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FAQ

What causes breakthrough cancer pain?

Breakthrough cancer pain, or BTCP, is brought on by many different factors and varies from patient to patient. Some cancer patients experience BTCP as a result of "incident pain" or after doing an activity such as walking, lifting, etc. Many patients have BTCP for no apparent reason.

How do I treat breakthrough cancer pain?

One treatment option for BTCP is SUBSYS, a transmucosal immediate release fentanyl medication that works quickly and lasts about as long as a breakthrough pain episode. Rapid-onset opioid medicine for breakthrough pain medication is taken on an as-needed basis and should be customized to when the flare starts, how long it lasts, and the patient's tolerance.

Does SUBSYS replace my current medication for my constant pain?

No, SUBSYS is created to work along with your current prescribed pain medication and to ease your BTCP. In fact, patients must remain on their around-the-clock opioid when taking SUBSYS.

Why won't my prescribed painkillers treat breakthrough cancer pain?

Treating BTCP by simply raising the dose of a traditionally prescribed long-acting pain medicine may result in overmedication and increased side effects such as constipation, sedation and confusion.

How does this spray work?

SUBSYS is a fentanyl sublingual transmucosal medicine, which means the fentanyl medication is quickly absorbed underneath the tongue. It minimizes the amount swallowed and absorbed in the stomach or intestines like traditional oral medications.

What is a Prior Authorization (PA)?

In an effort to control costs, Managed Care Organizations (MCOs) often limit access to brand-name medications, which can often cost more than generic medications. Prior Authorizations are one type of MCO process aimed at managing access to certain drugs only to those who truly need them. MCOs may require a prior approval with a medical justification, especially in instances when a less expensive option is available.

What is the INSYS Reimbursement Center?

A dedicated team of Prior Authorization Specialists will assist with logistics throughout the Prior Authorization process. Your Healthcare Provider must "opt-in" to the INSYS Reimbursement Center (IRC) program by signing Health Insurance Portability and Accountability Act (HIPAA) compliant forms for each patient. He or she is also responsible for providing any medical necessity justifications. The services conducted by the IRC are provided at no cost to the patient or healthcare provider. Additionally, the patient may be eligible for free product during the period of time when the Prior Authorization is in process.

How does the Prior Authorization process work?
  1. A healthcare provider prescribes a medication.
  2. The prescription is presented at the pharmacy.
  3. The pharmacist enters the medication information into the computer system.
  4. The pharmacist may receive notification from an MCO that a Prior Authorization is required (the prescription is denied until a healthcare provider provides a justification as to why the medication is needed).
  5. The pharmacist informs the patient and calls the healthcare provider's office.
  6. The healthcare provider then either allows the pharmacist to switch to a medication currently approved by the MCO, or informs the pharmacist he or she will request approval from the MCO (the Prior Authorization).
  7. The healthcare provider completes the appropriate forms and/or calls the MCO to seek approval.
  8. The MCO either approves or denies the request for medication. If denied, the healthcare provider and the patient may appeal the denial.
What does a patient have to do to seek Prior Authorization approval for SUBSYS?

Nothing. A healthcare provider or a staff member in their office will need to opt the patient into the INSYS Reimbursement Center by filling out the appropriate form. A dedicated specialist will assist with logistics throughout the PA process.

What if the Prior Authorization is denied?

If a Prior Authorization is denied, a healthcare provider and/or the patient can appeal the denial to the MCO by resubmitting the Prior Authorization form and offering additional medical justification. This is called a letter of medical necessity. If a patient and/or healthcare provider disagrees with the MCO denial, they may request an external review from a state board.

SUBSYS® is a prescription medication that contains fentanyl and is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain and who are opioid tolerant. Patients must stay under their healthcare provider's care while taking SUBSYS.

SUBSYS is only available through the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program.

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IMPORTANT RISK INFORMATION

IMPORTANT:
Do not use SUBSYS unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep SUBSYS in a safe place away from children. Get emergency medical help right away if:

  • A child uses SUBSYS -- SUBSYS can cause an overdose and death in any child who uses it
  • An adult who has not been prescribed SUBSYS uses it
  • An adult who is not already taking opioids around-the-clock, uses SUBSYS

These are medical emergencies that can cause death.

SUBSYS is a prescription medication that contains fentanyl and is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain and who are opioid tolerant.  Patients must stay under their healthcare provider's care while taking SUBSYS.

SUBSYS is only available through the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program.

SUBSYS can cause life-threatening breathing problems which can lead to death.

  • Do not take SUBSYS if you are not opioid tolerant.
  • 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.
  • Use SUBSYS exactly as prescribed by your healthcare provider.
  •  Do not take more than 2 doses of SUBSYS for each episode of breakthrough cancer pain.
  • Wait 4 hours before treating a new episode of breakthrough cancer 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 that in other medicines that contain fentanyl. Your starting dose of SUBSYS 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.

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 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, and sign the Patient-Prescriber Agreement form.

Do not use SUBSYS:

  • If you are not opioid tolerant
  • For short-term pain that you would expect to go away in a few days
  • If you are allergic to any of the ingredients in SUBSYS

Before using SUBSYS, tell your healthcare provider 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 plan to become pregnant. SUBSYS may cause serious harm to your unborn baby
  • 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

Tell your healthcare provider 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.

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, anti-depressants, sleeping pills, anti-anxiety medicines, antihistamines, muscle relaxants, or tranquilizers.

Do not drive, operate heavy machinery, or do other dangerous activities until you and your healthcare provider know how SUBSYS affects you.

Do not drink alcohol while using SUBSYS. It can increase your chance of getting dangerous side effects.

Possible side effects of SUBSYS:

Breathing problems that can become life-threatening

Call your healthcare provider 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 healthcare provider.

  • 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 healthcare provider. 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 (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including SUBSYS and is unlikely to go away without treatment.  Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using SUBSYS.

These are not all the possible side effects of SUBSYS.

Tell your healthcare provider if you have any side effects. For more information, ask your healthcare provider or pharmacist or visit www.subsysspray.com for the Medication Guide and the full Prescribing Information for SUBSYS.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 or fax to 1-800-FDA-0178.