Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - solution for injection - sufentanil 5 µg/ml - anesthetics

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

acelrx pharmaceuticals, inc. - sufentanil (unii: afe2yw0iiz) (sufentanil - unii:afe2yw0iiz) - dsuvia is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use: - not for home use or for use in children. discontinue treatment with dsuvia before patients leave the certified medically supervised healthcare setting. - not for use for more than 72 hours. the use of dsuvia beyond 72 hours has not been studied. - only to be administered by a healthcare provider. - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see warnings and precautions (5.3)] , reserve dsuvia for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. use of dsuvia is contraindicated in patients with: • significant respiratory depression [see  warnings and precautions (5.4)] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see  warnings and precautions (5.9)] • known or suspected gastrointestinal obstruction, including paralytic ileus [see  warnings and precautions (5.13)] • known hypersensitivity to sufentanil or components of dsuvia [see  adverse reactions (6.1, 6.2)]. risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.16)] . there are no available data with sufentanil in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, embryolethality and maternal toxicity were noted in rabbits when sufentanil was administered intravenously at 4.4 times the maximum human daily dose of 360 mcg/60 kg/day, based on a body surface area comparison during organogenesis. decreased live fetuses and pup survival were noted in rats treated with sufentanil late in gestation and throughout lactation at doses below the human daily dose of 360 mcg. no malformations were observed in either rats or rabbits at doses below the human daily dose of 360 mcg [see data] . 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 to 4% and 15 to 20%, respectively.  clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or non-medical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.16)] . labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. dsuvia is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including dsuvia, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data pregnant rats were treated with intravenous sufentanil doses of 0.005, 0.02, or 0.08 mg/kg/day (0.14, 0.6, or 2.2 times the maximum human daily dose of 360 mcg/60 kg, based on body surface area, respectively). no malformations or embryotoxic effects were noted despite maternal toxicity (increased mortality in the mid- and high-dose group). pregnant rabbits were treated with intravenous sufentanil doses of 0.005, 0.02, or 0.08 mg/kg/day (0.2, 1.0, or 4.4 times the maximum human daily dose of 360 mcg/60 kg, based on body surface area, respectively). decreased live fetuses per litter and decreased litter size in the high dose group were noted in the presence of maternal toxicity (decreased body weight gain and mortality in the high-dose group). no evidence of malformations or adverse effects on the fetus was reported in a published study in which pregnant rats were administered 10, 50, or 100 mcg/kg/day sufentanil (0.2, 1.4, or 2.8 times the maximum human daily dose of 360 mcg/60 kg, based on body surface area) continuously from gestation day 5 through gestation day 20 via subcutaneously implanted osmotic minipumps. pregnant rats were treated intravenously with sufentanil 0.005, 0.02, or 0.08 mg/kg/day (0.14, 0.6, or 2.2 times the maximum human daily dose of 360 mcg/60 kg, based on body surface area, respectively) from gestation day 16 through lactation day 21. sufentanil reduced birth weights in the mid- and high-dose groups, decreased live fetuses in the high-dose group, and decreased pup survival in all groups in the presence of maternal toxicity (decreased weight gain and increased mortality in all groups). risk summary the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dsuvia and any potential adverse effects on the breastfed infant from dsuvia or from the underlying maternal condition. clinical considerations monitor infants exposed to dsuvia through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible. dsuvia is not intended for chronic use [see  adverse reactions (6.2), clinical pharmacology (12.2), nonclinical toxicology (13.1)] . the safety and efficacy of the use of dsuvia in pediatric patients has not been established. the ability of pediatric patients to comply with the sublingual dosing instructions for dsuvia has not been evaluated.  use of dsuvia in younger children is not recommended as younger children may not be able to comply with the sublingual dosing instructions for dsuvia and could swallow the tablet or spit it out, which could impact the efficacy and safety of dsuvia. no special population studies were performed using dsuvia in elderly patients. of the 646 patients exposed to 30 mcg sufentanil or higher in the first hour of treatment, approximately 11% (72) of patients were ≥ 75 years of age and approximately 20% (126) patients were 65 to 75 years of age. the overall rate of adverse events and most common adverse events, such as nausea, tended to increase with age in patients who received sublingual sufentanil, although vomiting was less common in patients aged ≥ 75 years than in younger patients. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. as the dose of dsuvia cannot be titrated, monitor geriatric patients closely for signs of central nervous system and respiratory depression or consider an alternate medication that can be titrated [see warnings and precautions (5.4)] . because sufentanil is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. monitor closely for adverse events such as respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)] . sufentanil and its metabolites are known to be excreted by the kidney. no significant changes have been observed in subjects with mild or moderate renal impairment.  monitor closely for adverse events such as respiratory depression, sedation, and hypotension in patients with severe renal impairment [see clinical pharmacology (12.3)]. dsuvia contains sufentanil citrate, a schedule ii controlled opioid agonist that can be abused and may produce drug dependence. dsuvia contains sufentanil, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.3)] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of dsuvia increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of dsuvia with alcohol and/or other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of dsuvia abuse include those with a history of prolonged use of any opioid, including products containing sufentanil, those with a history of drug or alcohol abuse, or those who use dsuvia in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. dsuvia, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

grunenthal ltd - sufentanil citrate - sublingual tablet - 15microgram

Canada - English - Health Canada

janssen pharmaceutica, division of janssen-ortho inc. - sufentanil (sufentanil citrate) - liquid - 50mcg - sufentanil (sufentanil citrate) 50mcg - opiate agonists

Canada - English - Health Canada

janssen inc - sufentanil (sufentanil citrate) - liquid - 50mcg - sufentanil (sufentanil citrate) 50mcg - opiate agonists

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - sufentanil - suspension for injection - sufentanil 5 µg/ml - anesthetics