Simulect 20 mg powder and solvent for solution for injection or for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Simulect 20mg powder and solvent for solution for injection or infusion

basiliximab

Read all of this leaflet carefully before you start receiving 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, nurse or pharmacist.
• If you experience any side effects, talk to your doctor, nurse or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Simulect is and what it is used for
2. What you need to know before receiving Simulect
3. How Simulect is given
4. Possible side effects
5. How to store Simulect
6. Contents of the pack and other information

1. What Simulect is and what it is used for

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents, and children who are about to undergo a kidney transplant. Immunosuppressants reduce your body's response to substances it recognizes as "foreign"—including transplanted organs. Your body's immune system recognizes a transplanted organ as foreign and will attempt to reject it. Simulect works by stopping the immune cells that attack transplanted organs.

You will receive only two doses of Simulect. These will be given to you in the hospital around the time of your transplant surgery. Simulect is administered to prevent rejection of the new organ during the first 4 to 6 weeks after transplantation, when the risk of rejection is highest. During this time and after leaving the hospital, you will be taking other medicines to help protect your new kidney, such as ciclosporin and corticosteroids.

2. What you need to know before receiving Simulect

Carefully follow your doctor's instructions. If you have any doubts, consult your doctor, nurse, or pharmacist.

Do not receive Simulect

• if you are allergic (hypersensitive) to basiliximab or to any of the other components of Simulect listed in section 6 under “Composition of Simulect”. Inform your doctor if you suspect you have previously had an allergic reaction to any of these components.
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, nurse, or pharmacist before receiving Simulect:

• if you have previously received a transplant that your body rejected after a short period of time, or
• if you have previously gone to the operating room for a transplant that was ultimately not performed.

In such cases, you may have already received Simulect. Your doctor will check and discuss with you whether repeating treatment with Simulect is appropriate.

If you need to receive a vaccine, consult your doctor first.

Other medicines and Simulect

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

Elderly patients (65 years of age or older)

Simulect may be administered to elderly patients; however, available data are limited. Your doctor will discuss this with you before administering Simulect.

Children and adolescents (between 1 and 17 years of age)

Simulect may be administered to children and adolescents. The dose for children weighing less than 35 kg should be smaller than the dose usually administered to adults.

Pregnancy and breastfeeding

It is very important that you inform your doctor before your transplant if you are pregnant or think you might be pregnant. You must not receive Simulect if you are pregnant. You should use an adequate method of contraception to prevent pregnancy during treatment and for 4 months after receiving the last dose of Simulect. You must inform your doctor immediately if you become pregnant during this time, even if you are using contraceptive measures.

You should also inform your doctor if you are breastfeeding. Simulect may harm your baby. You must not breastfeed after receiving Simulect or until 4 months after the second dose.

Consult your doctor, nurse, or pharmacist before using any medicine while pregnant or breastfeeding.

Driving and using machines

There is no evidence indicating that Simulect affects your ability to drive or operate machinery.

Simulect contains sodium and potassium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; therefore, it is essentially “sodium-free”.

This medicine contains less than 39 mg (1 mmol) of potassium per vial, and is therefore considered essentially “potassium-free”.

3. How to receive Simulect

Simulect will only be administered to you if you are about to receive a new kidney. Simulect is given twice in the hospital, either administered slowly through a needle into your vein as an infusion lasting 20–30 minutes, or as an intravenous injection using a syringe.

If you have experienced serious allergic reactions to Simulect, or if you have developed complications after your transplant such as graft loss, the second dose of Simulect must not be given.

The first dose is administered just before the transplant surgery, and the second dose is given 4 days after the operation.

Normal dose for adults

The normal dose for adults is 20 mg for each infusion or injection.

Normal dose for children and adolescents (between 1 and 17 years of age)

• For children and adolescents weighing 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg.
• For children and adolescents weighing less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg.

If you have been given too much Simulect

An overdose of Simulect is unlikely to cause immediate side effects; however, it may prolong the time during which your immune system activity is reduced. Your doctor will monitor you to see if this has any consequences on your immune system and will treat them if necessary.

4. Possible side effects

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

Tell your doctor or nurse as soon as possible if you notice any unexpected symptoms while you are receiving Simulect, or during the 8 weeks following treatment, even if you do not think they are related to the medicine.

Unexpected severe allergic reactions have been reported in patients treated with Simulect. Immediately inform your doctor or nurse if you notice unexpected signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, rapid heartbeat, dizziness, lightheadedness, difficulty breathing, sneezing, wheezing or shortness of breath, significantly decreased urine production, fever, or flu-like symptoms.

In adults, the most commonly reported side effects were constipation, nausea, diarrhea, weight gain, headache, pain, swelling of the hands, ankles and feet, high blood pressure, anemia, changes in blood parameters (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various types of infections.

In children, the most commonly reported side effects were constipation, excessive growth of body hair, runny or stuffy nose, fever, high blood pressure, and various types of infections.

Reporting of side effects

If you experience any type of side effect, consult your doctor, nurse or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Simulect

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 label after EXP. The expiry date is the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

6. Contents of the pack and other information

Composition of Simulect

• The active substance is basiliximab. Each vial contains 20 mg of basiliximab.
• The other components are potassium dihydrogen phosphate; anhydrous disodium hydrogen phosphate; sodium chloride; sucrose; mannitol (E421); glycine.

Presentation of Simulect and contents of the pack

Simulect is presented as a white powder in a clear glass vial containing 20 mg of basiliximab. It is supplied in a pack together with a clear glass ampoule containing 5 ml of sterile water for injection. This solvent is used to dissolve the powder before administration.

Simulect is also available in vials containing 10 mg of basiliximab.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this summary:

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

INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION

This information is intended for healthcare professionals only:

Simulect must not be administered unless it is absolutely certain that the patient will receive the transplant and concomitant immunosuppressive therapy.

To prepare the infusion solution or injectable solution, add the 5 ml of water for injections from the ampoule to the vial containing Simulect powder, using aseptic techniques. Gently swirl the vial to dissolve the powder, avoiding foaming. The colorless, clear to opalescent solution is recommended to be used immediately after reconstitution. Reconstituted solutions should be inspected visually for the presence of particulate matter prior to administration. Do not use if foreign particles are present. After reconstitution, physical and chemical stability in use has been demonstrated for 24 hours at 2°C – 8°C or for 4 hours at room temperature. Discard the reconstituted solution if not used within this time. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration of storage and conditions prior to use are the responsibility of the user.

Reconstituted Simulect is administered either as an intravenous infusion over 20 to 30 minutes or as a bolus injection. The reconstituted solution is isotonic. For infusion, the reconstituted solution should be diluted to a volume of 50 ml or greater with 0.9% sodium chloride or 5% glucose solution. The first dose should be administered within two hours before transplantation surgery, and the second dose four days after transplantation. The second dose must not be administered if severe hypersensitivity reactions to Simulect or graft loss occur.

Since compatibility data with other intravenous substances are not available, Simulect must not be mixed with other medications/substances and should always be administered via a separate infusion line.

Compatibility has been verified with the following infusion equipment:

Infusion bag

• Baxter minibag NaCl 0.9%

Infusion sets

• Luer Lock®, H. Noolens
• Sterile vented i.v. administration set, Abbott
• Infusion set, Codan
• Infusomat®, Braun
• Infusionsgerät R 87 plus, Ohmeda
• Lifecare 5000®/Plumset Microdrip, Abbott
• Basic set with vent, Baxter
• Flashball device, Baxter
• Primary administration set with vent, Imed

Do not use after the expiry date stated on the container.

Keep in a refrigerator (between 2°C and 8°C).

Disposal of unused medicine and all materials that have come into contact with it must be in accordance with local regulations.