Relistor

The usual recommended dose of Relistor (Methylnaltrexone) is based on body weight:

• 6 mg for people who weigh 33 kg to less than 38 kg
• 8 mg for people who weigh 38 kg to less than 62 kg
• 12 mg for people who weight 62 kg to 114 kg
• 18 mg for people who weigh 115 kg to 126 kg

For people who weigh less than 33 kg or more than 126 kg, your doctor will calculate the dose of Relistor (Methylnaltrexone) that is appropriate for you.

Relistor (Methylnaltrexone) is injected once every other day under the skin of the upper arm, abdomen, or thigh.

It is important to use Relistor (Methylnaltrexone) exactly as prescribed by your doctor. If you (or a family member or friend) are injecting Relistor (Methylnaltrexone), a health care professional will show you how to inject the medication properly. Read the instructions provided in the package insert carefully. If you are not sure how to use Relistor (Methylnaltrexone), contact your doctor or pharmacist.

It is recommended that you use a different site for each injection. Do not inject into skin that is tender, red, bruised, hard, or has stretch marks or scars. If you are giving the injection to yourself, do not inject into the upper arm. You should be sitting or lying down when you receive Relistor (Methylnaltrexone). Do not stand up quickly after the injection as you may feel dizzy.

If you do not notice improvement within a week, contact your doctor.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Store Relistor (Methylnaltrexone) at room temperature, protect it from light, and keep it out of the reach of children. Do not allow it to freeze.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of sterile, clear and colourless to pale yellow aqueous solution for injection contains Relistor (Methylnaltrexone) bromide 20 mg. Each vial contains 12 mg of Relistor (Methylnaltrexone) bromide in 0.6 mL of sterile water for injection. Nonmedicinal ingredients: edetate calcium disodium, glycine hydrochloride, sodium chloride, and sterile water for injection. The solution is isotonic and the pH is adjusted during manufacture with hydrochloric acid and/or sodium hydroxide to approximately 3.4.

Do not use Relistor (Methylnaltrexone) if you:

• are allergic to Relistor (Methylnaltrexone) or to any of the ingredients of Relistor (Methylnaltrexone)
• have or may have a blockage of the gastrointestinal tract or abdominal pain that requires immediate surgery

There may be an interaction between Relistor (Methylnaltrexone) and any of the following:

• Naloxegol
• Naloxone
• Naltrexone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Relistor (Methylnaltrexone). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Relistor (Methylnaltrexone).

Gastrointestinal perforation: People with advanced illness who use Relistor (Methylnaltrexone) injection may be at increased risk of gastrointestinal perforation (a hole that forms in the wall of the gastrointestinal tract, such as through the stomach or intestines). People are especially at risk if they also have a weakened gastrointestinal wall due to conditions such as cancer, intestinal cancer, or gastrointestinal cancer. If you experience severe, worsening, or persistent abdominal pain that's intensified by movement, nausea and vomiting, or accompanied by Fever or chills, seek immediate medical attention. These could be symptoms of gastrointestinal perforation, which is a medical emergency.

Kidney function: People with severely reduced kidney function require lower doses of Relistor (Methylnaltrexone). If you have Kidney Disease or decreased kidney function, discuss with your doctor how Relistor (Methylnaltrexone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Relistor (Methylnaltrexone), and whether any special monitoring is needed.

Liver function: Relistor (Methylnaltrexone) is not recommended for people who have severely reduced liver function.

Severe diarrhea: Relistor (Methylnaltrexone) may cause severe diarrhea. If you experience this, stop using Relistor (Methylnaltrexone) and contact your doctor as soon as possible.

Pregnancy: Relistor (Methylnaltrexone) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Relistor (Methylnaltrexone), contact your doctor immediately.

Breast-feeding: It is not known if Relistor (Methylnaltrexone) passes into breast milk. If you are a breast-feeding mother and are using Relistor (Methylnaltrexone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Relistor (Methylnaltrexone) have not been established for children.