Subsys

• Risk factors: Personal or family history of alcohol or substance use disorder | Personal or family history of mental health problems

Subsys (fentanyl) is a controlled substance that has a risk for addiction and misuse. Take the medication exactly as prescribed. Don't change the dose or how often you take it without talking to your provider first.

Misusing Subsys (fentanyl) might cause it to work less well. It can also raise the risk for serious and possibly life-threatening side effects, such as dangerously slow breathing, inability to stay awake, and opioid overdose. Your healthcare provider will prescribe the lowest amount of Subsys (fentanyl) that's necessary to manage your pain for the shortest period of time possible.

Because of the risk for misuse, addiction, and overdose, Subsys (fentanyl) is included in the Risk Evaluation and Mitigation Strategy (REMS) program called the Transmucosal Immediate Release Fentanyl (TIRF) REMS program. Healthcare providers and pharmacies must register with the program, receive training on proper medication use, and discuss safe medication use with you.

• Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Older age | Being frail | Medical conditions that cause breathing problems (e.g., COPD, asthma, head injury) | Taking too much Subsys (fentanyl)

Opioids like Subsys (fentanyl) can cause dangerously slow breathing, which can be life-threatening. This can happen to anyone at recommended doses. But the risk is greatest when you first start treatment or if your dose goes up.

Don't take an opioid with alcohol or other medications that slow your body down (e.g., benzodiazepines, other opioids, muscle relaxants). Doing so raises your risk of extremely slowed breathing.

Your provider might prescribe naloxone (Narcan), a medication that can reverse slowed breathing from opioids. Carry it with you at all times in case you have breathing problems from the opioid medication. If you or your loved one notices that you have trouble breathing or bluish-colored lips, fingers, or toes, use naloxone if you have it and call 911 to get medical help right away.

• Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of Subsys (fentanyl) | Taking more opioids than prescribed | Alcohol use

Take opioid medications exactly as prescribed. Taking too much or taking it more often than prescribed can lead to an overdose. In addition, it can be especially dangerous if a child accidentally ingests opioid medications, such as Subsys (fentanyl). Store your medication out of reach from children, pets, or visitors to prevent accidental exposure or overdose.

Symptoms of an opioid overdose include not responding to sound or touch, extremely slowed breathing, extreme sleepiness, slow heartbeat, and cold or clammy skin. Be sure you and your loved ones know how to recognize an overdose. Your provider will probably prescribe naloxone (Narcan), a medication that can treat an opioid overdose. Carry naloxone with you at all times in case an overdose happens, and call 911 right away if this happens.

• Risk factors: Taking high doses of Subsys (fentanyl) | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness

Opioids can cause extreme sleepiness and lower your ability to think, react, and focus. Don't drink alcohol or take other medications that can cause sleepiness or "brain fog" (e.g., benzodiazepines, muscle relaxants, sleep medications) with Subsys (fentanyl). Doing so can worsen these side effects. Make sure you know how your opioid medication affects you before driving a car or doing activities that require your concentration. Talk to your healthcare provider right away if you feel too sleepy from taking Subsys (fentanyl).

Long-term use of opioids during pregnancy can cause your unborn baby to become dependent on the medication. This is because the opioid (fentanyl) can pass through the placenta to your unborn baby. Once your baby is born, they can experience withdrawal symptoms, such as high-pitched crying, poor feeding and sucking behavior, trembling, abnormal sleep patterns, and seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare provider know if you've used Subsys (fentanyl) or other opioids during pregnancy or if you notice these symptoms in your baby.

Tell your providers about all of the medications you're taking or planning to take with opioids like Subsys (fentanyl). Taking certain medications with opioids or changing your medication routine can raise your risk for dangerous side effects. Benzodiazepines, sedatives, and alcohol can worsen opioid side effects like slow breathing or severe sleepiness and can be life-threatening. In addition, taking opioids like Subsys (fentanyl) with certain antidepressants can also raise your risk of serotonin syndrome, a rare but serious side effect that can lead to fast heart rate, sweating, and muscle problems.

• Risk factors: Long-term use of Subsys (fentanyl)

Opioids like Subsys (fentanyl) can cause physical dependence when they're taken for a long time. This means that your body relies on the medication to function. You might experience withdrawal if you stop taking the medication suddenly or lower your dose too fast.

Withdrawal symptoms include anxiety, restlessness, irritability, sweating, and chills. Don't lower your dose or stop taking the medication suddenly without talking to your healthcare provider first. Your provider will slowly lower your dose to prevent withdrawal symptoms. Talk to your provider about alternative pain medications if you have concerns about the risk for dependence and withdrawal from opioid use.

Subsys (fentanyl) and other opioids can cause extremely low blood pressure. Your blood pressure might drop suddenly when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. Talk to your healthcare provider if dizziness or lightheadedness doesn't go away.

• Risk factors: Taking Subsys (fentanyl) for longer than 1 month

Some people taking opioids like Subsys (fentanyl) had low adrenal hormone levels. This might be more likely to happen after taking opioids for longer than 1 month. Symptoms include tiredness, dizziness, weakness, not feeling hungry, nausea, and vomiting. Let your provider know if you have these symptoms. If your adrenal hormone levels are too low, you might need to stop Subsys (fentanyl) and be treated with corticosteroids.

• Risk factors: History of seizure conditions

If you've had a seizure in the past, opioids can raise the risk of having seizures more often. Subsys (fentanyl) can also raise your risk of seizures in certain situations. Get medical help immediately if you have a seizure while you're taking this medication.