Relistor 12 mg/0.6 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Relistor 12 mg/0.6 ml solution for injection

Methylnaltrexone bromide

Read the entire leaflet carefully before you start using this medicine,because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Relistor is and what it is used for

2. What you need to know before using Relistor

3. How to use Relistor

4. Possible side effects

5. How to store Relistor

6. Contents of the pack and other information

1. What Relistor is and what it is used for

Relistor contains an active substance called methylnaltrexone bromide, which works by blocking the adverse effects of opioid pain medicines on the intestine.

It is indicated for the treatment of constipation caused by pain medications known as opioids (for example, morphine or codeine) used to manage moderate to severe pain. It is used in patients when other constipation treatments (laxatives) have not been effective. Your doctor has prescribed you opioids. Your doctor will advise you whether you should continue or discontinue your usual laxative therapy when starting this medicine.

This medicine should only be used in adults (18 years of age and older).

2. What you need to know before using Relistor

Do not use Relistor

• if you are allergic to methylnaltrexone bromide or to any of the other ingredients of this medicine (listed in section 6).
• if you or your doctor suspect that you have or have had intestinal obstruction or if your abdomen is in a condition requiring immediate surgical intervention (this condition must be diagnosed by your doctor).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Relistor

• If you have severe stomach symptoms that persist or worsen, contact your doctor immediately, as this may indicate a perforation of the intestinal wall (intestinal perforation). See section 4.

• If you have Crohn's disease or a gastrointestinal ulcer.

• If you feel unwell, vomit, tremble, sweat, have abdominal pain, and/or feel your heartbeat racing shortly after taking Relistor, speak with your doctor.

• If you have severe liver or kidney disease.

• If you develop severe or persistent diarrhoea (repeated watery stools), stop treatment and consult your doctor immediately.

• It is important to have access to a toilet and, if needed, assistance available, as you may have a bowel movement within 30 minutes after injection of the medicine.

• Inform your doctor if you experience persistent stomach pain, nausea, or vomiting, whether newly developed or worsening of pre-existing symptoms.

• Inform your doctor if you have had a colostomy, have a peritoneal catheter, or suffer from diverticular disease or faecal impaction, as this medicine should be used with caution in these cases.

• If you are receiving palliative treatment for your advanced illness, this medicine should only be used for a limited time, usually less than 4 months.

• This medicine must not be used to treat constipation unrelated to opioid use. Inform your doctor if you already had constipation before starting opioid medications (for pain).

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age, as the potential risks and benefits are unknown.

Use of Relistor with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may allow you to take other medicines, including those you were previously using for constipation.

Pregnancy and breastfeeding

It is unknown what effects methylnaltrexone bromide may have in pregnant women.

Your doctor will decide whether you can use Relistor if you are pregnant.

Women taking this medicine must not breastfeed, as it is unknown whether methylnaltrexone bromide passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Dizziness is a common side effect of this medicine. This may affect your ability to drive or operate machinery.

Important information about some of the ingredients of Relistor

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Relistor

Follow exactly the administration instructions for this medicine as given by your doctor.

If in doubt, please consult your doctor or pharmacist again.

The recommended dose for patients with chronic pain (except patients receiving palliative treatment for advanced illness) is 12 mg of methylnaltrexone bromide (0.6 ml of solution) administered by subcutaneous injection (under the skin), on demand, at least 4 times per week and no more than once daily (7 times per week).

The recommended dose for patients receiving palliative treatment for advanced illness is 8 mg of methylnaltrexone bromide (0.4 ml of solution) for patients weighing between 38–61 kg or a dose of 12 mg (0.6 ml of solution) for patients weighing between 62–114 kg. The dose is administered every 48 hours (every 2 days) by subcutaneous injection (under the skin).

Your doctor will determine your dose.

This medicine is administered by injection under the skin (subcutaneous injection) in: (1) the upper legs (thighs), (2) the abdomen (stomach, below the navel), and (3) the upper arms (if you are not self-injecting). (See INSTRUCTIONS FOR PREPARING AND ADMINISTERING A RELISTOR INJECTION.)

After receiving the injection, you may have a bowel movement within a time frame ranging from a few minutes to several hours. Therefore, it is recommended that you have access to a toilet or be near a commode.

If you use more Relistor than you should

If you have used more medicine than you should (either because you injected too much at one time, or because you used more than one injection within 24 hours), you may feel dizzy when standing up. In this case, contact a doctor or pharmacist immediately. Always carry the medicine packaging with you, even if it is empty.

If you forget to use Relistor

If you forget to administer a dose, inform your doctor or pharmacist as soon as possible. Do not take a double dose to make up for missed doses.

If you stop using Relistor

Consult a doctor or pharmacist if you wish to discontinue treatment with this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Cases of intestinal wall perforation (gastroduodenal perforation) have been observed in patients using Relistor. The frequency of this event is unknown based on the available data. If you experience severe or persistent stomach pain, stop taking this medicine and contact your doctor immediately.

The following adverse effects are very common and may affect more than 1 in every 10 patients. If you experience any of these adverse effects intensely or persistently, consult your doctor:

• Abdominal pain (stomach pain)
• Nausea
• Diarrhea (frequent liquid stools)
• Flatulence (gas, bloating)

Other common adverse effects, which may affect up to 1 in every 10 patients, are:

• Dizziness (lightheadedness)
• Symptoms similar to opioid withdrawal syndrome (such as feeling cold, chills, runny nose, sweating, goosebumps, hot flushes, rapid heartbeat)
• Injection site reactions (e.g., stinging, burning, pain, redness, swelling at the site where the medicine was injected)
• Vomiting

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Relistor

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Keep the vial in its outer packaging to protect it from light.

This medicine should only be used if the solution is clear, colourless to slightly yellow, and contains no particles or precipitate.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Relistor

• The active substance is methylnaltrexone bromide. Each 0.6 ml vial contains 12 mg of methylnaltrexone bromide. One ml of solution contains 20 mg of methylnaltrexone bromide.
• The other components are sodium chloride, calcium disodium edetate, glycine hydrochloride, water for injections, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

Appearance of the product and contents of the pack

Relistor is an injectable solution. It is transparent, colourless to pale yellow, and contains no particles or sediment.

Each vial contains 0.6 ml of solution.

Packs containing more than one vial include inner cartons each containing: one vial, one 1 ml syringe with retractable needle, and two alcohol-impregnated swabs.

The following pack sizes are available:

1 vial

Pack containing 2 vials, 2 injection syringes with retractable needles, and 4 alcohol-impregnated swabs (contains 2 inner carton packs)

Pack containing 7 vials, 7 injection syringes with retractable needles, and 14 alcohol-impregnated swabs (contains 7 inner carton packs).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Bausch Health Poland Sp. z o.o.,
ul. Przemyslowa 2,
35-959 Rzeszów,
Poland

Przedsiebiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra,
Poland

Date of the most recent revision of this leaflet: 11/2023

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu/.

QUESTIONS FOR THE PATIENT

This section contains important questions you will need to answer before using and during treatment with Relistor.

If you answer "No" to any of the following questions during your treatment with this medicine, please contact your doctor, nurse, or pharmacist.

1. Are you receiving opioid therapy (such as morphine or codeine) for your condition?

2. Has it been 48 hours or more since your last bowel movement?

3. Are you familiar with the self-injection technique, or has your doctor (or nurse or pharmacist) explained it to you?

4. Do you have sufficient mobility to reach the toilet, or do you have a caregiver who can assist you?

5. Do you have the contact number for your healthcare center?

INSTRUCTIONS FOR PREPARING AND ADMINISTERING A RELISTOR INJECTION

This section is divided into the following subsections:

Introduction

Step 1: Pre-injection instructions

Step 2: Preparing the syringe

Step 3: Choosing and preparing the injection site

Step 4a: Injecting Relistor using the pack containing syringe with retractable needle

Step 4b: Injecting Relistor using a standard syringe and needle

Step 5: Disposal of waste

Introduction

The following instructions explain how to inject Relistor. Please read them carefully and follow each step exactly. Your doctor, nurse, or pharmacist will instruct you on the techniques of self-administration. Do not attempt to give yourself an injection until you are certain you know how to do it. This injection must not be mixed in the same syringe with any other medicine.

You may receive a pack containing an inner carton with all necessary items for self-injection, or you may receive only the vial of medication. If you receive only the vial, you will need several alcohol swabs and an injection syringe.

Step 1: Pre-injection instructions

1. Choose a clean, flat, well-lit surface where you can place the contents of your Relistor pack. Make sure you have adequate time to complete the injection.

2. Wash your hands thoroughly with soap and lukewarm water.

1. Prepare the necessary materials for the injection: the Relistor vial, a 1 ml syringe for subcutaneous injection (with or without a retractable needle), 2 alcohol swabs, and a piece of gauze or cotton.

2. Make sure that the solution inside the vial is clear, colorless to pale yellow, and does not contain visible particles. If this is not the case, do not use the solution. Contact your pharmacist, nurse, or doctor for advice.

Step 2: Preparing the syringe

1. Remove the protective plastic cap from the vial.

1. Clean the rubber stopper of the vial with an alcohol swab and place the swab on the flat work surface. Be careful not to touch the rubber stopper again.

2. Take the syringe from your work surface. Hold the syringe barrel (body) with one hand and pull the needle cap straight off. Place the needle cap on the work surface. DO NOT touch the needle or allow it to come into contact with any other surface.

Carefully pull the syringe plunger out to the 0.4 ml mark for 8 mg of Relistor or to the 0.6 ml mark for 12 mg of Relistor. Your doctor, nurse, or pharmacist will have informed you of the dose prescribed for you and how often you should receive it. For patients receiving palliative treatment for advanced illness, the most common doses are included in the following table. Generally, the dose is administered every 48 hours (every two days) via a subcutaneous injection (under the skin).

For patients with chronic pain (except patients receiving palliative treatment for advanced disease), load the syringe to the 0.6 ml mark for 12 mg of Relistor.

1. Insert the straight needle vertically downward into the center of the vial stopper. Do not insert the needle at an angle, as it may bend or break. To prevent slipping, hold the vial with the other hand on the work surface. You will feel slight resistance as the needle pierces the stopper. Ensure that the needle tip is inside the vial.

1. To expel air from the syringe, gently push the plunger down to inject the air into the Relistor vial.

1. If you are using the supplied retractable needle syringe, DO NOT PUSH THE PLUNGER TO THE BOTTOM. Stop pushing the plunger when you feel resistance. If you push the plunger all the way to the bottom, you will hear a "click," indicating that the safety mechanism has been activated, after which the needle will retract into the syringe. If this occurs, discard the product and start again with a new vial and a new syringe.

With the needle still in the vial, turn the vial completely upside down (see figure). Hold the syringe at eye level so that you can see the dosage markings, and ensure that the needle tip remains submerged in the liquid at all times. Slowly pull the plunger back to the 0.4 ml or 0.6 ml mark on the syringe, or as instructed, depending on the dose prescribed by your doctor, nurse, or pharmacist. You may notice that a small amount of liquid or some bubbles remain in the vial after the syringe has been properly filled; this is normal.

1. With the needle still inserted in the inverted Relistor vial, check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe with your finger to allow them to rise to the top; continue holding the Relistor vial and syringe. Gently push the plunger upward until all air bubbles are expelled. If some solution is expelled into the vial, slowly pull the plunger back again to withdraw the correct amount of solution into the syringe. Due to the safety design of the syringe, a small air bubble may resist removal. This is not a cause for concern, as it will not affect the accuracy of the dose or pose any risk to your health.

1. Always make sure you have the correct dose in the syringe. If you are unsure, contact your doctor, nurse, or pharmacist.

1. Remove the syringe and needle from the vial. Keep the needle attached to the syringe. Do not touch the needle or allow it to come into contact with any surface. Once the medication has been drawn into the syringe, it must be used within 24 hours, as Relistor is sensitive to light and may not work properly if left in the syringe for more than 24 hours.

Step 3: Choosing and preparing the injection site

1. The three recommended areas of the body for Relistor injection are: (1) upper legs (thighs), (2) abdomen (stomach), and (3) upper arms (only if someone else administers the injection).

1. It is recommended to change the injection site each time an injection is administered. Avoid repeated injections at exactly the same site used previously. Do not inject in areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.

2. To prepare the skin area where Relistor will be injected, clean the injection site with an alcohol swab. DO NOT TOUCH THIS AREA AGAIN BEFORE ADMINISTERING THE INJECTION. Allow the injection site to air dry before injecting.

Step 4a: Injection of Relistor using the pack containing syringe and retractable needle

1. Hold the filled syringe with the needle pointing upward, and check again for air bubbles in the syringe. If there are any air bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger upward to expel the air bubbles out of the syringe.

2. Hold the syringe in one hand as if holding a pencil. With the other hand, gently pinch and firmly hold a clean area of skin.

3. Insert the entire needle into the skin at a slight angle (45 degrees) with a quick, short motion.

1. Once the needle has been inserted, release the skin pinch and slowly push the plunger fully down until the syringe is empty and you hear a click.

2. When you hear a "click," this indicates that the full contents have been injected. After this, the needle automatically retracts into the skin and becomes covered (inside the syringe). Minor bleeding at the injection site may occur. Press a gauze or cotton ball against the injection site. Do not rub the injection site. If needed, the injection site may be covered with a bandage.

Step 4b: Injecting the Relistor solution using a standard syringe and needle

1. Hold the filled syringe with the needle pointing upward, and check again for air bubbles. If there are any bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe. Slowly push the plunger upward to expel the air bubbles from the syringe.

2. Hold the syringe in one hand as if holding a pencil. With the other hand, gently pinch and firmly hold a clean area of skin.

3. Insert the entire needle into the skin at a slight angle (45 degrees) with a quick, short motion.

1. Once the needle has been inserted, release the skin pinch and slowly push the plunger fully down to inject Relistor.

2. Once the syringe is empty, quickly remove the needle from the skin at the same angle at which it was inserted. Minor bleeding at the injection site may occur. Press a gauze or cotton ball against the injection site. Do not rub the injection site. If necessary, the injection site may be covered with a bandage.

Step 5: Disposal of Waste

The syringe with the retracted needle or the syringe and needle should NEVER be reused. NEVER recap the needle. Dispose of the syringe with the retracted needle or the needle and syringe in a sharps-resistant container as instructed by your doctor, nurse, or pharmacist.