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SUBSYS
Overview
What is SUBSYS?
SUBSYS (fentanyl sublingual spray) is an opioid agonist, available as a sublingual spray designed to deliver doses of 100, 200, 400, 600, 800, 1200 and 1600 mcg of fentanyl. The chemical name of fentanyl is N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide.
Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 860:1) that is freely soluble in ethanol and methanol and practically insoluble in water (1:40). The molecular weight of the free base is 336.47. The pKa is 8.4.
The inactive ingredients in SUBSYS include: dehydrated alcohol 63.6% (V/V), purified water, propylene glycol, xylitol, and L-menthol.
What does SUBSYS look like?
What are the available doses of SUBSYS?
Sublingual spray in 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg dosage strengths. ()
What should I talk to my health care provider before I take SUBSYS?
How should I use SUBSYS?
SUBSYS is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS.
Limitations of Use:
Patients must require and use around-the-clock opioids when taking SUBSYS. ()
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ()
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
Initiate treatment with 100 mcg except patients already using Actiq. ()
Individually titrate to a tolerable dose that provides adequate analgesia using a single SUBSYS dose per breakthrough cancer pain episode. ()
No more than two doses can be taken per breakthrough pain episode. ()
Wait at least 4 hours before treating another episode of breakthrough pain with SUBSYS. ()
Limit consumption to four or fewer doses per day once successful dose is found. ()
When opioid therapy is no longer required, consider discontinuing SUBSYS along with a gradual downward titration of other opioids to minimize possible withdrawal effects. ().
What interacts with SUBSYS?
Sorry No Records found
What are the warnings of SUBSYS?
Sorry No Records found
What are the precautions of SUBSYS?
Sorry No Records found
What are the side effects of SUBSYS?
Sorry No records found
What should I look out for while using SUBSYS?
SUBSYS is contraindicated in:
Life-Threatening Respiratory Depression
Serious, life-threatening, and/or fatal respiratory depression has occurred in patients treated with SUBSYS, including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, especially during initiation of SUBSYS or following a dose increase. 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.
Accidental INGESTION
Accidental ingestion of even one dose of SUBSYS especially by children, can result in a fatal overdose of fentanyl .
Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. SUBSYS must be kept out of reach of children
Cytochrome P450 3A4 Interaction
The concomitant use of SUBSYS with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving SUBSYS and any CYP3A4 inhibitor or inducer .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
Risk of 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 .
Addiction, Abuse, and Misuse
SUBSYS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing SUBSYS, and monitor all patients regularly for the development of these behaviors and conditions .
Risk Evaluation and Mitigation Strategy (REMS) Access Program
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.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of SUBSYS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [].
What might happen if I take too much SUBSYS?
Clinical Presentation
Acute overdose with SUBSYS be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [.
Treatment of Overdose
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to fentanyl overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in SUBSYS, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle SUBSYS?
Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807Store between 5°-25°C (41°-77°F). Protect from light.Manufactured by:Actavis Elizabeth LLC200 Elmora Avenue, Elizabeth, NJ 07207 USA8013101/0108Repackaged byPreferred Pharmaceuticals, IncAnaheim, CA 92807SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.SUBSYS (fentanyl sublingual spray) is supplied as spray units. Each SUBSYS carton contains individual blister packages containing spray units of SUBSYS, a supply of small white disposal bags for disposing of used SUBSYS units and charcoal-lined disposal pouches, a supply of charcoal-lined disposal pouches (wrapped in aluminum foil) for use when disposing of the contents of unused SUBSYS units, a Medication Guide and a Package Insert. SUBSYS is supplied in individually sealed, protective blister packages. These blister packages are packed into 10 and 30 per shelf cartons.Each unit dose system consists of a white actuator attached to a light purple vial holder. The dosage strength is marked on the label on the actuator, the blister package and the shelf carton. See the protective blister package and shelf carton for product information.Note: Colors are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing.Storage and HandlingStore at 20-25ºC (68-77ºF) with excursions permitted between 15º and 30ºC (59º to 86ºF) until ready to use. [See USP Controlled Room Temperature.] Do not use if the blister package has been opened.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fentanyl is an opioid agonist whose principal therapeutic action is analgesia.
Non-Clinical Toxicology
SUBSYS is contraindicated in:Life-Threatening Respiratory Depression
Serious, life-threatening, and/or fatal respiratory depression has occurred in patients treated with SUBSYS, including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, especially during initiation of SUBSYS or following a dose increase. 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.
Accidental INGESTION
Accidental ingestion of even one dose of SUBSYS especially by children, can result in a fatal overdose of fentanyl .
Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. SUBSYS must be kept out of reach of children
Cytochrome P450 3A4 Interaction
The concomitant use of SUBSYS with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving SUBSYS and any CYP3A4 inhibitor or inducer .
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
Risk of 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 .
Addiction, Abuse, and Misuse
SUBSYS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing SUBSYS, and monitor all patients regularly for the development of these behaviors and conditions .
Risk Evaluation and Mitigation Strategy (REMS) Access Program
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.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of SUBSYS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [].
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status . Carbon dioxide (CO) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of SUBSYS, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of SUBSYS.
To reduce the risk of respiratory depression, proper dosing and titration of SUBSYS are essential . Overestimating the SUBSYS dosage can result in a fatal overdose with the first dose. The substitution of SUBSYS for any other fentanyl product may result in fatal overdose
SUBSYS could be fatal to individuals for whom it is not prescribed and for those who are not opioid-tolerant.
Accidental ingestion or exposure to even one dose of SUBSYS, especially in children, can result in respiratory depression and death due to an overdose of fentanyl.
The following serious adverse reactions are described, or described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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