An Overview of Prezista (Darunavir, TMC114)

dar-UE-na-vir

Brand Name: Prezista
Other Name(s): TMC 114, TMC114
Drug Class: Protease Inhibitors

Patient Information

PREZISTA (pre-ZIS-ta)
Darunavir

Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information.This information does not take the place of talking to your doctor or healthcare provider about your medical condition or your treatment.

What is the most important information I should know about PREZISTA?

• PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section "Who should not take PREZISTA?"
• PREZISTA may cause liver problems. Some people taking PREZISTA in combination 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.
  • 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
  • loss of appetite
• 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 symptoms below:
  • fever
  • tiredness
  • muscle or joint pain
  • blisters or skin lesions
  • mouth sores or ulcers
  • red or inflamed eyes, like "pink eye" (conjunctivitis)

  Rash occurred more often in patients taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.

See "What are the possible side effects of PREZISTA?" for more information about side effects.

What is PREZISTA?

PREZISTA is a prescription anti-HIV medicine used with other anti-HIV medicines used to treat adults and children 6 years of age and older. PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. PREZISTA is used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

How does PREZISTA work?

PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA can help to reduce the amount of HIV in your blood (called "viral load") and increase your CD4 (T) cell count. HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system and, thus, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections).

PREZISTA is always taken with and at the same time as ritonavir (NORVIR), in combination with other anti-HIV medicines. PREZISTA should also be taken with food.

Does PREZISTA cure HIV or AIDS?

PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infection, and Mycobacterium avium complex (MAC) infections. Because of this, it is very important for you to remain under the care of a healthcare provider. Although PREZISTA is not a cure for HIV or AIDS, PREZISTA can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection) and eventually dying from these conditions.

Does PREZISTA reduce the risk of passing HIV to others?

PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

What should I tell my doctor before I take PREZISTA?

PREZISTA may not be right for you. Before taking PREZISTA, tell your doctor or healthcare provider if you:

• are allergic to sulfa medicines.
• have diabetes. Anti-HIV medicines, such as PREZISTA, might increase sugar levels in the blood.
• have liver problems, including hepatitis B and/or C.
• have hemophilia. Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding.
• are pregnant or planning to become pregnant. 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. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry.
• are breastfeeding. Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby. Talk with your healthcare provider about the best way to feed your baby. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby.

Who should not take PREZISTA?**

Together with your healthcare provider, you need to decide whether taking PREZISTA is right for you.

Do not take or administer PREZISTA:

• to children younger than 6 years of age
• if you are or your child is allergic to darunavir or any of the other ingredients in PREZISTA
• if you are or your child is allergic to ritonavir (NORVIR®)
• if you take or your child takes any of the following types of medicines because you could experience serious side effects:

Type of Drug: Examples of Generic Names (Brand Names)

• Alpha 1-adrenoreceptor antagonist: alfuzosin (Uroxatral®)
• Ergot Derivatives (to treat migraine and headaches): dihydroergotamine (D.H.E. 45®, Migranal®);ergonovine; ergotamine (Cafergot®, Ergomar®); methylergonovine
• Gastrointestinal Motility Agent (to treat some digestive conditions): cisapride
• Neuroleptic (to treat psychiatric conditions): pimozide (Orap®)
• Sedative/hypnotics (to treat trouble sleeping and/or anxiety): oral midazolam; triazolam (Halcion®)
• Herbal Product: St. John's wort (Hypericum perforatum)
• HMG-CoA Reductase Inhibitors (also known as statins) (to lower cholesterol levels): lovastatin (Mevacor®, Altoprev®, Advicor®); simvastatin (Zocor®, Simcor®, Vytorin®)
• Antimycobacterial (to treat tuberculosis or Mycobacterium avium complex): rifampin (Rifadin®, Rifater®,Rifamate®, Rimactane®)
• PDE-5 inhibitor (to treat pulmonary arterial hypertension): sildenafil (Revatio®)

** The brands listed are the registered trademarks of their respective owners and are not trademarks of Tibotec Pharmaceuticals

Can PREZISTA be taken with other medications?**

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines (see "Who should not take PREZISTA?").

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 a condom.

Tell your healthcare provider if you take other anti-HIV medicines. PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended.

Tell your healthcare provider if you are taking any of the following medicines:

Type of Drug: Examples of Generic Names (Brand Names)

• Antiarrhythmics (to treat abnormal heart rhythms): bepridil; lidocaine; quinidine; amiodarone (Cordarone®); digoxin (Lanoxin®); flecainide (Tambocor®); propafenone (Rythmol®)
• Anticoagulants (to treat and prevent blood clots): warfarin (Coumadin®)
• Anticonvulsants (to treat epilepsy and prevent seizures): carbamazepine (Tegretol®, Carbatrol®); phenobarbital; phenytoin (Dilantin®, Phenytek®)
• Antidepressants (to treat depression): trazodone (Desyrel®); desipramine (Norpramin®)
• Antigout (to treat and prevent gout and to treat familial Mediterranean fever): colchicine (Colcrys®)
• Anti-infectives (to treat bacterial infections): clarithromycin (Biaxin®)
• Antifungals (to treat fungal infections): ketoconazole (Nizoral®); itraconazole (Sporanox®); voriconazole (Vfend®)
• Antimycobacterials (to treat tuberculosis or Mycobacterium avium complex): rifabutin (Mycobutin®)
• β-Blockers (to treat high blood pressure, heart attack, or heart failure or to lower pressure in the eye): metoprolol (Lopressor®, Toprol-XL®); timolol (Betimol®, Combigan®, Istalol®, Cosopt®, Timoptic®)
• Benzodiazepines (to treat anxiety and/or trouble with sleeping): midazolam administered by injection
• Calcium Channel Blockers (to treat heart disease): felodipine (Plendil®); nifedipine (Adalat®); nicardipine (Cardene®)
• Corticosteroids (to treat inflammation or asthma): dexamethasone; fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®)
• Endothelin receptor antagonist (to treat pulmonary arterial hypertension): bosentan (Tracleer®)
• HMG-CoA Reductase Inhibitors (also known as statins) (to lower cholesterol levels): atorvastatin (Lipitor®); pravastatin (Pravachol®); rosuvastatin (Crestor®)
• Immunosuppressants (to prevent organ transplant rejection): cyclosporine (Sandimmune®, Neoral®); tacrolimus (Prograf®); sirolimus (Rapamune®)
• Inhaled beta agonist: salmeterol (Serevent®)
• Narcotic Analgesics/Treatment of Opioid Dependence (to treat narcotic withdrawal and dependence): Methadone; buprenorphine; buprenorphine/naloxone
• Neuroleptics (to treat schizophrenia or bipolar disorder): risperidone (Risperdal®, Risperdal® Consta®, Risperdal® M-TAB®); thioridazine
• PDE-5 Inhibitors (to treat erectile dysfunction): sildenafil (Viagra®); vardenafil (Levitra®); tadalafil (Cialis®)
• PDE-5 Inhibitors (to treat pulmonary arterial hypertension): tadalafil (Adcirca®)
• Selective Serotonin Reuptake Inhibitors (SSRIs) (to treat depression, anxiety, or panic disorder): paroxetine (Paxil®); sertraline (Zoloft®)

** The brands listed are the registered trademarks of their respective owners and are not trademarks of Tibotec Pharmaceuticals

Tell your healthcare provider if you are taking any medicines that you obtained without a prescription.

This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your healthcare providers and pharmacists any time you get a new medicine. Both your healthcare provider and your pharmacist can tell you if you can take these other medicines with PREZISTA. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with PREZISTA.

How should I take PREZISTA?

Take PREZISTA tablets every day exactly as prescribed by your healthcare provider. You must take ritonavir (NORVIR®) at the same time as PREZISTA.

• Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first.
• Take PREZISTA and ritonavir (NORVIR®) with food.
• Swallow PREZISTA tablets whole with a drink.
• If your child is taking PREZISTA, your child's healthcare provider will decide the right dose based on your child's weight. Your child's healthcare provider will tell you how many PREZISTA tablets and how much ritonavir (NORVIR®) (capsules, tablet or solution) your child should take. Your child should take PREZISTA with ritonavir twice a day with food.If your child does not tolerate ritonavir oral solution, ask your child's healthcare provider for advice.

What should I do if I miss a dose?

People who take PREZISTA one time a day:

• If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 12 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 12 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.

People who take PREZISTA two times a day:

• If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 6 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.
  
• If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 6 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time.

If a dose of PREZISTA or ritonavir (NORVIR®) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA or ritonavir (NORVIR®) at any one time.