Sandimmune 25 mg/1
cyclosporine · CAPSULE, LIQUID FILLED · Novartis Pharmaceuticals Corporation
Sandimmune (cyclosporine) is an immunosuppressant medication taken by mouth that works by reducing the activity of the immune system. It is used to prevent organ rejection in transplant patients and to treat certain autoimmune conditions.
Key Facts
- Brand Name
- Sandimmune
- Generic Name
- cyclosporine
- NDC Code (Product)
0078-0240- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- NDA050625
- Drug Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 03/02/1990
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.
Dosage & Administration
DOSAGE AND ADMINISTRATION Recommended Dosage for Sandimmune Capsules Sandimmune (cyclosporine capsules) 25 mg and 100 mg and Neoral (cyclosporine capsules), MODIFIED 25 mg and 100 mg are not mutually substitutable on a mg-to-mg basis due to differences in pharmacokinetic profiles. If it is appropriate to switch from Neoral capsules, MODIFIED, to Sandimmune capsules, increase the frequency of cyclosporine monitoring (the cyclosporine dosage may need to be increased to reach the desired cyclosporine exposure and reduce the risk of insufficient efficacy). If it is appropriate to switch from Sandimmune capsules to Neoral capsules, increase the frequency of cyclosporine monitoring (the cyclosporine dosage may need to be decreased to reach the desired cyclosporine exposure and reduce the risk of cyclosporine-related adverse reactions). The initial oral dose of Sandimmune capsules should be given 4 to 12 hours prior to transplantation as a single dose of 15 mg/kg. Although a daily single dose of 14 to 18 mg/kg was used in most clinical trials, few centers continue to use the highest dose, most favoring the lower end of the scale. There is a trend towards use of even lower initial doses fo…
Warnings
WARNINGS Kidney, Liver, and Heart Transplant Sandimmune, when used in high dosages, can cause hepatotoxicity and nephrotoxicity (see BOXED WARNING) . Nephrotoxicity It is not unusual for serum creatinine and Blood Urea Nitrogen (BUN) levels to be elevated during Sandimmune therapy. These elevations in renal transplant patients do not necessarily indicate rejection, and each patient must be fully evaluated before dosage adjustment is initiated. Nephrotoxicity has been noted in 25% of cases of renal transplantation, 38% of cases of cardiac transplantation, and 37% of cases of liver transplantation. Mild nephrotoxicity was generally noted 2 to 3 months after transplant and consisted of an arrest in the fall of the preoperative elevations of BUN and creatinine at a range of 35 to 45 mg/dl and 2.0 to 2.5 mg/dl, respectively. These elevations were often responsive to dosage reduction. More overt nephrotoxicity was seen early after transplantation and was characterized by a rapidly rising BUN and creatinine. Since these events are similar to rejection episodes, care must be taken to differentiate between them. This form of nephrotoxicity is usually responsive to Sandimmune dosage reductio…
Contraindications
CONTRAINDICATIONS Sandimmune capsules and Sandimmune injection are contraindicated in patients with a hypersensitivity reaction to cyclosporine. Sandimmune injection is also contraindicated in patients with a history of a hypersensitivity reaction to Cremophor ® EL (polyoxyethylated castor oil).
Drug Interactions
Drug Interactions A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety All of the individual drugs cited below are well substantiated to interact with cyclosporine. In addition, concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) with cyclosporine, particularly in the setting of dehydration, may potentiate renal dysfunction. Caution should be exercised when using other drugs which are known to impair renal function (see WARNINGS, Nephrotoxicity) . Drugs That May Potentiate Renal Dysfunction Antibiotics Antineoplastic Antifungals Anti-Inflammatory Drugs Gastrointestinal Agents Immunosuppressives Other Drugs ciprofloxacin melphalan amphotericin B azapropazon cimetidine tacrolimus fibric acid derivatives (e.g., bezafibrate, fenofibrate) gentamicin ketoconazole colchicine ranitidine methotrexate tobramycin diclofenac trimethoprim with sulfamethoxazole naproxen vancomycin sulindac During the concomitant use of a drug that may exhibit additive or synergistic renal impairment potential with cyclosporine, close monitoring of renal function (in particular serum creatinine) should be performed. If a significant impairment of renal function occurs, r…
Adverse Reactions
ADVERSE REACTIONS The principal adverse reactions of Sandimmune therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia. Hypertension Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular Capillary Thrombosis Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resemble those seen in the hemolytic-uremic syndrome and include thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. Similar findings have been observed when other immunosuppressives have been employed post transplantation. Hypomagnesemia Hypomagnesemia has been reported in some, but not all, patients exhibiting convulsions while on cyclosporine therapy. Although magnesium-depletion studies in normal subjects suggest that hypomagnesemia is associated with neurologic disorders, multiple factors, including hypertension, high-dose meth…
Frequently Asked Questions
What is Sandimmune used for?
Sandimmune (cyclosporine) is an immunosuppressant medication taken by mouth that works by reducing the activity of the immune system. It is used to prevent organ rejection in transplant patients and to treat certain autoimmune conditions.
Is Sandimmune a controlled substance?
Sandimmune is not classified as a controlled substance by the DEA.
What is the generic name for Sandimmune?
The generic name for Sandimmune is cyclosporine. There are 12 other brand versions of cyclosporine.
What is the NDC code for Sandimmune 25 mg/1?
The NDC (National Drug Code) for Sandimmune 25 mg/1 is 0078-0240, listed by Novartis Pharmaceuticals Corporation.