AVINZA- morphine sulfate capsule, extended release
King Pharmaceuticals, Inc.
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
AVINZA® contains pellets of morphine sulfate, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing AVINZA. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving AVINZA for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of AVINZA, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and AVINZA should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of AVINZA or following a dose increase. Instruct patients to swallow AVINZA capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, dissolving, or chewing the pellets within the capsule can cause rapid release and absorption of a potentially fatal dose of morphine.
Accidental ingestion of AVINZA, especially in children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.3)].
Interaction with Alcohol
The co-ingestion of alcohol with AVINZA may result in an increase of plasma levels and potentially fatal overdose of morphine [see Warnings and Precautions (5.4). Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on AVINZA therapy.
AVINZA is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Limitations of Use
AVINZA is not for use:
- As an as-needed (prn) analgesic
- For pain that is mild or not expected to persist for an extended period of time
- For acute pain
- For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.
AVINZA 90 mg and 120 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with AVINZA [see Warnings and Precautions (5.2)].
Consider the following factors when selecting an initial dose of AVINZA:
- Total daily dose, potency, and any prior opioid the patient has been taking previously;
- Reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration);
- Patient’s degree of opioid experience and opioid tolerance;
- General condition and medical status of the patient;
- Concurrent medication;
- Type and severity of the patient’s pain.
AVINZA is administered at a frequency of once daily (every 24 hours).
Use of AVINZA as the First Opioid Analgesic
Initiate AVINZA therapy with the 30 mg capsule once daily (at 24-hour intervals). Adjust the dose of AVINZA in increments not greater than 30 mg every 4 days.
Conversion from Other Oral Morphine Formulations to AVINZA
Patients receiving other oral morphine formulations may be converted to AVINZA by administering the patient’s total daily oral morphine dose as AVINZA once-daily. AVINZA should not be given more frequently than every 24 hours.
Conversion from Parenteral Morphine or Other Non-Morphine Opioids (Parenteral or Oral) to AVINZA
While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient’s 24-hour oral morphine dose and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine dose and manage an adverse reaction. Consider the following general points:
- Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.
- Other parenteral or oral non-morphine opioids to oral morphine sulfate: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.
The first dose of AVINZA may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the AVINZA formulation.
Individually titrate AVINZA to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving AVINZA to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of opioid analgesics.
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the AVINZA dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 2 to 3 days, AVINZA dosage adjustments may be done every 3 to 4 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication.
The daily dose of AVINZA must be limited to a maximum of 1600 mg/day. AVINZA doses of over 1600 mg/day contain a quantity of fumaric acid that has not been demonstrated to be safe, and which may result in serious renal toxicity.
If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
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