section name header

Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

Based on concurrent use with ritonavir

Derm: acute generalized exanthematous pustulosis, rash, DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

Endo: Graves’ disease, hyperglycemia

GI: autoimmune hepatitis, constipation, diarrhea, HEPATOTOXICITY, nausea, vomiting

Metab: body fat redistribution

MS: polymyositis

Neuro: Guillan-Barré syndrome

Misc: immune reconstitution syndrome

Interactions

Drug-drug:

Drug-Natural Products:

Availability

(Generic available)

Route/Dosage

US Brand Names

Prezista

Action

  • Inhibits HIV-1 protease, selectively inhibiting the cleavage of HIV-encoded specific polyproteins in infected cells. This prevents the formation of mature virus particles.
Therapeutic effects:
  • Increased CD4 cell counts and decreased viral load with subsequent slowed progression of HIV infection and its sequelae.

Classifications

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: protease inhibitors

Pharmacokinetics

Absorption: Without ritonavir: 37% absorbed following oral administration; with ritonavir: 82%. Food absorption by 30%.

Distribution: Unknown.

Protein Binding: 95%.

Metabolism/Excretion: Extensively metabolized by the CYP3A isoenzymes. 41% eliminated unchanged in feces, 8% in urine.

Half-Life: 15 hr.

Time/Action Profile

ROUTEONSETPEAKDURATION
POunknown2.5–4 hr12 hr

Patient/Family Teaching

  • Emphasize the importance of taking darunavir with ritonavir exactly as directed, at evenly spaced times throughout day. Do not take more than prescribed amount and do not stop taking without consulting health care professional. If a dose of darunavir or ritonavir is missed by more than 6 hr, wait and take next dose at regularly scheduled time. If missed by less than 6 hr, take darunavir and ritonavir immediately and then take next dose at regularly scheduled time. If a dose is skipped, do not double doses. Advise patient to read the Patient Information sheet before starting therapy and with each Rx renewal in case changes have been made.
  • Instruct patient that darunavir should not be shared with others.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially St. John’s wort.
  • Inform patient that darunavir does not cure AIDS or prevent associated or opportunistic infections. Darunavir may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom during sexual contact and to avoid sharing needles or donating blood to prevent spreading HIV to others. Advise patient that the long-term effects of darunavir are unknown at this time.
  • Inform patient that darunavir may cause hyperglycemia, hepatotoxicity, and severe skin reactions. Advise patient to notify health care professional promptly if signs of hyperglycemia (increased thirst or hunger; unexplained weight loss; increased urination; fatigue; or dry, itchy skin), hepatotoxicity (unexplained fatigue, anorexia, nausea, jaundice, abdominal pain, or dark urine), DRESS, or rash occur.
  • Advise patient to notify health care professional if signs and symptoms of immune reconstitution syndrome (signs and symptoms of an infection) occur.
  • Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
  • Rep: Instruct females of reproductive potential using hormonal contraceptives to use an alternative nonhormonal method of contraception. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding. If pregnant patient is exposed to darunavir, register patient in Antiretroviral Pregnancy Registry by calling 1-800-258-4263 to monitor pregnancy outcomes.
  • Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Pronunciation

da-RU-na-veer

Code

NDC Code