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Prezista

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Prezista

Prezista

INDICATIONS

Adult Patients

PREZISTA®, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-na´ve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

Pediatric Patients

PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older [see Use In Specific Populations].

The indication for treatment-experienced pediatric patients 3 to less than 18 years of age is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two open-label Phase 2 trials in antiretroviral treatment-experienced pediatric subjects(24-week analysis for one trial in patients 6 to less than 18 years of age; 48-week analysis for one trial in patients 3 to less than 6 years of age) . The indication for treatment-na´ve pediatric patients or antiretroviral treatment-experienced patients with no darunavir resistance associated substitutions is based on one open-label Phase 2 trial of 48 weeks duration in antiretroviral treatment-na´ve subjects 12 to less than 18 years of age and pharmacokinetic modeling and simulation for patients 3 to less than 12 years of age.

In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:

  • Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/ritonavir [see CLINICAL PHARMACOLOGY].
  • The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response [see CLINICAL PHARMACOLOGY and Clinical Studies].

DOSAGE AND ADMINISTRATION

Adult Patients

PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.

Patients who have difficulty swallowing PREZISTA tablets can use the 100 mg/mL PREZISTA oral suspension.

Treatment-Na´ve Adult Patients

The recommended oral dose of PREZISTA is 800 mg (one 800 mg tablet or 8 mL of the oral suspension) taken with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL of a 80 mg/mL ritonavir oral solution) once daily and with food. An 8 mL darunavir dose should be taken as two 4 mL administrations with the included oral dosing syringe.

Treatment-Experienced Adult Patients

Table 1: Treatment-Experienced Adult Patients

With no darunavir resistance associated substitutions*  With at least one darunavir resistance associated substitution* 
Formulations: PREZISTA tablets or oral suspension (100 mg/mL) and ritonavir tablets/capsules (100 mg) or solution (80 mg/mL) 
PREZISTA 800 mg (one 800 mg tablet) or 8 mL†(oral suspension) once daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL (oral solution) once daily and with food  PREZISTA 600 mg (e.g. one 600 mg tablet) or 6 mL (oral suspension) twice daily with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL (oral solution) twice daily and with food 
* V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V
† An 8 mL darunavir dose should be taken as two 4 mL administrations with the included oral dosing syringe

For antiretroviral treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

Pediatric Patients (Age 3 To Less Than 18 Years)

Healthcare professionals should pay special attention to accurate dose selection of PREZISTA, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.

Prescribers should select the appropriate dose of PREZISTA/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for adults.

Before prescribing PREZISTA, children weighing greater than or equal to 15 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA oral suspension should be considered.

The recommended dose of PREZISTA/ritonavir for pediatric patients (3 to less than 18 years of age and weighing at least 10 kg is based on body weight (see Tables 2, 3, 4, and 5) and should not exceed the recommended adult dose. PREZISTA should be taken with ritonavir and with food.

The recommendations for the PREZISTA/ritonavir dosage regimens were based on the following:

Twice daily dosing
  • Results from two trials in treatment-experienced pediatric subjects 3 to less 18 years of age demonstrating similar darunavir plasma exposures, virologic response rate and safety profile compared to treatment-experienced adults.
Once daily dosing
  • Results from one trial in treatment-naive pediatric subjects 12 to less than 18 years of age demonstrating similar darunavir plasma exposures, virologic response rate and safety profile compared to treatment-naive adults.
  • Results from population pharmacokinetic modeling and simulation in children 3 to less than 12 years of age predicting similar darunavir plasma exposures compared to treatment-na´ve adults. Although no clinical trial was conducted to collect exposure-safety data, the predicted exposures from the once daily dosing is supported by exposures observed in a pediatric clinical trial where twice-daily dosing was administered.
Dosing recommendations for treatment-na´ve pediatric patients or antiretroviral treatment-experienced pediatric patients with no darunavir resistance associated substitutions
  • Pediatric patients weighing at least 10 kg but less than 15 kg

The weight-based dose in antiretroviral treatment-na´ve pediatric patients or antiretroviral treatment-experienced pediatric patients with no darunavir resistance associated substitutions is PREZISTA 35 mg/kg once daily with ritonavir 7 mg/kg once daily using the following table.

Table 2: Recommended dose for pediatric patients weighing 10 kg to less than 15 kg who are treatment-na´ve or treatment-experienced with no darunavir resistance associated substitutions*

Body weight (kg)  Formulation: PREZISTA oral suspension (100 mg/mL) and Ritonavir oral solution (80 mg/mL) 
Dose: once daily with food 
Greater than or equal to 10 kg to less than 11 kg  PREZISTA 3.6 mL‡ (350 mg) with ritonavir 0.8 mL (64 mg) 
Greater than or equal to 11 kg to less than 12 kg  PREZISTA 4 mL‡ (385 mg) with ritonavir 0.8 mL (64 mg) 
Greater than or equal to 12 kg to less than 13 kg  PREZISTA 4.2 mL (420 mg) with ritonavir 1 mL (80 mg) 
Greater than or equal to 13 kg to less than 14 kg  PREZISTA 4.6 mL‡ (455 mg) with ritonavir 1 mL (80 mg) 
Greater than or equal to 14 kg to less than 15 kg  PREZISTA 5 mL‡ (490 mg) with ritonavir 1.2 mL (96 mg) 
* darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
‡ The 350 mg, 385 mg, 455 mg and 490 mg darunavir dose for the specified weight groups were rounded up for suspension dosing convenience to 3.6 mL, 4 mL, 4.6 mL and 5 mL, respectively.

Pediatric patients weighing at least 15 kg

Pediatric patients weighing at least 15 kg can be dosed with PREZISTA oral tablet(s) or suspension using the following table:

Table 3: Recommended dose for pediatric patients weighing at least 15 kg who are treatment-na´ve or treatment-experienced with no darunavir resistance associated substitutions*

Body Weight (kg)  Formulation: PREZISTA tablet(s) and ritonavir capsules or tablets (100 mg)  Formulation: PREZISTA oral suspension (100 mg/mL) and ritonavir oral solution (80 mg/mL) 
  Dose: once daily with food  Dose: once daily with food 
Greater than or equal to 15 kg to less than 30 kg  PREZISTA 600 mg with ritonavir 100 mg  PREZISTA 6 mL (600 mg) with ritonavir 1.25 mL (100 mg) 
Greater than or equal to 30 kg to less than 40 kg  PREZISTA 675 mg with ritonavir 100 mg  PREZISTA 6.8 mL§∫ (675 mg) with ritonavir 1.25 mL (100 mg) 
Greater than or equal to 40 kg  PREZISTA 800 mg with ritonavir 100 mg  PREZISTA 8 mL∫ (800 mg) with ritonavir 1.25 mL (100 mg) 
* darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
§ The 675 mg dose using darunavir tablets for this weight group is rounded up to 6.8 mL for suspension dosing convenience.
∫ The 6.8 mL and 8 mL darunavir dose should be taken as two (3.4 mLor 4 mL respectively) administrations with the included oral dosing syringe

Dosing recommendations for treatment-experienced pediatric patients with at least one darunavir resistance associated substitutions
  • Pediatric patients weighing at least 10 kg but less than 15 kg

The weight-based dose in antiretroviral treatment-experienced pediatric patients with at least one darunavir resistance associated substitution is PREZISTA 20 mg/kg twice daily with ritonavir 3 mg/kg twice daily using the following table:

Table 4: Recommended dose for pediatric patients weighing 10 kg to less than 15 kg who are treatment-experienced with at least one darunavir resistance associated substitution*

Body weight (kg)  Formulation: PREZISTA oral suspension (100 mg/mL) and Ritonavir oral solution (80 mg/mL) 
  Dose: twice daily with food 
Greater than or equal to 10 kg to less than 11 kg  PREZISTA 2 mL (200 mg) with ritonavir 0.4 mL (32 mg) 
Greater than or equal to 11 kg to less than 12 kg  PREZISTA 2.2 mL (220 mg) with ritonavir 0.4 mL (32 mg) 
Greater than or equal to 12 kg to less than 13 kg  PREZISTA 2.4 mL (240 mg) with ritonavir 0.5 mL (40 mg) 
Greater than or equal to 13 kg to less than 14 kg  PREZISTA 2.6 mL (260 mg) with ritonavir 0.5 mL (40 mg) 
Greater than or equal to 14 kg to less than 15 kg  PREZISTA 2.8 mL (280 mg) with ritonavir 0.6 mL (48 mg) 
* darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V

Pediatric patients weighing at least 15 kg

Pediatric patients weighing at least 15 kg can be dosed with PREZISTA oral tablet(s) or suspension using the following table:

Table 5: Recommended dose for pediatric patients weighing at least 15 kg who are treatment-experienced with at least one darunavir resistance associated substitution*

Body Weight (kg)  Formulation: PREZISTA tablet(s) and ritonavir tablets, capsules (100 mg) or oral solution (80 mg/mL)  Formulation: PREZISTA oral suspension (100 mg/mL) and ritonavir oral solution (80 mg/mL) 
  Dose: twice daily with food  Dose: twice daily with food 
Greater than or equal to 15 kg to less than 30 kg  PREZISTA 375 mg with ritonavir 0.6 mL (48 mg)  PREZISTA 3.8 mL (375 mg) with ritonavir 0.6 mL (48 mg) 
Greater than or equal to 30 kg to less than 40 kg  PREZISTA 450 mg with ritonavir 0.75 mL (60 mg)  PREZISTA 4.6 mL (450 mg)§ with ritonavir 0.75 mL (60 mg) 
Greater than or equal to 40 kg  PREZISTA 600 mg with ritonavir 100 mg  PREZISTA 6 mL (600 mg) with ritonavir 1.25 mL (100 mg) 
* darunavir resistance associated substitutions: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V
§ The 375 mg and 450 mg dose using darunavir tablets for this weight group is rounded up to 3.8 mL and 4.6 mL for suspension dosing convenience.

Do not use PREZISTA/ritonavir in pediatric patients below 3 years of age [see WARNINGS AND PRECAUTIONS) and Nonclinical Toxicology].

Patients With Hepatic Impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available regarding the use of PREZISTA/ritonavir when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

PREZISTA 100 mg/mL Oral Suspension

PREZISTA (darunavir) 100 mg/mL oral suspension is supplied as a white to off-white opaque suspension for oral use, containing darunavir ethanolate equivalent to 100 mg of darunavir per mL of suspension.

PREZISTA 75 mg Tablets

PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with “75” on one side and “TMC” on the other side.

PREZISTA 150 mg Tablets

PREZISTA (darunavir) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir per tablet. Each tablet is debossed with “150” on one side and “TMC” on the other side.

PREZISTA 600 mg Tablets

PREZISTA (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir per tablet. Each tablet is debossed with “600MG” on one side and “TMC” on the other side.

PREZISTA 800 mg Tablets

PREZISTA (darunavir) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir per tablet. Each tablet is debossed with “800” on one side and “T” on the other side.

Storage And Handling

PREZISTA (darunavir) 100 mg/mL oral suspension is a white to off-white opaque liquid supplied in amber-colored multiple-dose bottles containing darunavir ethanolate equivalent to 100 mg of darunavir per mL packaged with a 6 mL oral dosing syringe with 0.2 mL gradations.

PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with “75” on one side and “TMC” on the other side.

PREZISTA (darunavir) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir per tablet. Each tablet is debossed with “150” on one side and “TMC” on the other side.

PREZISTA (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir per tablet. Each tablet is debossed with “600MG” on one side and “TMC” on the other side.

PREZISTA (darunavir) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir per tablet. Each tablet is debossed with “800” on one side and “T” on the other side.

PREZISTA is packaged in bottles in the following configuration:

100 mg/mL oral suspension – 200 mL bottles (NDC 59676-565-01)
75 mg tablets—bottles of 480 (NDC 59676-563-01)
150 mg tablets—bottles of 240 (NDC 59676-564-01)
600 mg tablets—bottles of 60 (NDC 59676-562-01)
800 mg tablets—bottles of 30 (NDC 59676-566-30)

Storage

PREZISTA Oral Suspension

  • Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F).
  • Do not refrigerate or freeze. Avoid exposure to excessive heat.
  • Store in the original container.
  • Shake well before each usage.

PREZISTA Tablets

  • Store at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F).

Manufactured by: PREZISTA oral suspension, Janssen Pharmaceutica, N.V. Beerse, Belgium. PREZISTA tablets, Janssen Ortho LLC, Gurabo, PR 00778. Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560. Revised: Apr 2014

Last reviewed on RxList: 4/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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