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Subsys spray

Generic Name: fentanyl (FEN-ta-nil)
Brand Name: Subsys

Subsys spray can be harmful or fatal if taken by children, patients for whom it has not been prescribed, or patients who are not tolerant to narcotic (opioid) pain medicine. Keep Subsys spray out of the reach of children.

Subsys spray is only for breakthrough pain caused by cancer in adult patients who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe and sometimes fatal breathing problems can occur in patients using Subsys spray, especially in patients who are not already using other narcotic medicines or patients who are taking certain other medicines. Ask your health care provider if Subsys spray may interact with other medicines that you take. Do not use Subsys spray for short-term pain (including headache, dental pain, or migraine) or for pain that occurs after surgery or injuries.

Do NOT take more than the recommended dose or use more often than prescribed. You must wait at least 4 hours after your last dose of Subsys spray before treating a NEW episode of breakthrough pain with Subsys spray.

Do not switch between Subsys spray and other medicines that contain fentanyl without first talking with your doctor. Different types of medicines that contain fentanyl may release different amounts of Subsys spray into your body. This may cause severe and possibly fatal overdose. Talk with your doctor or pharmacist for more information.


Subsys spray is used for:

Managing breakthrough pain in adult cancer patients who are already using and are tolerant to around-the-clock narcotic pain medicines.

Subsys spray is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use Subsys spray if:

  • you are allergic to any ingredient in Subsys spray or to any similar medicine (eg, sufentanil)
  • you have not been taking other narcotic pain medicines (eg, morphine, codeine) on a regular schedule
  • you have mild or short-term pain, including pain from injuries, surgery, dental pain, headache, or migraine
  • you are taking sibutramine or sodium oxybate (GHB)
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Subsys spray:

Some medical conditions may interact with Subsys spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mental or mood problems (eg, depression, schizophrenia), hallucinations, or suicidal thoughts or actions
  • if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury
  • if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney problems, sores or ulcers in your mouth, an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, low blood pressure, or seizures
  • if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence
  • if you have been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)

Some MEDICINES MAY INTERACT with Subsys spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), certain calcium channel blockers (eg, diltiazem, verapamil), cimetidine, crizotinib, macrolides (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nefazodone, other opioid medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), protease inhibitors (eg, ritonavir), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), or telithromycin because they may increase the risk of Subsys spray's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness
  • Serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur
  • Mixed agonist/antagonist analgesics (eg, pentazocine, buprenorphine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Subsys spray's effectiveness and withdrawal symptoms may occur
  • Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease Subsys spray's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Subsys spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Subsys spray:

Use Subsys spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Subsys spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Subsys spray refilled.
  • Subsys spray also comes with an additional patient leaflet with detailed instructions for use and disposal of Subsys spray. Talk to your pharmacist if you have questions about this information.
  • Subsys spray comes in several strengths. When you first start to use Subsys spray, your doctor may adjust your dose to find the dose that controls your pain the best. Be sure to follow the directions for using Subsys spray provided by your doctor. Do NOT change your dose of Subsys spray without checking with your doctor.
  • Each spray unit contains enough medicine for 1 spray. If your dose is 1 spray, you will use 1 unit for each dose. If your dose is 2 sprays, you will use 2 units for each dose.
  • Do not remove the spray unit from the blister package until you are ready to use it. Remove by cutting the dashed line with a pair of scissors.
  • To use a dose of Subsys spray, swallow any saliva in your mouth. Hold the spray unit upright with your thumb on the bottom and your first and middle fingers on the finger grips. Point the nozzle into your mouth and under your tongue. Squeeze your fingers and thumbs together to spray Subsys spray under your tongue. Hold the medicine under your tongue for 30 to 60 seconds. Do not spit out any medicine. Do not rinse your mouth.
  • If your dose is equal to 2 sprays of Subsys spray, repeat these steps.
  • After use, the spray unit will become locked. Dispose of it properly by placing it into one of the disposal bags provided in the carton containing the spray units. Remove the backing from the adhesive strip and fold the flap to seal the bag. Discard in the trash, out of the reach of children and away from pets.
  • If your breakthrough pain does NOT get better within 30 minutes after your dose, you may take a second dose as directed by your doctor. If your breakthrough pain does not get better after the second dose, contact your doctor. Do NOT take more than 2 doses per episode of breakthrough pain.
  • Wait at least 4 hours after your last dose of Subsys spray before treating a NEW episode of breakthrough pain. If you have more than 4 episodes of breakthrough pain per day, tell your doctor.
  • Remain on your around-the-clock narcotic pain medicine while you are taking Subsys spray as directed by your doctor. Contact your doctor if you stop taking your around-the-clock narcotic pain medicine for any reason.
  • Check with your doctor before including grapefruit or grapefruit juice in your diet while you use Subsys spray.
  • If you have unused spray units of Subsys spray that are no longer needed, follow the disposal directions in the additional patient leaflet that comes with Subsys spray. Ask your doctor or pharmacist if you are unsure how to dispose of unused medicine properly.
  • Subsys spray is usually used as needed. If you forget to use a dose of Subsys spray and you still have pain, use it when you remember and as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Subsys spray.

Important safety information:

  • Subsys spray may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Subsys spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Subsys spray.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Subsys spray; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Subsys spray may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Constipation is a common side effect of Subsys spray. Talk with your doctor about using laxatives or stool softeners while you use Subsys spray to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.
  • Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop using Subsys spray without checking with your doctor.
  • Tell your doctor or dentist that you use Subsys spray before you receive any medical or dental care, emergency care, or surgery.
  • Contact your doctor if your pain is not relieved or if it worsens after you use Subsys spray. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to Subsys spray so that your dose can be adjusted if needed.
  • Do not switch between Subsys spray and other medicines that contain fentanyl without first talking to your doctor. Different types of medicines that contain fentanyl may release different amounts of Subsys spray into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.
  • Use Subsys spray with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Subsys spray can be harmful, even fatal, if used in CHILDREN. Keep Subsys spray out of the reach of children.
  • PREGNANCY and BREAST-FEEDING: Subsys spray may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Subsys spray while you are pregnant. Subsys spray is found in breast milk. Do not breast-feed while using Subsys spray.

When used for long periods of time or at high doses, Subsys spray may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Subsys spray stops working well. Do not take more than prescribed.

Some people who use Subsys spray for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Subsys spray, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Subsys spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; nausea; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody vomit; blurred vision; chest pain; confusion; decreased, difficult, or painful urination; decreased sense of touch; difficulty swallowing; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes (eg, depression); seizures; severe or persistent dizziness, drowsiness, or headache; severe or persistent stomach pain; shortness of breath; slowed, shallow, or trouble breathing; sluggishness; swelling of the hands, ankles, or feet; throat pain; tremors; unusual bruising or bleeding; unusual weakness or tiredness; white patches or sores on the tongue or mouth.

If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Proper storage of Subsys spray:

Store Subsys spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original blister package, away from heat, moisture, and light. Do not store in the bathroom. Do not remove units from the blister package for storage in a temporary container. Keep Subsys spray out of the reach of children and away from pets.

General information:

  • If you have any questions about Subsys spray, please talk with your doctor, pharmacist, or other health care provider.
  • Subsys spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Subsys spray or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Subsys spray. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Subsys spray. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Subsys spray.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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