SUBSYS (Page 3 of 11)

2.6 Discontinuation of SUBSYS

For patients no longer requiring opioid therapy, consider discontinuing SUBSYS along with a gradual downward titration of other opioids to minimize possible withdrawal effects. In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, SUBSYS therapy can usually be discontinued immediately. [ see Drug Abuse and Dependence ( 9.3) ].

2.7 Disposal of SUBSYS

Patients and caregivers must be advised to dispose of used unit dose systems immediately after use and any unneeded unit dose systems remaining from a prescription as soon as they are no longer needed. Consumed units represent a special risk because they are no longer protected by the child resistant blister package, yet may contain enough medicine to be fatal to a child. [see Patient Counseling Information ( 17)].

Charcoal-lined disposal pouches are provided with every carton dispensed. A charcoal-lined disposal pouch is to be used by patients or their caregivers to dispose of the contents of any unneeded unit dose systems when they are no longer needed. Instructions for usage of the charcoal-lined disposal pouch are included in the Medication Guide and Instructions for Use.

3 DOSAGE FORMS AND STRENGTHS

SUBSYS is a sublingual spray available in 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg strengths. SUBSYS is supplied as spray units consisting of a white actuator attached to a light purple vial holder [see How Supplied/Storage and Handling ( 16)] . 100 mcg, 200 mcg, 400 mcg, 600 mcg, and 800 mcg doses are delivered as a single unit (spray). To administer 1200 mcg and 1600 mcg doses, two units (sprays) must be used.

Each dosage strength is differentiated by the color of the blister package, and carton as described below in Table 3. The strength of the spray unit is indicated on the actuator.

Table 3. Subsys Strengths
Dosage Strength (fentanyl base) Using Carton/Blister Package Color
100 mcg 1 × 100 mcg unit packaged in a single blister Blue
200 mcg 1 × 200 mcg unit packaged in a single blister Green
400 mcg 1 × 400 mcg unit packaged in a single blister Magenta (Pink)
600 mcg 1 × 600 mcg unit packaged in a single blister Purple
800 mcg 1 × 800 mcg unit packaged in a single blister Orange
1200 mcg 2 × 600 mcg units packaged in a single blister Brown
1600 mcg 2 × 800 mcg units packaged in a single blister Red

4 CONTRAINDICATIONS

SUBSYS is contraindicated in:

  • Opioid non-tolerant patients: Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients [see Indications and Usage ( 1); Warnings and Precautions ( 5.1)] .
  • Acute or postoperative pain including headache/migraine and dental pain, or in the emergency department [see Indications and Usage ( 1)] .
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.9)].
  • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.14)].
  • Known hypersensitivity (e.g., anaphylaxis) to fentanyl or components of SUBSYS [see Adverse Reactions ( 6.2)] .

5 WARNINGS AND PRECAUTIONS

5.1 Life-Threatening Respiratory Depression

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 [see Overdosage ( 10)] . Carbon dioxide (CO 2 ) 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 [see Dosage and Administration ( 2.5)] . 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 [see Warnings and Precautions ( 5.5)].

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.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information ( 17)].

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration ( 2.5)].

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with SUBSYS. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program). Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information ( 17)].

Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient. Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose. If naloxone is prescribed, educate patients and caregivers on how to treat with naloxone. [see Warnings and Precautions ( 5.4, 5.6), Patient Counseling Information ( 17)].

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