Sandoz Tacrolimus

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 Sandoz Tacrolimus.

Abnormal heart rhythms: Tacrolimus may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, Heart Attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how Sandoz Tacrolimus may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of Sandoz Tacrolimus. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Blood pressure: Tacrolimus treatment commonly causes mild-to-moderate increases in blood pressure. Monitor your blood pressure, and inform your doctor if there is an indication that your blood pressure is rising.

Diabetes: Tacrolimus may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Sandoz Tacrolimus. Your doctor will help to monitor this, but be sure to report any signs of high blood sugar (e.g., increased thirst, urination, unusual tiredness) to your doctor.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Sandoz Tacrolimus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Tacrolimus, and whether any special monitoring is needed.

High potassium levels in the blood: Tacrolimus may cause an increase in potassium levels in the blood. Some foods (e.g., bananas or orange juice) and some medications may increase the risk of this problem. Be sure to tell your doctor and pharmacist about all the medications you are taking (including non-prescription medications) and to talk to them about potassium-rich foods.

Infections: Tacrolimus reduces resistance to infections and may delay healing. Ensure proper treatment to avoid infection (e.g., dental work, skin injury). Avoid activities that increase the risk of infection.

Because tacrolimus reduces the body’s response to infection, conditions caused by bacteria or viruses that have been dormant in the body, such as chicken pox, hepatitis B, or Tuberculosis may be reactivated.

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.

Kidneys: Tacrolimus may affect kidney function. Your doctor will monitor your kidney function with laboratory tests while you are taking Sandoz Tacrolimus. Be sure to immediately report to your doctor any evidence of changes in kidney function such as changes in the appearance of urine, frequency of urination, and amount of urine produced.

Liver function: Liver disease or reduced liver function may cause Sandoz Tacrolimus to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Sandoz Tacrolimus may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Tacrolimus, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Sandoz Tacrolimus.

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.

Lymphoma and other malignancies: People taking immunosuppressant medications, such as tacrolimus, are at increased risk of developing a type of cancer known as lymphoma and certain types of Skin Cancer. This risk is related to the intensity and duration of treatment with immunosuppressant medications rather than to one specific medication.

Possible warning signs of cancer include a change in bowel or bladder habits, sores that don’t heal, unusual bleeding, change in appearance of a wart or mole, night sweats, a nagging cough or persistent and severe headaches. If you experience any of these, let your doctor know right away. This may help to detect any cancers early in their development.

Nerves: Tacrolimus may affect nerve function and cause symptoms such as tremors and headaches. Be sure to report any changes to your doctor at once.

Red blood cell aplasia: Tacrolimus has been reported to cause the body to stop producing red blood cells. If you experience symptoms of reduced red blood cell count such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that can occur when using tacrolimus. Make sure your doctor knows if you have experienced this condition before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Pregnancy: Adequate studies have not been conducted on the use of tacrolimus by pregnant women. Reports of the use of tacrolimus during pregnancy has been associated with high blood potassium levels and kidney problems in the newborn.

Sandoz Tacrolimus should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sandoz Tacrolimus, contact your doctor immediately.

Breast-feeding: Sandoz Tacrolimus passes into breast milk. Breast-feeding is not recommended while taking tacrolimus. If you are a breast-feeding mother and taking tacrolimus, it may affect your baby. Talk to your doctor.