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Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral®.
Neoral®, a systemic immunosuppressant may increase the susceptibility to infection and the development of neoplasia.
Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED have increased bioavailability in comparison to Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP). Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral®.
Cyclosporine, the active ingredient in Neoral®, in recommended dosages, can cause systemic hypertension and nephrotoxicity The risk increases with increasing dose and duration of cyclosporine therapy. Cyclosporine (oral) is an anti-infective agent, antirheumatic agent that is FDA approved for the treatment of rheumatoid arthritis, psoriasis, and for prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
Neoral® is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The initial oral dose of Neoral® can be given 4-12 hours prior to transplantation or be given postoperatively. In transplanted patients who are considered for conversion to Neoral® from Sandimmune®, Neoral® should be started with the same daily dose as was previously used with Sandimmune® (1:1 dose conversion). Until the blood trough concentration attains the pre-conversion value, it is strongly recommended that the cyclosporine blood trough concentration be monitored every 4 to 7 days after conversion to Neoral®.
Patients with lower than expected cyclosporine blood trough concentrations in relation to the oral dose of Sandimmune® may have poor or inconsistent absorption of cyclosporine from Sandimmune®. Transplant centers have found blood concentration monitoring of cyclosporine to be an essential component of patient management.
Neoral® is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, Neoral® should be discontinued.
While rebound rarely occurs, most patients will experience relapse with Neoral® as with other therapies upon cessation of treatment. Patients generally show some improvement in the clinical manifestations of psoriasis in 2 weeks.
Upon stopping treatment with cyclosporine, relapse will occur in approximately 6 weeks (50% of the patients) to 16 weeks (75% of the patients). To increase tear production in patients with keratoconjunctivitis sicca, the recommended dose of cycloSPORINE ophthalmic emulsion 0.05% (Restasis(TM)) is one drop in each eye twice daily, administered approximately 12 hours apart. There is limited information regarding Off-Label Guideline-Supported Use of Cyclosporine (oral) in adult patients. In a prospective randomized multicenter trial of immunosuppressive therapy in previously untreated adult patients with non-severe aplastic anemia, the combination of horse antithymocyte globulin (ATG), and cycloSPORINE was more effective than cycloSPORINE alone in terms of hematologic response, an earlier and improved quality of response, and fewer cases of non-response and disease progression. A weight-independent dosing regimen is suggested for oral cycloSPORINE that would depend only on the target trough levels.
The safety and effectiveness of cycloSPORINE ophthalmic emulsion have not established in patients younger than 16 years.
To increase tear production in pediatric patients 16 years or older with keratoconjunctivitis sicca, the recommended dose of cycloSPORINE ophthalmic emulsion 0.05% (Restasis(TM)) is one drop in each eye twice daily, administered approximately 12 hours apart. There is limited information regarding Off-Label Guideline-Supported Use of Cyclosporine (oral) in pediatric patients. Neoral® is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation. Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Neoral®. Psoriasis patients who are treated with Neoral® should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy.
Cyclosporine, the active ingredient of Neoral®, can cause nephrotoxicity and hepatotoxicity.
An increase in serum creatinine and BUN may occur during Neoral® therapy and reflect a reduction in the glomerular filtration rate.
Cyclosporine, the active ingredient of Neoral®, can cause nephrotoxicity and hepatotoxicity when used in high doses. Based on the historical Sandimmune® experience with oral solution, nephrotoxicity associated with cyclosporine had been noted in 25% of cases of renal transplantation, 38% of cases of cardiac transplantation, and 37% of cases of liver transplantation.
More overt nephrotoxicity was seen early after transplantation and was characterized by a rapidly rising BUN and creatinine. Although specific diagnostic criteria which reliably differentiate renal graft rejection from drug toxicity have not been found, a number of parameters have been significantly associated with one or the other. A form of a cyclosporine-associated nephropathy is characterized by serial deterioration in renal function and morphologic changes in the kidneys. When considering the development of cyclosporine-associated nephropathy, it is noteworthy that several authors have reported an association between the appearance of interstitial fibrosis and higher cumulative doses or persistently high circulating trough concentrations of cyclosporine. Impaired renal function at any time requires close monitoring, and frequent dosage adjustment may be indicated. In the event of severe and unremitting rejection, when rescue therapy with pulse steroids and monoclonal antibodies fail to reverse the rejection episode, it may be preferable to switch to alternative immunosuppressive therapy rather than increase the Neoral® dose to excessive blood concentrations.
Due to the potential for additive or synergistic impairment of renal function, caution should be exercised when coadministering Neoral with other drugs that may impair renal function. Occasionally patients have developed a syndrome of thrombocytopenia and microangiopathic hemolytic anemia which may result in graft failure.
Significant hyperkalemia (sometimes associated with hyperchloremic metabolic acidosis) and hyperuricemia have been seen occasionally in individual patients. Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis, and liver failure have been reported in patients treated with cyclosporine.
Hepatotoxicity, usually manifested by elevations in hepatic enzymes and bilirubin, was reported in patients treated with cyclosporine in clinical trials: 4% in renal transplantation, 7% in cardiac transplantation, and 4% in liver transplantation.
As in patients receiving other immunosuppressants, those patients receiving cyclosporine are at increased risk for development of lymphomas and other malignancies, particularly those of the skin. Patients receiving immunosuppressants, including Neoral, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
Patients receiving immunosuppressants, including Neoral, are at increased risk for opportunistic infections, including polyoma virus infections.
Consideration should be given to reducing the total immunosuppression in transplant patients who develop PML or PVAN. There have been reports of convulsions in adult and pediatric patients receiving cyclosporine, particularly in combination with high dose methylprednisolone.
Encephalopathy, including Posterior Reversible Encephalopathy Syndrome (PRES), has been described both in post-marketing reports and in the literature.
Cyclosporine nephropathy was detected in renal biopsies of 6 out of 60 (10%) rheumatoid arthritis patients after the average treatment duration of 19 months.
There is a potential, as with other immunosuppressive agents, for an increase in the occurrence of malignant lymphomas with cyclosporine. Patients should be thoroughly evaluated before and during Neoral® treatment for the development of malignancies.
Since cyclosporine is a potent immunosuppressive agent with a number of potentially serious side effects, the risks and benefits of using Neoral® should be considered before treatment of patients with psoriasis. Renal dysfunction is a potential consequence of Neoral® therefore renal function must be monitored during therapy.
An increase in serum creatinine and BUN may occur during Neoral® therapy and reflects a reduction in the glomerular filtration rate. There is an increased risk for the development of skin and lymphoproliferative malignancies in cyclosporine-treated psoriasis patients.
Tumors were reported in 32 (2.2%) of 1439 psoriasis patients treated with cyclosporine worldwide from clinical trials.
There were two lymphoproliferative malignancies; one case of non-Hodgkin’s lymphoma which required chemotherapy, and one case of mycosis fungoides which regressed spontaneously upon discontinuation of cyclosporine. Patients should not be treated concurrently with cyclosporine and PUVA or UVB, other radiation therapy, or other immunosuppressive agents, because of the possibility of excessive immunosuppression and the subsequent risk of malignancies. During treatment with cyclosporine, vaccination may be less effective; and the use of live attenuated vaccines should be avoided.
Before initiating treatment, a careful physical examination, including blood pressure measurements (on at least two occasions) and two creatinine levels to estimate baseline should be performed. In patients who are receiving cyclosporine, the dose of Neoral® should be decreased by 25%-50% if hypertension occurs.
Before initiating treatment, a careful dermatological and physical examination, including blood pressure measurements (on at least two occasions) should be performed.
Baseline laboratories should include serum creatinine (on two occasions), BUN, CBC, serum magnesium, potassium, uric acid, and lipids. Serum creatinine and BUN should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable. Blood pressure should be evaluated every 2 weeks during the initial 3 months of therapy and then monthly if the patient is stable, or more frequently when dosage adjustments are made. CBC, uric acid, potassium, lipids, and magnesium should also be monitored every 2 weeks for the first 3 months of therapy, and then monthly if the patient is stable or more frequently when dosage adjustments are made. In controlled trials of cyclosporine in psoriasis patients, cyclosporine blood concentrations did not correlate well with either improvement or with side effects such as renal dysfunction. Information for Patients: Patients should be advised that any change of cyclosporine formulation should be made cautiously and only under physician supervision because it may result in the need for a change in dosage. Patients should be informed of the necessity of repeated laboratory tests while they are receiving cyclosporine. Patients should be advised that during treatment with cyclosporine, vaccination may be less effective and the use of live attenuated vaccines should be avoided. Patients should be advised to take Neoral® on a consistent schedule with regard to time of day and relation to meals. In all patients treated with cyclosporine, renal and liver functions should be assessed repeatedly by measurement of serum creatinine, BUN, serum bilirubin, and liver enzymes. The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia.
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 has been found in patients treated with cyclosporine and may progress to graft failure. Hypomagnesemia has been reported in some, but not all, patients exhibiting convulsions while on cyclosporine therapy.
In controlled studies, the nature, severity, and incidence of the adverse events that were observed in 493 transplanted patients treated with Neoral® were comparable with those observed in 208 transplanted patients who received Sandimmune® in these same studies when the dosage of the two drugs was adjusted to achieve the same cyclosporine blood trough concentrations.
Based on the historical experience with Sandimmune®, the following reactions occurred in 3% or greater of 892 patients involved in clinical trials of kidney, heart, and liver transplants. The following reactions occurred in 2% or less of cyclosporine-treated patients: allergic reactions, anemia, anorexia, confusion, conjunctivitis, edema, fever, brittle fingernails, gastritis, hearing loss, hiccups, hyperglycemia, migraine (Neoral®), 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. Patients receiving immunosuppressive therapies, including cyclosporine and cyclosporine-containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic). 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. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral®.
In kidney, liver, and heart transplant patients Neoral® may be administered with other immunosuppressive agents.
Neoral® and Sandimmune® are not bioequivalent and cannot be used interchangeably without physician supervision. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy. The initial dose of Neoral® varies depending on the transplanted organ and the other immunosuppressive agents included in the immunosuppressive protocol. The Neoral® dose should subsequently be adjusted to attain the pre-conversion cyclosporine blood trough concentration.
In addition, clinical safety parameters such as serum creatinine and blood pressure should be monitored every two weeks during the first two months after conversion.
Of importance to blood concentration analysis are the type of assay used, the transplanted organ, and other immunosuppressant agents being administered. Older studies using a nonspecific assay often cited concentrations that were roughly twice those of the specific assays.
Neoral® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. The same initial dose and dosage range should be used if Neoral® is combined with the recommended dose of methotrexate. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.
If dose reduction is not effective in controlling abnormalities, or if the adverse event or abnormality is severe, Neoral® should be discontinued.
In the majority of patients rebound does not occur after cessation of treatment with cyclosporine. Before use, the unit-dose vial should be inverted several times to obtain a uniform, white, opaque emulsion. It is usually administered as a continuous infusion beginning 1 or 2 days prior to transplantation.
In another study, 34 mg of cycloSPORINE administered intralesionally was effective in treating psoriasis. Give the first dose 4 to 12 hours before surgery and continue the initial daily dose postoperatively until the patient can tolerate oral administration. Give the first dose 4 to 12 hours before surgery and continue the initial daily dose postoperatively for 1 to 2 weeks.
The initial dose, tapering schedule, and maintenance dose of prednisone must be individualized according to the status of the patient and function of the graft. Give the first dose 4 to 12 hours before surgery and continue the initial daily dose postoperatively until the patient can tolerate oral administration . Psoriasis patients with abnormal renal function, uncontrolled hypertension, or malignancies should not receive Neoral®.
Elderly patients should be monitored with particular care, since decreases in renal function also occur with age. Conversion from Neoral® to Sandimmune® should be made with increased monitoring to avoid the potential of underdosing. It is not unusual for serum creatinine and BUN levels to be elevated during cyclosporine therapy. Since these events are similar to renal rejection episodes, care must be taken to differentiate between them. It should be noted however, that up to 20% of patients may have simultaneous nephrotoxicity and rejection.
From 5%-15% of transplant recipients who have received cyclosporine will fail to show a reduction in rising serum creatinine despite a decrease or discontinuation of cyclosporine therapy. This is particularly true during the first 6 post-transplant months when the dosage tends to be highest and when, in kidney recipients, the organ appears to be most vulnerable to the toxic effects of cyclosporine.


The vasculopathy can occur in the absence of rejection and is accompanied by avid platelet consumption within the graft as demonstrated by Indium 111 labeled platelet studies. Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and comedications with hepatotoxic potential. This was usually noted during the first month of therapy when high doses of cyclosporine were used. Polyoma virus infections in transplant patients may have serious, and sometimes, fatal outcomes.
PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies and ataxia.
Manifestations include impaired consciousness, convulsions, visual disturbances (including blindness), loss of motor function, movement disorders and psychiatric disturbances. It is not clear whether the risk with cyclosporine is greater than that in rheumatoid arthritis patients or in rheumatoid arthritis patients on cytotoxic treatment for this indication. Moreover, use of Neoral® therapy with other immunosuppressive agents may induce an excessive immunosuppression which is known to increase the risk of malignancy.
Cyclosporine, the active ingredient in Neoral®, can cause nephrotoxicity and hypertension and the risk increases with increasing dose and duration of therapy.
The relative risk of malignancies is comparable to that observed in psoriasis patients treated with other immunosuppressive agents.
Additional tumors have been reported in 7 patients in cyclosporine postmarketing experience. There were four cases of benign lymphocytic infiltration: 3 regressed spontaneously upon discontinuation of cyclosporine, while the fourth regressed despite continuation of the drug.
Patients should also be warned to protect themselves appropriately when in the sun, and to avoid excessive sun exposure. For an adult weighing 70 kg, the maximum daily oral dose would deliver about 1 gram of alcohol which is approximately 6% of the amount of alcohol contained in a standard drink. Blood pressure and serum creatinine should be evaluated every 2 weeks during the initial 3 months and then monthly if the patient is stable. If hypertension persists, the dose of Neoral® should be further reduced or blood pressure should be controlled with antihypertensive agents.
Since Neoral® is an immunosuppressive agent, patients should be evaluated for the presence of occult infection on their first physical examination and for the presence of tumors initially, and throughout treatment with Neoral®. The increase in creatinine is generally reversible upon timely decrease of the dose of Neoral® or its discontinuation. If the serum creatinine is greater than or equal to 25% above the patient’s pretreatment level, serum creatinine should be repeated within two weeks. Patients without a history of previous hypertension before initiation of treatment with Neoral®, should have the drug reduced by 25%-50% if found to have sustained hypertension. Patients should be advised of the potential risks during pregnancy and informed of the increased risk of neoplasia. Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED should be diluted, preferably with orange or apple juice that is at room temperature. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided. The pathologic changes resembled those seen in the hemolytic-uremic syndrome and included thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. 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.
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.
Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients. For a given trough concentration, cyclosporine exposure will be greater with Neoral® than with Sandimmune®. In newly transplanted patients, the initial oral dose of Neoral® is the same as the initial oral dose of Sandimmune®.
Using the same trough concentration target range for Neoral® as for Sandimmune® results in greater cyclosporine exposure when Neoral® is administered.
Due to the increase in bioavailability of cyclosporine following conversion to Neoral®, the cyclosporine blood trough concentration may exceed the target range. While no fixed relationship has been established, blood concentration monitoring may assist in the clinical evaluation of rejection and toxicity, dose adjustments, and the assessment of compliance.
Therefore, comparison between concentrations in the published literature and an individual patient concentration using current assays must be made with detailed knowledge of the assay methods employed.
Results of a dose-titration clinical trial with Neoral® indicate that an improvement of psoriasis by 75% or more (based on PASI) was achieved in 51% of the patients after 8 weeks and in 79% of the patients after 16 weeks.
Thirteen cases of transformation of chronic plaque psoriasis to more severe forms of psoriasis have been reported. Patients are usually given the IV formulation prior to transplantation then converted to oral cycloSPORINE as soon as mucositis has subsided.
The IV dose is generally one-third the oral dose and should be adjusted based on clinical response, predefined blood concentrations, and tolerability. Renal dysfunction including structural kidney damage is a potential consequence of Neoral® and therefore renal function must be monitored during therapy. If patients are not properly monitored and doses are not properly adjusted, cyclosporine therapy can be associated with the occurrence of structural kidney damage and persistent renal dysfunction. The frequency and severity of serum creatinine elevations increase with dose and duration of cyclosporine therapy.
These elevations in renal transplant patients do not necessarily indicate rejection, and each patient must be fully evaluated before dosage adjustment is initiated. Renal biopsies from these patients will demonstrate one or several of the following alterations: tubular vacuolization, tubular microcalcifications, peritubular capillary congestion, arteriolopathy, and a striped form of interstitial fibrosis with tubular atrophy.
Among other contributing factors to the development of interstitial fibrosis in these patients are prolonged perfusion time, warm ischemia time, as well as episodes of acute toxicity, and acute and chronic rejection. The increased risk appears related to the intensity and duration of immunosuppression rather than to the use of specific agents.
These include cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), and polyoma virus-associated nephropathy (PVAN), especially due to BK virus infection, which have been observed in patients receiving cyclosporine.
Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. In many cases, changes in the white matter have been detected using imaging techniques and pathologic specimens. Five cases of lymphoma were detected: four in a survey of approximately 2,300 patients treated with cyclosporine for rheumatoid arthritis, and another case of lymphoma was reported in a clinical trial. Patients who may be at increased risk such as those with abnormal renal function, uncontrolled hypertension or malignancies, should not receive Neoral®. If patients are not properly monitored and doses are not properly adjusted, cyclosporine therapy can cause structural kidney damage and persistent renal dysfunction. Patients should be thoroughly evaluated before and during treatment for the presence of malignancies remembering that malignant lesions may be hidden by psoriatic plaques. Mild or moderate hypertension is encountered more frequently than severe hypertension and the incidence decreases over time. It is advisable to monitor serum creatinine and blood pressure always after an increase of the dose of nonsteroidal anti-inflammatory drugs and after initiation of new nonsteroidal anti-inflammatory drug therapy during Neoral® treatment. If the change in serum creatinine remains greater than or equal to 25% above baseline, Neoral® should be reduced by 25%-50%. If the patient continues to be hypertensive despite multiple reductions of Neoral®, then Neoral® should be discontinued. The combination of Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED with milk can be unpalatable.
Cyclosporine blood concentrations should be routinely monitored in transplant patients, and periodically monitored in rheumatoid arthritis patients.
Similar findings have been observed when other immunosuppressives have been employed post-transplantation. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. If a patient who is receiving exceptionally high doses of Sandimmune® is converted to Neoral®, particular caution should be exercised. Suggested initial doses are available from the results of a 1994 survey of the use of Sandimmune® in US transplant centers. Steroid doses may be further tapered on an individualized basis depending on status of patient and function of graft. Patients with suspected poor absorption of Sandimmune® require different dosing strategies.
Current assay results are also not interchangeable and their use should be guided by their approved labeling.
If significant clinical improvement has not occurred in patients by that time, the patient’s dosage should be increased at 2-week intervals. The emulsion can be used with artificial tears, allowing a 15-minute interval between products. The addition of methotrexate or replacement of cycloSPORINE with other antirheumatic therapy should be considered after 3 months at the maximum tolerated cycloSPORINE dose if the patient has achieved only partial response. Because of the risk of anaphylaxis with the IV formulation, reserve IV administration for patients who are unable to tolerate oral cycloSPORINE formulations. These elevations are likely to become more pronounced without dose reduction or discontinuation. Though none of these morphologic changes is entirely specific, a diagnosis of cyclosporine-associated structural nephrotoxicity requires evidence of these findings. The reversibility of interstitial fibrosis and its correlation to renal function have not yet been determined. Though resolution has occurred after reduction or discontinuation of cyclosporine and 1) administration of streptokinase and heparin or 2) plasmapheresis, this appears to depend upon early detection with Indium 111 labeled platelet scans. Because of the danger of oversuppression of the immune system resulting in increased risk of infection or malignancy, a treatment regimen containing multiple immunosuppressants should be used with caution. PVAN is associated with serious outcomes, including deteriorating renal function and renal graft loss. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated. Predisposing factors such as hypertension, hypomagnesemia, hypocholesterolemia, high-dose corticosteroids, high cyclosporine blood concentrations, and graft-versus-host disease have been noted in many but not all of the reported cases. The “maximal creatinine increase” appears to be a factor in predicting cyclosporine nephropathy. Although other tumors (12 skin cancers, 24 solid tumors of diverse types, and 1 multiple myeloma) were also reported in this survey, epidemiologic analyses did not support a relationship to cyclosporine other than for malignant lymphomas.
In recipients of kidney, liver, and heart allografts treated with cyclosporine, antihypertensive therapy may be required. If coadministered with methotrexate, CBC and liver function tests are recommended to be monitored monthly. Patients with malignant or premalignant changes of the skin should be treated with Neoral® only after appropriate treatment of such lesions and if no other treatment option exists.
If at any time the serum creatinine increases by greater than or equal to 50% above pretreatment level, Neoral® should be reduced by 25%-50%. For patients with treated hypertension, before the initiation of Neoral® therapy, their medication should be adjusted to control hypertension while on Neoral®. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral® to avoid toxicity due to high concentrations.
The dose of Neoral® should be titrated individually based on cyclosporine trough concentrations, tolerability, and clinical response. Once a patient is adequately controlled and appears stable the dose of Neoral® should be lowered, and the patient treated with the lowest dose that maintains an adequate response (this should not necessarily be total clearing of the patient). Long term experience with Neoral® in psoriasis patients is limited and continuous treatment for extended periods greater than one year is not recommended. Restasis(TM) is available only as single-use vials; vials should be discarded after application. If no response is achieved at the maximum tolerated cycloSPORINE dose after 3 months, discontinuation of cycloSPORINE therapy should be considered. Reversibility of arteriolopathy has been reported after stopping cyclosporine or lowering the dosage. The changes in most cases have been reversible upon discontinuation of cyclosporine, and in some cases improvement was noted after reduction of dose.
Patients should be treated with Neoral® only after complete resolution of suspicious lesions, and only if there are no other treatment options. Neoral® should be discontinued if reversibility (within 25% of baseline) of serum creatinine is not achievable after two dosage modifications. Neoral® should be discontinued if a change in hypertension management is not effective or tolerable.
Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations.
While several assays and assay matrices are available, there is a consensus that parent-compound-specific assays correlate best with clinical events. In clinical trials, cyclosporine doses at the lower end of the recommended dosage range were effective in maintaining a satisfactory response in 60% of the patients. Alternation with other forms of treatment should be considered in the long term management of patients with this life long disease. It appears that patients receiving liver transplant are more susceptible to encephalopathy than those receiving kidney transplant.
Creatinine levels returned to normal range in 7 of 11 patients in whom cyclosporine therapy was discontinued.
Seven patients had either a history of previous skin cancer or a potentially predisposing lesion was present prior to cyclosporine exposure. While calcium antagonists can be effective agents in treating cyclosporine-associated hypertension, they can interfere with cyclosporine metabolism. It is advisable to monitor serum creatinine after an increase of the dose of nonsteroidal anti-inflammatory drug and after initiation of new nonsteroidal anti-inflammatory therapy during Neoral® treatment.
Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed. The Neoral® dose is subsequently adjusted to achieve a pre-defined cyclosporine blood concentration. Of these, HPLC is the standard reference, but the monoclonal antibody RIAs and the monoclonal antibody FPIA offer sensitivity, reproducibility, and convenience. Another rare manifestation of cyclosporine-induced neurotoxicity, occurring in transplant patients more frequently than in other indications, is optic disc edema including papilloedema, with possible visual impairment, secondary to benign intracranial hypertension. Of the 16 patients with skin cancer, 11 patients had 18 squamous cell carcinomas and 7 patients had 10 basal cell carcinomas. Applied Pharmacokinetics, Principles of Therapeutic Drug Monitoring (1992) contains a broad discussion of cyclosporine pharmacokinetics and drug monitoring techniques. Blood concentration monitoring is not a replacement for renal function monitoring or tissue biopsies.



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