Brand names: Vivitrol
Contraindications
4 CONTRAINDICATIONS VIVITROL is contraindicated in: Patients receiving opioid analgesics [see Warnings and Precautions ( 5.3 )] . Patients with current physiologic opioid dependence [see Warnings and Precautions ( 5.3 )] . Patients in acute opioid withdrawal [see Warnings and Precautions ( 5.3 )] . Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids [see Warnings and Precautions ( 5.3 )] . Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent [see Warnings and Precautions ( 5.8 )]. VIVITROL is contraindicated in: Patients receiving opioid analgesics ( 4 ). Patients with current physiologic opioid dependence ( 4 ). Patients in acute opioid withdrawal ( 4 ). Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids ( 4 ). Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent ( 4 ).
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary The available data from published case series with VIVITROL use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are clinical considerations (see Clinical Considerations ). Reproduction and developmental animal studies have not been conducted for VIVITROL. Daily oral administration of naltrexone to female rats and rabbits increased the incidence of early fetal loss at exposures ≥ 11 times and ≥ 2 times the human exposure, respectively. Daily oral administration of naltrexone to pregnant rats and rabbits during the period of organogenesis did not induce malformation at exposures up to 175 times and 14 times the human exposure, respectively (see Data ). 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% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo-fetal risk Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. In addition, untreated opioid addiction often results in continued or relapsing illicit opioid use. Published studies have demonstrated that alcohol is associated with fetal harm including growth restriction, facial abnormalities, central nervous system abnormalities, behavioral disorders, and impaired intellectual development. Data Animal Data Reproduction and developmental studies have not been conducted for VIVITROL. Studies with naltrexone administered via the oral route have been conducted in pregnant rats and rabbits. Daily oral administration of naltrexone has been shown to increase the incidence o
5 interactions on record
VYLEESI may significantly decrease systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction due to severe consequence of treatment failure.
Source: NLP:bremelanotide
Coadministration may reduce efficacy of oral naltrexone if taken within 2 hours of lofexidine due to altered pharmacokinetics.
Source: NLP:lofexidine
Concomitant use may reduce efficacy of oral naltrexone, particularly if administered within 2 hours of lofexidine. Non-oral routes are not expected to have this interaction.
Source: NLP:lofexidine hydrochloride
Oral THC effects were enhanced by opioid receptor blockade.
Source: NLP:nabilone
Clinically important interactions between naltrexone and acamprosate were not observed.
Source: NLP:acamprosate calcium