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.

IMPORTANT SAFETY INFORMATION

AVINZA^® (morphine sulfate extended-release capsules) is a prescription drug that contains morphine. Each AVINZA® Capsule contains enough morphine to last for 24 hours and should be taken once a day. AVINZA^® is for adults 18 years or older with moderate to severe pain who need around-the-clock, nonstop treatment for an extended period of time.

• AVINZA^® Capsules are to be swallowed whole. DO NOT chew, crush, or dissolve the beads in capsules before swallowing. If the beads are chewed, crushed, or dissolved, the entire 24-hour dose may be absorbed into your body all at once. This can lead to serious problems, including overdose and death
• If you have trouble swallowing the capsules, you may open them and sprinkle all of the beads on a small amount of applesauce just before swallowing. Make sure to swallow all of the beads whole
• Do not drink alcoholic beverages while using AVINZA^®, or use prescription or nonprescription medications that contain alcohol. Consuming alcohol while taking AVINZA^® may cause the rapid release and absorption of a potentially deadly dose of morphine
• Because AVINZA^® may make you sleepy, you should not drive, operate heavy machinery, or perform any other possibly dangerous activities until you know how you react to AVINZA^®
• AVINZA^® should not be given to anyone other than the person for whom it was prescribed

Tell your healthcare professional about the following:

• Any and all other health or medical problems you may have
• All medicines (prescription and nonprescription) and vitamins you are taking. Do not take other medicines without your healthcare professional’s approval
• If you are pregnant or plan to become pregnant
• If you are breastfeeding, because morphine will pass through the milk and may harm the baby
• If you have abused drugs in the past. There is a risk of abuse or addiction with all opioid medications. You may have a higher chance of developing an abuse problem or addiction again while using AVINZA^®

AVINZA^® is not for everyone. Only you and your healthcare professional can know if AVINZA^® is right for you.
Make sure to follow your healthcare professional’s directions exactly.

• Do not change your dose unless your healthcare professional tells you to change it
• Do not take AVINZA^® more often than prescribed. You should not stop taking AVINZA^® all at once if you have been taking it for more than a few days. Your healthcare professional can instruct you on how to stop taking this medicine slowly to avoid uncomfortable symptoms

Constipation is a common side effect of medicines that contain morphine, including AVINZA^®. When you start taking AVINZA^®, discuss steps to prevent or relieve constipation with your healthcare professional. Other common side effects of AVINZA^® are nausea, drowsiness, headache, and itching. Some of these side effects may decrease with continued use.

Keep AVINZA^® in a secure place and out of the reach of children. Protect from theft. When AVINZA^® is no longer needed, the unused capsules should be destroyed by flushing them down the toilet.

Please see full Prescribing Information.