Isentress HD

Isentress HD Special Precautions

raltegravir

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Severe Skin and Hypersensitivity Reactions: Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking ISENTRESS, in most cases concomitantly with other drugs associated with these reactions. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents 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). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.
Drug Interactions: Antacids: Coadministration of ISENTRESS 400 mg twice daily with aluminum and magnesium antacids resulted in reduced raltegravir plasma levels. Coadministration of ISENTRESS 400 mg twice daily with aluminum and/or magnesium antacids is not recommended (see Interactions).
Coadministration of ISENTRESS 1200 mg (2 x 600 mg) once daily with calcium carbonate and aluminum/magnesium containing antacids resulted in reduced raltegravir plasma levels therefore coadministration is not recommended (see Interactions).
Atazanavir: Coadministration of ISENTRESS 1200 mg (2 x 600 mg) once daily with atazanavir resulted in increased raltegravir plasma levels therefore coadministration is not recommended (see Interactions).
Tipranavir/ritonavir: Coadministration of ISENTRESS 1200 mg (2 x 600 mg) once daily with tipranavir/ritonavir could result in decreased raltegravir trough plasma levels therefore coadministration is not recommended (see Interactions).
Strong inducers of drug metabolizing enzymes: Caution should be used when coadministering ISENTRESS 400 mg twice daily with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e.g., rifampin) due to reduced plasma concentrations of raltegravir. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age (see Interactions).
Strong inducers of drug metabolizing enzymes (e.g., rifampin) have not been studied with ISENTRESS 1200 mg (2 x 600 mg) once daily but could result in decreased raltegravir trough plasma level therefore coadministration with ISENTRESS 1200 mg (2 x 600 mg) once daily is not recommended (see Interactions).
Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including ISENTRESS. During the initial phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, and tuberculosis, or reactivation of varicella zoster virus), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Hepatic impairment The safety and efficacy of raltegravir have not been established in patients with severe underlying liver disorders. Therefore ISENTRESS should be used with caution in patients with severe hepatic impairment. Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination anti-retroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered. Patients with chronic hepatitis B or C and treated with combination anti-retroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse events.
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to combination anti-retroviral therapy. Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Excipients: Lactose: ISENTRESS tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use in Children: The safety, tolerability, pharmacokinetic profile, and efficacy of twice daily ISENTRESS (as 600 mg, 400 mg tablets, chewable tablets and another formulation) were evaluated in HIV-1 infected infants, children and adolescents 4 weeks to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066 (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions). The safety profile was comparable to that observed in adults (see Side Effects). See Dosage & Administration for dosing recommendations for children 2 years of age and older. Safety and effectiveness of ISENTRESS in infants less than 4 weeks of age have not been established.
ISENTRESS 1200 mg (2 X 600 mg) once daily has not been studied in pediatric patients. However, population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg (see Pharmacology under Actions).
Use in the Elderly: Clinical studies of ISENTRESS did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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