Sandoz Cyclosporine: Uses, Side Effects and Dosage

What is Sandoz Cyclosporine used for?

Sandoz Cyclosporine is indicated for the treatment of:

• Organ Transplant: Used to prevent rejection after an organ transplant. It is also used to treat organ rejection in patients who have been treated with other immunosuppressive drugs.
• Bone Marrow Transplant: Used to prevent rejection after a bone marrow transplant. It is also used to prevent or treat graft-versus-host-disease (GVHD).

Sandoz Cyclosporine is also indicated for the treatment of:

Serious Warnings and Precautions

• Transplant Patients:

  • You will be prescribed Sandoz Cyclosporine by a healthcare professional experienced in using immunosuppressive drugs and in the management of organ transplant patients.
  • Your healthcare professional will be in direct contact with your transplant center
  • You must be treated in medical centre with experienced healthcare professionals where your blood levels of cyclosporine can be monitored.

• Patients with Psoriasis, Rheumatoid Arthritis and Nephrotic Syndrome:

  • You will be prescribed Sandoz Cyclosporine by a healthcare professional experienced with its use. They will closely monitor you while you are being treated.
  • If you are taking Sandoz Cyclosporine to treat your psoriasis and you have previously been treated with PUVA, methotrexate, other immunosuppressive dugs, UVB, coal tar or radiation therapy you are at an increased risk of developing skin cancer.
  • Psoriasis: Used to treat severe psoriasis in patients who can’t use the usual treatments or in patients who did not respond to the usual treatments.
  • Rheumatoid Arthritis: Used to treat severe rheumatoid arthritis in patients who can’t use the usual treatments or in patients who did not respond to the usual treatments.
  • Nephrotic Syndrome: Used to treat kidney problems that are also being treated with steroids or are resistant to treatment with steroids.

How does Sandoz Cyclosporine work?

Sandoz Cyclosporine contain the medicinal ingredient cyclosporine. It belongs to a class of drugs called immunosuppressants. These drugs work to suppress or reduce your body’s immune response. Normally, your body's immune system works to protect you from infections and other foreign material. When you receive a transplant, this system does not recognize the new organ, and will try to reject it. Sandoz Cyclosporine works to reduce this response, so your body is more likely to accept the new organ.

Sandoz Cyclosporine does not completely suppress the immune system, so your body will still have some infection-fighting ability.

Sandoz Cyclosporine may be given alone but is often given with other drugs which also suppress your immune system. Together they help prolong the life of an organ transplant, or to suppress certain function of your immune system to treat your psoriasis, rheumatoid arthritis or nephrotic syndrome.

What are the ingredients in Sandoz Cyclosporine?

Medicinal ingredient:

Cyclosporine.

Non-medicinal ingredients:

Dehydrated alcohol, d-α tocopheryl polyethylene glycol 1000 succinate, macrogol-glycerol hydroxystearate, polyethylene glycol 400.

Capsule shell: gelatin, glycerin, sorbitol.

Sandoz Cyclosporine comes in the following dosage forms:

Capsule: 25 mg, 50 mg and 100 mg cyclosporine.

Do not use Sandoz Cyclosporine if:

• You have ever had a bad, unusual, or allergic reaction to cyclosporine or any of the non-medicinal ingredients of Sandoz Cyclosporine. (See “What are the ingredients in Sandoz Cyclosporine?”)

• You are being treated for psoriasis, rheumatoid arthritis or nephrotic syndrome, and you have one of the following conditions:

  • kidney problems (except for nephrotic syndrome);
  • uncontrolled blood pressure;
  • any type of cancer (except a skin cancer which is not a melanoma);
  • uncontrolled infection (not treated or cured);
  • inherited or acquired immune deficiency.
• you are taking bosentan, used to treat high blood pressure in the lungs

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Cyclosporine. Talk about any health conditions or problems you may have, including:

• if any of the following apply because Sandoz Cyclosporine contain alcohol:

  • You have or had alcohol related problems
  • You have epilepsy
  • You have any liver problems
  • You are pregnant
  • You breast-feeding
  • The medicine is given to a child
• if you are to receive any vaccinations. Sandoz Cyclosporine may make vaccinations less effective or increase your risk of getting an illness from a live vaccine.
• if you have high levels of potassium in your blood.
• if you suffer from gout.

Other warnings you should know about:

Tell all healthcare professionals you see (doctors, dentists, nurses, pharmacists) that you are taking Sandoz Cyclosporine. It is also a good idea to wear a Medic-Alert bracelet.

Immune system effects:

• Sandoz Cyclosporine suppress the function of your immune system. This means you are more likely to get bacterial, fungal or viral infections. To help reduce complications from these infections, talk to your healthcare professional immediately if you get any cold or flu-like symptoms (such as a fever or sore throat), any boils on your skin, or have pain when you urinate.

• The suppressed function of your immune system may also increase your chances of developing cancer. Although very rare, cancers of the white blood cells (lymphomas) and other types of cancer have occurred in people taking cyclosporine. To help detect any cancers as soon as possible, talk to your healthcare professional immediately if you have any of these symptoms:

  • a change in your bowel or bladder habits
  • any sore that doesn't heal
  • unusual bleeding or discharge

  • the appearance of a lump or thickened area in your breast or anywhere else on

    • your body
  • unexplained stomach upset or any trouble with swallowing
  • an obvious change in a wart or a mole
  • a nagging cough or hoarseness
  • night sweats

Progressive multifocal leukoencephalopathy: Treatment with Sandoz Cyclosporine can cause a serious infection of the brain called progressive multifocal leukoencephalopathy (PML). Talk to your healthcare professional immediately if you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say and muscle weakness, as these can be signs of PML.

Pregnancy and Breastfeeding:

• Do not Sandoz Cyclosporine if you are pregnant.
• You must use a reliable method of birth control while you are being treated with Sandoz Cyclosporine and for 2 months after stopping treatment.
• Talk to your healthcare professional immediately if you become pregnant, or think you might be pregnant, while you are taking Sandoz Cyclosporine. You want to discuss the possible benefits and risks of continuing with this drug.
• Do not breast feed while you are taking Sandoz Cyclosporine as it passes into breast milk and may harm your baby. Talk to your healthcare professional about other ways to feed your baby.

Blood tests and monitoring: Be sure to keep all appointments at your clinic. Some of these visits will be used to check the level of cyclosporine in your blood. For transplant patients, levels that are too low can cause transplant rejection, while levels that are too high may cause damage to other organs. It is therefore very important not to miss any tests or check-ups with your healthcare professional. Your liver and kidney function and your blood lipids (cholesterol) should be checked regularly. Your healthcare professional will also check your blood pressure before you start treatment and regularly thereafter.

Driving and using machines:

You may feel sleepy, disoriented, or have blurred vision, or experience seizures (fits), coordination or movement problems, or altered thinking or behavior after taking Sandoz Cyclosporine. Be careful when driving or operating machinery while you are taking Sandoz Cyclosporine until you know how it affects you.

Use in the elderly (65 years of age and older): There is limited experience with the use of cyclosporine in the elderly. Your healthcare professional will closely monitor your kidney function. If you are over the age of 65 years with psoriasis, you should only be treated in case of disabling disease.

Transplant patients: Your healthcare professional may give you magnesium supplements since

Sandoz Cyclosporine may reduce the amount of magnesium in your body.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sandoz Cyclosporine:

• medicines that may affect your blood potassium levels, such as potassium containing medicines or potassium sparing medicines (e.g. potassium sparing diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists)
• certain blood pressure lowering medicines called calcium antagonists
• methotrexate, a medicine used to treat cancer, severe psoriasis and severe rheumatoid arthritis

• medicines which may increase or decrease the blood levels of Sandoz Cyclosporine:

  • medicines which may decrease Sandoz Cyclosporine blood levels: barbiturates (medicines used to help you sleep), certain anticonvulsives, used to prevent seizures (e.g. carbamazepine, phenytoin, oxcarbazepine), octreotide, an antibiotic medicine used to treat tuberculosis, orlistat (used to help weight loss), herbal medicines containing St. John’s Wort (used to treat depression), ticlopidine (used after stroke), certain blood pressure lowering medicines (bosentan), and an antifungal medicine used to treat infections of the toes and nails (terbinafine).
  • medicines which may increase Sandoz Cyclosporine blood levels: antibiotics of the macrolides type (e.g. erythromycin, azithromycin), antifungal medicine of the azole type (e.g. voriconazole, itraconazole), medicines used for heart problems or high blood pressure (e.g. diltiazem, nicardipine, verapamil, amiodarone), metoclopramide (used to stop sickness), oral birth control, danazol (used to treat menstrual disorders), medicines used to treat gout (e.g. allopurinol, colchicines), cholic acid and derivatives (used to treat gallstones), protease inhibitors used to treat HIV, imatinib (used to treat leukemia or tumors), nefazodone (used to treat depression).
  • other medicines which may affect the kidneys, such as antibiotic medicines (e.g. gentamycin, tobramycin, ciprofloxacin), antifungal medicines containing amphotericin B, antibiotic medicines containing ciprofloxacin, medicines used to treat urinary tract infection containing trimethoprim, anti-cancer agents containing melphalan, medicines used to reduce the amount of acid in your stomach (acid secretion inhibitors of the H2-receptor antagonist type), other immunosuppressive drugs called calcineurin inhibitors (e.g. tacrolimus), pain killers (non-steroid anti-inflammatory medicines such as diclofenac), fibric acid derivatives (e.g. bezafibrate, fenofibrate) used to lower fat in the blood.
  • nifedipine (used to treat high blood pressure and heart pain).

  • medicines whose concentrations may increase when used together with Sandoz Cyclosporine including lercanidipine (used to lower high blood pressure), aliskiren (used to treat high blood pressure), digoxin (used to treat heart problems),

    • cholesterol lowering agents (HMG-CoA reductase inhibitors, also called statins), prednisolone (a steroid medicine used to treat inflammation), etoposide (used to treat cancer), dabigatran (oral blood thinner used to prevent stroke), repaglinide (oral medicine to treat diabetes), immunosuppressives (e.g. everolimus, sirolimus), ambrisentan and specific anticancer medicines called anthracyclines (e.g. doxorubicin).
  • medicines whose concentration may decrease when used together with Sandoz Cyclosporine including mycophenolate sodium or mofetil (an immunosuppressant) and eltrombopag (used to treat bleeding disorders).
  • caspofungin, used to treat fungal infections

Never take Sandoz Cyclosporine with grapefruit juice.

How to take Sandoz Cyclosporine?

• Always take Sandoz Cyclosporine exactly as your healthcare professional has told you. You should check with your healthcare professional if you are unsure.
• Sandoz Cyclosporine is an oral medicine that you will take in capsule form.
• Do not stop taking Sandoz Cyclosporine on your own even if you have been taking it for several years. Transplant patients: Although you may not notice any symptoms of rejection for several weeks, missing even a few doses of Sandoz Cyclosporine may lead to rejection of your transplanted organ.
• Do not change the dose on your own, no matter how you are feeling. Blood tests are one of the ways your healthcare professional knows how much Sandoz Cyclosporine you need. Based on these tests, and on your response to this drug, your healthcare professional may change your dose from time to time.
• Space your doses of Sandoz Cyclosporine as evenly as you can throughout the day. For example, if you take the drug 2 times a day, leave about 12 hours between each dose.

• Try to take your dose(s) at the same time(s) each day. This will help keep a constant amount of drug in your body and will also help you remember each dose. Sandoz Cyclosporine may be taken with or without food. But it is best to be consistent: once you decide when you are going to take it in relation to food, do it the same way each time.

• Never take Sandoz Cyclosporine with grapefruit juice.
• Leave the capsules in the blister foil until you need a dose. When you are ready to take a dose, remove the number of capsules you need to make up the dose your healthcare professional prescribed. Sandoz Cyclosporine capsules have a characteristic smell when the blister foil is opened. This is normal.
• Swallow the capsules whole. You may use any kind of drink except grapefruit juice.
• If you suffer from diarrhea or vomiting, talk to your healthcare professional as this can stop your body from absorbing the right amount of Sandoz Cyclosporine.
• If you were previously taking a different oral formulation of cyclosporine, your healthcare professional will monitor you more closely for a short period after you switch from one oral formulation to another. They will make sure that your cyclosporine blood levels are in the correct range. Never adjust the dose yourself unless your healthcare professional has told you to.

Usual dose:

Your healthcare professional will decide on the dose that is right for you based on your body weight and the condition that is being treated. If you are a transplant patient they will also use your blood levels of cyclosporine.

Overdose:

Missed Dose:

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Then skip the missed dose and go on as before. It is a good idea to ask your healthcare professional ahead of time what to do about missed doses.

• For transplant patients, missing even a few doses of Sandoz Cyclosporine may lead to rejection of your transplanted organ. That is why it is so important to take each of the doses your healthcare professional prescribes.
• Talk to your healthcare professional if you have trouble remembering doses, or if you are uncertain about how to take them. Also be sure to discuss any concerns you have about taking this drug as prescribed. Your healthcare professional can often suggest ways to overcome problems you have taking your medication.
• Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time — that way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.

What are possible side effects from using Sandoz Cyclosporine?

These are not all the possible side effects you may have when taking Sandoz Cyclosporine. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• headache (including migraine with vomiting and sensitivity to light)
• loss of appetite, nausea, vomiting, constipation or diarrhea
• weight gain
• acne or oily skin
• slight trembling of the hands
• increased growth of fine hairs on the body
• muscle or joint pains or cramping
• muscle spasm
• pain in legs and feet
• weakness, anxiety
• tingling in the fingers, toes or mouth
• night sweats
• hearing loss
• tender or swollen gums
• hot flushes
• rash
• breast enlargement in me

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Keep Sandoz Cyclosporine out of the reach and sight of children.

• A child who accidentally takes this drug may be seriously harmed. A locked drawer or cupboard is best if you have small children in the house.
• Sandoz Cyclosporine capsules should be kept in a dry place, at room temperature between 15 and 30°C. Remember to leave each capsule in its foil pack until you need to take it.

If you want more information about Sandoz Cyclosporine:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the manufacturer, Sandoz Canada Inc., at 1-800-361-3062.

Last revised: September 18, 2023