Acquired Immunodeficiency Syndrome (AIDS): A disease of the immune system caused by the Human Immunodeficiency Virus (HIV). When someone has AIDS, their CD4 cells die. This exposes the body to life-threatening infections.
Adherence: The ability to follow a prescribed treatment regimen. It means taking the right dose of a drug at the right time, as directed. Failure to adhere to an HIV treatment regimen can lead to treatment failure and drug resistance.
Antiretroviral Therapy: Treatment with drugs that keep viruses from multiplying in the body. The antiretroviral therapy recommended for HIV infection is known as Highly Active Antiretroviral Therapy (HAART).
CD4 Cell: A type of white blood cell that fights infections. The more CD4 cells a person has, the healthier their immune system is. HIV infects and kills CD4 cells, weakening the immune system.
CD4 Cell Count: The number of CD4 cells in a blood sample. Helps healthcare professionals decide when to begin HIV therapy and may show whether treatment is working. A normal CD4 cell count is usually between 500 and 1400.
Clinical Trial: A research study that uses human volunteers to help find new treatments for diseases and conditions. Clinical trials may be prospective (studying data from a time point forward) or retrospective (studying data from a point in the past).
Combination Therapy: Two or more drugs used together to control HIV infection. An example of combination therapy is the use of 2 NRTIs plus a PI or an NNRTI.
Dose: The amount of a medicine that should be taken during a given time period.
Drug Class: A group of drugs that have certain things in common and work in a similar way.
Drug-Drug Interaction: May happen when one drug is taken with another drug. Can cause a change in the way either drug works. It may also cause a side effect that does not normally happen with either drug alone.
Drug Resistance: When infections adapt to a drug and continue to multiply. This may happen even when someone is taking medicines that would normally fight the infection.
First-Line Regimen: The treatment plan and drugs used when someone is taking medication for an illness for the first time.
Highly Active Antiretroviral Therapy (HAART): Treatment regimens that stop or slow the HIV virus from reproducing and keep HIV disease from progressing. The usual HAART regimen combines 3 or more HIV drugs from at least 2 different classes.
Human Immunodeficiency Virus (HIV): The virus that causes AIDS. HIV-1 causes most HIV infections throughout the world. HIV-2 is found mostly in Africa.
Immune Reconstitution: Can happen when someone’s CD4 cell count goes up after they start HIV treatment. Fever, swelling, redness, or discharge may mean that their immune system is getting stronger. But this reaction can be very serious and must be treated accordingly.
Immune Response: When the body defends itself against a foreign invader, such as a virus or bacteria.
Immune System: The group of cells and organs whose job is to protect the body from infections.
Immunocompromised: Someone whose immune system has been weakened so it can no longer protect them from infections.
Immunodeficiency: Inability to produce normal amounts of the disease-fighting cells that protect the body against infections.
Immunosuppression: Inability of the immune system to work as well as it should. May be caused by drugs, including chemotherapy, or by diseases such as HIV infection.
Integrase Inhibitor: A class of HIV drugs that blocks or prevents HIV from putting itself into the DNA of CD4 cells.
Lipodystrophy: A problem with the way the body distributes fat.
Mother-to-Child Transmission (MTCT): The passing of HIV from an infected mother to her infant. The infant may become infected while in the womb, during labor and delivery, or through breastfeeding.
Mutation: A change in a virus that can be passed down to future generations of the virus. This changed virus can then become resistant to different HIV drugs.
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI): A class of HIV drug that sticks tightly to a protein that HIV needs to make more copies of itself. Because HIV can’t use the protein, it can’t complete the copying process.
Nucleoside Reverse Transcriptase Inhibitor (NRTI): A class of HIV drug (also known as nukes) that pretends to be something HIV needs to multiply. When HIV uses a nuke, it cannot complete the copying process.
Pill Burden: The number of pills taken in an HIV drug regimen. A high pill burden may cause people to stop taking their medicines as directed.
Protease Inhibitors (PIs): A class of HIV drugs that prevents new copies of HIV from being infectious. PIs inhibit a protein called protease, and without it, HIV can’t make copies of itself.
Resistance: When a person doesn’t respond to one or more HIV drugs.
Salvage Therapy: A treatment regimen for people who have had treatment failure with at least 2 HIV drugs and who have a high level of drug resistance.
Side Effect: When a drug causes a reaction in the body that it is not meant to cause. Usually refers to something unwanted, such as headache, skin irritation, or liver damage.
Standard of Care: A treatment plan that experts agree is the best way to treat a certain disease or condition.
T Cell: A type of white blood cell that fights disease. T cells include CD4 cells and CD8 cells, both important players in the body's immune system.
Tolerability: How well a drug is handled by the body.
Treatment-Experienced: A person with HIV who is currently taking HIV drugs or who has taken HIV drugs in the past.
Treatment Failure: When an HIV treatment stops controlling HIV infection. This can happen when a person isn’t taking the drug as directed, when the HIV strain becomes resistant to treatment, and/or when the drug is causing harm to the body.
Treatment-Naïve: A person with HIV who has never taken HIV drugs.
Treatment Regimen: A plan of treatment, usually with drugs, that is designed to make a person’s health better.
Undetectable Viral Load: When the amount of HIV in the blood is too low to be seen on a viral load test. Getting to undetectable is a good thing, but it does not mean your HIV is cured, and you can still pass it to others.
Viral Load: The amount of HIV found in a blood sample. When viral load goes up or down, your healthcare professional can get an idea of how well treatment is working.
Important Safety Information
What is the most important information I should know about PREZISTA®?
- PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
- PREZISTA® may cause liver problems. Some people taking PREZISTA®, together with Norvir® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA®. 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 if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale- colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite
PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.
PREZISTA® is always taken with and at the same time as ritonavir (Norvir®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food.
PREZISTA® 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 PREZISTA®.
Please read Important Safety Information below, and talk to your healthcare provider to learn if PREZISTA® is right for you.
- PREZISTA® may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild
Who should not take PREZISTA®?
- Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), apixaban (Eliquis®), avanafil (Stendra®), boceprevir (Victrelis®), cisapride (Propulsid®), colchicine (Colcrys®, Col-Probenecid®) if you have liver or kidney problems, dabigatran etexilate (Pradaxa®) in specific renal impairment groups, dihydroergotamine (D.H.E.45®, Embolex®, Migranal®), dronedarone (Multaq®), ergotamine (Cafergot®, Ergomar®), everolimus (Zortress®, Afinitor®), indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), lovastatin (Mevacor®, Altoprev®, Advicor®), methylergonovine, oral midazolam (Versed®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), rifapentine (Priftin®), rivaroxaban (Xarelto®), saquinavir (Invirase®), salmeterol (Advair®, Serevent®), sildenafil (Revatio®) only when used to treat pulmonary arterial hypertension, simeprevir (Olysio®), simvastatin (Zocor®, Simcor®, Vytorin®), the herbal supplement or products containing St. John's Wort (Hypericum perforatum), telaprevir (Incivek®), triazolam (Halcion®), or voriconazole (VFend®)
- Before taking PREZISTA®, tell your healthcare provider if you are taking sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), or pravastatin (Pravachol®)
- Tell your healthcare provider if you are taking estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms
Serious problems can happen if you or your child takes any of these medicines with PREZISTA®.
This is not a complete list of medicines. Be sure to tell your healthcare provider about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start any new medicines while you are taking PREZISTA® without first talking to your healthcare provider.
What should I tell my doctor before I take PREZISTA®?
- Before taking PREZISTA®, tell your healthcare provider if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
- Tell your healthcare provider if you are pregnant or planning to become pregnant, or are breastfeeding
- The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare provider will need to decide if taking PREZISTA® is right for you
- Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk
What are the possible side effects of PREZISTA®?
- High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA®
- Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA®. The cause and long-term health effects of these conditions are not known at this time
- Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
- The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare provider. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare provider
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.
Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
Please see accompanying full Product Information for more details.