United States - English - NLM (National Library of Medicine)

merck sharp & dohme llc - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital d

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 651.6 mg (equivalent: raltegravir, qty 600 mg) - tablet, film coated - excipient ingredients: hypromellose; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; carnauba wax; titanium dioxide; lactose monohydrate; triacetin; iron oxide yellow; iron oxide black - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 434.4 mg (equivalent: raltegravir, qty 400 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; calcium hydrogen phosphate; hypromellose; poloxamer; sodium stearylfumarate; magnesium stearate; butylated hydroxytoluene; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; iron oxide black; macrogol 3350 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 108.6 mg (equivalent: raltegravir, qty 100 mg) - tablet, chewable - excipient ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; iron oxide red; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; flavour; hypromellose; macrogol 400 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - raltegravir potassium, quantity: 27.16 mg (equivalent: raltegravir, qty 25 mg) - tablet, chewable - excipient ingredients: hyprolose; sucralose; saccharin sodium; sodium citrate dihydrate; mannitol; sodium stearylfumarate; magnesium stearate; iron oxide yellow; crospovidone; purified water; strong ammonia solution; ethylcellulose; oleic acid; medium chain triglycerides; sorbitol; ammonium glycyrrhizinate; fructose; flavour; hypromellose; macrogol 400 - isentress or isentress hd, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection in adults, adolescents and children from the age of 2 years.,this indication is based on analyses of plasma hiv-1 rna levels in controlled studies of isentress (see section 5.1).,the indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of isentress through at least 24 weeks in a multicentre, open label, noncomparative study in hiv-1 infected, treatment-experienced children and adolescents 2 to 18 years of age.,the use of other active antiretroviral agents in combination with isentress is associated with a greater likelihood of treatment response (see section 5.1).,there are no study results demonstrating the effect of isentress on clinical progression of hiv-1 infection.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg

United States - English - NLM (National Library of Medicine)

avera mckennan hospital - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - isentress1 is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. this indication is based on analyses of plasma hiv-1 rna levels up through 48 weeks in three double-blind controlled studies of isentress. two of these studies were conducted in clinically advanced, 3-class antiretroviral (nnrti, nrti, pi) treatment-experienced adults and one was conducted in treatment-naïve adults. the use of other active agents with isentress is associated with a greater likelihood of treatment response [see clinical studies (14)] . the safety and efficacy of isentress have not been established in pediatric patients. registered trademark of merck & co., inc. copyright © 2007, 2009 merck & co., inc. all rights reserved none pregnancy category c isentress should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no adequate and well-controlled studies in pregnant women. in addi

United States - English - NLM (National Library of Medicine)

a-s medication solutions - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 2 kg. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) (see data) . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk for major birth defects and miscarriage for the indicated population is unknown. 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 (see data) . in animal reproduction studies in rats and rabbits, no evidence of adverse developmental outcomes was observed with oral administration of raltegravir during organogenesis at doses that produced exposures up to approximately 4 times the maximum recommended human dose (mrhd) of 1200 mg (see data) . data human data based on prospective reports from the apr of over 850 exposures to raltegravir during pregnancy resulting in live births (including over 450 exposures in the first trimester), there was no difference between the overall risk of birth defects for raltegravir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of defects in live births was 3.1% (95% ci: 1.7% to 5.1%) following first trimester exposure to raltegravir-containing regimens and 3.7% (95% ci: 2.1% to 6.0%) following second and third trimester exposure to raltegravir-containing regimens. there are limited data on the use of isentress 1200 mg (2 x 600 mg) once daily in pregnant women. animal data in a combined embryo/fetal and pre/postnatal development study, raltegravir was administered orally to rats at doses of 100, 300, 600 mg/kg/day on gestation day 6 to 20 or from gestation day 6 to lactation day 20. no effects on pre/postnatal development were observed up to the highest dose tested. embryo-fetal findings were limited to an increase in the incidence of supernumerary ribs in the 600 mg/kg/day group. systemic exposure (auc) at 600 mg/kg/day was approximately 3 times higher than exposure at the mrhd of 1200 mg. in pregnant rabbits, raltegravir was administered orally at doses of 100, 500, or 1000 mg/kg/day during the gestation days 7 to 20. no embryo/fetal effects were noted up to the highest dose of 1000 mg/kg/day. systemic exposure (auc) at 1000 mg/kg/day was approximately 4 times higher than exposures at the mrhd of 1200 mg. in both species, raltegravir has been shown to cross the placenta, with fetal plasma concentrations observed in rats approximately 1.5 to 2.5 times greater than in maternal plasma and fetal plasma concentrations in rabbits approximately 2% that of maternal concentrations on gestation day 20. risk summary the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. there are no data on the presence of raltegravir in human milk, the effects on the breastfed infant, or the effects on milk production. when administered to lactating rats, raltegravir was present in milk (see data). because of the potential for: 1) hiv transmission (in hiv-negative infants), 2) developing viral resistance (in hiv-positive infants), and 3) adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving isentress/isentress hd. data raltegravir was excreted into the milk of lactating rats following oral administration (600 mg/kg/day) from gestation day 6 to lactation day 14, with milk concentrations approximately 3 times that of maternal plasma concentrations observed 2 hours postdose on lactation day 14. isentress hiv-1 infected children the safety, tolerability, pharmacokinetic profile, and efficacy of twice daily isentress 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 dosage and administration (2.3), clinical pharmacology (12.3) and clinical studies (14.4)] . the safety profile was comparable to that observed in adults [see adverse reactions (6.1)] . hiv-1 exposed neonates the safety and pharmacokinetics of isentress for oral suspension were evaluated in 42 full-term hiv-1 exposed neonates at high risk of acquiring hiv-1 infection in a phase 1, open-label, multicenter clinical study, impaact p1110. cohort 1 neonates received 2 single doses of isentress for oral suspension: the first within 48 hours of birth and the second at 7 to 10 days of age. cohort 2 neonates received daily dosing of isentress for oral suspension for 6 weeks: 1.5 mg/kg once daily starting within 48 hours of birth through day 7 (week 1); 3 mg/kg twice daily on days 8 to 28 of age (weeks 2 to 4); and 6 mg/kg twice daily on days 29 to 42 of age (weeks 5 and 6). sixteen neonates were enrolled in cohort 1 (10 were exposed and 6 were unexposed to raltegravir in utero ) and 26 in cohort 2 (all unexposed to raltegravir in utero ); all infants received a standard of care antiretroviral drug regimen for prevention of mother to child transmission. all enrolled neonates were followed for safety for a duration of 24 weeks. the 42 infants were 52% male, 69% black and 12% caucasian. hiv-1 status was assessed by nucleic acid test at birth, week 6 and week 24; all patients were hiv-1 negative at completion of the study. the safety profile was comparable to that observed in adults [see adverse reactions (6.1)] . isentress is not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. isentress hd isentress hd once daily has not been studied in pediatric patients. however population pk modeling and simulation support the use of 1200 mg (2 × 600 mg) once daily in pediatric patients weighing at least 40 kg [see clinical pharmacology (12.3)] . clinical studies of isentress/isentress hd did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. 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. no dosage adjustment of isentress is necessary for patients with mild to moderate (child-pugh a and b) hepatic impairment. no hepatic impairment study has been conducted with isentress hd and therefore administration in subjects with hepatic impairment is not recommended. the effect of severe hepatic impairment on the pharmacokinetics of raltegravir has not been studied [see clinical pharmacology (12.3)] . no dosage adjustment of isentress or isentress hd is necessary in patients with any degree of renal impairment [see clinical pharmacology (12.3)]. the extent to which isentress may be dialyzable is unknown; therefore, dosing before a dialysis session should be avoided. bring this booklet to your child's appointments. isentress (raltegravir) for oral suspension instructions for use for babies and toddlers before you start - be sure you understand these instructions before you start. call your doctor if you have any questions. - it is very important that you measure the water and isentress carefully using the correct syringe. - before you give isentress to your child, check the expiration date. the expiration date is printed on the box and the isentress packets. - do not open the isentress packets until you are ready to mix a dose. - the amount of isentress depends on your child's age and weight, so it will change over time. your doctor will tell you the right dose at each check-up after weighing your child. be sure to keep your doctor's appointments so you get new dosing information as your child grows. during your child's first week of life, you will give isentress 1 time a day. after the first week of life, you will give it 2 times a day. - this booklet tells you how to: mix isentress into a liquid form measure the right dose using a syringe give mixed isentress to your child clean up - mix isentress into a liquid form - measure the right dose using a syringe - give mixed isentress to your child - clean up kit contents - prescription (on box) - 2 mixing cups - instructions for use (this booklet) - prescribing information - 6 syringes - 60 packets of isentress the kit has an extra cup and set of syringes in case one is lost or damaged. do not use any damaged cups or syringes. step 1. get ready - put your child in a safe place. you will need both hands to prepare isentress. - wash your hands with soap and water. - take out what you need from the kit as shown below to make 1 dose and place on a clean surface: step 2. fill a clean glass with water step 3. fill the blue syringe with water step 4. check for air bubbles step 5. add the 10ml of water to the mixing cup add the 10 ml of water from the syringe to the mixing cup by pushing all the way down on the plunger. step 6. add isentress to the mixing cup step 7. mix isentress and water step 8. check your prescription find the dose amount in 'ml' prescribed by your doctor. this is written on the prescription label on the box from your pharmacy. remember that the dose may change each time you go to the doctor, so make sure you check the prescribed dose each time. be sure to go to all of your doctor's appointments so your child gets the right dose! step 9. choose the syringe you need your doctor will prescribe the dose in milliliters (ml). choose the right syringe for your child's dose: then find the ml mark on the syringe that matches your child's dose. step 10. measure isentress - your child's dose may be different from the one shown in this figure. - there will usually be some leftover mixed isentress in the mixing cup. step 11. check for air bubbles step 12. give isentress to your child slowly push in the plunger to give the dose of mixed isentress to your child. if your child fusses, take the tip of the syringe out of the mouth and try again. it is important that your child takes all of the prescribed dose (a little left in the syringe tip is ok). step 13. clean up pour the leftover mixed isentress into the trash. do not pour it into the sink. pull the plungers out of any syringes you used. hand wash the syringes, plungers, and mixing cup with warm water and dish soap. do not wash in the dishwasher. how should i store isentress? store the isentress for oral suspension kit at room temperature between 68°f to 77°f (20°c to 25°c). store in the original container. keep isentress and all medicines out of the reach of children. for more information, go to www.isentress.com or call 1-800-622-4477.

United States - English - NLM (National Library of Medicine)

h.j. harkins company inc. - raltegravir potassium (unii: 43y000u234) (raltegravir - unii:22vkv8053u) - raltegravir 400 mg - adult patients: isentress® and isentress® hd are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adult patients. pediatric patients: isentress is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients 4 weeks of age and older. isentress hd is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in pediatric patients weighing at least 40 kg. none 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlant