July 29, 2016
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Prezista

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Prezista




Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Testing Prior To Initiation Of PREZISTA/ritonavir

In treatment-experienced patients, treatment history, genotypic and/or phenotypic testing is recommended to assess drug susceptibility of the HIV-1 virus [see Microbiology]. Refer to Dosage and Administration (2.3), (2.4) and (2.5) for dosing recommendations.

Appropriate laboratory testing such as serum liver biochemistries should be conducted prior to initiating therapy with PREZISTA/ritonavir [see WARNINGS AND PRECAUTIONS].

Monitoring During Treatment With PREZISTA/ritonavir

Patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases should be monitored for elevation in serum liver biochemistries, especially during the first several months of PREZISTA/ritonavir treatment [see WARNINGS AND PRECAUTIONS].

Recommended Dosage In 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 per 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 or capsule or 1.25 mL of a 80 mg per mL ritonavir oral solution) once daily and with food. An 8 mL PREZISTA dose should be taken as two 4 mL administrations with the included oral dosing syringe.

Treatment-Experienced Adult Patients

The recommended oral dosage for treatment-experienced adult patients is summarized in Table 1.

Baseline genotypic testing is recommended for dose selection. However, when genotypic testing is not feasible, PREZISTA 600 mg taken with ritonavir 100 mg twice daily is recommended.

Table 1: Recommended PREZISTA/ritonavir Dosage in Treatment-Experienced Adult Patients

Baseline Resistance Formulation and Recommended Dosing
PREZISTA tablets with ritonavir tablets or capsule PREZISTA oral suspension (100 mg/mL) with ritonavir oral solution (80 mg/mL)
With no darunavir resistance associated substitutions* One 800 mg PREZISTA tablet with one 100 mg ritonavir tablet/capsule, taken once daily with food 8 mL† PREZISTA oral suspension with 1.25 mL ritonavir oral solution, taken once daily with food
With at least one darunavir resistance associated substitutions*, or with no baseline resistance information One 600 mg PREZISTA tablet with one 100 mg ritonavir tablet/capsule, taken twice daily with food 6 mL PREZISTA oral suspension with 1.25 mL ritonavir oral solution, taken twice daily 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

Recommended Dosage During Pregnancy

The recommended dosage in pregnant patients is PREZISTA 600 mg taken with ritonavir 100 mg twice daily with food.

PREZISTA 800 mg taken with ritonavir 100 mg once daily should only be considered in certain pregnant patients who are already on a stable PREZISTA 800 mg with ritonavir 100 mg once daily regimen prior to pregnancy, are virologically suppressed (HIV-1 RNA less than 50 copies per mL), and in whom a change to twice daily PREZISTA 600 mg with ritonavir 100 mg may compromise tolerability or compliance.

Recommended Dosage In 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 pediatric clinical trial data and population pharmacokinetic modeling and simulation [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

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 mL or 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.

The use of PREZISTA/ritonavir in pediatric patients below 3 years of age is not recommended [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Not Recommended In Patients With Severe Hepatic Impairment

No dosage 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 Oral Suspension

PREZISTA 100 mg per mL 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 Tablets
  • 75 mg: white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir. Each tablet is debossed with “75” on one side and “TMC” on the other side.
  • 150 mg: white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir. Each tablet is debossed with “150” on one side and “TMC” on the other side.
  • 600 mg: orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir. Each tablet is debossed with “600MG” on one side and “TMC” on the other side.
  • 800 mg: dark red, oval-shape, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir. Each tablet is debossed with “800” on one side and “T” on the other side.

Storage And Handling

PREZISTA (darunavir) 100 mg per 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: Janssen Pharmaceutica, N.V. Beerse, Belgium. Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/30/2016

Indications
Dosage
How Supplied

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