Active ingredient: fentanyl
Inactive ingredients: dehydrated alcohol 63.6%, purified water, propylene glycol, xylitol, and L-menthol.
If you use too much Subsys or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room right away.
Tell your doctor if you are pregnant or plan to become pregnant. Subsys may cause serious harm to your unborn baby.
- Always keep Subsys in a safe place away from children and from anyone for whom it has not been prescribed. Protect Subsys from theft.
- Store Subsys at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
- Keep Subsys in the original blister package. Do not remove Subsys units from the blister packages for storage in a temporary container.
- Use the Subsys Child Safety Kit to help you store Subsys and your other medicines out of the reach of children. It is very important that you use the items in the Subsys Child Safety Kit to help protect the children in your home or visiting your home.
- Call Insys Therapeutics, Inc. at 1-877-978-2797 fora Subsys Child Safety Kit.
The Subsys Child Safety Kit contains important information on the storage and handling of Subsys.
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.
- 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 your healthcare provider about how to treat your pain.
- Use Subsys exactly as prescribed by your healthcare provider.
- You must 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.
- 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. Your healthcare provider will prescribe a starting dose of Subsys that may be different than other fentanyl containing medicines you may have been taking.
- Do not use Subsys for short-term pain that you would expect to go away in a few days, such as:
- pain after surgery
- headache or migraine
- dental pain
- Never give Subsys to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
Subsys is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.
- Prevent theft, misuse or abuse. Keep Subsys in a safe place to protect it from being stolen. Subsys can be a target for people who abuse opioid (narcotic) medicines or street drugs.
- Selling or giving away this medicine is against the law.
Subsys is available only through a program called the TIRF 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
Subsys can cause serious side effects, including:
- Breathing problems that can become life-threatening. See “Drug Precautions”.
- Call your doctor or get emergency medical help right away if you:
- have trouble breathing
- have drowsiness with slowed breathing
- have shallow breathing (little chest movement with breathing)
- feel faint, very dizzy, confused, or have other unusual symptoms
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 doctor.
- Call your doctor or get emergency medical help right away if you:
- Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
- Physical dependence. Do not stop using Subsys or any other opioid, without talking to your doctor. You could become sick with withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
- A chance of abuse or addiction. This chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.
The most common side effects of Subsys are:
- nausea
- vomiting
- shortness of breath
- sleepiness
- dizziness
- headache
- constipation
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Subsys. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Respiratory Depression
Fatal respiratory depression has occurred in patients treated with transmucosal immediate-release fentanyl products such as Subsys, including following use in opioid non-tolerant patients and improper dosing. The substitution of Subsys for any other fentanyl product may result in fatal overdose.
Due to the risk of respiratory depression, Subsys is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.
Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. Subsys must be kept out of reach of children.
The concomitant use of Subsys with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
Medication Errors
Substantial differences exist in the pharmacokinetic profile of Subsys compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to Subsys.
- When dispensing, do not substitute a Subsys prescription for other fentanyl products.
Abuse Potential
Subsys contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.
Subsys can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Subsys in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Because of the risk for misuse, abuse, addiction, and overdose, Subsys is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
Tell your doctor if you are breastfeeding or plan to breastfeed. Subsys can pass into your breast milk. It can cause serious harm to your baby. You should not use Subsys while breastfeeding.
Subsys (generic: fentanyl) is a prescription medication used to treat breakthrough pain (sudden temporary flares of pain) in adults with cancer who are already taking other opioid pain medicines around-the-clock for cancer pain. This medicine belongs to a group of drugs called opioid narcotic analgesics which help to relieve pain by binding to certain opioid receptors in the body.
This medication comes in liquid form to be sprayed under the tongue every 4 hours as needed.
Common side effects of Subsys include nausea, vomiting, constipation, and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you.
Subsys is a prescription medicine used to manage breakthrough pain in adults with cancer, who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
The recommended starting Subsys dose is 100 mcg. You may take one additional dose after waiting 30 minutes, if needed. Do not take more than 2 doses per breakthrough pain episode. After taking 2 doses, you must wait at least 4 hours before taking another dose.
If after taking the 100 mcg dose your pain is adequately relieved then your dose will remain at 100 mcg every 4 hours. If necessary, your dosage may be slowly increased. Generally, the Subsys dose is only increased when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.
Normally, Subsys is increased from 100 mcg to 200 mcg. If further increase is necessary your Subsys dose may be increased to 400 mcg. Further increases are sometimes required.
Before using Subsys, tell your doctor if you:
- have sores or ulcers in your mouth
- have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
- have or had a head injury or brain problem
- have liver or kidney problems
- have seizures
- have a slow heart rate or other heart problems
- have low blood pressure
- have mental health problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
- have a past or present drinking problem (alcoholism), or a family history of drinking problems
- have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem
- have any other medical conditions
- are pregnant or breastfeeding
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with Subsys. Sometimes, the doses of certain medicines and Subsys may need to be changed if used together.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Subsys there are no specific foods that you must exclude from your diet when receiving Subsys.
Before you can begin to use Subsys:
- Your doctor will explain the TIRF REMS ACCESS program to you.
- You will sign the TIRF REMS ACCESS program Patient-Prescriber Agreement form.
- 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.
Using Subsys:
- Use Subsys exactly as prescribed. Do not use Subsys more often than prescribed.
- Subsys comes in several strengths. When you are first prescribed Subsys, your doctor will start you with the lowest strength medicine, and will change the dose until you and your healthcare provider find the right dose for you. Do not change your dose of Subsys unless your healthcare provider tells you to. Each Subsys unit contains enough medicine for 1 spray.
- As your dose is adjusted, your doctor will tell you whether your dose of Subsys is 1 or 2 sprays given underneath the tongue.
- If your dose of Subsys is 1 spray, then you will use 1 Subsys unit for each dose.
- If your dose of Subsys is 2 sprays, then you will use 2 Subsys units for each dose.
- Take 1 dose of Subsys when you get an episode of breakthrough cancer pain.
- If you are still in pain after 30 minutes, take 1 more dose of Subsys as instructed by your healthcare provider.
- Do not take more than 2 doses of Subsys for an episode of breakthrough cancer pain. If your breakthrough pain does not get better after the second dose of Subsys, call your healthcare provider for instructions. Do not use another dose of Subsys at this time.
- Wait at least 4 hours before treating a new episode of breakthrough cancer pain with Subsys.
- Keep taking your around-the-clock opioid pain medicine while taking Subsys.
- If you have more than 4 episodes of breakthrough cancer pain in a day, talk to your doctor. The dose of your around-the-clock opioid pain medicine may need to be adjusted.
What to avoid while using Subsys:
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how Subsys affects you. Subsys can make you sleepy. Ask your healthcare provider when it is okay to do these activities.
- Do not drink alcohol while using Subsys. It can increase your chance of getting dangerous side effects.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines that may make you sleepy, such as:
- other pain medicines
- anti-depressants
- sleeping pills
- anti-anxiety medicines
- antihistamines
- muscle relaxants
- tranquilizers
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
This is not a complete list of Subsys drug interactions. Ask your doctor or pharmacist for more information.