Important Safety Information
Warnings & Precautions
- Severe Skin and Hypersensitivity Reactions:
- Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme
- Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure
In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE. Rash occurred most commonly during the first 6 weeks of therapy
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, angioedema) - Monitor clinical status including liver transaminases, and initiate appropriate therapy
- Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction
- Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
- Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE
- Hepatic Impairment: INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients
- Pregnancy Category B: INTELENCE should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women
- The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in patients taking INTELENCE and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%)
- INTELENCE should not be coadministered with the following ARVs: atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without low-dose ritonavir, and other NNRTIs
- INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum)
- Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE as it may alter the therapeutic effect or adverse reaction profile of INTELENCE or the coadministered drug(s)
This is not a complete list of potential drug interactions
Please see the full Prescribing Information in PDF format for more details.
Indication
INTELENCE, in combination with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in ARV treatment–experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs.
This indication is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, 3-class ARV (NNRTI, N(t)RTI, protease inhibitor [PI]) treatment-experienced adults.
The following points should be considered when initiating therapy with INTELENCE:
- Treatment history and, when available, resistance testing, should guide the use of INTELENCE
- The use of other active ARVs with INTELENCE is associated with an increased likelihood of treatment response
- In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N(t)RTIs
- The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naïve adult patients
Warnings & Precautions
- Severe Skin and Hypersensitivity Reactions:
- Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking INTELENCE. These include cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme
- Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure
In the DUET studies, Grade 3 and 4 rashes were reported in 1.3% of patients receiving INTELENCE compared to 0.2% of patients in the placebo arm. Discontinuation rate due to rash was 2.2% in patients taking INTELENCE. Rash occurred most commonly during the first 6 weeks of therapy
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, angioedema) - Monitor clinical status including liver transaminases, and initiate appropriate therapy
- Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction
- Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
- Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy, including INTELENCE
- Hepatic Impairment: INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients
- Pregnancy Category B: INTELENCE should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women
- The most common adverse drug reactions (≥2%) of at least moderate intensity (≥Grade 2) reported in patients taking INTELENCE and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%)
- INTELENCE should not be coadministered with the following ARVs: atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without low-dose ritonavir, and other NNRTIs
- INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum)
- Caution should be used when prescribing agents such as substrates, inhibitors, or inducers of CYP3A, CYP2C9, CYP2C19, and/or P-glycoprotein in patients receiving INTELENCE as it may alter the therapeutic effect or adverse reaction profile of INTELENCE or the coadministered drug(s)
This is not a complete list of potential drug interactions
© Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P. 2010. All rights reserved.
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Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., which is solely responsible for its contents.
The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.
This information is intended for the use of our customers, patients, and healthcare professionals in the United States only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States.
INTELENCE is a trademark of Tibotec Pharmaceuticals, Ltd.
This site was last updated on: March 10 2010 at 8:40 EDT.