Relistor

Relistor

What is Relistor?

Relistor reduces constipation caused by taking opioid medications. Methylnaltrexone treats constipation without reducing the pain-relieving effects of the opioid.

Relistor is given to adults who use opioid medicines to treat severe chronic pain that is not caused by cancer.

Relistor injection is also intended for use in adults with advanced disease who are receiving palliative care (treatment to relieve suffering and improve quality of life during serious illness).

This medicine is usually given after laxatives have been tried without success in treating constipation.

Warnings

Relistor can cause a perforation (a hole or tear) in your stomach or intestines.Stop using this medicine and seek medical help immediately if you have severe stomach pain.

While using this medicineYou may have symptoms of opioid withdrawal,such as anxiety, sweating, chills, yawning, stomach pain or diarrhea.

Stop using Relistor and call your doctor if you have severe or persistent diarrhea.

Before you take this medicine

You should not use Relistor if your stomach or intestines are blocked.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a stomach ulcer;

• perforation (hole or tear) in your stomach or intestines;

• kidney disease;

• liver disease; or

• Colitis or other intestinal diseases such as Crohn's disease, diverticulitis or Ogilvie syndrome.

Tell your doctor if you are pregnant.If you use Relistor during pregnancy, your newborn may experience withdrawal symptoms.

You should not breast-feed while using methylnaltrexone.

Relistor is not intended for use by anyone under the age of 18.

How should I use Relistor?

Take Relistor exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use.

Stop using laxatives before you start using methylnaltrexone.

Relistor can induce a bowel movement within 30 minutes. Make sure you are near a toilet when using this medicine.

Take RelistorTabletson an empty stomach, at least 30 minutes before the first meal of the day.

Take the tablets with a full glass of water.

The Relistor injection is injected under the skin. A doctor will give you the first dose and may teach you how to properly use the medication yourself.

Carefully read and follow all instructions for use that come with your medicine. Ask your doctor or pharmacist if you do not understand all the instructions.

Your doctor will show you where on your body to inject Relistor. Use a different site for each injection. Do not inject in the same place twice in a row.

Do not prepare an injection until you are ready to give it. Do not use if the medicine looks cloudy, has changed color, or contains particles. Call your pharmacist for a new medicine.

Each injection bottle (bottle) or pre-filled syringe is for single use only. Throw it away after one use, even if it still contains medicine.

Do not use this medicine more than once every 24 hours.

Call your doctor if your symptoms do not improve after 3 days. You can use other laxatives after 3 days of treatment with Relistor.

Store this medicine at room temperature, away from moisture, heat and light. Do not freeze. Keep thatTabletsin the original container, along with the 2 canisters of moisture-absorbing preservative.

Use the needle and syringe only once and then place them in a puncture-proof sharps container. Follow state or local laws regarding disposal of this container. Keep it out of the reach of children and pets.

After you stop taking your opioid pain medication, you should also stop using Relistor.

Dosage information

Usual adult dose for constipation – medication-related:

Opioid-induced constipation in patients with chronic non-cancer pain:
-Oral: 450 mg orally once daily in the morning
-Parenteral: 12 mg subcutaneously once daily

Comments:
-Discontinue any maintenance therapy with laxatives before starting. If the response after 3 days is suboptimal, laxatives can be used as needed.
-Patients should stay close to a toilet after receiving this medicine.
-Re-evaluate the ongoing need for this medication if the opioid regimen is changed to avoid adverse reactions.

Opioid-induced constipation in patients with advanced disease:
Parenteral: Weight-based dosage: Administer subcutaneously every other day as needed, but not more frequently than 1 dose in 24 hours:
Under 38 kg: 0.15 mg/kg
38 kg to less than 62 kg: 8 mg (0.4 ml)
62 kg to 114 kg: 12 mg subcutaneously (0.6 ml)
More than 114 kg: 0.15 mg/kg subcutaneously

Notes: To determine injection volume for patients weighing less than 38 kg or more than 114 kg: Multiply patient weight (kg) by 0.0075 and round up to the nearest 0.1 mL

Used:
-For the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain or advanced disease who are receiving palliative care and in whom the response to laxative therapy has been inadequate.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for the next scheduled dose. Do not take extra medicine to make up for a missed dose.

Do not use this medicine more than once in 24 hours.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

If you have an opioid medication in your body, an overdose of methylnaltrexone can cause opioid withdrawal symptoms. Common withdrawal symptoms include yawning, irritability, sweating, chills, vomiting, diarrhea, and body aches.

What should I avoid when using Relistor?

Do not use any other laxatives that your doctor has not prescribed.

Side effects of Relistor

If necessary, get emergency medical helpSigns of an allergic reaction to Relistor: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Methylnaltrexone can cause a perforation (a hole or tear) in your stomach or intestines.Stop using this medicine and seek medical help immediately if you have severe stomach pain that worsens or does not go away.

Stop using Relistor and call your doctor immediately if you have:

• severe or persistent diarrhea;

• extreme dizziness or feeling like you might faint;

• bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds;

• nausea or vomiting, which are new or worsening symptoms; or

• Symptoms of opioid withdrawal– Anxiety, sweating, chills, yawning, stomach pain, diarrhea.

Common side effects of Relistor may include:

• stomach pain, bloating, flatulence;

• mild nausea or diarrhea;

• headache, muscle cramps;

• dizziness, tremors, feelings of anxiety;

• runny nose; or

• Chills, sweating, or hot flashes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Relistor?

Other medications may interact with methylnaltrexone, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

References

1. Relistor-Produktetikett

More information

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