AVINZA: Around-the-clock opioid analgesic
for the management of moderate to severe pain
Indication
AVINZA® (morphine sulfate extended-release capsules) CII 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. See Limitations of Use below.
Important Safety Information
Abuse Potential
AVINZA® (morphine sulfate extended-release capsules) CII 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. 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.
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of AVINZA® (morphine sulfate extended-release capsules) CII, even when the drug has been used as recommended and not misused or abused. 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 Exposure
Accidental ingestion of AVINZA, especially in children, can result in a fatal overdose of morphine.
Interaction with Alcohol
The co-ingestion of alcohol with AVINZA may result in an increase of plasma levels and potentially fatal overdose of morphine. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on AVINZA therapy.
AVINZA is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment, known or suspected paralytic ileus, or hypersensitivity (e.g., anaphylaxis) to morphine.
Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely, particularly when initiating and titrating AVINZA and when AVINZA is given concomitantly with other drugs that depress respiration.
Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, as in these patients, even usual therapeutic doses of AVINZA® (morphine sulfate extended-release capsules) CII may decrease respiratory drive to the point of apnea.
Hypotension, profound sedation, coma, or respiratory depression may result if AVINZA is used concomitantly with other CNS depressants. If AVINZA therapy is to be initiated in a patient taking a CNS depressant, start with a lower AVINZA dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.
AVINZA may cause severe hypotension and there is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs. Avoid the use of AVINZA in patients with circulatory shock as AVINZA may cause vasodilation that can further reduce cardiac output and blood pressure.
Monitor patients taking AVINZA who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression as AVINZA may reduce respiratory drive and the resultant CO2 retention can further increase intracranial pressure.
AVINZA is contraindicated in patients with paralytic ileus. Avoid the use of AVINZA in patients with other GI obstruction. The morphine in AVINZA may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase.
The morphine in AVINZA may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.
Avoid the use of mixed agonist/antagonist analgesics in patients who have received or are receiving a course of therapy with an opioid agonist analgesic. Mixed agonists/antagonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.
When discontinuing AVINZA® (morphine sulfate extended-release capsules) CII, gradually taper the dose and do not abruptly discontinue AVINZA.
AVINZA may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of AVINZA and know how they will react to the medication.
Most common adverse reactions (≥10%) are constipation, nausea, somnolence, vomiting and headache.
Individualize dosing based on patient's prior analgesic treatment experience, and titrate as needed to provide adequate analgesia and minimize adverse reactions. When AVINZA is the first opioid analgesic, initiate AVINZA therapy with the 30 mg capsule once daily (at 24-hour intervals) and adjust the dose of AVINZA in increments not greater than 30 mg every 4 days. Instruct patients to swallow AVINZA capsules intact, or to sprinkle the capsule contents on applesauce and immediately swallow without chewing.
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.
Indication
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.
- 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® (morphine sulfate extended-release capsules) CII 90 mg and 120 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
By using the AVINZA Coupon, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
The Coupon is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare or other federal or state health programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico [formerly known as "La Reforma de Salud" ]).
The Coupon is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs.
By using the Coupon, patients will pay a minimum of $20 per prescription. (Savings are limited to $30 for each of 6 uses.) Coupon may be used twice per month.
You must deduct the value received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
Offer cannot be combined with any other rebate/ coupon, free trial, or similar offer for the specified prescription.
The Coupon will be accepted only at participating pharmacies.
The Coupon is not health insurance.
Offer good only in the U.S. and Puerto Rico.
Pfizer reserves the right to rescind, revoke, or amend the program without notice.
Coupon and Program expire 12/31/12.
No membership fees apply. Patients must be 18 or older. For help with the AVINZA Co-pay Coupon, call 1-866-917-9794.
Pfizer Inc., ATTN: AVINZA. PO Box 29387, Mission, KS 66201-9618.
AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc., a wholly owned subsidiary of Pfizer Inc.
