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Label Changes for:

Prezista (darunavir) Tablets

October 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008
The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Table 1 (new)


  • General
  • Skin Rash
  • Sulfa Allergy
  • Drug Interactions


  • Initial Section
  • Antiretroviral Treatment-Na├»ve Adult Subjects
    • Study TMC114-C211
      • Table 2
    • Laboratory Abnormalities
      • Table 3
  • Antiretroviral Treatment-Experienced Adult Subjects
    • Study TMC114-C214
      • Table 4
    • Laboratory Abnormalities
      • Table 5
  • Postmarketing Experience (new subsection)
    • ...Rarely, events of hypersensitivity (including facial edema), and rhabdomyolysis (associated with co-administration with HMG-CoA reductase inhibitors and Prezista) have been reported.


  • Potential for Prezista/rtv to Affect Other Drugs (new)
  • Potential for Other Drugs to Affect Darunavir (new)
  • Table 6 (updated)
  • The following language was added after Table 6: "In addition to the drugs included in Table 6, the interaction between Prezista/rtv and the following drugs were evaluated in clinical studies and no dose adjustments are needed for either drug [see Clinical Pharmacology (12.3)]: atazanavir, efavirenz, etravirine, nevirapine, omeprazole, ranitidine, and tenofovir disoproxil fumarate."


  • Pregnancy
    • Pregnancy Category C (new)
    • Prezista should be used during pregnancy only if the potential benefit justifies the potential risk.
    • In the juvenile toxicity study where rats were directly dosed with darunavir, deaths occurred from post-natal day 5 through 11...
  • Pediatric Use
    • Prezista/rtv should not be used in pediatric patients below 3 years of age in view of toxicity and mortality observed in juvenile rats dosed with darunavir (from 20 mg/kg to 1000 mg/kg) up to days 23 to 26 of age [see Use in Specific Populations (8.1), Clinical Pharmacology (12.3) and Nonclinical Toxicology (13.2)].


  • Carcinogenesis, Mutagenesis, and Impairment of Fertility
    • Carcinogenesis and Mutagenesis


  • Instructions for Use
    • Patients Taking 800 mg of Prezista Once Daily (new)


  • What is the most important information I should know about Prezista?
  • How should I take Prezista?
  • What are the possible side effects of Prezista?


Table 1: Drugs That Are Contraindicated With Prezista/rtv



Prezista must be co-administered with ritonavir and food to achieve the desired antiviral effect. Failure to administer Prezista with ritonavir and food may result in a loss of efficacy of darunavir.

Skin Rash:

In clinical trials (n=3063), rash (all grades, regardless of causality) occurred in 10.3% of subjects treated with Prezista [also see Adverse Reactions (6)]. Rash was mostly mild-to-moderate, often occurring within the first four weeks of treatment and resolving with continued dosing. The discontinuation rate due to rash in subjects using Prezista/rtv was 0.5%.

Severe skin rash, accompanied by fever and/or elevations of transaminases in some cases, has been reported in 0.4% of subjects. Stevens-Johnson Syndrome has been rarely (<0.1%) reported. Treatment with Prezista should be discontinued if severe rash develops.

Sulfa Allergy:

The following sentence was added:

"In clinical studies with Prezista/rtv, the incidence and severity of rash was similar in subjects with or without a history of sulfonamide allergy."

Drug Interactions:

See Table 1 for a listing of drugs that are contraindicated for use with Prezista/rtv due to potentially lifethreatening adverse events, significant drug-drug interactions, or loss of therapeutic effect to Prezista [see Contraindications (4)]. Please refer to Table 6 for established and other potentially significant drug-drug interactions [see Drug Interactions (7.3)].