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APTIVUS®(十)
2013-10-23 21:00:58 来源: 作者: 【大 中 小】 浏览:20247次 评论:0条
mnia		 1.7% (1.7) 3.7% (5.5)
Respiratory, Thoracic and Mediastinal Disorders
   Dyspnea 2.1% (2.1) 1.0% (1.4)
Skin and Subcutaneous Tissue Disorders
   Rash 3.1% (3.1) 3.8% (5.7)

Less Common Adverse Reactions
Other adverse reactions reported in <2% of adult patients (n=1474) treated with APTIVUS/ritonavir 500/200 mg in Phase 2 and 3 clinical trials are listed below by body system:

Blood and Lymphatic System Disorders: thrombocytopenia

Gastrointestinal Disorders: abdominal distension, dyspepsia, flatulence, gastroesophageal reflux disease, pancreatitis

General Disorders: influenza-like illness, malaise

Hepatobiliary Disorders: hepatitis, hepatic failure, hyperbilirubinemia, cytolytic hepatitis, toxic hepatitis, hepatic steatosis

Immune System Disorders: hypersensitivity

Investigations: hepatic enzymes increased, liver function test abnormal, lipase increased

Metabolism and Nutrition Disorders: anorexia, decreased appetite, diabetes mellitus, facial wasting, hyperamylasemia, hypercholesterolemia, hyperglycemia, mitochondrial toxicity

Musculoskeletal and Connective Tissue Disorders: muscle cramp

Nervous System Disorders: dizziness, intracranial hemorrhage, somnolence

Psychiatric Disorders: sleep disorder

Renal and Urinary Disorders: renal insufficiency

Skin and Subcutaneous System Disorders: exanthem, lipoatrophy, lipodystrophy acquired, lipohypertrophy, pruritus


Laboratory Abnormalities
Treatment-emergent laboratory abnormalities reported at 48 weeks in the controlled clinical trials 1182.12 and 1182.48 in adults are summarized in Table 3 below.

 

Table 3      Treatment-Emergent Laboratory Abnormalities Reported in ≥2% of Adult Patients (48-week Analyses)
    Randomized, Controlled Clinical Trials 1182.12 and 1182.48
    Percentage of Patients (rate per 100 patient-exposure years)
  Limit APTIVUS/ritonavir (500/200 mg BID) + OBR
(n=738)		 Comparator PI/ritonavir + OBR*
(n=724)
* Comparator PI/ritonavir: lopinavir/ritonavir 400/100 mg BID, indinavir/ritonavir 800/100 mg BID, saquinavir/ritonavir 1000/100 mg BID, amprenavir/ritonavir 600/100 mg BID
Hematology
   WBC count decrease
   Grade 3		 <2.0 x 103/μL 5.4% (5.6) 4.8% (7.7)
   Grade 4 <1.0 x 103/μL 0.3% (0.3) 1.1% (1.7)
Chemistry
   Amylase
   Grade 3		 >2.5 x ULN 5.7% (5.9) 6.4% (10.4)
   Grade 4 >5 x ULN 0.3% (0.3) 0.7% (1.1)
 
   ALT
 
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