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

theratechnologies inc. - ibalizumab (unii: lt369u66ce) (ibalizumab - unii:lt369u66ce) - ibalizumab 150 mg in 1 ml - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in heavily treatment-experienced adults with multidrug resistant hiv-1 infection failing their current antiretroviral regimen. trogarzo is contraindicated in patients with a prior hypersensitivity reaction to trogarzo or any components of the product [see warnings and precautions (5.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy. this registry does not include trogarzo, but likely includes patients’ concomitant antiretroviral drugs.  healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (cd4+ t cell and b cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero. immunoglobulin g (igg) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus (see clinical considerations). there are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. the 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. in a reproductive study in monkeys, reversible decreases in cd4+ t cells and b cells and increases in cd8+ t cells were observed within the first 4 weeks after birth in infants born to pregnant monkeys receiving ibalizumab-uiyk intravenously (see data ). lymphocyte counts returned to near normal levels by 3 months of age. one infant monkey died from a systemic viral infection that may be related to ibalizumab-uiyk-induced immunosuppression. no malformations or premature births were observed in this study. clinical considerations fetal/neonatal adverse reactions immunoglobulin g (igg) antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. administration of trogarzo during pregnancy may affect immune responses in the in utero-exposed infant. for infants with perinatal exposure to trogarzo, immune phenotyping of the peripheral blood, including cd4+ t cell and b cell counts, is recommended. expert consultation is also recommended to provide guidance on monitoring and management (e.g., need for antibiotic or immunoprophylaxis) of exposed infants based on the degree of immunosuppression observed. the safety of administering live or live-attenuated vaccines in exposed infants is unknown. data animal data in an enhanced pre- and post-natal development (eppnd) study, pregnant cynomolgus monkeys were administered intravenous doses of either vehicle or 110 mg/kg ibalizumab-uiyk every week from gestation day 20-22 (gd 20-22) until parturition on gd 160 ± 10. significant changes in infant monkey immune cell levels on postnatal day (pnd) 14 (mean decreases of 78% in cd4+ t cells and 46% in b cells and increases of 2.3-fold in cd8+ t cells) and pnd 28 (mean decreases of 73% in cd4+ t cells and increases of 2.2-fold in cd8+ t cells), attributed to in utero ibalizumab-uiyk exposure, were observed relative to concurrent controls. the lymphocyte changes correlated with infant ibalizumab-uiyk serum concentrations and appeared to return to near normal levels between pnd 28-91, when ibalizumab-uiyk concentrations were nearly undetectable. although ibalizumab-uiyk exposure in these infant monkeys may be significantly higher than in human infants following in utero exposure at the recommended human maintenance dose, the risk of ibalizumab-uiyk-induced immunosuppression in human infants is possible. no meaningful differences in infant monkey lymphocyte counts were observed on pnd 180. further, no differences in immune cell function were observed in a t cell-dependent response assay conducted on pnd 138 to 180 ± 2 following immunization of the infant monkeys with keyhole limpet hemocyanin. one treatment-group infant monkey died on pnd 24 from a systemic viral infection with secondary superficial bacterial infection which was acquired during the postnatal period. despite the low incidence (1 of 20 infants), the death may be related to ibalizumab-uiyk-induced immunosuppression. decreases in cd4+ t cells (93%), and b cells (92%) were observed in this infant on pnd 14, and decreased cellularity was observed in the spleen, thymus and mandibular lymph node. unlike the rest of the ibalizumab-exposed infant monkey population, this infant also exhibited a decrease in cd8+ t cells of 71% on pnd 14. body weight was also decreased in this infant between pnd 14 and 24. no structural abnormalities were observed among the ibalizumab-uiyk-exposed infants. in addition, no maternal toxicities, including no changes in maternal lymphocyte subsets or effects on embryo-fetal survival, were observed. 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 the risk of postnatal transmission of hiv-1 infection. no data are available regarding the presence of trogarzo in human milk, the effects on the breastfed child, or the effects on milk production. human igg is present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts. because of the potential for hiv-1 transmission, instruct mothers not to breastfeed if they are receiving trogarzo. the safety and effectiveness of trogarzo in pediatric patients have not been established. no studies have been conducted with trogarzo in geriatric patients.

European Union - English - EMA (European Medicines Agency)

theratechnologies europe limited - ibalizumab - hiv infections - antivirals for systemic use - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of adults infected with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen.

Israel - English - Ministry of Health

stern healthcare ltd, israel - ibalizumab - concentrate for solution for infusion - ibalizumab 200 mg/vial - ibalizumab - trogarzo, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in heavily treatment-experienced adults with multidrug resistant hiv-1 infection failing their current antiretroviral regimen.

Canada - English - Health Canada

viiv healthcare ulc - fostemsavir (fostemsavir tromethamine) - tablet (extended-release) - 600mg - fostemsavir (fostemsavir tromethamine) 600mg - miscellaneous antiretrovirals*

Canada - English - Health Canada

viiv healthcare ulc - cabotegravir (cabotegravir sodium) - tablet - 30mg - cabotegravir (cabotegravir sodium) 30mg - hiv integrase inhibitors

Canada - English - Health Canada

viiv healthcare ulc - cabotegravir; rilpivirine - suspension (extended-release) - 200mg; 300mg - cabotegravir 200mg; rilpivirine 300mg - hiv integrase inhibitors

Canada - English - Health Canada

viiv healthcare ulc - cabotegravir; rilpivirine - suspension (extended-release) - 200mg; 300mg - cabotegravir 200mg; rilpivirine 300mg - hiv integrase inhibitors

European Union - English - EMA (European Medicines Agency)

viiv healthcare b.v. - cabotegavir sodium, cabotegravir - hiv infections - antivirals for systemic use - 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

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - cabotegravir - prolonged release suspension for injection - cabotegravir 200 mg / 1 ml - vocabria injection is indicated, in combination with rilpivirine injection, 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 without present or past evidence of viral resistance to, and no prior virological failure with agents of the nnrti and ini class

Israel - English - 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.