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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.
DOSAGE AND ADMINISTRATION
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].
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.
Titration and Maintenance of Therapy
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.
Discontinuation of AVINZA
When a patient no longer requires therapy with AVINZA, use a gradual downward titration of the dose every 2 to 4 days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue AVINZA.
Administration of AVINZA
Instruct patients to swallow AVINZA capsules intact. The pellets in the capsules are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].
Alternatively, the contents of the AVINZA capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:
- Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing.
- Rinse the mouth to ensure all pellets have been swallowed.
- Discard any unused portion of the AVINZA capsules after the contents have been sprinkled on applesauce.
Do not administer AVINZA pellets through a nasogastric or gastric tubes.
Dosage Forms And Strengths
AVINZA contains white to off-white color pellets, have an outer opaque capsule with colors as identified below and are available in six dose strengths:
Each 30 mg capsule has a yellow opaque cap with “AVINZA” printed on it and a white opaque body printed with “30” and “505”.
Each 45 mg capsule has a light blue opaque cap with “AVINZA” printed on it and a white opaque body printed with “45” and “509”.
Each 60 mg capsule has a bluish-green opaque cap with “AVINZA” printed on it and a white opaque body printed with “60” and “506”.
Each 75 mg capsule has an orange opaque cap with “AVINZA” printed on it and a white opaque body printed with “75” and “510”.
Each 90 mg capsule has a red opaque cap with “AVINZA” printed on it and a white opaque body printed with “90” and “507”.
Each 120 mg capsule has a blue-violet opaque cap with “AVINZA” printed on it and a white opaque body printed with “120” and “508”.
Storage And Handling
30 mg Capsule: size 3 capsule, yellow cap and white, opaque body imprinted AVINZA 30 mg and 505.
NDC 60793-605-01: Bottles of 100 capsules.
45 mg Capsule: size 3 capsule, light blue cap and white, opaque body imprinted AVINZA 45 mg and 509.
NDC 60793-603-01: Bottles of 100 capsules.
60 mg Capsule: size 3 capsule, bluish-green cap and white, opaque body imprinted AVINZA 60 mg and 506.
NDC 60793-606-01: Bottles of 100 capsules.
75 mg Capsule: size 1 capsule, orange cap and white, opaque body imprinted AVINZA 75 mg and 510.
NDC 60793-604-01: Bottles of 100 capsules.
90 mg Capsule: size 1 capsule, red cap and white, opaque body imprinted AVINZA 90 mg and 507.
NDC 60793-607-01: Bottles of 100 capsules.
120 mg Capsule: size 1 capsule, blue-violet cap and white, opaque body imprinted AVINZA 120 mg and 508.
NDC 60793-608-01: Bottles of 100 capsules.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in USP.
CAUTION: DEA Order Form Required.
Manufactured for: King Pharmaceuticals, Inc., Bristol, TN 37620. AVINZA® Information Service: 1-800-776-3637. Utilizing technology developed by: Alkermes Pharma Ireland Limited. Monksland, Athlone, Co Westmeath, Ireland. Revised: 11/2012
Last reviewed on RxList: 5/31/2013
This monograph has been modified to include the generic and brand name in many instances.
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