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

CONTRAINDICATIONS

  • Table 1 (new)

WARNINGS AND PRECAUTIONS

  • General
  • Skin Rash
  • Sulfa Allergy
  • Drug Interactions

ADVERSE REACTIONS

  • 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.

DRUG INTERACTIONS

  • 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."

USE IN SPECIFIC POPULATIONS

  • 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)].

NONCLINICAL TOXICOLOGY

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

PATIENT COUNSELING INFORMATION

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

PATIENT PACKAGE INSERT

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

CONTRAINDICATIONS

Table 1: Drugs That Are Contraindicated With Prezista/rtv

WARNINGS AND PRECAUTIONS

General:

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)].

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