Sandimmune

Sandimmune (cyclosporine) is a cyclic polypeptide immunosuppressant agent used to prevent organ rejection after a kidney, liver, or heart transplant. Sandimmune is also used to treat severe psoriasis or severe rheumatoid arthritis. Sandimmune is available in generic form. Common side effects of Sandimmune include:

• headache,
• nausea,
• vomiting,
• diarrhea,
• stomach upset,
• acne,
• cramps,
• increased hair growth on the face/body,
• shaking fingers/hands (tremor),
• swollen/red/painful gums,
• dizziness,
• flushing, and
• high blood pressure.

Tell your doctor if you have serious side effects of Sandimmune including:

• fever,
• sweating,
• chills,
• sores in your mouth,
• weight loss,
• problems speaking or walking, and
• decreased vision.

The initial oral dose of Sandimmune is given 4-12 hours prior to transplantation as a single dose of 15 mg/kg. The single daily dose is continued postoperatively for 1-2 weeks and tapered 5% per week to a maintenance dose of 5-10 mg/kg/day. Sandimmune may interact with etoposide, lithium, methotrexate, nefazodone, repaglinide, St. John's wort, ACE inhibitors, heart or blood pressure medication, medicines used to treat ulcerative colitis, other medicines used to prevent organ transplant rejection, pain or arthritis medicines, IV antibiotics, antiviral medicines, or cancer medicine. Tell your doctor all medications and supplements you are taking. Sandimmune should be used only when prescribed during pregnancy. Cyclosporine used during pregnancy has resulted in newborns with problems such as low birth weight and being born too early (premature). Other serious problems have been reported, including death. This medication passes into breast milk. Breastfeeding is not recommended while using this drug.

Our Sandimmune (cyclosporine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Sandimmune Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• problems with speech, thought, vision, or muscle movement (may start gradually and get worse quickly);
• a seizure;
• severe headache, blurred vision, pounding in your neck or ears;
• pale skin, easy bruising, unusual bleeding;
• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• kidney problems--urinating less, swelling in your feet or ankles, feeling tired or short of breath;
• liver problems--loss of appetite, stomach pain (upper right side), jaundice (yellowing of the skin or eyes); or
• signs of infection--fever, chills, flu symptoms, mouth sores, skin sores, sore throat, cough, trouble breathing.

Common side effects may include:

• tremors or shaking;
• acne, increased growth of facial or body hair;
• increased blood pressure;
• nausea, diarrhea; or
• swollen or painful gums.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sandimmune (Cyclosporine)

 

Sandimmune Professional Information

SIDE EFFECTS

The principal adverse reactions of Sandimmune (cyclosporine) 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 methylprednisolone, hypocholesterolemia, and nephrotoxicity associated with high plasma concentrations of cyclosporine appear to be related to the neurological manifestations of cyclosporine toxicity.

Clinical Studies

The following reactions occurred in 3% or greater of 892 patients involved in clinical trials of kidney, heart, and liver transplants:

Body System/ Adverse Reactions	Randomized Kidney Patients		All Sandiimmune (cyclosporine) Patients
	Sandimmune (N=227) %	Azathioprine (N=228) %	Kidney (N=705) %	Heart (N=112) %	Liver (N=75) %
Genitourinary
Renal Dysfunction	32	6	25	38	37
Cardiovascular
Hypertension	26	18	13	53	27
Cramps	4	< 1	2	< 1	0
Skin
Hirsutism	21	< 1	21	28	45
Acne	6	8	2	2	1
Central Nervous System
Tremor	12	0	21	31	55
Convulsions	3	1	1	4	5
Headache	2	< 1	2	15	4
Gastrointestinal
Gum Hyperplasia	4	0	9	5	16
Diarrhea	3	< 1	3	4	8
Nausea/Vomiting	2	< 1	4	10	4
Hepatotoxicity	< 1	< 1	4	7	4
Abdominal Discomfort	< 1	0	< 1	7	0
Autonomic Nervous System
Paresthesia	3	0	1	2	1
Flushing	< 1	0	4	0	4
Hematopoietic
Leukopenia	2	19	< 1	6	0
Lymphoma	< 1	0	1	6	1
Respiratory
Sinusitis	< 1	0	4	3	7
Miscellaneous
Gynecomastia	< 1	0	< 1	4	3

The following reactions occurred in 2% or less of patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, muscle pain, peptic ulcer, thrombocytopenia, tinnitus.

The following reactions occurred rarely: anxiety, chest pain, constipation, depression, hair breaking, hematuria, joint pain, lethargy, mouth sores, myocardial infarction, night sweats, pancreatitis, pruritus, swallowing difficulty, tingling, upper GI bleeding, visual disturbance, weakness, weight loss.

Renal Transplant Patients in Whom Therapy Was Discontinued

Reason for Discontinuation	Randomized Patients		All Sandimmune Patients
	Sandimmune (N=227) %	Azathioprine (N=228) %	(N=705) %
Renal Toxicity	5.7	0	5.4
Infection	0	0.4	0.9
Lack of Efficacy	2.6	0.9	1.4
Acute Tubular Necrosis	2.6	0	1.0
Lymphoma/Lymphoproliferative Disease	0.4	0	0.3
Hypertension	0	0	0.3
Hematological Abnormalities	0	0.4	0
Other	0	0	0.7

Sandimmune (cyclosporine) was discontinued on a temporary basis and then restarted in 18 additional patients.

Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine -containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). Both generalized and localized infections can occur. Pre-existing infections may also be aggravated. Fatal outcomes have been reported. (See WARNINGS)

Infectious Complications in the Randomized Renal Transplant Patients

Complication	Sandimmune Treatment (N=227) % of Complications	Standard Treatment* (N=228) % of Complications
Septicemia	5.3	4.8
Abscesses	4.4	5.3
Systemic Fungal Infection	2.2	3.9
Local Fungal Infection	7.5	9.6
Cytomegalovirus	4.8	12.3
Other Viral Infections	15.9	18.4
Urinary Tract Infections	21.1	20.2
Wound and Skin Infections	7.0	10.1
Pneumonia	6.2	9.2
*Some patients also received ALG.

Cremophor® EL (polyoxyethylated castor oil) is known to cause hyperlipemia and electrophoretic abnormalities of lipoproteins. These effects are reversible upon discontinuation of treatment but are usually not a reason to stop treatment.

Postmarketing Experience

Hepatotoxicity

Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure; serious and/or fatal outcomes have been reported. (See WARNINGS, Hepatotoxicity)

Increased Risk of Infections

Cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), sometimes fatal; and polyoma virus-associated nephropathy (PVAN), especially BK virus resulting in graft loss have been reported. (See WARNINGS, Polyoma Virus Infection)

Headache, including Migraine

Cases of migraine have been reported. In some cases, patients have been unable to continue cyclosporine, however, the final decision on treatment discontinuation should be made by the treating physician following the careful assessment of benefits versus risks.

Pain of Lower Extremities

Isolated cases of pain of lower extremities have been reported in association with cyclosporine. Pain of lower extremities has also been noted as part of Calcineurin-Inhibitor Induced Pain Syndrome (CIPS) as described in the literature.

Read the entire FDA prescribing information for Sandimmune (Cyclosporine)

&Copy; Sandimmune Patient Information is supplied by Cerner Multum, Inc. and Sandimmune Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.