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Tabulated Summary of Adverse Reactions: Adverse drug reactions (ADRs) reported in adult patients treated with Edurant are summarised as follows. Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, are included in a footnote as follows. The ADRs are listed by system organ class (SOC) and frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1000 to <1/100). Within each frequency grouping, ADRs are presented in order of decreasing frequency.
Adverse drug reactions reported in antiretroviral treatment-naive HIV-1 infected adult patients treated with Edurant (pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials), N=686: Blood and Lymphatic System: Common: Decreased white blood cell count#, decreased haemoglobin#, decreased platelet count#.
Immune System Disorders: Uncommon: Immune reactivation syndrome.
Metabolism and Nutrition Disorders: Very Common: Increased total cholesterol (fasted)#, increased low density lipoprotein (LDL)-cholesterol (fasted)#. Common: decreased appetite, increased triglycerides (fasted)#,
Psychiatric Dsorders: Very Common: Insomnia*. Common: Abnormal dreams, depression*, sleep disorders, depressed mood.
Nervous System Disorders: Very Common: Headache*, dizziness. Common: Somnolence.
Gastrointestinal Disorders: Very Common: Nausea, increased pancreatic amylase#. Common: Abdominal pain*, vomiting, increased lipase#, abdominal discomfort, dry mouth.
Hepatobiliary Disorders: Very Common: Increased transaminases#. Common: Increased bilirubin.
Skin and Subcutaneous Tissue Disorders: Common: Rash*.
General Disorders and Administration Site Conditions: Common: Fatigue.
N=number of subjects.
*In the week 96 analysis of the Phase III controlled trials ECHO and THRIVE, the most frequently reported adverse drug reactions (ADRs) (≥2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2%).
#Selected treatment emergent clinical laboratory abnormalities (grade 3 or grade 4), considered as ADRs, reported in Edurant-treated patients from the 96 week pooled data from the ECHO and THRIVE trials were increased pancreatic amylase (3.8%), increased AST (2.3%), increased ALT (1.6%), increased LDL cholesterol (fasted, 1.5%), decreased white blood cell count (1.2%), increased lipase (0.9%), increased bilirubin (0.7%), increased triglycerides (fasted, 0.6%), decreased haemoglobin (0.1%), decreased platelet count (0.1%) and increased total cholesterol (fasted, 0.1%).
No new ADR terms were identified in adult patients in the Phase III ECHO and THRIVE trials between 48 weeks and 96 weeks nor in the Phase IIb TMC278-C204 trial through 240 weeks.
Laboratory Abnormalities: In the Edurant arm in the week 96 analysis of the Phase III ECHO and THRIVE trials, mean change from baseline in total cholesterol (fasted) was 5 mg/dL, in high density lipoprotein (HDL)-cholesterol (fasted) 4 mg/dL, in LDL-cholesterol (fasted) 1 mg/dL, and in triglycerides (fasted) -7 mg/dL.
In the pooled Phase III ECHO and THRIVE trials, serum creatinine increased minimally over 96 weeks of treatment with Edurant. Most of this increase occurred within the first 4 weeks of treatment, with a mean change of 0.1 mg/dL (range: -0.3 mg/dL to 0.6 mg/dL) observed overall. In subjects who entered the trials with mild or moderate renal impairment, the serum creatinine increase observed was similar to that seen in subjects with normal renal function. These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate and no subject discontinued treatment due to increases in serum creatinine. Creatinine increases were comparable by background N(t)RTIs.
In the pooled Phase III ECHO and THRIVE trials, at week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.87; -7.39) nmol/L in the Edurant arm and of +0.1 (-12.63; 12.8) nmol/L in the efavirenz arm. At week 96, the mean change from baseline in adrenocorticotropic hormone (ACTH)-stimulated cortisol levels was lower in the Edurant group (+18.4±8.36 nmol/L) than in the efavirenz group (+54.1±7.24 nmol/L). Mean values for both basal and ACTH-stimulated cortisol values at week 96 were within the normal range. These changes in adrenal safety parameters were not clinically relevant. There were no clinical signs or symptoms suggestive of adrenal or gonadal dysfunction in adults.
Description of Selected Adverse Reactions: Lipodystrophy: CART has been associated with redistribution of body fat (lipodystrophy) in HIV infected patients, including loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see Precautions).
Immune Reactivation Syndrome: In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise (immune reactivation syndrome) (see Precautions).
Other Special Populations: Patients Co-Infected with Hepatitis B and/or Hepatitis C Virus: In patients co-infected with hepatitis B or C virus receiving Edurant, the incidence of hepatic enzyme elevation was higher than in patients receiving who were not co-infected. This observation was the same in the efavirenz arm. The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
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