USA - engelsk - NLM (National Library of Medicine)

a-s medication solutions - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)] . limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)] . priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years and older for the treatment of latent tuberculosis infection caused by mycobacterium tuberculosis in patients at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, hiv-infected patients, or those with pulmonary fibrosis on radiograph) [see clinical studies (14.2)] . limitations of use active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. priftin must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection [see dosage and administration (2.2) and clinical studies (14.2)] . - priftin in combination with isoniazid is not recommended for individuals presumed to be exposed to rifamycin-resistant or isoniazid-resistant m. tuberculosis . priftin is contraindicated in patients with a history of hypersensitivity to rifamycins. risk summary based on animal data, priftin may cause fetal harm when administered to a pregnant woman. available data from clinical trials, case reports, epidemiology studies and postmarketing experience with priftin use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, adverse maternal or fetal outcomes. in two clinical trials, a total of 59 patients who were treated with rifapentine in combination with other anti-tuberculosis drugs became pregnant. overall, the reported rate of miscarriage following rifapentine exposure in these two clinical trials did not represent an increase over the background rate of miscarriage reported in the general population (see data) . there are risks associated with active tuberculosis during pregnancy. when administered during the last few weeks of pregnancy, priftin may be associated with maternal postpartum hemorrhage and bleeding in the exposed neonates (see clinical considerations) . in animal reproduction and developmental toxicity studies, adverse developmental outcomes (including cleft palate or mal-positioned aortic arches) were observed following administration of rifapentine to pregnant rats and rabbits at doses approximately 0.6 and 0.3 to 1.3 times, respectively, of the recommended human dose based on body surface area comparisons (see data) . based on animal data, advise pregnant women of the risk for fetal harm. as rifapentine is always used in combination with other antituberculosis drugs such as isoniazid, ethambutol, and pyrazinamide, refer to the prescribing information of the other drug(s) for more information on their associated risks of use during pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, cesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death. labor or delivery when administered during the last few weeks of pregnancy, priftin may increase the risk for maternal postpartum hemorrhage and bleeding in the exposed neonate. monitor prothrombin time of pregnant women and neonates who are exposed to priftin during the last few weeks of pregnancy. treatment with vitamin k may be indicated. data human data fourteen patients with active tuberculosis treated with multiple antituberculosis drugs including priftin became pregnant during clinical studies. six delivered normal infants, four had first trimester spontaneous abortions (of these, one patient abused ethanol and another patient was hiv-infected), one had an elective abortion, and outcome was unknown in three patients. these data are, however, limited by the quality of reporting and confounded by comorbid medical conditions and multiple antituberculosis drug exposures. in the trial that compared the safety and effectiveness of priftin in combination with isoniazid to isoniazid alone for the treatment of latent tuberculosis infection, a total of 45 (2.5%) women in the priftin/isoniazid arm and 71 (4.1%) women in the isoniazid arm became pregnant. among the 46 total pregnancies in the priftin/isoniazid arm, there were 31 live births, 6 elective abortions, 7 spontaneous abortions, and 2 unknown outcomes. of the 31 live infants, 21 were reported healthy while in the other ten cases no further details were available. the rate of spontaneous abortion in the priftin/isoniazid arm (15%) and the rate of spontaneous abortion in the isoniazid arm (19%) did not represent an increase over the background rate of 15 to 20 percent reported in the general population. further interpretation of these results is limited by the quality of adverse event reporting. animal data animal studies in rats and rabbits revealed malformations and other adverse developmental outcomes in both species. pregnant rats given oral rifapentine during organogenesis (gestational days 5 through 15) at 40 mg/kg/day (0.6 times the human dose of 600 mg based on body surface area comparisons) produced pups with cleft palates and mal-positioned aortic arches, delayed ossification, increased number of ribs, a decrease in litter size and mean litter weight, an increase in number of stillbirths, and an increase in mortality during lactation. when rifapentine was administered orally to mated female rats late in gestation, at 20 mg/kg/day (0.3 times the human dose based on body surface area), pup weights and gestational survival (live pups born/pups born) were reduced compared to controls. increased resorptions and postimplantation loss, decreased mean fetal weights, increased numbers of stillborn pups, and slightly increased pup mortality during lactation were also noted. when pregnant rabbits received oral rifapentine at 10 mg/kg to 40 mg/kg (0.3 times to 1.3 times the human dose based on body surface area) during organogenesis (gd6 to gd18), major fetal malformations occurred including: ovarian agenesis, pes varus, arhinia, microphthalmia, and irregularities of the ossified facial tissues. at 40 mg/kg/day, there were increases in postimplantation loss and the incidence of stillborn pups. risk summary there are no data on the presence of rifapentine or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. since priftin may produce a red-orange discoloration of body fluids, there is a potential for discoloration of breast milk. monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for priftin and any potential adverse effects on the breastfed infant from priftin or from the underlying maternal condition. clinical considerations monitor infants exposed to rifapentine through breast milk for signs of hepatotoxicity to include irritability, prolonged unexplained crying, yellowing of the eyes, loss of appetite, vomiting, and changes in color of the urine (darkening) or stool (lightening, pale or light brown). contraception use of priftin may reduce the efficacy of hormonal contraceptives. advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with priftin [see warnings and precautions (5.5) and drug interactions (7.3)] . the safety and effectiveness of priftin in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. the safety and effectiveness of priftin in combination with isoniazid once-weekly regimen has been evaluated in pediatric patients (2 to 17 years of age) for the treatment of latent tuberculosis infection. in clinical studies, the safety profile in children was similar to that observed in adult patients [see adverse reactions (6.1) and clinical studies (14.2)] . in a pharmacokinetic study conducted in 2 to 11-year-old pediatric patients with latent tuberculosis infection, priftin was administered once weekly based on weight (15 mg/kg to 30 mg/kg, up to a maximum of 900 mg). exposures (auc) in children 2 to 11 years old with latent tuberculosis infection were higher (average 31%) than those observed in adults receiving priftin 900 mg once weekly [see dosage and administration (2.2) and clinical pharmacology (12.3)] . clinical studies with priftin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. in a pharmacokinetic study with priftin, no substantial differences in the pharmacokinetics of rifapentine and 25-desacetyl metabolite were observed in the elderly compared to younger adults [see clinical pharmacology (12.3)] .

USA - engelsk - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - rifapentine (unii: xjm390a33u) (rifapentine - unii:xjm390a33u) - priftin® (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (tb) caused by mycobacterium tuberculosis . priftin must always be used in combination with one or more antituberculosis (anti-tb) drugs to which the isolate is susceptible [see dosage and administration (2.1) and clinical studies (14.1)] . limitations of use do not use priftin monotherapy in either the initial or the continuation phases of active antituberculous treatment. priftin should not be used once weekly in the continuation phase regimen in combination with isoniazid (inh) in hiv-infected patients with active pulmonary tuberculosis because of a higher rate of failure and/or relapse with rifampin (rif)-resistant organisms [see warnings and precautions (5.4) and clinical studies (14.1)] . priftin has not been studied as part of the initial phase treatment regimen in hiv-infected patients with active pulmonary tuberculosis. priftin is indicated in adults and children 2 years

Den europeiske union - engelsk - EMA (European Medicines Agency)

pfizer ltd. - sitaxentan sodium - hypertension, pulmonary - antihypertensives, - treatment of patients with pulmonary arterial hypertension (pah) classified as who functional class iii, to improve exercise capacity. efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.

Kenya - engelsk - Pharmacy and Poisons Board

macleods pharmaceuticals limited 304 atlanta arcade, marol church road, andheri - isoniazid bp and rifapentine - coated tablet - 300mg and 300mg - rifapentine

Canada - engelsk - Health Canada

pfizer canada ulc - sitaxsentan sodium - tablet - 100mg - sitaxsentan sodium 100mg - miscellaneous vasodilatating agents

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

viiv healthcare pty ltd - rilpivirine hydrochloride, quantity: 27.5 mg (equivalent: rilpivirine, qty 25 mg); dolutegravir, quantity: 50 mg - tablet, film coated - excipient ingredients: macrogol 3350; silicified microcrystalline cellulose; povidone; sodium starch glycollate type a; polyvinyl alcohol; microcrystalline cellulose; magnesium stearate; lactose monohydrate; iron oxide yellow; croscarmellose sodium; iron oxide red; mannitol; purified talc; titanium dioxide; sodium stearylfumarate; polysorbate 20 - juluca (dolutegravir/rilpivirine) is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna less than 50 copies per ml) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1 pharmacodynamic properties, clinical trials).

Israel - engelsk - Ministry of Health

gilead sciences israel ltd - bictegravir as sodium; emtricitabine; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; bictegravir as sodium 50 mg - emtricitabine, tenofovir alafenamide and bictegravir - biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (hiv 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Israel - engelsk - Ministry of Health

gilead sciences israel ltd - bictegravir as sodium; emtricitabine; tenofovir alafenamide as fumarate - film coated tablets - tenofovir alafenamide as fumarate 25 mg; emtricitabine 200 mg; bictegravir as sodium 50 mg - emtricitabine, tenofovir alafenamide and bictegravir - biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (hiv 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Israel - engelsk - Ministry of Health

glaxo smith kline (israel) ltd - dolutegravir as sodium; rilpivirine as hydrochloride - film coated tablets - rilpivirine as hydrochloride 25 mg; dolutegravir as sodium 50 mg - dolutegravir and rilpivirine - juluca is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically-suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor

Israel - engelsk - Ministry of Health

glaxo smith kline (israel) ltd - cabotegravir as sodium - film coated tablets - cabotegravir as sodium 30 mg - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the nnrti and ini class for: • oral lead in to assess tolerability of vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection. • oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.