Sandimmune

The recommended dose of Sandimmune (Cyclosporine) varies according to weight and circumstances. Your doctor may adjust the dose based on levels of Sandimmune (Cyclosporine) in your blood stream.

For solid organ transplants, the recommended oral dose is 10 mg to 15 mg per kilogram of body weight daily (in 2 divided doses), starting at least 12 hours before surgery. The dose usually stays the same for 1 or 2 weeks after the operation, and then is reduced gradually by the doctor so that a particular level of the medication in the bloodstream is reached. If you have been given the injection to start with, the usual starting dose is 3 mg to 5 mg per kg of body weight per day given into a vein (intravenously). The doctor will likely try to switch you over to one of the oral forms of the medication.

For bone marrow transplants, the first dose is normally given by injection the day before the operation at a dose of 3 mg to 5 mg per kg of body weight. The oral form of the medication is then usually given at a daily dose of about 12.5 mg per kilogram of body weight in 2 divided doses. This dose is usually continued for 3 to 6 months and then decreased gradually until it is stopped, about one year after the operation.

For treatment of psoriasis, the recommended oral starting dose is 2 mg per kilogram of body weight per day in 2 divided doses. If no improvement is seen in one month, the doctor may increase the daily dose gradually. The daily dose of Sandimmune (Cyclosporine) should not go above 5 mg per kilogram of body weight per day. If there is still no improvement after 6 weeks of treatment, the treatment should be stopped. If the psoriasis improves, the doctor may gradually decrease the dose. Psoriasis often returns once the medication is stopped, so the goal of treatment is usually to find the smallest dose that will be effective.

For treatment of rheumatoid arthritis, the recommended oral dose is 2.5 mg per kilogram of body weight per day in 2 divided doses for the first 6 weeks of treatment. If the desired improvement is not seen, the doctor may increase the dose gradually as long as the medication is still well tolerated.

For nephrotic syndrome, the recommended oral starting dose is 3.5 mg per kilogram of body weight per day for adults and 4.2 mg per kilogram of body weight per day for children. People with reduced kidney function should not receive more than 2.5 mg per kg body weight per day. The dose is usually increased to a maximum of 5 mg per kilogram in adults, or 6 mg per kilogram in children. Treatment should be stopped if no improvement is seen within 3 months of starting treatment.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

The injectable form of Sandimmune (Cyclosporine) is given by infusion into a vein over several hours by a health care professional in a hospital setting. The injectable form of Sandimmune (Cyclosporine) should be stored away from light at room temperature between 15°C and 30°C. It should not be frozen or put in the refrigerator.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each mL of sterile liquid contains 50 mg of Sandimmune (Cyclosporine). Supplied as 1 mL and 5 mL ampules. Nonmedicinal ingredients: polyoxyethylated castor oil and ethanol.

Do not take Sandimmune (Cyclosporine) if you:

• are allergic to Sandimmune (Cyclosporine) or any ingredients of the medication
• are taking Sandimmune (Cyclosporine) for psoriasis or rheumatoid arthritis and also have:
  • abnormal kidney function
  • any type of condition that negatively affects the function of the immune system
  • cancer (except nonmelanoma Skin Cancer)
  • uncontrolled high blood pressure
  • uncontrolled infection

There may be an interaction between Sandimmune (Cyclosporine) and any of the following:

• Acetazolamide
• Aliskiren
• Allopurinol
• Amiodarone
• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• amiodarone
• amphotericin B
• androgens (male hormones; Danazol, methyltestosterone, nandrolone, testosterone)
• angiotensin converting enzyme inhibitors (ACEIs; e.g., Ramipril, Lisinopril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• Aprepitant
• Aripiprazole
• avanafil
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, Phenobarbital, secobarbital)
• BCG
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• biologic agents (e.g., Adalimumab, Infliximab, Natalizumab, Rituximab)
• birth control pills
• boceprevir
• Bosentan
• Bromocriptine
• Buprenorphine
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• caspofungin
• Ceftriaxone
• chloramphenicol
• chloroquine
• Cimetidine
• Clonidine
• Colchicine
• conivaptan
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• dabigatran
• Deferasirox
• Digoxin
• Disopyramide
• Dronedarone
• echinacea
• Enzalutamide
• Eplerenone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Ezetimibe
• Felodipine
• Fenofibrate
• Fentanyl
• fosphenytoin
• fusidic acid
• Gemfibrozil
• glicalazide
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• Glyburide
• grapefruit juice
• H2 antagonists (e.g., Famotidine, Ranitidine)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine

• Hydroxyurea
• imipenem – cilastatin
• Leflunomide
• lidocaine
• Mefloquine
• mestranol
• Metoclopramide
• Metronidazole
• mifepristone
• Minoxidil
• Mirtazapine
• Modafinil
• multivitamins/minerals
• mycophenolate
• Nabumetone
• nefazodone
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Norfloxacin
• Octreotide
• Omeprazole
• Ondansetron
• Oxcarbazepine
• Paroxetine
• Perampanel
• Phenytoin
• Pimecrolimus
• Pimozide
• potassium-sparing diuretics (e.g., Amiloride, Spironolactone, triamterene)
• primidone
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• Propafenone
• Prucalopride
• pyrizinamide
• Repaglinide
• rifabutin
• rifampin
• Rivaroxaban
• Roflumilast
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, paroxetine, Sertraline)
• salmeterol
• Sirolimus
• Silodosin
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Tacrolimus
• telaprevir
• terbinafine
• Theophylline
• Ticlopidine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Trimethoprim
• tyrosine kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib, Sunitinib)
• Ulipristal
• vaccines
• vitamin E
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sandimmune (Cyclosporine). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Sandimmune (Cyclosporine).

Cancer: Sandimmune (Cyclosporine) reduces the number of cells that fight infection in the body (white blood cells). This may increase your risk of developing infections and cancer, especially those of the skin and lymphoid tissue.

People with psoriasis may be at increased risk of developing skin cancer as a result of previous psoriasis treatments. While you are taking Sandimmune (Cyclosporine), it is important to limit your exposure to the sun and use appropriate sun protection such as sunscreen and protective clothing. Your doctor will monitor you for skin cancer while you are taking Sandimmune (Cyclosporine). Talk to your doctor if you have any concerns.

Dental health: It is particularly important to maintain good dental hygiene while you are on this medication, and to see a dentist regularly for teeth cleaning.

High blood pressure: Sandimmune (Cyclosporine) may cause high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking Sandimmune (Cyclosporine).

High Cholesterol: Sandimmune (Cyclosporine) may increase cholesterol. Your doctor should monitor the amount of cholesterol in your blood regularly while you are taking Sandimmune (Cyclosporine).

Infection: Sandimmune (Cyclosporine) works by reducing the number of white blood cells in the body, making it easier to develop an infection. If possible, avoid contact with people who have contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: Sandimmune (Cyclosporine) can have harmful effects on the kidney when taken for long periods of time. If you experience signs of decreased kidney function, such as reduced urine production, fluid build-up or swelling in the ankles, feet and hands, fatigue or abdominal pain, contact your doctor as soon as possible.

If you have reduced kidney function or Kidney Disease, discuss with your doctor how Sandimmune (Cyclosporine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandimmune (Cyclosporine), and whether any special monitoring is needed.

Liver function: People taking Sandimmune (Cyclosporine) may have changes in liver function that produce abnormal liver test results. Liver disease or reduced liver function may cause Sandimmune (Cyclosporine) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Sandimmune (Cyclosporine) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandimmune (Cyclosporine), and whether any special monitoring is needed.

Your doctor will likely recommend regular liver tests while you are taking this medication. If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Sandimmune (Cyclosporine) or stop taking it altogether.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Potassium levels: Sandimmune (Cyclosporine) increases the risk of high levels of potassium in your body, especially for people who have decreased kidney function. Your doctor will monitor the amount of potassium in your blood with blood tests. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor, as these may be signs of too much potassium.

Vaccines: People taking Sandimmune (Cyclosporine) may not respond as well to vaccines or may be at risk of becoming ill from a live vaccine. Talk to your doctor if you need any vaccinations while taking this medication.

Pregnancy: Sandimmune (Cyclosporine) should be used during pregnancy only if the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Do not stop taking Sandimmune (Cyclosporine) without guidance from your doctor.

Breast-feeding: Sandimmune (Cyclosporine) passes into breast milk and may affect your baby. If you are a breast-feeding mother and are taking Sandimmune (Cyclosporine), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Many studies have shown that children require higher doses per kilogram of body weight than adults. Sandimmune (Cyclosporine) is not recommended for children in the treatment of psoriasis or rheumatoid arthritis.