50 mg / ml concentrate for solution for infusion
ciclosporin
What Sandimmun is and what it is used for
What Sandimmun is
The name of this drug is Sandimmun. It contains the active substance ciclosporin. The concentrate is reconstituted with a solution that is administered as an intravenous infusion. It belongs to a group of medicines called immunosuppressants. These drugs are used to suppress the body’s immune reactions.
What Sandimmun is used for and how Sandimmun works
Sand immune is used to control the body’s immune system after an organ transplant, including bone marrow and stem cell transplants. It prevents transplanted organs from being rejected by blocking the development of certain cells that would normally attack the transplanted tissue.
Ciclosporin contained in Sandimmun may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Sandimmun
Do not use Sandimmun
Sandimmun will only be prescribed to you by a doctor with experience in transplants.
Always follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not use Sandimmun:
- if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6; see also section “Sandimmun contains castor oil and ethanol” below).
- together with agents containing Hypericum perforatum ( St. John’s wort ).
- together with agents containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to lower high blood pressure ).
Do not use Sandimmun and tell your doctor if the above applies to you. If you are not sure, talk to your doctor before taking Sandimmun.
Warnings and cautions
Before and during treatment with Sandimmun, tell your doctor immediately:
- if you have any signs of infection, such as fever or sore throat. Sand immunity weakens the immune system and can also affect the body’s ability to fight infection.
- if you have liver problems.
- if you have kidney problems. Your doctor will take blood samples at regular intervals and may change your dose if necessary.
- if you get high blood pressure. Your doctor will check your blood pressure at regular intervals and may, if necessary, give you a medicine that lowers your blood pressure.
- if you have low magnesium levels in your body. Your doctor may give you magnesium supplements, especially immediately after surgery.
- if you have high potassium levels in your blood.
- if you have gout.
- if you are to be vaccinated.
If any of the above applies to you before or during treatment with Sandimmun, tell your doctor straight away.
Sunlight and sun protection
Sand immune weakens your immune system. This increases your risk of getting cancer, especially skin cancer and cancer of the lymphatic system. You should limit your exposure to sunlight and UV light by:
- wear appropriate clothing that protects.
- often apply 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 the above apply to you (or you are not sure), tell your doctor before taking Sandimmun. The reason for this is that the medicine contains alcohol (see the section “Sandimmun contains castor oil and ethanol” below).
Check during treatment with Sandimmun
Your doctor will check:
- ciclosporin levels in your blood, especially if you have had a transplant,
- your blood pressure before starting treatment and at regular intervals during treatment,
- how well your liver and kidneys are working,
- your blood fats.
If you have any further questions on the use of Sandimmun or if it has been prescribed for you, ask your doctor.
Children and young people
The experience of treating children with Sandimmun is limited.
Elderly people (from 65 years)
Experience in treating elderly patients with Sandimmun is limited. Your doctor should monitor how well your kidneys are working. If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun if your disease is very serious.
Other drugs and Sandimmun
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before or during treatment with Sandimmun:
- Drugs that can affect your potassium levels. These include medicines containing potassium, potassium supplements, diuretics, so-called potassium-sparing diuretics, and certain medicines that lower blood pressure.
- Methotrexate is used to treat tumors, severe psoriasis, and severe rheumatoid arthritis.
- Drugs that can increase or decrease the level of ciclosporin (the active substance in Sandimmun) in the blood. Your doctor may need to check the level of ciclosporin in your blood when you start or stop taking other medicines.
- Drugs that can increase ciclosporin levels in the blood are antibiotics (for example erythromycin or azithromycin), antifungals (voriconazole, itraconazole), medicines for heart problems or high blood pressure ( diltiazem, nicardipine, verapamil, loperamide ), metokamide -pills, danazol (for menstrual disorders), medicines for gout (allopurinol), cholic acid and its derivatives (used for gallstones ), protease inhibitors for HIV, imatinib (used for leukemia or tumors ), colchicine, telaprevir (used for hepatitis C).
- Drugs that can lower ciclosporin levels in the blood are barbiturates (for difficulty sleeping), certain seizures (such as carbamazepine or phenytoin ), octreotide (used for acromegaly or neuroendocrine tumors in the stomach), antibacterial drugs for tuberculosis ( or listen), orlistat, herbal medicines containing St. John’s wort, ticlopidine (used after stroke ), certain medicines that lower blood pressure ( bosentan ), and terbinafine (a medicine used to treat fungus on the toes and nails).
- Drugs that can affect your kidneys. These include antibacterial drugs (gentamycin, tobramycin, ciprofloxacin ), antifungal drugs that contain amphotericin B, drugs for urinary tract infections that contain trimethoprim, cancer drugs that contain melphalan, drugs that lower the acid content of the stomach. tacrolimus, analgesics (non-steroidal anti-inflammatory drugs such as diclofenac ), and drugs containing fibrates (used to lower blood fats).
- Nifedipine is used to treat high blood pressure and pain in the heart. You can get swollen gums that grow down over your teeth if you take nifedipine while taking ciclosporin.
- Digoxin (for heart problems), cholesterol-lowering drugs (HMG-CoA reductase inhibitors also called statins), prednisolone, etoposide (used in cancer), repaglinide (for diabetes ), immunosuppressive drugs (everolimus, sirolimus), ambrisentan and specific cold drugs anthracyclines (eg doxorubicin).
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Sandimmun.
Sand immune with food and drink
Do not take Sandimmun with grapefruit or grapefruit juice. These can namely affect how Sandimmun works.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about any possible risks of taking Sandimmun during pregnancy.
- Tell your doctor if you are pregnant or planning to become pregnant. Experience with Sandimmun treatment during pregnancy is limited. Generally, Sandimmun should not be taken during pregnancy. If you need to be treated with this medicine, your doctor will talk to you about the benefits and possible risks of taking it during pregnancy.
- Tell your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with Sandimmun. The active substance ciclosporin passes into breast milk. This can affect the baby.
Hepatitis C
Tell your doctor if you have hepatitis C. Your liver function may change when you treat hepatitis C and this may affect the levels of ciclosporin in your blood. Your doctor may need to monitor your cyclosporine blood levels closely and make dose adjustments after you start treatment for hepatitis C.
Driving and using machines
Sand immune contains alcohol. This may affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Sandimmun contains castor oil and ethanol
Sandimmun concentrate for infusion solution, the solution contains castor oil which can cause severe allergic reactions.
Sandimmun concentrate for solution for infusion contains 278 mg alcohol ( ethanol ) per ml corresponding to 34.4% by volume. A 100 mg dose of Sandimmun contains 556 mg of ethanol. This corresponds to almost 14 ml of beer or 6 ml of wine. The low amount of alcohol in this medicine does not produce any noticeable effects.
How Sandimmun is used
Carefully follow all instructions given to you by your doctor. Consult a doctor if you are unsure.
How much Sandimmun you should get
Your doctor will decide which dose of Sandimmun is right for you. It depends on your body weight and the reason you are receiving the medicine.
- The total daily dose is usually between 3 and 5 mg per kilogram of your weight. This is divided into two occasions per day.
- Higher doses are often used before and shortly after transplantation. Lower doses are used as soon as the transplanted organ or bone marrow has stabilized.
- Your doctor will adjust the dose so that it is the best for you. To be able to do this, the doctor may need to take some blood samples.
How Sandimmun is used
The drug will be diluted before use in a ratio of 1:20 to 1: 100 with saline or 5% glucose solution and then given to you as a slow infusion over about 2 to 6 hours. The diluted solution must be discarded after 24 hours.
How long Sandimmun should be used
You will need to switch to another cyclosporine preparation, either capsules or oral solution (both taken by mouth), as soon as possible.
If you take more Sandimmun than you should
Too much of the drug can affect the kidneys. Blood tests and visits to the hospital will take place regularly. Then you get the opportunity to talk to the doctor about the treatment and any problems.
If you have ingested too much Sandimmun or if e.g. a child inadvertently ingested the medicine immediately contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
Tell your doctor immediately if you get any of the following serious side effects:
- Signs of anaphylactoid reactions occurred after intravenous administration of Sandimmun. These reactions can cause symptoms such as redness of the face and upper chest, fluid in the lungs, shortness of breath, wheezing, changes in blood pressure (you may feel dizzy), and increased heart rate ( tachycardia ).
- Like other drugs that act on the immune system, cyclosporine can affect the body’s ability to fight infections and can also cause tumors or other cancers, especially in the skin. Signs of infection can be fever or sore throat.
- Vision changes, coordination difficulties, clumsiness, memory loss, difficulty speaking or understanding what others are saying, and muscle weakness. This may be a sign of an infection in the brain, called progressive multifocal leukoencephalopathy.
- Impact on the brain with signs such as seizures, confusion, disorientation, less constructability, personality changes, agitation, insomnia, vision changes, blindness, coma, paralysis in all or parts of the body, neck stiffness, impaired coordination with or without unusual speech or unusual eye movements.
- Swelling in the back of the eye. This can lead to blurred vision. It can also affect vision due to higher pressure in the head ( benign intracranial hypertension ).
- Liver problems and liver damage with or without yellowing of the skin and eyes, nausea, loss of appetite, and dark urine.
- Kidney problems can lead to significantly less urine being produced in the body.
- A low number of red blood cells or platelets. Signs of this are pale skin, fatigue, shortness of breath, dark urine (a sign that the red blood cells are broken down), bruising or bleeding without an obvious cause, confusion, disorientation, you feel less alert and kidney problems.
Other side effects can be:
Very common: may affect more than 1 in 10 people
- Kidney problems.
- High blood pressure.
- Headache.
- Uncontrollable tremors in the body.
- Abnormally strong growth of body and facial hair.
- High levels of blood fats.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Common: may affect up to 1 in 10 people
- Seizures.
- Liver problem.
- High blood sugar.
- Fatigue.
- Loss of appetite.
- Nausea, vomiting, abdominal discomfort/pain, diarrhea.
- Abnormal hair growth.
- Acne, hot flashes.
- Fever.
- Low white blood cell count.
- Numbness or tingling.
- Muscle pain, muscle twitching.
- Gastric ulcer.
- Overgrowth of the gums on the teeth.
- High levels of uric acid or potassium in the blood, and low magnesium levels in the blood.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Uncommon: may affect more than 1 in 100 people
- Symptoms of brain disease include sudden seizures, mental confusion, insomnia, disorientation, visual disturbances, unconsciousness, the feeling of weakness in arms and legs, and impaired movement patterns.
- Rash.
- General swelling.
- Weight gain.
- The low number of red blood cells and a low number of platelets can increase the risk of bleeding.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Rare: may affect more than 1 in 1,000 people
- Nerve problems with numbness or tingling in fingers and toes.
- Inflammation of the pancreas with severe pain in the upper abdomen.
- Weakness in the muscles, loss of muscle strength, muscle pain in the legs or hands, or the whole body.
- Degradation of red blood cells which includes problems with the kidneys with symptoms such as swelling of the face, stomach, hands, and/or feet, decreased urination, difficulty breathing, chest pain, seizures, and unconsciousness.
- Altered menstrual cycle, enlargement of the mammary glands in men.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Very rare: may affect more than 1 in 10,000 people
- Swelling in the posterior parts of the eye may be associated with increased pressure in the head and with visual disturbances.
If this side effect affects you badly, tell your doctor.
Has been reported: occurs an unknown number of users.
- Severe liver problems both with and without yellowing of the eyes and skin, nausea, loss of appetite, dark-colored urine, swelling of the face, feet, hands, and/or whole body.
- Bleeding under the skin or purple spots on the skin, sudden bleeding for no apparent reason.
- Migraine or severe headache, often with nausea, vomiting, and photosensitivity.
- Pain in legs and feet.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Additional side effects are in children and adolescents
No additional side effects are expected in children and adolescents compared to adults.
How to store Sandimmun
- 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.
- This medicine does not require any special storage instructions regarding temperature.
- Once an ampoule has been opened, the contents should be used immediately.
- After dilution, the solution should be used immediately or stored in a refrigerator (2 ° C – 8 ° C) and discarded after 24 hours.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is cyclosporine. One ml of the infusion concentrate contains 50 mg of ciclosporin.
- The other ingredients are anhydrous ethanol and polyoxyl castor oil.
What the medicine looks like and the contents of the pack
Sandimmun concentrate for solution for infusion is supplied in ampoules of 1 ml concentrate. The concentrate is a clear brownish-yellow oily liquid. It is used by your doctor or nurse who prepares a solution which will then be given to you as a slow infusion.
A pack containing 10 ampoules of 1 ml
Marketing Authorisation Holder
Novartis Sverige AB, Box 1218, 164 28 Kista