Physician

AVINZA® is Available in 6 Dosage Strengths

Avinza Capsules

  • 6 dosing options—30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg1
  • More precise dosing options for opioid conversion
  • Enhanced flexibility for titration decisions
    • Titrate as often as every other day in opioid-tolerant patients1
  • Plasma concentrations maintained throughout the 24-hour dosing interval1
  • Steady-state plasma concentrations achieved in 48 to 72 hours1
  • NOT for use as a prn analgesic1
  • AVINZA® is not indicated for postoperative use1

AVINZA® is indicated for once-daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time.

INDICATIONS

  • AVINZA® (morphine sulfate extended-release capsules) is a modified-release formulation of morphine sulfate indicated for once-daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
  • AVINZA® is NOT intended for use as a prn analgesic
  • The safety and efficacy of using AVINZA® in a postoperative setting has not been evaluated. AVINZA® is not indicated for postoperative use. If the patient has been receiving the drug prior to surgery, resumption of the presurgical dose may be appropriate once the patient is able to take the drug by mouth. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

 

IMPORTANT SAFETY INFORMATION

AVINZA® Capsules must be swallowed whole or the contents of the capsules sprinkled on applesauce. The capsule beads must not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine

  • Patients must not consume alcoholic beverages or use prescription or nonprescription medications containing alcohol while on AVINZA® therapy due to the risk of the rapid release and absorption of a potentially fatal dose of morphine
  • Morphine sulfate is a Schedule II controlled substance that can be abused in a manner similar to other legal or illegal opioids
  • AVINZA® is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product
  • AVINZA®, like all opioids, is contraindicated in patients with respiratory depression (in the absence of resuscitative equipment), acute or severe bronchial asthma, and known or suspected paralytic ileus
  • Use only with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, pre-existing respiratory depression, and in patients with substantially decreased respiratory reserve. In such patients, usual therapeutic doses may result in apnea
  • AVINZA® should be administered cautiously and in reduced dosages in patients with severe renal or hepatic insufficiency, Addison’s disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients
  • Dosing
    • The daily dose of AVINZA® must be limited to a maximum of 1600 mg/day. Doses of AVINZA® over 1600 mg/day contain a quantity of fumaric acid that may result in serious renal toxicity
    • The 45-mg, 60-mg, 75-mg, 90-mg, and 120-mg capsules are for use in opioid-tolerant patients only. When the patient no longer requires therapy with AVINZA®, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient
  • Adverse Events
    • The most common serious adverse events reported during clinical studies with AVINZA® were vomiting, nausea, death (in patients treated for pain due to underlying malignancy), dehydration, dyspnea, and sepsis
    • Additional common adverse events reported during clinical studies include constipation, somnolence, and headache
    • Serious adverse events caused by morphine include respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest

Please see full Prescribing Information.