Relistor
Generic Name: methylnaltrexone bromide
Date of Approval: April 24, 2008
Company: Progenics Pharmaceuticals, Inc. and Wyeth Pharmaceuticals
Treatment for: Opioid-Induced Constipation
FDA Approves Relistor
The U.S. Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
In clinical studies, Relistor significantly decreased the constipating effects of opioids without interfering with pain relief.
About Relistor and Opioids
Relistor, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.
Opioids provide pain relief by specifically interacting with mu-opioid receptors within the central nervous system (CNS) - the brain and spinal cord. However, opioids also interact with mu-opioid receptors found outside the CNS, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. Relistor selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. Because of its chemical structure, Relistor does not affect the opioid-mediated analgesic effects on the CNS. The efficacy and safety profile of Relistor was established in two phase 3 clinical trials. Use of Relistor beyond four months has not been studied.
Important Safety Information for Relistor
- Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
- If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician.
- Use of Relistor has not been studied in patients with peritoneal catheters.
- The most common adverse reactions with Relistor in clinical trials were abdominal pain, flatulence, and nausea.
Source: Wyeth
Relistor Patient Information
Read the Patient Information that comes with Relistor before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is Relistor?
Relistor is a prescription medicine used to treat constipation that is caused by prescription pain medicines, called opioids, in patients receiving supportive care for their advanced illness, when other medicines for constipation, called laxatives, have not worked well enough.
What should I tell my healthcare provider before taking Relistor?
Tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if Relistor can harm your unborn baby. If you become pregnant while using Relistor, tell your healthcare provider right away.
- are breast-feeding or plan to breast-feed. It is not known if Relistor passes into your breast milk.
Tell your healthcare provider about all medicines you take. Continue taking your other medicines for constipation unless your healthcare provider tells you to stop taking them.
How should I take Relistor?
- Take Relistor exactly as your healthcare provider tells you.
- Take Relistor by an injection under the skin (subcutaneous injection) of the upper arm, abdomen, or thigh.
- Do not take more than one dose in a 24-hour period.
- Most patients have a bowel movement within a few minutes to a few hours after taking a dose of Relistor.
- If you stop taking your prescription pain medicine, check with your healthcare provider before continuing to take Relistor.
- If you take more Relistor than prescribed, talk to your healthcare provider right away.
See the detailed Patient Instructions for Use at the end of this Patient Information leaflet for information about how to prepare and inject Relistor.
What are the possible side effects of Relistor?
Common side effects of Relistor include:
- abdominal (stomach) pain
- gas
- nausea
- dizziness
- diarrhea
- If you get diarrhea that is severe or does not stop while taking Relistor, stop taking Relistor and call your healthcare provider.
- If you get abdominal pain that will not go away, or nausea or vomiting that is new or worse, call your healthcare provider.
These are not all of the possible side effects of Relistor. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Relistor?
- Store Relistor vials at 68 to 77°F (20 to 25°C).
- Do not freeze Relistor.
- Keep Relistor away from light until you are ready to use it.
- If Relistor has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. The syringe does not need to be kept away from light during the 24-hour period.
Keep Relistor and all medicines, needles and syringes out of the reach of children.
General information about Relistor
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Relistor for a condition for which it was not prescribed. Do not give Relistor to other people, even if they have the same symptoms that you have. It may harm them.
For more information, please visit www.relsitor.com.
What are the ingredients in Relistor?
Active ingredient: methylnaltrexone bromide
Inactive ingredients: sodium chloride, edetate calcium disodium USP, glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.
Marketed by: Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101
Under license from: Progenics Pharmaceuticals, Inc. Tarrytown, NY 10591
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