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Subsys Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Subsys safely and effectively. Before taking Subsys please consult with your doctor. See full prescribing information for Subsys.

Warning

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. [see Patient Counseling Information (17) and How Supplied/Storage and Handling (16.1) ] The concomitant use of SUBSYS with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see Drug Interactions (7)]. 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. [see Dosage and Administration (2.1),Warnings and Precautions (5.2,) and Clinical Pharmacology (12.3)] - 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. [See Warnings and Precautions (5.10)] Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483. WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL See full prescribing information for complete boxed warning. Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients (1) and in management of acute or postoperative pain, including headache/migraines. (4) Keep out of reach of children. (5.3) Use with CYP3A4 inhibitors may cause fatal respiratory depression. (7) When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS. ( 5.1) When dispensing, do not substitute with any other fentanyl products. (5.1) Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. (9.1) SUBSYS is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. (5.10)

Indications And Usage

SUBSYS is indicated for the management of breakthrough pain in adult cancer patients 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 around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, SUBSYS is contraindicated in the management of acute or postoperative pain. SUBSYS is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain. SUBSYS is an opioid agonist 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 opioid therapy for their underlying persistent cancer pain. Patients must remain on around-the-clock opioids when taking SUBSYS. (1) Limitations of Use: SUBSYS may be dispensed only to patients enrolled in the TIRF REMS ACCESS program. Limitations of Use: As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS ACCESS Program, SUBSYS may be dispensed only to outpatients enrolled in the program. [see Warnings and Precautions (5.10)]. For inpatient administration (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use) of SUBSYS, patient enrollment is not required.

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Dosage And Administration

Table 1. Initial Dosing Recommendations for Patients on ACTIQ
Current ACTIQ Dose (mcg) Initial SUBSYS Dose (mcg)
200 100 mcg spray
400 100 mcg spray
600 200 mcg spray
800 200 mcg spray
1200 400 mcg spray
1600 400 mcg spray

Dosage Forms And Strengths

SUBSYS is a sublingual spray available in 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg strengths [see How Supplied (16.3) and Storage and Handling (16.1)]. Sublingual spray in 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg dosage strengths. (3)

Contraindications

SUBSYS is contraindicated: in opioid non-tolerant patients. in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients. in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products. Opioid non-tolerant patients. (4) Management of acute or postoperative pain including headache/migraine and dental pain (4) Intolerance or hypersensitivity to fentanyl, SUBSYS, or its components. (4)

Warning and Cautions

See Boxed Warning - WARNING RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL Clinically significant respiratory and CNS depression can occur. Monitor patients accordingly. (5.1) Full and consumed SUBSYS units contain medicine that can be fatal to a child. Ensure proper storage and disposal. (5.3, 16.2) Use with other CNS depressants and moderate or strong CYP450 3A4 inhibitors may increase depressant effects including respiratory depression, hypotension, and profound sedation. Consider dosage adjustments if warranted. (5.4) Titrate SUBSYS cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression and in patients susceptible to intracranial effects of CO2 retention. (5.6, 5.7) 5.1 Respiratory Depression Respiratory depression is the chief hazard of opioid agonists, including fentanyl, the active ingredient in SUBSYS. Respiratory depression is more likely to occur in patients with underlying respiratory disorders and elderly or debilitated patients, usually following large initial doses in opioid non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the "sighing" pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous. 5.2 Important Information Regarding Prescribing and Dispensing SUBSYS is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. When dispensing, DO NOT substitute a SUBSYS prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetic profile of SUBSYS compared to other fentanyl products that result in clinically important differences in the rate and extent of absorption of fentanyl. As a result of these differences, the substitution of the same dose of SUBSYS for the same dose of any other fentanyl product may result in a fatal overdose. There are no conversion directions available for patients on any other fentanyl products. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) All patients should be titrated from the 100 mcg dose. Titrate each patient individually to provide adequate analgesia while minimizing side effects. [See Dosage and Administration (2.1) and Clinical Pharmacology (12.3)] 5.3 Patient/Caregiver Instructions Patients and their caregivers must be instructed that SUBSYS contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. Patients and their caregivers must be instructed to keep both used and unused dosage units out of the reach of children. All used units should be disposed of immediately after use as they represent a special risk to children. [see How Supplied/Storage and Handling (16.1, 16.2), Patient Counseling Information (17), and Medication Guide]. Physicians and dispensing pharmacists must specifically question patients or caregivers about the presence of children in the home (on a full time or visiting basis) and counsel them regarding the dangers to children from inadvertent exposure. SUBSYS could be fatal to individuals for whom it is not prescribed and for those who are not opioid-tolerant. 5.4 Additive CNS Depressant Effects The concomitant use of SUBSYS with other CNS depressants, including other opioids, sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages may produce increased depressant effects (e.g., respiratory depression, hypotension, and profound sedation). Concomitant use with strong and moderate inhibitors of CYP450 3A4 isoform (e.g., erythromycin, ketoconazole, and certain protease inhibitors) may increase fentanyl levels, resulting in increased depressant effects [see Drug Interactions (7)]. Patients on concomitant CNS depressants must be monitored for a change in opioid effects. Consideration should be given to adjusting the dose of SUBSYS if warranted. 5.5 Effects on Ability to Drive and Use Machines Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Warn patients taking SUBSYS of these dangers and counsel them accordingly. 5.6 Chronic Pulmonary Disease Because potent opioids can cause respiratory depression, titrate SUBSYS with caution in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression. In such patients, even normal therapeutic doses of SUBSYS may further decrease respiratory drive to the point of respiratory failure. 5.7 Head Injuries and Increased Intracranial Pressure Administer SUBSYS with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted. 5.8 Cardiac Disease Intravenous fentanyl may produce bradycardia. Therefore, use SUBSYS with caution in patients with bradyarrhythmias. 5.9 MAO Inhibitors SUBSYS is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics. 5.10 Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) ACCESS Program Because of the risk of misuse, abuse, addiction and overdose [see Drug Abuse and Dependence (9)], SUBSYS is available only through a restricted program under a REMS called the TIRF REMS ACCESS program. Under the TIRF REMS ACCESS program, outpatients, prescribers who prescribe to outpatients, pharmacies, and distributors must enroll in the program. For inpatient administration (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use) of SUBSYS, patient and prescriber enrollment is not required. Required components of the TIRF REMS ACCESS program are: Healthcare professionals who prescribe SUBSYS must review the prescriber educational materials for the TIRF REMS ACCESS program, enroll in the program, and agree to comply with the REMS requirements. To receive SUBSYS, patients must understand the risks and benefits and sign a Patient-Prescriber Agreement. Pharmacies that dispense SUBSYS must enroll in the program and agree to comply with the REMS requirements. Wholesalers and distributors that distribute SUBSYS must enroll in the program and distribute only to authorized pharmacies. Further information, including a list of qualified pharmacies/distributors, is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.

Adverse Reactions

Most common adverse reactions during treatment (frequency ≥5%): vomiting, nausea, constipation, dyspnea, and somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Insys Therapeutics, Inc., at 1-855-978-2797 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SUBSYS has been evaluated in a total of 359 opioid-tolerant patients with breakthrough cancer pain. The duration of SUBSYS use varied during the open-label study. Safety data from a long-term extension study showed that the average duration of therapy in the open-label study was 66 days. The maximum duration of therapy was 149 days. The dose range studied in these trials ranged from 100 mcg per dose to 1600 mcg per dose. The most commonly observed adverse reactions seen with SUBSYS are typical opioid side effects such as nausea, vomiting, somnolence, and constipation. Expect opioid side effects and manage them accordingly. The most serious adverse reactions associated with all opioids including SUBSYS are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of respiratory depression. The most common adverse reaction leading to discontinuation of SUBSYS was nausea. There were also adverse reactions of abdominal distension, anorexia, confusional state, disorientation, somnolence, and constipation. The clinical trials of SUBSYS were designed to evaluate safety and efficacy in treating breakthrough cancer pain; all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received SUBSYS for breakthrough cancer pain along with a concomitant opioid for persistent cancer pain. Table 3 lists adverse reactions with an overall frequency of 5% or greater that occurred during titration in the clinical trials. Adverse reactions are listed in descending order of frequency within each system organ class. Table 3. Percent of Patients with Specific Adverse Events During Titration in the Clinical Trials (Events in 5% or More of Patients) System Organ Class Titration n=359 (%) Gastrointestinal Disorders Nausea 47 (13.1%) Vomiting 37 (10.3%) Constipation 18 (5.0%) Nervous System Disorders Somnolence 34 (9.5%) Dizziness 26 (7.2%) A patient was counted only once within each category. The following adverse reactions occurred during titration in the clinical trials with an overall frequency of 1% or greater and are listed in descending order of frequency within each system organ class. Cardiac Disorders: Tachycardia Gastrointestinal Disorders: Diarrhea, stomatitis, dry mouth General Disorders and Administration Site Conditions: Application site irritation, pyrexia, edema peripheral, fatigue, asthenia Metabolism and Nutrition Disorders: Decreased appetite Nervous System Disorders: Lethargy, sedation, tremor, headache Psychiatric Disorders: Depression, confusional state, hallucination, insomnia Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and Subcutaneous Tissue Disorders: Pruritus The following reactions occurred during titration in the clinical trials with an overall frequency of less than 1% and are listed in descending order of frequency within each system organ class. Eye Disorders: Vision blurred, dry eye Gastrointestinal Disorders: Abdominal pain Infections and Infestations: Oral candidiasis, cellulitis Injury, Poisoning and Procedural Complications: Fall Metabolism and Nutrition Disorders: Dehydration, anorexia Musculoskeletal and Connective Tissue Disorders: Back pain, arthralgia, joint swelling Psychiatric Disorders: Anxiety, agitation Renal and Urinary Disorders: Urinary retention Respiratory, Thoracic and Mediastinal Disorders: Cough, increased bronchial secretion, dysphonia, pharyngolaryngeal pain Skin and Subcutaneous Tissue Disorders: Hyperhidrosis Vascular Disorders: Hot flush Table 4 lists adverse reactions with an overall frequency of 5% or greater for the total safety database subsequent to titration during the clinical trials. Table 4. Adverse Reactions Subsequent to Titration in 5% or More of Patients System Organ Class Dosing n=269 Gastrointestinal Disorders Vomiting 43 (16.0%) Nausea 28 (10.4%) Constipation 28 (10.4%) General Disorders and Administration Site Conditions Asthenia 26 (9.7%) Respiratory, Thoracic and Mediastinal Disorders Dyspnea 28 (10.4%) Psychiatric Disorders Anxiety 16 (5.9%) A patient was counted only once within each category. The following adverse reactions occurred during the dosing period of the clinical trial with an overall frequency of 1% or greater and are listed in descending order of frequency within each system organ class. Blood and Lymphatic System Disorders: Anemia, neutropenia, lymphadenopathy, thrombocytopenia, leukopenia Cardiac Disorders: Tachycardia, sinus tachycardia Gastrointestinal Disorders: Diarrhea, stomatitis, abdominal pain, abdominal distension, gastritis, dysphagia, dyspepsia, gastroesophageal reflux disease, ascites, hematemesis General Disorders and Administration Site Conditions: Edema peripheral, fatigue, pyrexia, chest pain, drug withdrawal syndrome, chills, irritability, malaise, application site irritation Infections and Infestations: Oral candidiasis, pneumonia, urinary tract infection, oral herpes, gastroenteritis, laryngitis Injury, Poisoning and Procedural Complications: Contusion Investigations: Weight decreased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose increased, blood lactate increased Metabolism and Nutrition Disorders: Anorexia, dehydration, hypokalemia, decreased appetite, hyponatremia, hypocalcemia, hypoalbuminemia, cachexia Musculoskeletal and Connective Tissue Disorders: Back pain, arthralgia, muscular weakness Nervous System Disorders: Hypoesthesia, lethargy, sedation, tremor, somnolence, headache, dizziness Psychiatric Disorders: Depression, restlessness, agitation, confusional state, insomnia, hallucination, disorientation Renal and Urinary Disorders: hypertension, hypotension Respiratory, Thoracic and Mediastinal Disorders: Cough, increased bronchial secretion, wheezing, pharyngolaryngeal pain, hypoxia, dyspnea exertional Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus In a single-dose mucositis study, a group of patients with Grade 1 or 2 oral mucositis (n=9) and without oral mucositis (n=9) were included in a clinical trial designed to support the safety of SUBSYS. Two of the nine subjects with mucositis (one with Grade 1 and one with Grade 2) reported a burning sensation in the oral mucosa after treatment. Both of these events were considered mild and probably related to treatment. There was no change in grade of mucositis after treatment for any subject.

Drug Interactions

Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4); therefore potential interactions may occur when SUBSYS is given concurrently with agents that affect CYP3A4 activity. The concomitant use of SUBSYS with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazodone) or moderate CYP3A4 inhibitors (e.g., amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug effects including fatal respiratory depression. Patients receiving SUBSYS concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time. Dosage increase should be done conservatively. The concomitant use of SUBSYS with CYP3A4 inducers (e.g., barbiturates, carbamazepine, efavirenz, glucocorticoids, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort, or troglitazone) may result in a decrease in fentanyl plasma concentrations, which could decrease the efficacy of SUBSYS. Patients receiving SUBSYS who stop therapy with, or decrease the dose of, CYP3A4 inducers should be monitored for signs of increased SUBSYS activity and the dose of SUBSYS should be adjusted accordingly. Concomitant use of SUBSYS with an MAO inhibitor, or within 14 days of discontinuation, is not recommended [see Warnings and Precautions (5.9)]. Boxed Warning and Warnings and Precautions (5.4, 7)

Use In Specific Populations

Safety and effectiveness in pediatric patients below 18 years of age have not been established. (8.4) Administer SUBSYS with caution to patients with liver or kidney dysfunction. (8.6) 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. SUBSYS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No epidemiological studies of congenital anomalies in infants born to women treated with fentanyl during pregnancy have been reported. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures in newborn infants characteristic of neonatal abstinence syndrome. In women treated acutely with intravenous or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl. Fentanyl is embryocidal in rats as evidenced by increased resorptions in pregnant rats at doses of 30 mcg/kg intravenously or 160 mcg/kg subcutaneously. Conversion to human equivalent doses indicates this is within the range of the human recommended dosing for SUBSYS. Fentanyl citrate was not teratogenic when administered to pregnant animals. Published studies demonstrated that administration of fentanyl (10, 100, or 500 mcg/kg/day) to pregnant rats from day 7 to 21, of their 21 day gestation, via implanted microosmotic minipumps was not teratogenic (the high dose was approximately 3-times the human dose of 1600 mcg per pain episode on a mg/m2 basis). Intravenous administration of fentanyl (10 or 30 mcg/kg) to pregnant female rats from gestation day 6 to 18, was embryo or fetal toxic, and caused a slightly increased mean delivery time in the 30 mcg/kg/day group, but was not teratogenic. 8.2 Labor and Delivery Fentanyl readily passes across the placenta to the fetus; therefore do not use SUBSYS during labor and delivery since it may cause respiratory depression in the fetus or in the newborn infant. 8.3 Nursing Mothers Fentanyl is excreted in human milk; therefore, do not use SUBSYS in nursing women because of the possibility of sedation and/or respiratory depression in their infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing by women using SUBSYS. 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 18 years have not been established. 8.5 Geriatric Use Of the 359 patients in clinical studies of SUBSYS in breakthrough cancer pain, 27% were 60 years of age and older, 17% were 65 years of age and older, and 3% were 75 years of age and older. No difference was noted in the safety profile of the group over 65 years of age as compared to younger patients in SUBSYS clinical trials. Elderly patients have been shown to be more sensitive to the effects of fentanyl when administered intravenously, compared with the younger population. Therefore, monitor patients for respiratory depression and CNS effects when titrating SUBSYS in elderly patients. 8.6 Patients with Renal or Hepatic Impairment Insufficient information exists to make recommendations regarding the use of SUBSYS in patients with impaired renal or hepatic function. Fentanyl is metabolized primarily via the human CYP450 3A4 isoenzyme system and mostly eliminated in urine. If the drug is used in these patients, monitor patients closely for signs of respiratory and central nervous system depression. 8.7 Gender Both male and female opioid tolerant patients with cancer were studied for the treatment of breakthrough cancer pain. No clinically relevant gender differences were noted either in dosage requirement or in observed adverse reactions.

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