Dsuvia

Dsuvia is a prescription medication used in adults in a certified, medically supervised, healthcare setting for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 

Dsuvia belongs to a group of drugs called opioids. These work by changing the way pain is perceived by the brain.

This medication comes as a sublingual tablet to be administered by a healthcare provider. Do not chew or swallow the tablet. Do not eat or drink and minimize talking for 10 minutes after receiving the tablet.

Common side effects include nausea, headache, vomiting, dizziness, and low blood pressure. Dsuvia can also cause drowsiness. Do not drive or operate heavy machinery until you know how Dsuvia affects you.

Dsuvia is a prescription medication used 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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Dsuvia. See the “Dsuvia Precautions” section.

Common side effects of Dsuvia include the following:

• Nausea

• Headache

• Vomiting

• Low blood pressure

Dsuvia can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Dsuvia affects you.

This is not a complete list of Dsuvia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone

• Medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort.

• Alcohol and other sedating medications such as:

  • Barbiturate medications including butalbital, pentobarbital (Nembutal), phenobarbital (Luminal)

  • Benzodiazepine medications including clonazepam (Klonopin), diazepam (Diastat), lorazepam (Ativan), midazolam (Versed), alprazolam (Xanax), temazepam (Restoril)

  • Hypnotic medications including eszopiclone (Lunesta), zeleplon (Sonata), zolpidem (Ambien)

  • First generation antihistamine medications including diphenhydramine (Benedryl), doxylamine (Diclectin), promethazine (Phenergan), hydroxyzine (Vistaril), chlorpheniramine (Chlor-Trimeton)

  • Muscle relaxant medications including baclofen (Lioresal), carisoprodol (Somadril), cyclobenzaprine (Flexeril), methocarbamol (Robaxin), tizanidine (Zanaflex), gabapentin (Neurontin), pregabalin (Lyrica)

  • Opioid pain relieving medications including tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)

  • Antidepressant medications including amitriptyline (Elavil), trazodone (Oleptro), mirtazapine (Remeron), doxepin (Sinequan), nortriptyline (Pamelor), nefazodone (Serzone)

  • Antipsychotic medications including olanzepine (Zyprexa), clozapine (Clozaril), haloperidol (Haldol), fluphenazine (Prolixin), quetiapine (Seroquel), prochlorperazine (Compazine)

• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)

• Medications that affect serotonin citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)

• Diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), and triamterene (Dyrenium, Dyazide, Maxzide)

• Anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), dicyclomine (Bentyl), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

• Medications that lower the effects of opioids such as butorphanol, nalbuphine (Nubain), pentazocine (Talwin), and buprenorphine (Belbuca, Buprenex, Butrans).

This is not a complete list of Dsuvia drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Dsuvia including the following:

• Severe breathing difficulty (Respiratory depression). Dsuvia can cause life-threatening breathing difficulty. Get immediate help if you start experiencing breathing difficulty or are not able to breathe.

• Serotonin syndrome. Using Dsuvia with medications that affect serotonin levels can lead to serotonin syndrome. Tell your doctor right away if you experience any of the following symptoms:

  • Confusion
  • Restlessness
  • Diarrhea
  • Sweating
  • Fast heart beats

• Adrenal Insufficiency. Adrenal insufficiency has been reported with opioid use, more often following greater than one month of use. Tell your doctor right away if you experience nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. 

• Severe hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure too. Lie down if you feel faint or dizzy. Call your doctor right away.

• Dsuvia Risk Evaluation and Mitigation Strategy (REMS) Program. Dsuvia is only available through a restricted program. Talk to you doctor to see if you qualify for Dsuvia REMS program.

Do not take Dsuvia if you:

• Are allergic to Dsuvia or to any of its ingredients.
• Have or have history of breathing difficulty with opioid use.
• Sudden onset of severe asthma.
• Have certain gastrointestinal (GI) issues (known or suspected gastrointestinal obstruction, including paralytic ileus).

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Dsuvia, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Dsuvia, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Dsuvia or to any of its ingredients
• Have asthma or other breathing conditions
• Have history of seizures
• Have gastrointestinal (GI) problems
• Have heart problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Prolonged use of Dsuvia during pregnancy can result in withdrawal in the newborn, which can be life-threatening. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Dsuvia has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Dsuvia, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take Dsuvia exactly as prescribed.
• Dsuvia can only be administered by a healthcare professional.
• Dsuvia comes in sublingual (under the tongue) tablet form and is taken as needed with at least 1 hour in between doses.
• Do not receive more than 12 tablets in 24 hours.
• Do not chew or swallow the tablet.
• After receiving Dsuvia, do not eat, drink or talk for at least 10 minutes.

Take this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication

The recommended dose of Dsuvia (sufentanil) for the management of sudden onset of severe pain is 30 mcg as needed with at least 1 hours in between doses. Do not receive more than 12 tablets in 24 hours.

Dsuvia is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: 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

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

• 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.