Dsuvia (Sublingual)

Sufentanil sublingual tablet is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medications do not work well or cannot be tolerated. This medicine should only be used for up to 72 hours. Sufentanil is part of a group of medications called narcotic analgesics (pain medicines) that work on the central nervous system (CNS) to relieve pain.

Using sufentanil for a long time may lead to habit-forming behavior, resulting in mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop them from using narcotics to manage their pain. Mental dependence (addiction) is unlikely to happen when narcotics are used for this reason. Physical dependence may cause withdrawal side effects if the treatment is stopped suddenly. Since sufentanil is only used for a short time (72 hours or less) to relieve pain, physical dependence is unlikely to develop.

This medicine is available only through a restricted distribution program known as the Dsuvia™ REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important that your doctor closely monitors your progress while you are using this medicine. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) in the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, talk to your doctor.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause sleep-related breathing problems (for example, sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Contact your doctor immediately if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take other medicines that affect serotonin levels in your body.

You may experience dizziness, lightheadedness, or fainting, especially when you stand up quickly from a lying or sitting position. Getting up slowly may help. If this problem continues or worsens, consult your doctor.

Using this medicine while pregnant may lead to serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Inform your doctor right away if you think you are pregnant or plan to become pregnant while using this medicine.

Using too much of this medicine may lead to infertility (being unable to have children). Talk to your doctor before using this medicine if you plan to have children.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the drug must be weighed against the good it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

The dose of this medicine will be different for different patients. Follow your clinician's orders or the directions on the label. The following information includes only the average doses of this medication. If your dose is different, do not change it unless your physician tells you to do so.

The amount of medication that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical issue for which you are using the medicine.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sufentanil sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sufentanil sublingual tablet in the elderly. However, elderly patients are more likely to have confusion and serious drowsiness and age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving sufentanil sublingual tablet.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is not advised. Your physician may decide not to treat you with this drug or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following medicines is normally not advised, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Piritramide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may additionally cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is normally not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you inform your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland issue) or
• Alcohol abuse or
• Brain tumor, history of or
• Breathing or lung issues (eg, apnea, COPD, low oxygen levels, sleep apnea) or
• Cor pulmonale (serious heart condition) or
• Depression, history of or
• Drug dependence, especially with narcotics, or history of or
• Electrolyte imbalance or
• Gallbladder disease or
• Head injury, history of or
• Heart rhythm issues (eg, slow heartbeat) or
• Mental health issues, history of or
• Stomach or bowel problems or
• Weakened immune system—Use with caution. May increase risk for more serious side effects.

• Asthma, acute or severe or
• Lung or breathing problems (eg, respiratory depression), serious or
• Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (swelling of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

Rare

• Bloody urine
• blue lips, fingernails, or skin
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• decreased frequency or amount of urine
• decreased urine output
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• extremely shallow or slow breathing
• fainting
• fast heartbeat
• increased blood pressure
• increased thirst
• indigestion
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness or fainting
• loss of appetite
• lower back or side pain
• nausea
• painful urination
• seeing, hearing, or feeling things that are not there
• severe constipation
• severe vomiting
• slow or irregular heartbeat
• stomach pain or upset
• swelling of the face, fingers, or lower legs
• tenderness in the stomach area
• troubled breathing
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting
• weakness
• weight gain

Incidence not known

• Agitation
• cough
• darkening of the skin
• diarrhea
• difficulty swallowing
• fever
• hives, itching, skin rash
• mental depression
• overactive
• reflexes
• poor coordination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• shivering
• talking or acting with excitement you cannot control
• tightness in the chest
• trembling or shaking
• twitching

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blue lips and fingernails
• blurred vision
• chest pain
• choking
• cold and clammy skin
• constricted pupils
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• pale or blue lips, fingernails, or skin
• severe sleepiness
• slow heartbeat
• swelling in the legs and ankles

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Rare

• Anxiety
• belching
• bloated
• confusion about identity, place, and time
• difficulty having a bowel movement (stool)
• drowsiness
• dry mouth
• excess air or gas in the stomach or bowels
• false or unusual sense of well-being
• feeling of warmth
• forgetfulness
• full feeling
• heartburn
• indigestion
• muscle spasm
• passing gas
• redness of the face, neck, arms and occasionally, upper chest
• sleepiness or unusual drowsiness
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Dsuvia

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is placed under your tongue.

It is very important that you understand the rules of the Dsuvia™ REMS program to prevent addiction, abuse, and misuse of sufentanil. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your doctor or pharmacist for the medication guide if you do not have one.

Do not chew or swallow the tablet.

Do not eat or drink and minimize talking for 10 minutes after receiving the tablet. If you have excessive dry mouth, you may be given ice chips before receiving this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sublingual dosage form (tablets):For pain: Adults—30 micrograms (mcg) placed under the tongue as needed with a minimum of 1 hour between doses. The dose is usually not more than 12 tablets per day. Children—Use and dose must be determined by your doctor.

• How do you take the Dsuvia (sufentanil) tablet?
• What is the Dsuvia REMS program?
• Is Dsuvia (sufentanil) a controlled substance?