SUSTIVA (Page 3 of 10)

5.10 Lipid Elevations

Treatment with SUSTIVA has resulted in increases in the concentration of total cholesterol and triglycerides [see Adverse Reactions (6.1) ]. Cholesterol and triglyceride testing should be performed before initiating SUSTIVA therapy and at periodic intervals during therapy.

5.11 Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including SUSTIVA. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

5.12 Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

6 ADVERSE REACTIONS

The most significant adverse reactions observed in patients treated with SUSTIVA are:

  • psychiatric symptoms [see Warnings and Precautions (5.4) ],
  • nervous system symptoms [see Warnings and Precautions (5.5) ],
  • rash [see Warnings and Precautions (5.7) ].

The most common (>5% in either efavirenz treatment group) adverse reactions of at least moderate severity among patients in Study 006 treated with SUSTIVA in combination with zidovudine/lamivudine or indinavir were rash, dizziness, nausea, headache, fatigue, insomnia, and vomiting.

6.1 Clinical Trials Experience in Adults

Because clinical studies are conducted under widely varying conditions, the adverse reaction rates reported cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.

Selected clinical adverse reactions of moderate or severe intensity observed in ≥2% of SUSTIVA-treated patients in two controlled clinical trials are presented in Table 3.

Table 3: Selected Treatment-Emergenta Adverse Reactions of Moderate or Severe Intensity Reported in ≥2% of SUSTIVA-Treated Patients in Studies 006 and ACTG 364
Study 006 LAM-, NNRTI-, and Protease Inhibitor-Naive Patients Study ACTG 364 NRTI-experienced, NNRTI-, and Protease Inhibitor-Naive Patients
Adverse Reactions SUSTIVAb +ZDV/LAM(n=412) SUSTIVAb +Indinavir(n=415) Indinavir+ZDV/LAM(n=401) SUSTIVAb + Nelfinavir+ NRTIs (n=64) SUSTIVAb + NRTIs(n=65) Nelfinavir+NRTIs(n=66)
180 weeksc 102 weeksc 76 weeksc 71.1 weeksc 70.9 weeksc 62.7 weeksc
a Includes adverse events at least possibly related to study drug or of unknown relationship for Study 006. Includes all adverse events regardless of relationship to study drug for Study ACTG 364.
b SUSTIVA provided as 600 mg once daily.
c Median duration of treatment.
d Includes erythema multiforme, rash, rash erythematous, rash follicular, rash maculopapular, rash petechial, rash pustular, and urticaria for Study 006 and macules, papules, rash, erythema, redness, inflammation, allergic rash, urticaria, welts, hives, itchy, and pruritus for ACTG 364.
— = Not Specified.
ZDV = zidovudine, LAM = lamivudine.
Body as a Whole
Fatigue 8% 5% 9% 0 2% 3%
Pain 1% 2% 8% 13% 6% 17%
Central and Peripheral Nervous System
Dizziness 9% 9% 2% 2% 6% 6%
Headache 8% 5% 3% 5% 2% 3%
Insomnia 7% 7% 2% 0 0 2%
Concentration impaired 5% 3% <1% 0 0 0
Abnormal dreams 3% 1% 0
Somnolence 2% 2% <1% 0 0 0
Anorexia 1% <1% <1% 0 2% 2%
Gastrointestinal
Nausea 10% 6% 24% 3% 2% 2%
Vomiting 6% 3% 14%
Diarrhea 3% 5% 6% 14% 3% 9%
Dyspepsia 4% 4% 6% 0 0 2%
Abdominal pain 2% 2% 5% 3% 3% 3%
Psychiatric
Anxiety 2% 4% <1%
Depression 5% 4% <1% 3% 0 5%
Nervousness 2% 2% 0 2% 0 2%
Skin & Appendages
Rashd 11% 16% 5% 9% 5% 9%
Pruritus <1% 1% 1% 9% 5% 9%

Pancreatitis has been reported, although a causal relationship with efavirenz has not been established. Asymptomatic increases in serum amylase levels were observed in a significantly higher number of patients treated with efavirenz 600 mg than in control patients (see Laboratory Abnormalities).

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