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(SIGH-kloe-spore-EEN)
Sandimmune, Neoral, Sangcya
Class: Immunosuppressive

 Action Suppresses cell-mediated immune reactions and some humoral immunity, but exact mechanism is not known.

 Indications Prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants in conjunction with adrenal corticosteroid therapy; treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Unlabeled use(s): Prophylaxis in other transplant procedures; treatment of aplastic anemia, atopic dermatitis, Behcet’s disease, biliary cirrhosis, Crohn’s disease, rheumatoid arthritis, severe psoriasis, nephrotic syndrome, pulmonary sarcoidosis, pyoderma gangrenosum, ulcerative colitis, alopecia areata. Ophthalmic form for treatment of keratoconjunctivitis sicca, use after keratoplasty and treatment of corneal melting syndrome.

 Contraindications Hypersensitivity polyoxyethylated castor oil, which is present in concentrate for injection.

 Route/Dosage

ADULTS & CHILDREN: PO 15 mg/kg/day (range 14–18 mg/kg/day) beginning 4–12 hr before transplantation. Continue for 1–2 wk postoperatively then taper dose by 5%/wk to maintenance level of 5–10 mg/kg/day. Lower doses may be used on basis of patient response, rejection rate and cyclosporine plasma concentrations. IV 5–6 mg/kg/day as single IV dose starting 4–12 hr before transplantation. Switch to oral form as soon as patient can tolerate.

 Interactions

Amiodarone, diltiazem, fluconazole, imipenem-cilastatin, ketoconazole, macrolide antibiotics (eg, erythromycin), nicardipine: May increase cyclosporine concentrations. Aminoglycosides, amphotericin B, NSAIDs, trimethoprim-sulfamethoxazole, melphalan, quinolones: Additive nephrotoxicity possible. Azathioprine, corticosteroids, cyclophosphamide, verapamil: May cause additive immunosuppression, increasing risk of infection and malignancy. Carbamazepine, hydantoins, phenobarbital, rifampin, rifabutin: May decrease cyclosporine effects. Digoxin: May cause elevated digoxin concentrations and toxicity. Etoposide: May increase etoposide concentrations. Lovastatin: May cause severe myopathy or rhabdomyolysis; avoid concurrent use. Metoclopramide: Increases absorption of cyclosporine. Potassium-sparing diuretics: Causes hyperkalemic effects; avoid concomitant use.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Hypertension; MI. CNS: Tremor; convulsions; headache; confusion; flushing; ataxia; hallucinations; mania; depression; encephalopathy. DERM: Hirsutism; acne; brittle fingernails. GI: Gingival hyperplasia; diarrhea; nausea, vomiting; abdominal discomfort; anorexia; gastritis; peptic ulcer; hiccoughs. GU: Renal dysfunction. HEMA: Lymphoma; hemolytic anemia; leukopenia; anemia; thrombocytopenia. HEPA: Hepatotoxicity. META: Hyperglycemia; hyperkalemia; hyperuricemia. OTHER: Paresthesia; gynecomastia; allergic reactions including anaphylaxis; cramps.

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Although safety and efficacy have not been established, patients as young as 6 mo have received drug. May require higher doses than adults. Absorption: Absorption during long-term use is erratic. Patients with malabsorption may have difficulty achieving therapeutic concentrations with oral use. Anaphylactic reactions: Occur rarely with IV use. Have epinephrine 1: 1000 and oxygen readily available. Convulsions: Have occurred, particularly in combination with high-dose methylprednisolone. Nephrotoxicity: Common adverse effect; may respond to decreased dose. Renal impairment: Requires close monitoring and possible dosage adjustment.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Give with adrenal corticosteroids but not with other immunosuppressive agents.

Intravenous

  • Dilute parenteral solution immediately before use. Dilute each 1 ml (50 mg) concentrate in 20–100 ml of 0.9% Sodium Chloride for Injection or D5W. Observe for particulate matter and discoloration. Give IV infusion slowly over 2–6 hr.
  • Store in glass container at room temperature. Protect from light. Solutions diluted with D5W are stable for 24 hr.

Oral

  • Use calibrated pipettes for oral doses. Prepare solution in glass container just before administering to patient.
  • Prepare with room-temperature white or chocolate milk or orange juice to improve flavor. Stir well and give to patient to drink. Do not use plastic utensils (drug binds to plastics). Do not allow mixture to stand before administering.
  • Do not refrigerate or freeze. Use within 2 mo after opening.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note hypersensitivity to cyclosporine or polyoxyethylated castor oil.
  • Perform renal and hepatic function tests in conjunction with potassium and lipid level determinations before beginning treatment and periodically repeat tests during drug therapy.
  • Assess vital signs initially and note hypertension, especially with children.
  • Note any signs of infection (eg, fever, sore throat, tiredness), unusual bleeding, hematuria or bruising.
  • Have emergency equipment available for IV drug administration and assess vital signs frequently (eg, q 5–10 min × 4) or according to hospital policy.
  • Ensure medical asepsis and eliminate any potential sources of environmental contamination.
  • Weigh patient daily and monitor I&O.
OVERDOSAGE: SIGNS & SYMPTOMS
  Hepatotoxicity, nephrotoxicity

 Patient/Family Education

  • Instruct patient on necessity for frequent laboratory monitoring while taking medication.
  • Instruct patient on proper technique for self-monitoring of BP and vital signs.
  • Instruct patient to report any adverse reactions: infection (eg, fever, sore throat, fatigue, frequency, dysuria, cloudy urine), unusual bleeding (eg, hematuria, bleeding of gums, bruising), chest pain, headache, tremors or liver dysfunction (eg, abdominal pain, jaundice, dark urine, pruritus, light-colored stools).
  • Direct patient to avoid contact with others who may have infections.
  • Caution patient to avoid any trauma.
  • Advise patient to use soft toothbrush, practice frequent oral hygiene and have regular dental checkups.
  • Counsel patient on need for balanced diet and fluid intake according to specific physician orders.
  • Advise patient to consult physician before any vaccinations.

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