Methylnaltrexone Bromide Injection

Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain

RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioidinduced constipation (OIC) in adult patients with chronic non-cancer pain.

Opioid-Induced Constipation In Adult Patients With Advanced Illness

RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

Use of RELISTOR injection beyond four months has not been studied in the advanced illness population.

Included as part of the "PRECAUTIONS" Section

During clinical trials of RELISTOR administered orally and subcutaneously, one accidental case of methylnaltrexone bromide overdose was reported and no adverse events were reported as a result of the overdosage.

A study of healthy subjects noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus. Monitor for signs or symptoms of orthostatic hypotension and initiate treatment as appropriate.

If a patient on opioid therapy receives an overdose of RELISTOR, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms such as chills, rhinorrhea, diaphoresis or reversal of central analgesic effect. Base treatment on the degree of opioid withdrawal symptoms, including changes in blood pressure and heart rate, and on the need for analgesia.

You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

Before you use methylnaltrexone, tell your doctor if you have severe or ongoing diarrhea.

Prepare your dose in a syringe only when you are ready to give yourself an injection. After loading a syringe, if you cannot give the injection right away keep it at room temperature and use it within 24 hours.

Methylnaltrexone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

You should not use this medication if you are allergic to methylnaltrexone, or if you have a blockage in your stomach or intestines.

To make sure you can safely use methylnaltrexone, tell your doctor if you have any of these other conditions:

• cancer;
• a stomach ulcer; or
• colitis or other intestinal disorder.

FDA pregnancy category B. Methylnaltrexone is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether methylnaltrexone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Your doctor or pharmacist can provide more information about methylnaltrexone.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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