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What is Dsuvia, and how does it work?
Dsuvia (sufentanil) is an opioid agonist 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.
What are the side effects of Dsuvia?
Common side effects of Dsuvia include:
ACCIDENTAL EXPOSURE AND Dsuvia REMS PROGRAM; LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE, AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Accidental Exposure and Dsuvia Risk Evaluation and Mitigation Strategy (REMS) Program
Accidental exposure to or ingestion of Dsuvia, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, Dsuvia is only available through a restricted program called the Dsuvia REMS Program.
- Dsuvia must only be dispensed to patients in a certified medically supervised healthcare setting.
- Discontinue use of Dsuvia prior to discharge or transfer from the certified medically supervised healthcare setting.
Life-Threatening Respiratory Depression
- Serious, life-threatening, or fatal respiratory depression may occur with use of Dsuvia. Monitor for respiratory depression, especially during initiation of Dsuvia.
Addiction, Abuse, and Misuse
- Dsuvia exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
- Assess each patient's risk prior to prescribing Dsuvia, and monitor all patients regularly for the development of these behaviors or conditions.
Cytochrome P450 3A4 Interaction
- The concomitant use of Dsuvia with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression.
- In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration.
- Monitor patients receiving Dsuvia and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
- Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate
- Limit dosages and durations to the minimum required
- Follow patients for signs and symptoms of respiratory depression and sedation.
What is the dosage for Dsuvia?
Important Administration Instructions
- Dsuvia is only to be administered by the healthcare provider.
- Dsuvia is only to be used in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments.
- Dsuvia treatment must be discontinued prior to the patient leaving the certified medically supervised setting.
- The recommended dosage of Dsuvia is 30 mcg sublingually as needed with a minimum of 1 hour between doses. Do not exceed 12 tablets in 24 hours.
- The maximum cumulative daily dose of sufentanil is 360 mcg or 12 tablets (12 tablets x 30 mcg/dose).
What drugs interact with Dsuvia?
Table 2 includes clinically significant drug interactions with Dsuvia.
Table 2 : Clinically Significant Drug Interactions with Dsuvia
|Inhibitors of CYP3A4|
|Clinical Impact:||The concomitant use of
Dsuvia and CYP3A4 inhibitors can increase the plasma concentration of sufentanil, resulting in increased or prolonged opioid effects.|
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the sufentanil plasma concentration will decrease, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to sufentanil.
|Intervention:||If concomitant use is necessary, consider an alternate medication that permits dose titration. Monitor patients for respiratory depression and sedation at frequent intervals.|
If a CYP3A4 inhibitor is discontinued, consider an alternate medication that permits dose titration. Monitor for signs of opioid withdrawal.
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir)|
|Clinical Impact:||The concomitant use of
Dsuvia and CYP3A4 inducers can decrease the plasma concentration of
sufentanil, resulting in decreased efficacy or onset of a withdrawal
syndrome in patients who have developed physical dependence to sufentanil.|
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the sufentanil plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
|Intervention:||If concomitant use is necessary, consider an alternate medication that permits dose titration. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider less frequent dosing of Dsuvia and monitor for signs of respiratory depression.|
|Examples:||Rifampin, carbamazepine, phenytoin|
|Benzodiazepines and other Central Nervous System (CNS) Depressants|
|Clinical Impact:||Due to additive pharmacologic effect, the concomitant use of benzodiazepines or CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.|
|Intervention:||Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation.|
|Examples:||Alcohol, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids.|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.|
|Intervention:||If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Dsuvia if serotonin syndrome is suspected.|
|Examples:||Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (e.g., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).|
|Monoamine Oxidase Inhibitors (MAOIs)|
|Clinical Impact:||MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma).|
|Intervention:||The use of Dsuvia is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.|
|Examples:||phenelzine, tranylcypromine, linezolid|
|Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics|
|Clinical Impact:||May reduce the analgesic effect of Dsuvia and/or precipitate withdrawal symptoms.|
|Intervention:||Avoid concomitant use.|
|Examples:||Butorphanol, nalbuphine, pentazocine, buprenorphine|
|Clinical Impact:||Sufentanil may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of the muscle relaxant as necessary or consider discontinuing use of Dsuvia.|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.|
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.|
|Clinical Impact:||The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.|
|Intervention:||Monitor patients for signs of urinary retention or reduced gastric motility when Dsuvia is used concomitantly with anticholinergic drugs.|
Does Dsuvia cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
- 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 abuse similar to other opioids including (fentanyl, morphine, oxycodone, hydromorphone).
- Dsuvia can be abused and is subject to misuse, addiction, and criminal diversion.
- All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
- Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
- Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes:
- a strong desire to take the drug,
- difficulties in controlling its use,
- persisting in its use despite harmful consequences,
- a higher priority given to drug use than to other activities and obligations,
- increased tolerance, and sometimes
- a physical withdrawal.
- "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 drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
- Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
- Dsuvia, like other opioids, can be diverted for non-medical 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 re-evaluation 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 chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.
- Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
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Is Dsuvia safe to use while pregnant or breastfeeding?
- Inform female patients of reproductive potential that Dsuvia can (or may) cause fetal harm and to inform the prescriber of a known or suspected pregnancy.
- Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs.
Dsuvia (sufentanil) is an opioid agonist 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. Serious side effects of Dsuvia include life-threatening respiratory depression. Dsuvia contains sufentanil citrate, a Schedule II controlled opioid agonist that can be abused and may produce drug dependence.
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