subsys

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 medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Subsys may also be used for purposes not listed in this medication guide.

Important information

Do not use Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of Subsys (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.

Keep Subsys out of the reach of children. The amount of fentanyl in each Subsys spray unit can be fatal to a child.

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.

Before using Subsys

Do not take Subsys 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.

You should not use this medicine if you are allergic to fentanyl.

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.

Fentanyl may be habit-forming, even at regular doses. Never share Subsys with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Subsys to any other person is against the law.

To make sure Subsys is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

• low blood pressure, slow heartbeats or other heart rhythm disorder;

• mental illness such as depression, schizophrenia, or hallucinations;

• a personal or family history of drug or alcohol addiction;

• liver or kidney disease; or

• mouth sores or ulcers.

Tell your doctor if there are children living in the home where you will store this medicine. Keep out of the reach of children. The amount of fentanyl in each Subsys spray unit can be fatal to a child.

Subsys is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use Subsys while you are pregnant, your baby could become dependent on fentanyl. 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

Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while you are using this medicine.

How should I take Subsys?

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. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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.

<<p>You must wait at least 4 hours after your last dose of Subsys before you can treat a new pain episode.

Do not treat more than 4 pain episodes per day with Subsys. Call your doctor if you have breakthrough pain more than 4 times in one day.

Do not stop using Subsys suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store in the original carton at room temperature, away from heat and moisture. 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 out of the reach of children. The amount of fentanyl in each Subsys spray unit can be fatal to a child.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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 drowsiness, weak pulse, and slow breathing (breathing may stop).

What should I avoid?

This medication 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 can occur when alcohol is combined with fentanyl.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while using Subsys.

Subsys side effects

Get emergency medical help if you have any signs of an allergic reaction to Subsys: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow heart rate, weak or shallow breathing, sighing, severe drowsiness;

• confusion, extreme fear, unusual thoughts or behavior; or

• a light-headed feeling, like you might pass out.

Common Subsys side effects may include:

• constipation, nausea;

• drowsiness; or

• headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Subsys?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using Subsys with a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not take fentanyl if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with Subsys, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your medications and any you start or stop using during treatment.