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ISENTRESS is a brand name for Raltegravir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults ISENTRESS® and ISENTRESS HD® (raltegravir) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. 1.1 Pediatrics Pediatrics (2 - 18 years of age and weighing at least 7kg): ISENTRESS® is indicated in combination with…
Verbatim from this product's HC label. Tap a section to expand.
). 2 Geriatrics Geriatrics ( 65 years of age): Clinical studies of ISENTRESS® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from 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.
2 CONTRAINDICATIONS • ISENTRESS® is contraindicated in patients who are hypersensitive to any component of this medicine. For a complete listing of components, see section
). Cases of myopathy and rhabdomyolysis have been reported with raltegravir. A relationship to raltegravir is not clear in a majority of these cases; however there have ISENTRESS® and ISENTRESS HD® (raltegravir potassium) Page 10 of 69 been isolated post-market reports of myopathy and rhabdomyolysis either with an association to raltegravir or where a relationship to raltegravir could not be ruled out.
Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions. 1 Pregnant Women Human Data ISENTRESS has not been studied in pregnant women.
ISENTRESS should not be used in pregnant women unless the potential benefits outweigh the potential risks to the fetus. Prospective reports of 1032 exposures to raltegravir during pregnancy resulting in 967 live births are available from the antiretroviral pregnancy registry (APR).
These reports include 514 first trimester exposures (424 exposures in the periconception period). 7%) following second or third trimester exposure to raltegravir. The rate of miscarriage is not reported in the APR. The background rates of spontaneous abortion and fetal death/stillbirth in the US general population are 15-20% and ~3%, respectively.
The background risk for major birth defects and miscarriage for the indicated population is unknown. S. reference population of the Metropolitan Atlanta Congenital Defects MACDP. Methodological limitations of the APR include the use of MACDP as the external comparator group.
The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. There are limited data on the use of ISENTRESS 1200 mg (2 x 600 mg) once daily in pregnant women.
1 Special Populations 06/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 11 8 ADVERSE REACTIONS ................................................................................................
29 9 DRUG INTERACTIONS ................................................................................................ 36 10 CLINICAL PHARMACOLOGY .......................................................................................
37 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 41 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 41 PART II: SCIENTIFIC INFORMATION .......................................................................................
• ISENTRESS® is contraindicated in patients who are hypersensitive to any component of this medicine. For a complete listing of components, see section 6 DOSAGE FORMS, COMPOSITION AND PACKAGING of the product monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Raltegravir in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Animal Data Developmental toxicity studies were performed in rabbits (at doses up to 1000 mg/kg/day) and rats (at doses up to 600 mg/kg/day). The highest doses in these studies produced systemic exposures in these species approximately 3-to 4-fold above the exposure at the recommended human dose.
No treatment related external, visceral, or skeletal changes were observed in rabbits. 4- fold above the exposure at the recommended human dose). In both rabbits and rats, no treatment related effects on embryonic/fetal survival or fetal weights were observed.
5-fold greater than in maternal plasma at 1 hour and 24 hours postdose, respectively. In rabbits, at a maternal dose of 1000 mg/kg/day, mean drug concentrations in fetal plasma were approximately 2% of the mean maternal concentration at both 1 and 24 hours postdose.
Toxicokinetic studies demonstrated placental transfer of drug in both species. Antiretroviral Pregnancy Registry (APR) To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS®, an International Antiretroviral Pregnancy Registry has been established.
2 Breastfeeding Women It is not known whether raltegravir is secreted in human milk. However, raltegravir is secreted in the milk of lactating rats. In rats, at a maternal dose of 600 mg/kg/day, mean drug concentrations in milk were approximately 3-fold greater than in maternal plasma.
Breast-feeding is not recommended while taking ISENTRESS®. In addition, it is recommended that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV. 1 ADVERSE REACTIONS, Clinical Trial Adverse Reactions - Pediatrics) Safety and effectiveness of ISENTRESS® in children under 2 years 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 4 DOSAGE and ADMINISTRATION and 10 CLINICAL PHARMACOLOGY sections).
Use of once daily dosing regimen 1200 mg (2 x 600 mg) is NOT recommended for pediatric patients below 40 kg. 4 Geriatrics (≥65 years of age) Clinical studies of ISENTRESS® did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from 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. 1 Adverse Reaction Overview The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. […]
42 13 PHARMACEUTICAL INFORMATION ............................................................................ 42 14 CLINICAL TRIALS ........................................................................................................
43 15 MICROBIOLOGY ........................................................................................................ 60 16 NON-CLINICAL TOXICOLOGY .....................................................................................
61 PATIENT MEDICATION INFORMATION […]