SUBSYS® is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage breakthrough pain in cancer patients 18 years of age and older who are already routinely taking other opiod pain medicines around-the-clock for cancer pain. SUBSYS is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use SUBSYS if you are not opioid tolerant.
SUBSYS is prescribed when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. SUBSYS is an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
IMPORTANT SAFETY INFORMATION
Get emergency help right away if you take too much SUBSYS (overdose). When you first start taking SUBSYS, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking SUBSYS with other opioid medicines, that may make you sleepy, such as other pain medicines, antidepressants, sleeping pills, antianxiety medicines, antihistamines, or tranquilizers, or with alcohol or street drugs can cause severe drowsiness, confusion, breathing problems, coma, and death.
Never give anyone else your SUBSYS. They could die from taking it. Store SUBSYS away from children and in a safe place to prevent stealing or abuse.
Selling or giving away SUBSYS is against the law.
If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using SUBSYS. You may no longer be opioid tolerant. Talk to a healthcare provider about how to treat your pain.
Because of the risk for misuse, abuse, addiction, and overdose, SUBSYS is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive SUBSYS, you must:
Talk to your healthcare provider
Understand the benefits and risks of SUBSYS.
Agree to all of the instructions.
Sign the Patient-Prescriber Agreement form.
For more information about the TIRF REMS ACCESS program, go to www.TIRFREMSaccess.com or call 1-866-822-1483.
SUBSYS is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your SUBSYS prescription filled.
Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, antidepressants, sleeping pills, antianxiety medicines, antihistamines, or tranquilizers.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
SUBSYS can cause life-threatening breathing problems which can lead to death.
Do not take SUBSYS if:
You are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for your cancer pain, and your body is used to these medicines.
You have severe asthma, trouble breathing, or other lung problems.
You have a bowel blockage or have narrowing of the stomach or intestines.
You have a short-term pain that you would expect to go away in a few days, such as:
Pain after surgery
Headache or migraine
You have an allergy to any of the ingredients in SUBSYS (fentanyl, dehydrated alcohol 63.6%, purified water, propylene glycol, xylitol, and L-menthol).
Before using SUBSYS, tell your healthcare provider if you have a history of:
Trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
Head injury, seizures
Liver, kidney, thyroid problems
Pancreas or gallbladder problems
Abuse of street or prescription drugs, alcohol addiction
Mental problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
Slow heart rate or other heart problems
Low blood pressure
Tell your healthcare provider if you are:
Pregnant or planning to become pregnant. Prolonged use of SUBSYS during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
Breastfeeding. SUBSYS passes into breast milk and may harm your baby.
Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking SUBSYS with certain other medicines can cause serious side effects that could lead to death.
Do not take any medicine while using SUBSYS until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using SUBSYS.
Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, antidepressants, sleeping pills, antianxiety medicines, antihistamines, muscle relaxants, or tranquilizers.
When taking SUBSYS:
Do not change your dose. Take SUBSYS exactly as prescribed by your healthcare provider. See detailed “Instructions for Use” for information about how to take SUBSYS.
Use SUBSYS exactly as prescribed by your healthcare provider. Do not use more than 2 doses of SUBSYS for each episode of breakthrough cancer pain. You must wait four hours before treating a new episode of breakthrough pain with SUBSYS.
Your healthcare provider will prescribe a starting dose of SUBSYS that may be different than other fentanyl containing medicines you may have been taking.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking SUBSYS without talking to your healthcare provider.
After you stop taking SUBSYS, see the “Instructions for Use” section at the end of the Medication Guide for information about the right way to dispose of SUBSYS when no longer needed.
Do not drive, operate heavy machinery, or do other dangerous activities until you and your healthcare provider know how SUBSYS affects you. SUBSYS can make you sleepy, dizzy, or lightheaded.
Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol while using SUBSYS. Using products containing alcohol during treatment with SUBSYS may cause you to overdose and die.
Do not switch from SUBSYS to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of SUBSYS is not the same as the amount of fentanyl in other medicines that contain fentanyl.
Possible side effects of SUBSYS:
The most common side effects of SUBSYS are:
Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, weakness, anxiety, depression, rash, trouble sleeping, low red blood cell count, swelling of the arms, hands, legs and feet. Call your healthcare provider if you have any of these symptoms and they are severe.
Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
These are not all the possible side effects of SUBSYS.
Breathing problems that can become life-threatening
Get emergency medical help if you have:
Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion
These symptoms can be a sign that you have used too much SUBSYS or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not use any more SUBSYS until you have talked to your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov.
Thank you for your interest in the SUBSYS (fentanyl sublingual spray) card.
You must be at least 18 years of age and Privately Insured to participate in the SUBSYS Patient Savings Program. For more information please contact Trial Card at 1-855-766-6502.
SUBSYS SPECIALTY PHARMACY NETWORK
SUBSYS is available through retail pharmacies as well as a Specialty Pharmacy Network that offers Patient Co-Pay Assistance programs, Prior Authorization Assistance and Compassionate Patient programs. Please contact your physician’s staff for an updated list of INSYS’ specialty pharmacy partners.
For questions on the SUBSYS CARES program call: 1-800-200-2332
INSYS Ancillary Services
INSYS Patient Services Center
If you have been prescribed an INSYS product, we are here to help you.
Take advantage of other resources and programs available to you such as:
- Programs for under-insured patients
- Specialty Pharmacy identification
Please download, print, sign and fax the consent form to: (844) 793-4412.