Please click here for full Prescribing Information, including Boxed WARNINGS.

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Possible Side Effects1

What is the most important information I should know about SANDIMMUNE?

WARNINGS

Only doctors experienced in the management of systemic immunosuppressive medicines at doses used in solid organ transplantation and in the management of organ transplant patients should prescribe SANDIMMUNE®.

Patients receiving SANDIMMUNE® have an increased risk of infection that may lead to certain cancers. This increased risk of infection and the possibility of developing cancers may be related to how long and how much of these medicines are used in transplant patients. In kidney, liver, and heart transplant patients, SANDIMMUNE® should be given with adrenal corticosteroids but not with other immunosuppressive medicines.

SANDIMMUNE® and Neoral® (cyclosporine, USP) MODIFIED are not bioequivalent and cannot be used interchangeably without doctor supervision.

The absorption of cyclosporine during chronic administration of SANDIMMUNE® Capsules and Oral Solution may not be the same and must be monitored.

Do NOT take SANDIMMUNE® Injection if you are allergic to SANDIMMUNE® (cyclosporine, USP) and/or Cremophor® EL (polyoxyethylated castor oil).

SANDIMMUNE® may cause serious side effects, including:

  • Serious problems with your kidney (nephrotoxicity) and liver (hepatotoxicity). The risk increases with increasing doses of cyclosporine and with other drugs that impair kidney function. Your doctor should do regular blood tests to check your kidney function while you take this medicine
  • Damage in blood vessels from blood clots (thrombotic microangiopathy). Occasionally, patients have developed low platelet counts (thrombocytopenia) and loss of red blood cells in the small blood vessels, leading to reduced blood count (microangiopathic hemolytic anemia) that may result in graft failure
  • Increased levels of potassium and uric acid have occurred
  • Problems with your liver. Cases of liver problems and liver injury have been reported
  • Increased risk of getting certain cancers. People taking antirejection medicines have a higher risk of getting lymphoma and other cancers, especially skin cancer. Avoid excessive sun exposure. Talk to your health care provider about your risk for cancer. This risk is related to how long and how much of the medicines are used
  • Increased risk of serious infections. People taking antirejection medicines, including SANDIMMUNE®, have a higher risk of getting bacterial, viral, fungal (yeast), and protozoal infections, including opportunistic infections. These infections may be serious and may lead to death
  • Polyoma virus infections. People taking antirejection medicines, including SANDIMMUNE®, have an increased risk of infections including polyoma virus infections that may be serious and may lead to death. BK virus can affect how your kidney works and cause your transplanted kidney to fail. Cases of a brain infection called progressive multifocal leukoencephalopathy (PML), which may cause death, have been reported
  • Neurotoxicity. There have been reports of convulsions in adult and pediatric patients receiving cyclosporine, particularly in combination with high-dose methylprednisolone. Nervous system problems (including encephalopathy) have been reported. You should tell your health care provider right away if you have any of the following symptoms: confusion, coma, muscle tremors, movement disorders, numbness and tingling, headache, seizures, or vision changes
  • SEVERE ALLERGIC REACTION. Approximately 1 in 1000 patients receiving SANDIMMUNE® Injection has experienced severe allergic reaction (anaphylaxis)
  • High blood pressure is a common side effect of cyclosporine therapy
  • AVOID receiving any live vaccines while taking cyclosporine
  • Do NOT eat grapefruit or drink grapefruit juice

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. SANDIMMUNE® may affect the way other medicines work, and other medicines may affect how SANDIMMUNE® works. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

What Are the Most Common Side Effects of SANDIMMUNE?

The most common side effects of SANDIMMUNE® are as follows:

  • Kidney problems (Renal Dysfunction)
  • Shaking of body (Tremor)
  • Excessive hair growth (Hirsutism)
  • High blood pressure (Hypertension)
  • Enlarged gums (Hyperplasia)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

LEARN MORE ABOUT THE SANDIMMUNE SAVINGS CARD

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Sandimmune ISI

Important Safety Information & Indications and Usage

IMPORTANT SAFETY INFORMATION

WARNINGS

Only doctors experienced in the management of systemic immunosuppressive medicines at doses used in solid organ transplantation and in the management of organ transplant patients should prescribe Sandimmune®.

Patients receiving Sandimmune® have an increased risk of infection that may lead to certain cancers. This increased risk of infection and the possibility of developing cancers may be related to how long and how much of these medicines are used in transplant patients. In kidney, liver, and heart transplant patients, Sandimmune® should be given with adrenal corticosteroids but not with other immunosuppressive medicines.

Sandimmune® and Neoral® (cyclosporine, USP) MODIFIED are not bioequivalent and cannot be used interchangeably without doctor supervision.

The absorption of cyclosporine during chronic administration of Sandimmune® Capsules and Oral Solution may not be the same and must be monitored.

Do NOT take Sandimmune® Injection if you are allergic to Sandimmune® (cyclosporine, USP) and/or Cremophor® EL (polyoxyethylated castor oil).

Sandimmune® may cause serious side effects, including:

  • Serious problems with your kidney (nephrotoxicity) and liver (hepatotoxicity). The risk increases with increasing doses of cyclosporine and with other drugs that impair kidney function. Your doctor should do regular blood tests to check your kidney function while you take this medicine.
  • Damage in blood vessels from blood clots (thrombotic microangiopathy). Occasionally, patients have developed low platelet counts (thrombocytopenia) and loss of red blood cells in the small blood vessels, leading to reduced blood count (microangiopathic hemolytic anemia) that may result in graft failure.
  • Increased levels of potassium and uric acid have occurred.
  • Problems with your liver. Cases of liver problems and liver injury have been reported.
  • Increased risk of getting certain cancers. People taking antirejection medicines have a higher risk of getting lymphoma and other cancers, especially skin cancer. Avoid excessive sun exposure. Talk to your health care provider about your risk for cancer. This risk is related to how long and how much of the medicines are used.
  • Increased risk of serious infections. People taking antirejection medicines, including Sandimmune®, have a higher risk of getting bacterial, viral, fungal (yeast), and protozoal infections, including opportunistic infections. These infections may be serious and may lead to death.
  • Polyoma virus infections. People taking antirejection medicines, including Sandimmune®, have an increased risk of infections including polyoma virus infections that may be serious and may lead to death. BK virus can affect how your kidney works and cause your transplanted kidney to fail. Cases of a brain infection called progressive multifocal leukoencephalopathy (PML), which may cause death, have been reported.
  • Neurotoxicity. There have been reports of convulsions in adult and pediatric patients receiving cyclosporine, particularly in combination with high-dose methylprednisolone. Nervous system problems (including encephalopathy) have been reported. You should tell your health care provider right away if you have any of the following symptoms: confusion, coma, muscle tremors, movement disorders, numbness and tingling, headache, seizures, or vision changes.
  • SEVERE ALLERGIC REACTION. Approximately 1 in 1000 patients receiving Sandimmune® Injection has experienced severe allergic reaction (anaphylaxis).
  • High blood pressure is a common side effect of cyclosporine therapy.
  • AVOID receiving any live vaccines while taking cyclosporine.
  • Do NOT eat grapefruit or drink grapefruit juice.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Sandimmune® may affect the way other medicines work, and other medicines may affect how Sandimmune® works. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

The most common side effects are kidney problems (renal dysfunction), shaking of the body (tremor), excessive hair growth (hirsutism), high blood pressure (hypertension), and enlarged gums (gum hyperplasia).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS AND USAGE

Sandimmune® (cyclosporine, USP) Capsules is a prescription medicine given to help prevent rejection in patients who have had a kidney, liver, or heart transplant. Sandimmune® should always be used with adrenal corticosteroids.

Because of the risk of a severe allergic reaction (anaphylaxis), Sandimmune® Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.

Please click here for full Prescribing Information, including Boxed WARNINGS.

Reference: 1. SANDIMMUNE [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2015.