INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

17.1 Safe Use

Before initiating treatment with EXALGO, explain the points listed below to caregivers and patients. Instruct patients to read the Medication Guide each time EXALGO is dispensed because new information may be available.

• Advise patients that EXALGO is for use only in patients who are already receiving opioid pain medicine and their body is used to taking these medications.
• Advise patients that EXALGO contains hydromorphone, and should be taken only as directed.
• Advise patients that EXALGO must be swallowed whole. The extended release tablets may release all their contents at once if broken, chewed, crushed, or dissolved resulting in risk of fatal overdose of hydromorphone.
• Advise patients not to take another dose of EXALGO within 24 hours.
• Advise patients never to change the dose of EXALGO without first consulting their healthcare provider. Individualization of dosage is essential to make optimal use of this medication. Advise patients regarding the need to contact their healthcare provider if pain control is inadequate and to report episodes of breakthrough pain and adverse experiences occurring during therapy to their healthcare provider.
• Advise patients to keep EXALGO tablets in a secure place out of the reach of children. Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.
• Advise patients that EXALGO must not be given to anyone other than the individual for whom it was prescribed. Instruct patients against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

17.2 Risk of Gastrointestinal Obstruction

Advise patients that people with certain stomach or intestinal problems such as narrowing of the intestines or previous surgery may be at higher risk of developing a blockage. Symptoms include abdominal distension, abdominal pain, severe constipation, or vomiting. Instruct patients to contact their healthcare provider immediately if they develop these symptoms.

17.3 Mental and/or Physical Ability

Caution patients that EXALGO may cause drowsiness, dizziness, or lightheadedness, and may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.

17.4 Avoidance of Alcohol or Other CNS Depressants

Advise patients not to combine EXALGO with other pain medications, sleep aids, or tranquilizers except by the orders of a healthcare professional, and not to consume alcohol while taking EXALGO, because dangerous additive effects could occur, resulting in serious injury or death.

17.5 Pregnancy

Advise women of childbearing potential who become, or who plan to become, pregnant to consult their healthcare professional regarding the effects of EXALGO and other drug use during pregnancy on themselves and their unborn child. Advise women that EXALGO can pass through breast milk and may cause serious harm to a nursing infant so they should not breastfeed while taking EXALGO.

17.6 Cessation of Therapy

Advise patients that if they have been receiving treatment with EXALGO for more than a few days to weeks and the medicine is no longer needed, it is important to taper the dose and that abruptly discontinuing the medication could cause withdrawal symptoms. Provide patients with a dose schedule to accomplish a gradual discontinuation of the medication.

Advise patients that if they stop taking this medication for 3 or more days, to contact their healthcare professional before restarting their medication, to avoid complications of being opioid non-tolerant.

17.7 Drug of Abuse

Advise patients that the active ingredient in EXALGO is hydromorphone, which is a drug that some people abuse. EXALGO must be taken only by the patient for whom it was prescribed, and it must be protected from theft or misuse in the work or home environment.

17.8 Constipation

Advise patients that taking EXALGO has the potential to cause severe constipation. Consider the use of appropriate laxatives and/or stool softeners and other therapeutic approaches with the initiation of EXALGO therapy.

Advise patients that the drug is contained within a non-absorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body and patients should not be alarmed if they occasionally notice something that looks like a tablet in their stool.

17.9 Storage/Destruction of Unused Tablets

Advise patients that when EXALGO is no longer needed to flush the unused tablets down the toilet.

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