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Subsys spray (fentanyl sublingual [under the tongue]) is an opioid pain medication. An opioid is sometimes called a narcotic.
Subsys spray is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Subsys is taken together with other non-fentanyl narcotic pain medicines that are used around the clock.
Subsys is not for treating pain that is not cancer-related.
Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device). Subsys is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of taking this medication.
Do not use Subsys spray unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Subsys is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.
Fentanyl can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Subsys in larger amounts, or for longer than prescribed.
Some medicines can interact with fentanyl and worsen the effects on your breathing. Before using this medicine, tell your doctor if you are taking an antibiotic or any medicines to treat high blood pressure, heart rhythm disorders, depression, or viral infections such as hepatitis, HIV or AIDS.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Fentanyl may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Do not use Subsys unless you are already using an around-the-clock opioid medicine and are tolerant to it. You should not use Subsys if you are allergic to fentanyl, or if you have:
severe asthma or other breathing problems; or
a stomach or bowel obstruction (including paralytic ileus).
To make sure Subsys is safe for you, tell your doctor if you have ever had:
breathing problems, sleep apnea;
any type of breathing problem or lung disease;
a head injury, brain tumor, or seizures;
low blood pressure, slow heartbeats or other heart rhythm disorder;
drug or alcohol addiction, depression, schizophrenia, or hallucinations;
liver or kidney disease;
urination problems; or
problems with your thyroid, gallbladder, or pancreas.
Tell your doctor if there are children living in the home where you will store this medicine. The amount of fentanyl in this medicine can be fatal to a child.
If you use Subsys while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breast-feed while you are using this medicine.
Use Subsys exactly as prescribed by your doctor. Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Take this medicine exactly as prescribed by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away fentanyl is against the law.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).
If you switch to Subsys from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms). Your doctor may change your dose to make sure you get the best results.
Point the Subsys spray nozzle into your mouth, lift your tongue, and spray the medicine under your tongue. Hold the liquid under the tongue for 30 to 60 seconds. Do not spit, swallow, or rinse your mouth during this time.
You may use a second dose of Subsys 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after taking the second tablet. Do not take more than 2 doses for each episode of breakthrough cancer pain.
You must wait at least 4 hours after your last dose of Subsys before you can treat a new pain episode.
Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine. Do not treat more than 4 pain episodes per day with this medicine.
Do not stop using Subsys suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature, away from heat and moisture. Do not freeze. Keep your medicine in a place where others cannot get to it. Keep track of the amount of medicine used. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Keep this medicine out of the reach of children or pets. The amount of fentanyl in each Subsys spray unit can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.
Carefully follow disposal instructions when this medicine is no longer needed. Dispose of used Subsys spray units in the disposal bags provided with this medication. Empty any unused spray units into the disposal bottle provided.
Since Subsys is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).
This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how Subsys will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Do not drink alcohol. Dangerous side effects or death could occur.
Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while taking Subsys.
Get emergency medical help if you have signs of an allergic reaction to Subsys: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
slow heart rate, sighing, shallow breathing, breathing that stops during sleep;
severe drowsiness, feeling like you might pass out;
confusion, extreme fear, unusual thoughts or behavior; or
low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are malnourished or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common Subsys side effects may include:
headache, dizziness, drowsiness, pale skin, feeling weak or tired;
constipation, nausea, vomiting; or
swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make Subsys less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.
Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
other narcotic medications - opioid pain medicine or prescription cough medicine;
a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Subsys only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Subsys (www.drugs.com/subsys.html).
Note: This document contains side effect information about fentanyl. Some of the dosage forms listed on this page may not apply to the brand name Subsys.
For the ConsumerApplies to fentanyl: lozenge/troche, spray, tablet
Other dosage forms:
Sublingual route (Spray)
Warning: Life-Threatening Respiratory Depression, Accidental Ingestion; Cytochrome P450 3A4 Interaction; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants; Risk of Medication Errors; Addiction, Abuse, and Misuse; REMS; and Neonatal Opioid Withdrawal SyndromeSerious, life-threatening, and/or fatal respiratory depression has occurred. Monitor closely, especially upon initiation or following a dose increase. Due to the risk of fatal respiratory depression, fentanyl sublingual spray is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.Accidental ingestion of fentanyl sublingual spray, especially by children, can result in a fatal overdose of fentanyl. Keep out of reach of children. Ensure proper storage and disposal.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Concomitant use of opioids with benzodiazepines or other 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 and follow patients for signs and symptoms of respiratory depression and sedation.When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl sublingual spray.When dispensing, do not substitute with any other fentanyl products.Fentanyl sublingual spray exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Fentanyl sublingual spray is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.Prolonged use of fentanyl sublingual spray during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available..
Buccal mucosa route (Film; Lozenge/Troche; Tablet)
Due to the risk of fatal respiratory depression, transmucosal fentanyl citrate is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Monitor for respiratory depression during treatment. Accidental ingestion of fentanyl can result in a fatal overdose, especially in children; keep out of reach of children. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in a fatal overdose of fentanyl and monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Fentanyl is a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Assess risk prior to initiation and monitor for signs of misuse, abuse, and addiction during treatment. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise patient of potential fetal risk and ensure appropriate treatment will be available.
Sublingual route (Tablet)
Due to the risk of fatal respiratory depression, sublingual fentanyl citrate is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Monitor for respiratory depression during treatment. Accidental ingestion of fentanyl can result in a fatal overdose, especially in children; keep out of reach of children. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in fatal overdose and monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Fentanyl is a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Assess risk prior to initiation and monitor for signs of misuse, abuse, and addiction during treatment. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise patient of potential fetal risk and ensure appropriate treatment will be available.
Along with its needed effects, fentanyl (the active ingredient contained in Subsys) 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 immediately if any of the following side effects occur while taking fentanyl:
More common
Less common
Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:
Symptoms of overdose
Some side effects of fentanyl 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
Less common
Incidence not known
For Healthcare Professionals
Applies to fentanyl: buccal film, buccal tablet, compounding powder, injectable solution, intravenous solution, nasal spray, oral lozenge, oral transmucosal lozenge, sublingual spray, sublingual tablet, transdermal device, transdermal film extended release
GeneralThe most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation.
Nervous systemVery common (10% or more): Somnolence, dizziness
Common (1% to 10%): Sedation, pyrexia, fatigue, lethargy, tremor, headache, chills, irritability, malaise, confusion, abnormal thinking, anxiety, dysphoria
Uncommon (0.1% to 1%): Hyperesthesia
Very rare (less than 0.01%): Severe hemiplegic migraine
Frequency not reported: Slurred speech, paresthesia, hypesthesia, tremor
Postmarketing reports: Loss of consciousness, vertigo, coma, shock, convulsion
Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.
CardiovascularOne report has suggested that epidural fentanyl (the active ingredient contained in Subsys) may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.
Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.
Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Sinus tachycardia, chest pain, hypertension, hypotension, palpitations
Rare (less than 0.1%): Arrhythmias, cardiac arrest
Frequency not reported: Syncope, vasodilation, bradycardia, bigeminy, myocardial infarct
Postmarketing reports: Circulatory depression
GastrointestinalVery common (10% or more): Nausea (18%), vomiting (10%), constipation
Common (1% to 10%): Dry mouth, abdominal distension, gastritis, dysphagia, dyspepsia, gastroesophageal reflux disease, ascites, hematemesis, taste perversion, abdominal pain, dehydration, anorexia, cachexia, vomiting, dry mouth, mouth ulcers/stomatitis, tongue edema
Uncommon (0.1% to 1%): Abdomen enlarged, flatulence
Rare (less than 0.1%): Choledochoduodenal sphincter spasm
Frequency not reported: Diarrhea
Postmarketing reports: Ileus, dental caries, tooth loss, gingival recession, gingivitis, gingival bleeding, lip edema, pharyngeal edema, gum bleeding, ulcer
GenitourinaryUncommon (0.1% to 1%): Urinary retention
Very rare (less than 0.01%): Priapism
Frequency not reported: Urinary tract infection, urination impaired, hematuria, urinary urgency, dysuria
DermatologicApproximately 60% of patients had some redness at the skin site 24-hours after removal of the iontophoretic transdermal system. The majority of skin events were categorized as mild, erythema and papules were observed; 2 patients had hyperpigmentation at the application site lasting 2 to 3 weeks; 3 patients had a rectangular mark at the application site which persisted for up to 3 months.
Very common(10% or more): Iontophoretic transdermal system: Application site reaction-Erythema (14%)
Common (1% to 10%): Application site irritation, pruritus
Uncommon (0.1% to 1%): Hyperhidrosis, rash
Rare (less than 0.1%): Systemic rashes
Frequency not reported: vesicles, papules/pustules, dry and flaky skin, vesiculobullous rash wound site oozing/bleeding, wound site inflammation/erythema
Postmarketing reports: Application site discharge, application site bleeding, application site infection, rash and scab, erosion, hyperesthesia, application site necrosis
HypersensitivityRare (less than 0.1%): Anaphylaxis
HematologicThe hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl (the active ingredient contained in Subsys) solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.
Common (1% to 10%): Anemia, neutropenia, lymphadenopathy, thrombocytopenia, leukopenia, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose increased, blood lactate increased, hypoalbuminemia, vasodilation
ImmunologicUncommon (0.1% to 1%): Oral candidiasis, cellulitis, pneumonia, urinary tract infection, oral herpes, gastroenteritis, laryngitis
Very rare (less than 0.01%): Recurrent herpes simplex infection following epidural administration
MetabolicCommon (1% to 10%): Asthenia, peripheral edema, weight decreased, hypokalemia, hyponatremia, hypocalcemia
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone
Frequency not reported: abnormal healing, dehydration
EndocrineUncommon (0.1% to 1%): Hot flush
MusculoskeletalCommon (1% to 10%): Fall/accidental injury, back pain, arthralgia, joint swelling, muscular weakness, myoclonus, involuntary muscle contractions, muscle rigidity (involving the respiratory musculature including the glottis)
Frequency not reported: Leg cramps, myalgia
Postmarketing reports: Abnormal gait/incoordination
OcularUncommon (0.1% to 1%): Vision blurred, dry eye
Rare (less than 0.1%): Abnormal vision
PsychiatricCommon (1% to 10%): Depression, confusional state, hallucination, insomnia
Uncommon (0.1% to 1%): Anxiety, agitation, restlessness, agitation, disorientation, abnormal dreams, depersonalization, depression, emotional lability, euphoria, delirium
Frequency not reported: Nervousness
RespiratoryCommon (1% to 10%): Dyspnea, rhinitis, yawning, respiratory distress, apnea, bradypnea, hypoventilation, respiratory depression
Uncommon (0.1% to 1%): Cough, increased bronchial secretion, dysphonia, pharyngolaryngeal pain, wheezing, hypoxia, exertional dyspnea
Very rare (less than 0.01%): Acute noncardiogenic pulmonary edema
Frequency not reported: Asthma, hiccup, atelectasis, hyperventilation
Postmarketing reports: Respiratory arrest
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Subsys (www.drugs.com/subsys.html).
December 16, 2020
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