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INTELENCE is a brand name for Etravirine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: INTELENCE® (etravirine), in combination with other antiretroviral agents, is indicated for: • the treatment of human immunodeficiency virus type 1 (HIV-1) infection in treatment- experienced adult and pediatric (from 6 to <18 years of age and weighing ≥30 kg) patients who have failed prior therapy and have HIV-1…
Verbatim from this product's HC label. Tap a section to expand.
). The adult indication is based on safety and efficacy data at 48 weeks from two Phase III, double- blinded, placebo-controlled trials in treatment-experienced patients who had a least one NNRTI resistance-associated mutation and multiple primary protease inhibitor mutations (see 14 CLINICAL TRIALS for description of studies).
1 Pediatrics Pediatrics (<6 years of age) The safety and efficacy of Intelence in pediatric patients <6 years of age have not been established. 3 Pharmacokinetics) Pediatrics (from 6 to <18 years of age) Intelence, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced pediatric patients 6 years to <18 years of age and weighing ≥30 kg, including those with NNRTI resistance.
This indication is based on 24-week analyses of a single-arm, on-going Phase II trial evaluating safety, PK, and antiretroviral activity in Intelence in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age.
The results of 48 weeks analysis were similar to those of 24 weeks (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION, and 10 CLINICAL PHARMACOLOGY). 2 Geriatrics Geriatrics (>65 years of age) Clinical studies of Intelence did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
In general, caution should be exercised when administering Intelence in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function, concomitant disease or other drug therapy (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION, and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS • Co-administration of Intelence is contraindicated with the combination ombitasvir/paritaprevir/ritonavir and with drugs containing dasabuvir (see 9 DRUG INTERACTIONS) • Intelence (etravirine) is contraindicated in patients who are hypersensitive to etravirine or to any ingredient in the formulation or component of the container.
For a complete listing, see
, Laboratory Abnormalities). 7% of patients receiving placebo. Immune Immune Reconstitution Immune reconstitution inflammatory syndrome has been reported in patients treated with combination antiretroviral therapy, including Intelence.
During the initial phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (such as MAC, CMV, PCP and TB), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves’ disease, and autoimmune hepatitis, 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 and sometimes there can be an atypical presentation.
2%), a decrease in total body clearance is not expected in patients with renal impairment. No special precautions or dose adjustments are required in patients with renal impairment. As etravirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
Skin Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking Intelence (etravirine). During both clinical development and postmarket, cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and erythema multiforme have been reported.
1%). Hypersensitivity reactions including DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) have also been reported and were characterized by rash, constitutional findings, and infrequently organ dysfunction, including hepatic failure.
Discontinue Intelence immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia).
3 Pharmacokinetics) Pediatrics (from 6 to <18 years of age) Intelence, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced pediatric patients 6 years to <18 years of age and weighing ≥30 kg, including those with NNRTI resistance.
This indication is based on 24-week analyses of a single-arm, on-going Phase II trial evaluating safety, PK, and antiretroviral activity in Intelence in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age.
The results of 48 weeks analysis were similar to those of 24 weeks (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION, and 10 CLINICAL PHARMACOLOGY). 2 Geriatrics Geriatrics (>65 years of age) Clinical studies of Intelence did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
In general, caution should be exercised when administering Intelence in elderly patients, reflecting the greater frequency of decreased hepatic, renal or cardiac function, concomitant disease or other drug therapy (see 7 WARNINGS AND PRECAUTIONS, 4 DOSAGE AND ADMINISTRATION, and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS • Co-administration of Intelence is contraindicated with the combination ombitasvir/paritaprevir/ritonavir and with drugs containing dasabuvir (see 9 DRUG INTERACTIONS) • Intelence (etravirine) is contraindicated in patients who are hypersensitive to etravirine or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations The following points should be considered when initiating therapy with Intelence: • Do not use Intelence with only N[t]RTIs in the setting of previous NNRTI failure.
This is based on an analysis of an exploratory Phase 2 clinical trial in patients who had experienced virologic failure on an NNRTI- and N[t]RTI-containing regimen (See 14 CLINICAL TRIALS for Description of Studies). • The use of other active antiretroviral agents with Intelence is associated with an increased likelihood of treatment response.
• Co-administration of Intelence is contraindicated with the combination ombitasvir/paritaprevir/ritonavir and with drugs containing dasabuvir (see 9 DRUG INTERACTIONS) • Intelence (etravirine) is contraindicated in patients who are hypersensitive to etravirine or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 0 Page 5 of 52
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Clinical status including liver transaminases should be monitored and appropriate therapy initiated. Delay in stopping Intelence treatment after the onset of severe rash may result in a life-threatening reaction. 2% of placebo subjects.
A total of 2% of HIV-1-infected patients receiving Intelence discontinued from Phase III trials due to rash. Most frequently, rash was mild to moderate, occurred in the second week of therapy and was infrequent after week 4. Rash was mostly self-limiting and generally resolved within 1 to 2 weeks on continued therapy.
The incidence of rash was higher in females (see 8 ADVERSE REACTIONS). 1 Pregnant Women There are no adequate and well-controlled studies with etravirine in pregnant women. Studies in animals have not shown evidence of developmental toxicity or effect on reproductive function and fertility (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity).
), was evaluated in combination with other antiretroviral agents in an open- label study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum. Etravirine pharmacokinetic data are available for 13 women in the second trimester, 10 women in the third trimester and 10 women postpartum.
The exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure. 0 Page 10 of 52 for those pregnant patients that require concomitant medications or have comorbidities that may further increase etravirine exposure (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Pregnancy and Postpartum).
There were no relevant clinical findings in the mothers or in the newborns in this trial. Intelence should be used during pregnancy only if the potential benefit justifies the potential risk.
Antiretroviral Pregnancy Registry:
To monitor maternal-fetal outcomes of pregnant women exposed to Intelence, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263. 2 Breast-feeding Etravirine is excreted in human breast milk.
Because of both the potential for HIV transmission and the potential for adverse events in nursing infants, mothers should be instructed not to breast- feed if they are receiving Intelence. 2 lbs), received Intelence in combination with other antiretroviral agents (see 8 ADVERSE REACTIONS).
The safety and effectiveness of Intelence in pediatric patients less than 6 years of age or in treatment-naive patients have not been established. 4 Geriatrics There were insufficient numbers of subjects aged 65 and over in the clinical studies to determine whether they respond differently from younger subjects.
In general, caution […]
• Treatment history and, when available, resistance testing, should guide the use of Intelence. • The safety and efficacy of Intelence have not been established in treatment-naive adult/pediatric patients. • Intelence must always be given in combination with other antiretroviral medicinal products.
• It is recommended that the dosage of Intelence be taken following a meal. The type of food does not affect the exposure to etravirine. 4 Administration). 3 Pharmacokinetics). 3 Pharmacokinetics). ). Intelence tablet(s) should be taken orally, following a meal.
Children (<6 years of age) The safety and efficacy of Intelence in pediatric patients <6 years of age have not yet been established. 3 Pharmacokinetics). Pregnancy No dose adjustment is required during pregnancy and postpartum. Given the increased etravirine exposure during pregnancy, caution should be applied for those pregnant patients that require concomitant medications or have comorbidities that may further increase etravirine exposure.
Hepatic Impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic insufficiency). 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
4 Administration Patients should be instructed to swallow the Intelence tablet(s) whole with a liquid such as water. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water. The patient should be instructed to do the following: • place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medication, • stir well for about 1 minute until the water looks milky, • if desired, add up to 30 mL (2 tablespoons) more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water), • drink it immediately, • rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.
The use of grapefruit juice, warm liquids (>40°C) or carbonated beverages should be avoided. In case of any doubt that a child will take the entire dose of the tablet(s) dispersed in water, treatment with another antiretroviral […]