PREZISTA (Page 10 of 12)

14.4 Pediatric Patients

The pharmacokinetic profile, safety and antiviral activity of PREZISTA/ritonavir were evaluated in 3 randomized, open-label, multicenter studies.

TMC114-C212

Treatment-experienced pediatric subjects between the ages of 6 and less than 18 years and weighing at least 20 kg were stratified according to their weight (greater than or equal to 20 kg to less than 30 kg, greater than or equal to 30 kg to less than 40 kg, greater than or equal to 40 kg) and received PREZISTA tablets with either ritonavir capsules or oral solution plus background therapy consisting of at least two non-protease inhibitor antiretroviral drugs. Eighty patients were randomized and received at least one dose of PREZISTA/ritonavir. Pediatric subjects who were at risk of discontinuing therapy due to intolerance of ritonavir oral solution (e.g., taste aversion) were allowed to switch to the capsule formulation. Of the 44 pediatric subjects taking ritonavir oral solution, 23 subjects switched to the 100 mg capsule formulation and exceeded the weight-based ritonavir dose without changes in observed safety.

The 80 randomized pediatric subjects had a median age of 14 (range 6 to less than 18 years), and were 71% male, 54% Caucasian, 30% Black, 9% Hispanic and 8% other. The mean baseline plasma HIV-1 RNA was 4.64 log10 copies/mL, and the median baseline CD4+ cell count was 330 cells/mm3 (range: 6 to 1505 cells/mm3). Overall, 38% of pediatric subjects had baseline plasma HIV-1 RNA ≥100,000 copies/mL. Most pediatric subjects (79%) had previous use of at least one NNRTI and 96% of pediatric subjects had previously used at least one PI.

Seventy-seven pediatric subjects (96%) completed the 24-week period. Of the patients who discontinued, one patient discontinued treatment due to an adverse event. An additional 2 patients discontinued for other reasons, one patient due to compliance and another patient due to relocation.

The proportion of pediatric subjects with HIV-1 RNA less than 400 copies/mL and less than 50 copies/mL was 64% and 50%, respectively. The mean increase in CD4+ cell count from baseline was 117 cells/mm3.

TMC114-C228

Treatment-experienced pediatric subjects between the ages of 3 and less than 6 years and weighing greater than or equal to 10 kg to less than 20 kg received PREZISTA oral suspension with ritonavir oral solution plus background therapy consisting of at least two active non-protease inhibitor antiretroviral drugs. Twenty-one subjects received at least one dose of PREZISTA/ritonavir.

The 21 subjects had a median age of 4.4 years (range 3 to less than 6 years), and were 48% male, 57% Black, 29%, Caucasian and 14% other. The mean baseline plasma HIV-1 was 4.34 log10 copies/mL, the median baseline CD4+ cell count was 927 × 106 cells/L (range: 209 to 2,429 × 106 cells/L) and the median baseline CD4+ percentage was 27.7% (range: 15.6% to 51.1%). Overall, 24% of subjects had a baseline plasma HIV-1 RNA greater than or equal to 100,000 copies/mL. All subjects had used greater than or equal to 2 NRTIs, 62% of subjects had used greater than or equal to 1 NNRTI and 76% had previously used at least one HIV PI.

Twenty subjects (95%) completed the 48 week period. One subject prematurely discontinued treatment due to vomiting assessed as related to ritonavir.

The proportion of subjects with HIV-1 RNA less than 50 copies/mL at Week 48 was 71%. The mean increase in CD4+ percentage from baseline was 4%. The mean change in CD4+ cell count from baseline was 187 × 106 cells/L.

TMC114-C230

Treatment-naïve pediatric subjects between the ages of 12 and less than 18 years and weighing at least 40 kg received the adult recommended dose of PREZISTA/ritonavir 800/100 mg once daily plus background therapy consisting of at least two non-protease inhibitor antiretroviral drugs.

The 12 randomized pediatric subjects had a median age of 14.4 years (range 12.6 to 17.3 years), and were 33.3% male, 58.3% Caucasian and 41.7% Black. The mean baseline plasma HIV-1 RNA was 4.72 log10 copies/mL, and the median baseline CD4+ cell count was 282 cells/mm3 (range: 204 to 515 cells/mm3). Overall, 41.7% of pediatric subjects had baseline plasma HIV-1 RNA ≥100,000 copies/mL.

All subjects completed the 48 week treatment period.

The proportion of subjects with HIV-1 RNA less than 50 copies/mL and less than 400 copies/mL was 83.3% and 91.7%, respectively. The mean increase in CD4+ cell count from baseline was 221 × 106 cells/L.

16 HOW SUPPLIED/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 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 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 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 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 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).

Keep PREZISTA out of reach of children.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instruction for Use).

Instructions for Use

Advise patients to take PREZISTA and ritonavir with food every day on a regular dosing schedule, as missed doses can result in development of resistance. PREZISTA must always be used with ritonavir in combination with other antiretroviral drugs. Advise patients not to alter the dose of either PREZISTA or ritonavir, discontinue ritonavir, or discontinue therapy with PREZISTA without consulting their physician [see Dosage and Administration (2)].

Hepatotoxicity

Inform patients that drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA co-administered with 100 mg of ritonavir. Advise patients about the signs and symptoms of liver problems [see Warnings and Precautions (5.2)].

Severe Skin Reactions

Inform patients that skin reactions ranging from mild to severe, including Stevens-Johnson Syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, have been reported with PREZISTA co-administered with 100 mg of ritonavir. Advise patients to discontinue PREZISTA/ritonavir immediately if signs or symptoms of severe skin reactions develop. These can include but are not limited to severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia [see Warnings and Precautions (5.3)].

Drug Interactions

PREZISTA/ritonavir may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort [see Contraindications (4), Warnings and Precautions (5.4, 5.5) and Drug Interactions (7)].

Contraception

Instruct patients receiving combined hormonal contraception or the progestin only pill to use an effective alternative (non-hormonal) contraceptive method or add a barrier method during therapy with PREZISTA/ritonavir because hormonal levels may decrease [see Drug Interactions (7.3) and Use in Specific Populations (8.3)].

Fat Redistribution

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZISTA/ritonavir, and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.7)].

Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.8)].

Pregnancy Registry

Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to PREZISTA [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].

Product of Ireland

Manufactured by:
PREZISTA oral suspension
Janssen Pharmaceutica, NV
Beerse, Belgium

PREZISTA tablets
Janssen Ortho LLC
Gurabo
PR 00778

Or

Janssen Cilag SpA
Latina
IT

Manufactured for:
Janssen Therapeutics
Division of Janssen Products, LPTitusville NJ 08560

PREZISTA® is a registered trademark of Janssen Pharmaceuticals.

© 2006 Janssen Pharmaceutical Companies

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2019
PATIENT INFORMATION
PREZISTA ® (pre-ZIS-ta) (darunavir)oral suspension PREZISTA ® (pre-ZIS-ta) (darunavir)tablet
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 healthcare provider about your medical condition or your treatment.Also read the Patient Information leaflet for ritonavir.
What is the most important information I should know about PREZISTA?
  • Ask your healthcare provider or pharmacist about medicines that should not be taken with PREZISTA. For more information, see “Who should not take PREZISTA?” and “What should I tell my healthcare provider before taking PREZISTA?
  • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with ritonavir have developed liver problems, which may be life-threatening. Your healthcare provider should do blood tests before and during your PREZISTA and ritonavir combination treatment. 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. Tell your healthcare provider if you have any of the below signs and symptoms of 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
  • tiredness
  • 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. Tell your healthcare provider right away if you develop a rash. Stop taking PREZISTA and ritonavir combination treatment and tell your healthcare provider right away if you have 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 people 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 HIV-1 (Human Immunodeficiency Virus-type 1) medicine used with ritonavir and other antiretroviral medicines to treat HIV-1 infection in adults and children 3 years of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).PREZISTA should not be used in children under 3 years of age.When used with other antiretroviral medicines to treat HIV-1 infection, PREZISTA may help:
  • reduce the amount of HIV-1 in your blood. This is called “viral load”.
  • increase the number of CD4+ (T) cells in your blood that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).PREZISTA does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.Avoid doing things that can spread HIV-1 infection to others:

  • Do not share or re-use needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

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

Who should not take PREZISTA?Do not take PREZISTA with any medicine that contains:
  • alfuzosin
  • cisapride
  • colchicine, if you have liver or kidney problems
  • dronedarone
  • elbasvir and grazoprevir
  • ergot-containing medicines:
    • dihydroergotamine
    • ergotamine tartrate
    • methylergonovine
  • ivabradine
  • lomitapide
  • lovastatin
  • lurasidone
  • midazolam, when taken by mouth
  • naloxegol
  • pimozide
  • ranolazine
  • rifampin
  • sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
  • simvastatin
  • St. John’s wort (Hypericum perforatum)
  • triazolam

Serious problems can happen if you or your child take any of these medicines with PREZISTA.

What should I tell my healthcare provider before taking PREZISTA?Before taking PREZISTA, tell your healthcare provider if you:
  • have liver problems, including hepatitis B or hepatitis C
  • are allergic to sulfa medicines
  • have high blood sugar (diabetes)
  • have hemophilia
  • have any other medical conditions
  • are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant while taking PREZISTA.
    • Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take PREZISTA.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if PREZISTA can pass into your breast milk.
    • Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZISTA. Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with PREZISTA.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take PREZISTA with other medicines.
How should I take PREZISTA?
  • Take PREZISTA exactly as your healthcare provider tells you.
  • You must take ritonavir at the same time as PREZISTA.
  • Do not change your dose or stop treatment with PREZISTA without talking to your healthcare provider.
  • Take PREZISTA and ritonavir with food.
  • If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your healthcare provider will help decide whether PREZISTA tablets or oral suspension is right for you.
  • 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 much PREZISTA (tablets or oral suspension) and how much ritonavir (capsules, tablets or solution) your child should take. Your child should take PREZISTA with ritonavir with food. If your child does not tolerate ritonavir oral solution, ask your child’s healthcare provider for advice.
  • PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the “Instructions for Use” that come with PREZISTA oral suspension for information about the right way to prepare and take a dose.
  • It is important that you do not miss or skip doses of PREZISTA during treatment.
  • If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of PREZISTA?PREZISTA may cause serious side effects, including:
  • See “What is the most important information I should know about PREZISTA?
  • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA.
  • Changes in body fat can happen in people who take HIV-1 medicines. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.
  • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA.

The most common side effects of PREZISTA include:

  • diarrhea
  • nausea
  • rash
  • headache
  • stomach-area (abdominal) pain
  • vomiting
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.These are not all of the possible side effects of PREZISTA.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store PREZISTA?
  • Store PREZISTA oral suspension and tablets at room temperature 77°F (25°C).
  • Do not refrigerate or freeze PREZISTA oral suspension.
  • Keep PREZISTA oral suspension away from high heat.
  • PREZISTA oral suspension should be stored in the original container.

Keep PREZISTA and all medicines out of the reach of children.

General information about the safe and effective use of PREZISTA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them.This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. For more information, call 1-800-526-7736.
What are the ingredients in PREZISTA? Active ingredient: darunavirInactive ingredients:PREZISTA oral suspension: citric acid monohydrate, hydrochloric acid (for pH adjustment), hydroxypropyl cellulose, masking flavor, methylparaben sodium, microcrystalline cellulose, purified water, sodium carboxymethylcellulose, strawberry cream flavor, and sucralose.PREZISTA 75 mg and 150 mg tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).PREZISTA 600 mg tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).PREZISTA 800 mg tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).Product of IrelandManufactured by: PREZISTA oral suspension, Janssen Pharmaceutica NV, Beerse, Belgium PREZISTA tablets, Janssen Ortho LLC, Gurabo, PR 00778 or Janssen Cilag SpA, Latina, ITManufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560PREZISTA® is a registered trademark of Janssen Pharmaceuticals© 2006 Janssen Pharmaceutical Companies

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