Sandimmun 250 mg/5 ml concentrate for solution for infusion: detailed information

Brand name Sandimmun 250 mg/5 ml concentrate for solution for infusion

Form solution for infusion, concentrate

Active substance / Dosage

CICLOSPORINE · 250 mg

Prescription type Hospital Use Only

ATC code

L04A L04AD L04AD01

Registration number 56798

Manufacturer Novartis Farmaceutica S.A.

Sandimmun 250 mg/5 ml concentrate for solution for infusion solution for infusion, concentrate

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Sandimmun is and what it is used for
2. What you need to know before using Sandimmun
3. How to use Sandimmun
4. Possible adverse effects
5. Storage of Sandimmun
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Sandimmun 250mg/5 ml concentrate for solution for infusion

ciclosporin

Read the entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

What Sandimmun is and what it is used for
What you need to know before using Sandimmun
How to use Sandimmun
Possible adverse effects
How to store Sandimmun
Contents of the pack and other information

1. What Sandimmun is and what it is used for

What Sandimmun is

The name of your medicine is Sandimmun. It contains the active substance ciclosporin. The concentrate is used to prepare a solution that is administered by intravenous infusion. It belongs to a group of medicines known as immunosuppressants. These medicines are used to reduce the body's immune responses.

What Sandimmun is used for and how it works

Sandimmun is used to control your body's immune system after an organ transplant, including bone marrow and stem cell transplants. It prevents rejection of transplanted organs by suppressing the development of certain cells that would normally attack the transplanted tissue.

2. What you need to know before using Sandimmun

Sandimmun will only be prescribed by a physician experienced in transplantation.

Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet.

Do not use Sandimmun:

If you are allergic to ciclosporin or to any of the other ingredients of this medicine (listed in section 6; also see section “Sandimmun contains castor oil and ethanol”).
with medications containing Hypericum perforatum (St. John's wort).
with medications containing dabigatran etexilate (used to prevent blood clots after surgery) or bosentan and aliskiren (used to lower high blood pressure).

If any of these apply to you, do not use Sandimmun and inform your doctor. If you are unsure, consult your doctor before using Sandimmun.

Warnings and precautions

Before and during treatment with Sandimmun, inform your doctor immediately:

if you develop any signs of infection, such as fever or sore throat. Sandimmun suppresses the immune system and may also affect your body’s ability to fight infections.
if you have liver problems.
if you have kidney problems. Your doctor will perform regular blood tests and may adjust your dose if necessary.
if you have high blood pressure. Your doctor will monitor your blood pressure regularly and may prescribe medication to lower it if needed.
if you have low levels of magnesium in your body. Your doctor may administer magnesium supplements, especially shortly after transplantation.
if you have high levels of potassium in your blood.
if you suffer from gout.
if you need to receive a vaccine.

If any of the above conditions occur before or during treatment with Sandimmun, inform your doctor immediately.

Sun protection and sunlight exposure

Sandimmun suppresses your immune system. This may increase the risk of developing cancer, particularly of the skin and lymphatic system. Therefore, you should limit your exposure to sunlight and UV radiation by:

wearing appropriate protective clothing,
frequently applying a sunscreen with a high protection factor.

Talk to your doctor before taking Sandimmun:

if you have or have had alcohol-related problems,
if you have epilepsy,
if you have any liver problems,
if you are pregnant,
if you are breastfeeding,
if this medicine is prescribed for a child.

If any of these situations apply to you (or you are unsure), inform your doctor before taking Sandimmun. This is because this medicine contains alcohol (see section “Sandimmun contains castor oil and ethanol” below).

Monitoring during treatment with Sandimmun

Your doctor will monitor:

blood levels of ciclosporin, especially if you have undergone transplantation,
your blood pressure before starting treatment and regularly during treatment,
the function of your liver and kidneys,
your blood lipid levels (fats).

If you have any questions about how Sandimmun works or why it has been prescribed for you, consult your doctor.

Children and adolescents

Experience with Sandimmun in children is limited.

Elderly population (aged 65 years and older)

Experience with Sandimmun in elderly patients is limited. Your doctor should monitor your kidney function.

Other medicines and Sandimmun

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun:

Medicines that may affect your potassium levels. These include medicines containing potassium, potassium supplements, potassium-sparing diuretics, and certain medicines used to lower blood pressure.
Methotrexate. Used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
Medicines that may increase or decrease ciclosporin (the active substance in Sandimmun) levels in your blood. Your doctor may check your ciclosporin blood levels when starting or stopping other medicines.
Medicines that may increase ciclosporin levels in your blood include: antibiotics (such as erythromycin or azithromycin), antifungal agents (voriconazole, itraconazole), medicines used for heart disorders or high blood pressure (diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to prevent vomiting), oral contraceptives, danazol (used to treat menstrual disorders), medicines used to treat gout (allopurinol), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), colchicine, telaprevir (used to treat hepatitis C), cannabidiol (used, among others, for treating epileptic seizures).
Medicines that may decrease ciclosporin levels in your blood include: barbiturates (used to help you sleep), certain anticonvulsants (such as carbamazepine or phenytoin), octreotide (used to treat acromegaly or neuroendocrine tumors of the intestine), antibacterial medicines used to treat tuberculosis, orlistat (used to help lose weight), herbal medicines containing St. John’s wort, ticlopidine (used after stroke), certain medicines that lower blood pressure (bosentan), and terbinafine (an antifungal medicine used to treat foot and nail infections).
Medicines that may affect your kidneys. These include: antibacterial medicines (gentamicin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, medicines used for urinary tract infections containing trimethoprim, cancer medicines containing melphalan, medicines used to reduce stomach acid (H2-receptor antagonists), tacrolimus, painkillers (non-steroidal anti-inflammatory drugs such as diclofenac), fibric acid derivatives (used to reduce blood fat levels).
Nifedipine. Used to treat high blood pressure and chest pain. You may experience swollen gums that could grow over your teeth if you are taking nifedipine during ciclosporin treatment.
Digoxin (used to treat heart disorders), cholesterol-lowering medicines (HMG-CoA reductase inhibitors, also known as statins), prednisolone, etoposide (used to treat cancer), repaglinide (an oral antidiabetic medicine), immunosuppressants (everolimus, sirolimus), ambrisentan, and specific anticancer medicines called anthracyclines (such as doxorubicin).
Sodium mycophenolate or mycophenolate mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).

If any of these situations apply to you (or you are unsure), inform your doctor or pharmacist before using Sandimmun.

Use of Sandimmun with food and drinks

Do not take Sandimmun with grapefruit or grapefruit juice. This is because it may affect how Sandimmun works.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine.

Inform your doctor if you are pregnant or plan to become pregnant. Experience with Sandimmun in pregnant women is limited. In general, Sandimmun should not be administered during pregnancy. If it is necessary for you to use this medicine, your doctor will discuss the potential benefits and risks of using it during pregnancy.
Inform your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Sandimmun. This is because ciclosporin, the active ingredient, passes into breast milk and could affect your baby.

Hepatitis C

Inform your doctor if you have hepatitis C. Your liver function may change during hepatitis C treatment, which could affect ciclosporin blood levels. Your doctor may need to closely monitor your ciclosporin blood levels and adjust the dose after starting hepatitis C treatment.

Driving and using machines

You may feel drowsy, disoriented, or experience blurred vision after taking Sandimmun. Be cautious when driving or operating machinery while taking Sandimmun until you know how it affects you.

Sandimmun contains castor oil and ethanol

This medicine may cause severe allergic reactions because it contains castor oil.

Sandimmun concentrate for solution for infusion contains 278 mg of alcohol (ethanol) per ml, corresponding to 34.4% v/v. A 100 mg dose of Sandimmun contains 556 mg of ethanol, equivalent to approximately 14 ml of beer or 6 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effect.

3. How to use Sandimmun

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again.

What dose of Sandimmun you will receive

Your doctor will determine the correct dose of Sandimmun for you. This depends on your body weight and the reason for which you are receiving this medicine.

The usual total daily dose is between 3 and 5 mg per kilogram of body weight. This is divided into two doses.
Higher doses are usually used before and immediately after your transplant. Lower doses are used once your transplanted organ or bone marrow has stabilized.
Your doctor will adjust the dose to one that is ideal for you. For this, your doctor may need to perform some blood tests.

How Sandimmun will be used

The medicine will be diluted before use between 1:20 and 1:100 with either saline or 5% glucose solution, using an appropriate aseptic technique, and administered by slow intravenous infusion over 2 to 6 hours. Diluted solutions of the medicine must be discarded 24 hours after preparation.

How long Sandimmun will be used

You will be switched to cyclosporine in capsule or oral solution form (both administered by mouth) as soon as possible.

If you have received more Sandimmun than you should have

Too much of the medicine may affect your kidneys. Blood tests and regular hospital visits will be performed. This will give you the opportunity to discuss your treatment and any problems you may have with your doctor.

If you think you have received too much Sandimmun, inform your doctor immediately.

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.

Some adverse effects may be serious

Tell your doctor immediately if you notice any of the following serious adverse effects:

Signs of anaphylactoid reactions after intravenous administration of Sandimmun. These reactions may include redness of the face and upper chest, fluid in the lungs, difficulty breathing, wheezing, changes in blood pressure (you may feel faint), and rapid heart rate (tachycardia).
Like other medicines that affect the immune system, cyclosporine may affect your body's ability to fight certain infections and may cause tumors or other malignant diseases, especially of the skin. Signs of infection may include fever or sore throat.
Vision disturbances, lack of coordination, clumsiness, memory loss, difficulty speaking or understanding others, and muscle weakness. These may be signs of a brain infection called progressive multifocal leukoencephalopathy.
Problems in the brain with symptoms such as seizures, confusion, disorientation, reduced sensation, personality changes, agitation, insomnia, vision disturbances, blindness, coma, paralysis of part or all of the body, torticollis, lack of coordination with or without abnormal speech or eye movements.
Inflammation at the back of the eye that may be associated with blurred vision. It may also affect your vision due to increased pressure inside the head (benign intracranial hypertension).
Liver injury and dysfunction, with or without yellowing of the eyes or skin, nausea, vision loss, and dark urine.
Kidney problems, which may greatly reduce the amount of urine you produce.
Decrease in the number of red blood cells or platelets. These signs include pale skin, fatigue, shortness of breath, dark urine (a sign of red blood cell breakdown), bleeding or bruising without apparent reason, confusion, disorientation, lack of attention, and kidney problems.

Other adverse effects include:

Very common: may affect more than 1 in 10 people

Kidney problems.
High blood pressure.
Headache.
Uncontrollable body tremors.
Excessive growth of facial and body hair.
Increased blood lipids.