Warnings:

Fentanyl has a risk for abuse and addiction, which can lead to overdose and death. Fentanyl may also cause severe, possibly fatal, breathing problems. Do not use this product unless you have been regularly taking moderate to large amounts of opioid pain medication. Otherwise, it may cause overdose (even death). To lower your risk, your doctor should have you use the smallest dose of fentanyl that works, and use it for the shortest possible time. See also How to Use section for more information about addiction.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you use the wrong dose/strength. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to use fentanyl and what other drugs you should avoid using with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Carefully follow the specific directions for using fentanyl sublingual spray. Different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that might affect breathing or that can affect how fentanyl works. Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally uses or swallows this drug, get medical help right away.

Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program before receiving your prescription. Only doctors and pharmacies enrolled in this program may prescribe or dispense this medication. Ask your doctor or pharmacist for details.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Uses

See also Warning section.This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

How to use Subsys Spray, Non-Aerosol

See also Warning section.

Read the Medication Guide and the Instructions For Use Leaflet provided by your pharmacist before you start using fentanyl and each time you get a refill. Learn all preparation, usage, and disposal instructions. If you have any questions, ask your doctor or pharmacist.

Open the blister package with scissors right before using this medication. Swallow any saliva in your mouth. Spray the medication in your mouth underneath the tongue. Hold the medication under your tongue for 30 to 60 seconds. Do not spit out the medication or rinse out your mouth after using the spray.

Use this medication as directed by your doctor. If the pain is not relieved 30 minutes after using this medication, you may take another dose. Do not use more than 2 doses of this medication for each episode of breakthrough pain. Tell your doctor if you do not get pain relief within 30 minutes of using the second dose of this medication or if you have another episode of breakthrough pain within 4 hours of using this medication. You must wait at least 4 hours before using this medication again to treat another episode of breakthrough pain. Follow your doctor's instructions on taking another medication to treat the pain before you can use this medication again.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor will direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You should continue to also take your long-acting opioid medication as directed by your doctor. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using fentanyl safely with other drugs.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain does not get better or if it gets worse, or if you have more than 4 episodes of breakthrough pain daily, or if you need to use 2 doses of medication for each episode of pain.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.