oral solution, and oral powder from DailyMed. The Patient Counseling Information section of the labels includes information for people taking ritonavir.
• Ritonavir-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved HIV medicines, from AIDSinfo.

Manufacturer Information

AbbVie Inc.
Main number: 800-633-9110
Patient assistance: 800-222-6885

The above Patient Version drug summary is based on the following FDA label(s): Capsule; Tablet (film coated), solution, powder.