Galena Biopharma, Inc.

Galena Biopharma, Inc. Drugs

• Abstral
  

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  Abstral

  

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  Healthcare professionals who prescribe ABSTRAL 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 ABSTRAL [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 Dose Titration

  The objective of dose titration is to identify an effective and tolerable maintenance dose for ongoing management of breakthrough cancer pain episodes. The effective and tolerable dose of ABSTRAL will be determined by dose titration in individual patients.

  Carefully supervise patients until a dose that provides adequate analgesia with tolerable side effects is reached for breakthrough pain control.

  Starting Dose: Individually titrate ABSTRAL to a dose that provides adequate analgesia with tolerable side effects. Begin titration of all patients with an initial dose of ABSTRAL of 100 mcg. Due to differences in the pharmacokinetic properties and individual variability, even patients switching from other fentanyl containing products to ABSTRAL must start with the 100 mcg dose. However, for patients converting from Actiq, see Table 1: Initial Dosing Recommendations for Patients on ACTIQ. ABSTRAL is not equivalent on a mcg per mcg basis with all other fentanyl products, therefore, do not switch patients on a mcg per mcg basis from any other fentanyl product. ABSTRAL is NOT a generic version of any other fentanyl product.

  Start all patients with a single 100 mcg tablet.

  If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose. If adequate analgesia is not obtained after ABSTRAL, the patient may use a second ABSTRAL dose (after 30 minutes) as directed by their health care provider. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL.

  Titration Steps: If adequate analgesia was not obtained with the first 100 mcg dose, continue dose escalation in a stepwise manner over consecutive breakthrough episodes until adequate analgesia with tolerable side effects is achieved. Increase the dose by 100 mcg multiples up to 400 mcg as needed. If adequate analgesia is not obtained with a 400 mcg dose, the next titration step is 600 mcg. If adequate analgesia is not obtained with a 600 mcg dose, the next titration step is 800 mcg. During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose. Instruct patients not to use more than 4 tablets at one time. If adequate analgesia is not obtained 30 minutes after the use of ABSTRAL, the patient may repeat the same dose of ABSTRAL. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain. Rescue medication as directed by the health care provider can be used if adequate analgesia is not achieved after use of ABSTRAL.

  The efficacy and safety of doses higher than 800 mcg have not been evaluated in clinical studies in patients.

  In order to minimize the risk of ABSTRAL-related adverse reactions and to identify the appropriate dose, it is imperative that patients be supervised closely by health professionals during the titration process.

  2.2 Conversion from Actiq

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

  For patients being converted from Actiq, prescribers must use the Initial Dosing Recommendations for Patients on Actiq. See Table 1 for initial dosing recommendations. 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 Abstral Dose (mcg) 200 100 mcg 400 200 mcg 600 200 mcg 800 200 mcg 1200 200 mcg 1600 400 mcg For patients converting from Actiq doses of 200 mcg and 400 mcg, initiate titration with 100 mcg and 200 mcg of Abstral, respectively and proceed using multiples of this strength. For patients converting from Actiq doses of 600 and 800 mcg, initiate titration with 200 mcg and 200 mcg Abstral, respectively and proceed using multiples of this strength. For patients converting from Actiq doses of 1200 and 1600 mcg, initiate titration with 200 mcg and 400 mcg Abstral, respectively and proceed using multiples of this strength.

  2.3 Maintenance Therapy

  Once an appropriate dose for pain management has been established, instruct patients to use only one ABSTRAL tablet of the appropriate strength per dose. Maintain patients on this dose.

  If adequate analgesia is not obtained after use of ABSTRAL, the patient may use a second ABSTRAL dose (after 30 minutes) as directed by their health care provider. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain.

  Patients must wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL.

  2.4 Dose Re-adjustment

  If the response (analgesia or adverse reactions) to the titrated ABSTRAL dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained.

  If more than four episodes of breakthrough pain are experienced per day, re-evaluate the dose of the longacting opioid used for persistent underlying cancer pain. If the long-acting opioid or dose of long-acting opioid is changed, re-evaluate and re-titrate the ABSTRAL dose as necessary to ensure the patient is on an appropriate dose.

  Limit the use of ABSTRAL to treat four or fewer episodes of breakthrough pain per day.

  It is imperative that any dose re-titration is monitored carefully by a healthcare professional.

  2.5 Administration of ABSTRAL

  Place ABSTRAL tablets on the floor of the mouth directly under the tongue immediately after removal from the blister unit. Do not chew, suck, or swallow ABSTRAL tablets. Allow ABSTRAL tablets to completely dissolve in the sublingual cavity. Advise patients not to eat or drink anything until the tablet is completely dissolved.

  In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking ABSTRAL.

  2.6 Discontinuation of Therapy

  For patients no longer requiring opioid therapy, consider discontinuing ABSTRAL 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, ABSTRAL therapy can usually be discontinued immediately.

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• Sunmark Enema
  

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  Sunmark Enema

  

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  2.1 Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  Adults

  The recommended adult oral dosage of ZUPLENZ (ondansetron) oral soluble film is 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Dosage and Administration (2.6)]. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatrics

  Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.2 Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  Adults

  The recommended adult oral dosage is one 8 mg ZUPLENZ oral soluble film given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ZUPLENZ oral soluble film should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].

  Pediatrics

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ZUPLENZ oral soluble film given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ZUPLENZ oral soluble film should be administered three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].

  2.3 Prevention of Nausea and Vomiting Associated with Radiotherapy

  Adults

  The recommended adult oral dosage of ZUPLENZ oral soluble film is one 8 mg film given three times a day [see Dosage and Administration (2.6)].

  For total body irradiation, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatrics

  Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.4 Prevention of Postoperative Nausea and/or Vomiting

  Adults

  The recommended adult oral dosage of ZUPLENZ oral soluble film is 16 mg given successively as two 8 mg films 1 hour before induction of anesthesia. Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Dosage and Administration (2.6)].

  Pediatrics

  Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.5 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater)2, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3)]. In such patients, a total daily dose of 8 mg should not be exceeded.

  2.6 Important Administration Instructions

  With dry hands, fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the ZUPLENZ oral soluble film from the pouch. Immediately place the film on top of the tongue where it dissolves in 4 to 20 seconds. Once the ZUPLENZ oral soluble film is dissolved, swallow with or without liquid [see Clinical Pharmacology (12.3)]. Wash hands after taking ZUPLENZ.

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