Insys Therapeutics, Inc.

Insys Therapeutics, Inc. Drugs

• Subsys
  

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  Subsys

  

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  Healthcare professionals who prescribe SUBSYS on an outpatient basis must enroll in the TIRF REMS ACCESS program and comply with the requirements of the REMS to ensure safe use of SUBSYS. [see Warnings and Precautions (5.10)]

  As with all opioids, the safety of patients using such products is dependent on health care professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

  2.1 Initial Dose

  SUBSYS is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products other than Actiq. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.)

  Patients on Actiq

  The initial dose of SUBSYS is always 100 mcg with the only exception of patients already using Actiq.

  a. For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations for Patients on Actiq table below (Table 1). Patients must be instructed to stop the use of Actiq and dispose of any remaining units. 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 b. For patients converting from Actiq doses 400 mcg and below, titration should be initiated with 100 mcg SUBSYS and should proceed using multiples of this strength. c. For patients converting from Actiq doses of 600 and 800 mcg, titration should be initiated with 200 mcg SUBSYS and should proceed using multiples of this strength. d. For patients converting from Actiq doses of 1200 and 1600 mcg, titration should be initiated with 400 mcg SUBSYS and should proceed using multiples of this strength.

  All Other Patients

  Individually titrate SUBSYS to a dose that provides adequate analgesia and minimizes side effects. The initial dose of SUBSYS to treat episodes of breakthrough cancer pain is always 100 mcg. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS as SUBSYS is not equivalent on a mcg per mcg basis with any other fentanyl product [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Prescribe an initial titration supply of 100 mcg SUBSYS units, which limits the number of units in the home during titration.

  Avoid prescribing a higher dose until patients have used up all units to prevent confusion and possible overdose.

  2.2 Dose Titration

  From the 100 mcg initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single SUBSYS dose per breakthrough cancer pain episode with tolerable side effects. Patients should record their use of SUBSYS over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted. For each breakthrough pain episode treated, if pain is not relieved after 30 minutes, patients may take ONLY ONE additional dose of the same strength for that episode. Thus patients should take a maximum of two doses of SUBSYS for any breakthrough pain episode. Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with SUBSYS. If there is a need to titrate to a 200 mcg dose, prescribe 200 mcg SUBSYS units. Subsequent titration steps are 400 mcg, 600 mcg, 800 mcg, 1200 mcg and 1600 mcg. See Table 2. To reduce the risk of overdose during titration, patients should have only one strength of SUBSYS available at any time. Table 2. Titration Steps SUBSYS DOSE Using 100 mcg 1 × 100 mcg unit 200 mcg 1 × 200 mcg unit 400 mcg 1 × 400 mcg unit 600 mcg 1 × 600 mcg unit 800 mcg 1 × 800 mcg unit 1200 mcg 2 × 600 mcg unit 1600 mcg 2 × 800 mcg unit

  SUBSYS Titration Process

  2.3 Maintenance Dosing

  Once titrated to a dose that provides adequate pain relief and tolerable side effects, patients should generally use ONLY ONE SUBSYS dose of the appropriate strength per breakthrough pain episode.

  On those occasions when the breakthrough pain episode is not relieved within 30 minutes after administration of the SUBSYS dose, the patient may take ONLY ONE additional dose using the same strength for that episode.

  Patients MUST wait at least 4 hours before treating another episode of breakthrough pain with SUBSYS. Once a successful dose has been found, patients should limit consumption to four or fewer doses per day.

  Dosage adjustment of SUBSYS may be required in some patients in order to continue to provide adequate relief of breakthrough pain.

  If signs of excessive opioid effects appear following administration of a single SUBSYS dose, subsequent doses should be decreased.

  Generally, only increase the SUBSYS dose when a single administration of the current dose fails to adequately treat the breakthrough pain episode for several consecutive episodes.

  If the patient experiences greater than four breakthrough pain episodes per day, the dose of the maintenance (around-the-clock) opioid used for persistent pain should be re-evaluated. In addition, if pain worsens, re-evaluate the patient for changes in the underlying pain condition.

  2.4 Administration of SUBSYS

  The blister package should be opened with scissors immediately prior to product use. The patient should carefully spray the contents of the unit into his or her mouth underneath the tongue.

  2.5 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.

  2.6 Oral Mucositis

  In cancer patients with mucositis, exposure to SUBSYS was greater than in patients without mucositis. For patients with Grade 1 mucositis, the increased maximum serum concentration and overall exposure requires closer monitoring for respiratory depression and central nervous system depression, particularly during initiation of therapy with SUBSYS. For patients with Grade 2 mucositis or higher, avoid use of SUBSYS unless the benefits outweigh the potential risk of respiratory depression from increased exposure. [see Clinical Pharmacology (12.3)]

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