Relistor 12 mg/0.6 ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Relistor 12 mg/0.6 ml injectable solution

Methylnaltrexone bromide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as 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. It may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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 gut.

It is indicated for the treatment of constipation caused by medicines for moderate to severe pain known as opioids (for example, morphine or codeine). It is used in patients when other constipation medicines (laxatives) have not worked. 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 that 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 using 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 to your doctor.
• If you have severe liver or kidney disease.
• If you develop severe or persistent diarrhea (repeated watery bowel movements), stop treatment and consult your doctor immediately.
• It is important to have a toilet nearby and, if needed, assistance available, as you may have a bowel movement within 30 minutes after receiving the injection.
• 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 fecal 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 give 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

Tell 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

The effects of methylnaltrexone bromide in pregnant women are unknown. Your doctor will decide whether you can use Relistor if you are pregnant.

Women taking this medicine should 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 instructions for administration of this medicine given by your doctor. If in doubt, 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 toilet facilities or be near a toilet.

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 used more than one injection within 24 hours), you may feel dizzy when standing up, so inform a doctor or pharmacist immediately. Always carry the medicine carton 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 forgotten doses.

If you stop using Relistor

Consult a doctor or pharmacist if you wish to stop 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 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 10 patients. If you experience any of these adverse effects intensely or persistently, consult your doctor:

• Abdominal pain (stomach pain)
• Nausea
• Diarrhoea (frequent liquid bowel movements)
• Flatulence (gas, wind)

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

• Dizziness (lightheadedness)
• Opioid withdrawal-like symptoms (such as feeling cold, chills, runny nose, sweating, goosebumps, hot flushes, rapid heartbeat)
• Reactions at the injection site (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 via 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 stated on the carton and vial following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions.

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

This medicine should only be used if the solution is clear, colourless to pale yellow, and free from particles or precipitates.

Medicines must 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 helps protect the environment.

6. Contents of the pack 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 cardboard containers 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 cardboard containers)

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

Only some 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 Poland Sp. z o.o.,
ul. Kosztowska 21,
41-409 Mysłowice,
Poland

Bausch Health Poland Sp. z o.o.,
ul. Kosztowska 21,
41-409 Mysłowice,
Poland

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

Date of latest 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 must answer before and during treatment with Relistor.

If you answer "No" to any of the following questions at any time during your treatment, 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 facility?

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 with syringe and 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. Your doctor, nurse, or pharmacist will instruct you on the self-administration technique. Do not attempt to give yourself an injection until you are certain you know how to do it correctly. This injection must not be mixed in the same syringe with any other medication.

You may have a pack containing an inner cardboard container 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 a 1 ml 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.

3. Prepare the materials needed for the injection: the Relistor vial, a 1 ml syringe for subcutaneous injection (with or without retractable needle), 2 alcohol-impregnated swabs, and a gauze pad or cotton ball.

4. Check that the solution in the vial is clear, colourless to pale yellow, and free from visible particles. If it is not, do not use the solution. Contact your pharmacist, nurse, or doctor for advice.

Step 2: Preparing the syringe

1. Remove the plastic protective cap from the vial.

2. Clean the rubber stopper of the vial with an alcohol-impregnated swab and place the swab on your work surface. Be careful not to touch the rubber stopper again.

3. Pick up the syringe from your work surface. Hold the barrel (body) of the syringe in 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 touch any other surface.

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

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

1. Insert the needle straight down 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 your other hand on the work surface. You will feel slight resistance as the needle pierces the stopper. Ensure that the tip of the needle is inside the vial.

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

1. If you are using the supplied retractable needle syringe, DO NOT PUSH THE PLUNGER ALL THE WAY DOWN. Stop pushing the plunger when you feel resistance. If you push the plunger fully down, you will hear a "click," indicating that the safety mechanism has been activated and the needle will retract into the syringe. If this happens, discard the product and start again with a new vial and syringe.

With the needle still in the vial, turn the vial completely upside down (see figure). Hold the syringe at eye level so you can see the dosage markings, and ensure that the needle tip remains submerged in the liquid. Slowly pull back the plunger to the 0.4 ml or 0.6 ml mark on the syringe, or as instructed by your doctor, nurse, or pharmacist, depending on the dose prescribed. You may notice some liquid or bubbles remaining 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 bubbles are present, 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 back the plunger again to withdraw the correct amount of solution into the syringe. Due to the safety design of the syringe, a small air bubble may be difficult to remove. 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 ensure that 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 body areas 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 given. Avoid repeated injections at the exact same site used previously. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.

2. To prepare the skin area for Relistor injection, 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: Injecting Relistor using the pre-filled syringe with retractable needle

1. Hold the filled syringe with the needle pointing upward and recheck the syringe for air bubbles. If bubbles are present, gently tap the syringe with your finger until the air bubbles rise to the top. 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 a fold of clean skin and hold it firmly.

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

1. Once the needle is 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 dose has been injected and the needle automatically retracts from the skin and becomes covered (inside the syringe). Minor bleeding at the injection site may occur. Press a gauze pad or cotton ball over the injection site. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

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

1. Hold the filled syringe with the needle pointing upward and recheck the syringe for air bubbles. If bubbles are present, gently tap the syringe with your finger until the air bubbles rise to the top. 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 a fold of clean skin and hold it firmly.

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

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

2. After the syringe is empty, quickly remove the needle from the skin at the same angle used for insertion. Minor bleeding at the injection site may occur. Press a gauze pad or cotton ball over the injection site. Do not rub the injection site. If needed, you may cover the injection site with a bandage.

Step 5: Disposal of waste

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