Prezista

DRUG DESCRIPTION

PREZISTA (darunavir) is an inhibitor of the human immunodeficiency virus (HIV-1) protease.

PREZISTA (darunavir), in the form of darunavir ethanolate, has the following chemical name: [(1S,2R)-3-[[(4aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3R,3aS,6aR) hexahydrofuro[2,3-b]furan-3-yl ester monoethanolate. Its molecular formula is C27H37N3O7S • C2H5OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula:

PREZISTA (darunavir) Structural Formula Illustration

Darunavir ethanolate is a white to off-white powder with a solubility of approximately 0.15 mg/mL in water at 20°C.

PREZISTA 100 mg/mL oral suspension is available as a white to off-white opaque suspension for oral administration.

PREZISTA 75 mg tablets are available as white, caplet-shaped, film-coated tablets for oral administration.

PREZISTA 150 mg tablets are available as white, oval-shaped, film-coated tablets for oral administration.

PREZISTA 600 mg tablets are available as orange, oval-shaped, film-coated tablets for oral administration.

PREZISTA 400 mg tablets are available as light orange, oval-shaped, film-coated tablets for oral administration.

Each mL of the oral suspension contains darunavir ethanolate equivalent to 100 mg darunavir. In addition, each mL contains the inactive ingredients hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment) and purified water.

Each 75 mg tablet contains darunavir ethanolate equivalent to 75 mg of darunavir. Each 150 mg tablet contains darunavir ethanolate equivalent to 150 mg of darunavir. Each 400 mg tablet contains darunavir ethanolate equivalent to 400 mg of darunavir. Each 600 mg tablet contains darunavir ethanolate equivalent to 600 mg of darunavir. During storage, partial conversion from ethanolate to hydrate may occur; however, this does not affect product quality or performance. Each tablet also contains the inactive ingredients colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. The tablet film coating, OPADRY® White, contains polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The tablet film coating, OPADRY® Orange, contains FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.

All dosages for PREZISTA are expressed in terms of the free form of darunavir.

What are the possible side effects of darunavir (Prezista)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking darunavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • increased urination or extreme thirst;
  • signs of a new infection, such as fever or chills, cough,...

Read All Potential Side Effects and See Pictures of Prezista »

What are the precautions when taking darunavir (Prezista)?

Before taking darunavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C), alcohol use, diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack).

If you have diabetes, this product may increase your blood sugar. Check your blood sugar levels regularly...

Read All Potential Precautions of Prezista »


Prezista Consumer (continued)

SIDE EFFECTS: Since darunavir is always taken with other HIV medications, it may be difficult to tell whether darunavir is causing certain side effects. However, darunavir is known to cause diarrhea, nausea, vomiting, heartburn, stomach pain, weakness, and headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Darunavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking darunavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C), alcohol use, diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack).

If you have diabetes, this product may increase your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. Your doctor may need to adjust your diabetes medication(s).

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe certain HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Prezista Patient Information Including Side Effects

Brand Names: Prezista

Generic Name: darunavir (Pronunciation: da ROON a veer)

  • What is darunavir (Prezista)?
  • What are the possible side effects of darunavir (Prezista)?
  • What is the most important information I should know about darunavir (Prezista)?
  • What should I discuss with my healthcare provider before taking darunavir (Prezista)?
  • How should I take darunavir (Prezista)?
  • What happens if I miss a dose (Prezista)?
  • What happens if I overdose (Prezista)?
  • What should I avoid while taking darunavir (Prezista)?
  • What other drugs will affect darunavir (Prezista)?
  • Where can I get more information?

What is darunavir (Prezista)?

Darunavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Darunavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Darunavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.

Darunavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of darunavir (Prezista)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking darunavir and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • the first sign of any skin rash, no matter how mild;
  • increased urination or extreme thirst;
  • signs of a new infection, such as fever or chills, cough, flu symptoms, easy bruising or bleeding;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • nausea, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • diarrhea, bloating, upset stomach, mild stomach pain;
  • muscle pain;
  • weakness;
  • headache; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about darunavir (Prezista)?

Do not take darunavir with astemizole (Hismanal), cisapride (Propulsid), pimozide (Orap), lovastatin (Mevacor), simvastatin (Zocor), oral midazolam (Versed), triazolam (Halcion), rifampin (Rifadin, Rimactane, Rifater), St. John's wort, terfenadine (Seldane), or an ergot medicine such as Ergomar, Ergotrate, Cafergot, D.H.E. 45, Migranal, Methergine, and others.

These drugs can cause life-threatening side effects if you use them while you are taking darunavir.

There are many other medicines that can interact with darunavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking darunavir will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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