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Subsys
Subsys (generic name: fentanyl sublingual spray) is a potent opioid analgesic used to manage breakthrough pain in cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy for chronic pain. Subsys is part of the fentanyl family, which is an extremely powerful synthetic opioid. It is intended for patients who require immediate pain relief due to sudden and intense episodes of pain that "break through" their regular pain management regimen.
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Frequently Asked Questions
How quickly does Subsys work?
Subsys provides pain relief within 5 to 15 minutes after administration due to its rapid sublingual absorption, making it highly effective for breakthrough pain episodes.
Can I use Subsys if I’m not taking other opioids?
No, Subsys is only intended for opioid-tolerant patients who are already receiving chronic opioid therapy for cancer pain. It should never be used by individuals who are opioid-naive.
How many doses of Subsys can I take per day?
Patients should not exceed four doses per day of Subsys for breakthrough pain. Any concerns about pain management should be discussed with a healthcare provider.
Can I drive while using Subsys?
Subsys may cause significant drowsiness or sedation, impairing your ability to drive or operate heavy machinery. Do not drive until you know how Subsys affects you.
What should I do if I suspect an overdose?
An overdose of Subsys can cause life-threatening respiratory depression. If you suspect an overdose, seek emergency medical attention immediately and administer naloxone (an opioid overdose reversal agent) if available.
Comprehensive Drug Guide
How Does Subsys Work?
Subsys contains fentanyl, a synthetic opioid that works by binding to mu-opioid receptors in the brain and spinal cord. This binding results in a powerful reduction in pain perception and alters the body’s response to pain. Fentanyl’s potency and fast onset of action make Subsys particularly effective for treating breakthrough pain in cancer patients who are opioid-tolerant.
Common Dosages
- 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg per spray.
Typical Dosing
- Initial dosing: The starting dose for Subsys in opioid-tolerant patients is typically 100 mcg, administered under the tongue.
- Doses can be titrated up in increments, with a physician’s guidance, based on the patient’s pain response and tolerance, but should not exceed four doses per day.
- Patients are monitored closely to adjust the dose to the lowest effective dose that controls pain.
Typical Dosing
FDA Approved Indications
- The management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to around-the-clock opioid therapy for chronic cancer pain.
Who Shouldn't Take Subsys?
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
- Significant respiratory depression without ventilatory support.
- Known hypersensitivity to fentanyl or any components of the product.
- Opioid-naive patients: Subsys should only be used in patients who are already opioid-tolerant.
Advice From The Pharmacist
- Subsys is intended for sublingual use only and should never be swallowed or inhaled. Place the spray under the tongue and allow it to fully absorb without rinsing or swallowing immediately.
- Patients should avoid consuming alcohol or using other central nervous system depressants (such as sedatives or benzodiazepines) while using Subsys, as this can increase the risk of severe respiratory depression or fatal overdose.
- Subsys carries a high risk of dependence, abuse, and overdose, so it should only be used as prescribed by a healthcare provider. Ensure it is kept in a secure place away from children or unauthorized individuals.
Side Effects of Subsys
Common Side Effects
- Nausea or vomiting
- Constipation
- Drowsiness or sedation
- Dizziness
- Headache
- Dry mouth
Uncommon/Severe Side Effects
- Respiratory depression: Fentanyl can cause life-threatening breathing difficulties, especially in opioid-naive individuals or when combined with other depressants.
- Addiction and dependence: Subsys carries a high risk for addiction, even when used as prescribed.
- Severe hypotension: Low blood pressure can occur, especially in those with underlying cardiovascular conditions.
Risks and Warnings of Subsys
- Respiratory Depression and Overdose: Subsys, like other fentanyl products, can cause profound respiratory depression, which can be fatal. Patients using Subsys must be opioid-tolerant and monitored closely for signs of overdose.
- Addiction, Abuse, and Misuse: Subsys carries a high potential for abuse and dependence. Even patients using the medication as prescribed should be monitored for signs of misuse.
- Medication Errors: It is important to only use the prescribed dose and follow instructions exactly to avoid dangerous dosing errors.
- Interactions with CNS Depressants: Use of Subsys with other central nervous system depressants, including alcohol and benzodiazepines, significantly increases the risk of sedation, respiratory depression, coma, and death.
Interactions with Subsys
Common Drug Interactions
- CNS depressants: Co-administration with sedatives, alcohol, or benzodiazepines increases the risk of respiratory depression and death.
- Cytochrome P450 3A4 inhibitors: Medications that inhibit CYP3A4, such as ketoconazole or ritonavir, can increase fentanyl levels, raising the risk of severe side effects or overdose.
- MAO inhibitors: Use of Subsys with monoamine oxidase inhibitors (MAOIs) can cause dangerous interactions, including serotonin syndrome.
Alternatives to Subsys
- Actiq (fentanyl lozenge): Another fast-acting fentanyl product used to treat breakthrough cancer pain in opioid-tolerant patients.
- Fentora (fentanyl buccal tablet): A buccal form of fentanyl used for breakthrough cancer pain in opioid-tolerant patients.
- Lazanda (fentanyl nasal spray): A fentanyl nasal spray used for the same indication as Subsys but administered intranasally.
- Morphine: A long-acting opioid commonly used in chronic pain management but with different pharmacokinetics compared to fentanyl.
