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

Neoral Logo

About Neoral1

Neoral is a prescription medicine given to help prevent rejection in patients who have had a kidney, liver, or heart transplant. Rejection happens when the body's immune system senses the new organ as "foreign" and attacks it.

Neoral is used with other transplant medications as part of a long-term treatment plan to help control your body's immune system.

If Neoral is Right for You, You Have the Right to Stick With It. Ask your doctor to write "Dispense as Written" on your prescriptions to receive brand-name Neoral.

GET THE Neoral SAVINGS CARD

GET THE Neoral TRIAL VOUCHER

QUICK LINKS

Neoral ISI

INDICATIONS AND USAGE

Neoral (cyclosporine, USP) MODIFIED Capsules is a prescription medicine given to help prevent rejection in patients who have had a kidney, liver, or heart transplant. Neoral has been used in combination with azathioprine and corticosteroids.

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 Neoral.

Patients receiving Neoral 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, Neoral is given with other immunosuppressive medicines.

Neoral Capsules MODIFIED and Oral Solution MODIFIED cannot be substituted with Sandimmune (cyclosporine, USP) Capsules and Oral Solution without careful monitoring. For a given blood concentration, cyclosporine levels will be greater with Neoral than with Sandimmune. Cyclosporine blood concentrations should be monitored to avoid toxicity due to high concentrations.

Do NOT take Neoral if you are allergic to cyclosporine or to any of the ingredients in Neoral.

Neoral 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 Neoral, 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 Neoral, 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.
  • 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. Neoral may affect the way other medicines work, and other medicines may affect how Neoral 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.

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

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