Prezista Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Prezista Tablet contains darunavir, an HIV-1 protease inhibitor used to treat HIV infection. It must always be taken together with a low dose of ritonavir or cobicistat, plus other anti-HIV medicines, and is never used on its own. Prezista works by stopping the HIV virus from multiplying, which helps reduce viral load and support the immune system.

What is Prezista Tablet

Prezista is an antiviral medicine used to treat HIV infection. It contains darunavir, a protease inhibitor that stops the HIV virus from multiplying in the body. It must always be taken together with a low dose of ritonavir or cobicistat (a "booster" medicine) plus other anti-HIV medicines, never on its own.

Prezista Tablet uses

• Treatment of HIV-1 infection in adults, always combined with ritonavir or cobicistat and other antiretroviral medicines
• Treatment of HIV-1 infection in children 3 years of age and older (specific weight limits apply depending on the product and booster used)

Benefits of Prezista Tablet

• Can reduce the amount of HIV virus in the blood (viral load)
• Can help increase CD4+ (T) cell counts, supporting the immune system
• May lower the risk of illnesses linked to HIV infection when used as part of ongoing combination therapy
• Helps reduce viral load
• Supports preservation or recovery of CD4 cells
• Can be effective in some patients with resistance to other HIV medicines

How Prezista Tablet works

Darunavir blocks HIV protease, an enzyme the virus needs to multiply. By stopping the virus from making new infectious copies of itself, it helps lower the amount of HIV in the blood and allows the immune system (CD4 cell count) to recover.

Prezista Tablet dosage

Always take Prezista together with ritonavir or cobicistat, as prescribed — it does not work properly without this booster medicine. Take it with food; the type of food does not matter, but a meal or snack should be eaten shortly before or with the dose.

Tablets should be swallowed whole with a drink such as water or milk, not chewed or crushed. Oral suspension should be shaken well before each use and measured with the supplied oral dosing syringe or pipette, not a kitchen spoon.

Adults and children are generally dosed once or twice daily depending on treatment history and resistance test results, as determined by the doctor. Do not skip doses, double up on a missed dose, or stop treatment without talking to your doctor.

If a dose is missed, instructions differ for once-daily versus twice-daily regimens and depend on how many hours have passed since the missed dose — contact your doctor or pharmacist for guidance. If vomiting occurs shortly after taking a dose, another dose may need to be taken with food; contact your doctor if unsure.

Available forms and strengths

• Oral suspension (100 mg/mL)
• Tablet

Side effects of Prezista Tablet

Common

• Diarrhea
• Nausea
• Headache
• Rash
• Vomiting
• Abdominal pain or distension
• Tiredness (fatigue)
• Dizziness
• Difficulty sleeping (insomnia)

Serious

• Severe or life-threatening skin reactions, including Stevens-Johnson Syndrome, toxic epidermal necrolysis, and DRESS (rash with fever, swelling, fatigue, and organ effects)
• Drug-induced liver injury/hepatitis, which can occasionally be severe or fatal
• Diabetes mellitus or worsening of existing diabetes, and high blood sugar
• Inflammation of the pancreas (pancreatitis)
• Immune reconstitution inflammatory syndrome and autoimmune disorders (e.g., Graves' disease, Guillain-Barré syndrome)
• Increased bleeding in people with hemophilia
• Kidney problems, including acute renal failure and darunavir crystals in the kidney
• Changes in body fat distribution (central weight gain, fat loss in limbs/face)
• Increases in cholesterol and triglyceride levels
• Bone problems such as osteonecrosis (joint stiffness, aches, especially hip, knee, shoulder)

Warnings and precautions

• Prezista must always be taken together with ritonavir or cobicistat; without this booster, blood levels of the medicine will be too low to fight HIV effectively, risking loss of treatment effect and development of drug resistance.
• Several other medicines must not be combined with Prezista because of the risk of serious or life-threatening reactions, including certain heart rhythm drugs, some cholesterol medicines, certain sedatives, some antipsychotics, and the herbal product St. John's Wort.
• Serious, sometimes fatal, liver problems have occurred with this medicine, particularly in people with existing liver disease such as chronic hepatitis B or C.
• Severe skin reactions, including rare cases of Stevens-Johnson Syndrome and toxic epidermal necrolysis, have occurred and require immediate medical attention and discontinuation of the medicine.
• People with a known allergy to sulfa (sulfonamide) medicines should use this drug with caution, since darunavir contains a sulfonamide chemical group.
• This medicine does not cure HIV or AIDS, does not prevent passing HIV to others, and people taking it can still develop other infections or illnesses related to HIV.
• Prezista with ritonavir should only be used during pregnancy if the potential benefit outweighs the potential risk, and a pregnancy registry exists to monitor outcomes. Prezista with cobicistat is not recommended during pregnancy because drug levels become too low to control the virus effectively.
• Women taking Prezista should not breastfeed, both because of the risk of passing HIV to the infant through breast milk and because of potential side effects in the nursing infant.
• No dose adjustment is generally required for darunavir/ritonavir in people with kidney problems, since the drug is not substantially removed by dialysis, but caution and monitoring are still advised, especially with cobicistat combinations.
• Prezista should not be used in people with severe liver problems. In mild to moderate liver impairment it can be used with caution and monitoring, but increased unbound drug levels may occur.
• Alcohol use is best limited, especially if liver function is abnormal.
• Prezista combined with ritonavir or cobicistat has little or no effect on the ability to drive or use machines, but some patients have experienced dizziness, which should be considered before driving or operating machinery.

Storage

• Store oral suspension and tablets at room temperature, with excursions permitted between 15-30°C (59-86°F)
• Do not refrigerate or freeze the oral suspension
• Avoid exposure to excessive heat
• Store the oral suspension in its original container
• Keep out of the sight and reach of children

When to see a doctor

• Seek medical help immediately if you notice yellowing of the skin or eyes, dark urine, pale stools, nausea, vomiting, loss of appetite, or pain below the ribs on the right side, as these can be signs of serious liver problems.
• Stop the medicine and get medical help right away if you develop a severe rash, especially if it comes with fever, tiredness, muscle or joint pain, blisters, mouth sores, or red/irritated eyes, as this may signal a dangerous skin reaction.
• Contact your doctor promptly if you notice symptoms of a new infection (such as fever or swollen glands) shortly after starting treatment, as this could be a sign of immune reconstitution inflammatory syndrome.
• Tell your doctor right away if you develop symptoms such as unusual muscle weakness, tingling that spreads from hands and feet, rapid heartbeat, or tremor, which could indicate an autoimmune reaction related to immune system changes.
• Seek medical advice if you notice increased or unusual bleeding, especially if you have hemophilia, since this medicine can increase the risk of bleeding events.

Alternatives

• Atazanavir
• Lopinavir/ritonavir