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SANDIMMUNE I.V. is a brand name for Cyclosporine (also known as Ciclosporin), supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Solid Organ Transplantation NEORAL capsules and oral solution and SANDIMMUNE I.V. (cyclosporine) are indicated in the prevention of graft rejection following solid organ transplantation and in the treatment of transplant rejection in patients previously receiving other immunosuppre ssive agents. Bone Marrow…
Verbatim from this product's HC label. Tap a section to expand.
V. given below are intended to serve as guideline only. Routine monitoring of cyclosporine blood levels is required; this can be carried out by means of an RIA method based on monoclonal antibodies. Routine monitoring of cyclosporine blood levels is also required when switching a patient from one oral cyclosporine formulation to another.
The results obtained will serve as a guide for determining the actual dosage required to achieve the desired target concentration in individual patients. Because of considerable inter- and intra-individual variations in absorption and elimination and the possibility of pharmacokinetic drug interactions (see 9 DRUG INTERACTIONS), doses should be titrated individually according to clinical response and tolerability.
In transplant patients, routine monitoring of cyclosporine trough blood levels is required to avoid adverse effects due to high levels and to prevent organ rejection due to low levels (see 7 WARNINGS AND PRECAUTIONS). In patients treated for non-transplant indications, monitoring of cyclosporine blood levels is of limited value except in the case of unexpected treatment failure or relapse, where it may be appropriate to establish the possibility of very low levels caused by non-compliance, impaired gastrointestinal absorption, or pharmacokinetic interactions (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment Solid organ transplantation Treatment with NEORAL may be initiated within 12 hours prior to surgery at a dose of 10 to 15 mg/kg given in two divided doses, 12 hours apart. This dose should be maintained as the daily dose for one to two weeks post-operatively before being gradually reduced in accordance with blood levels until a maintenance dose of about 2 to 6 mg/kg given in two divided doses is reached.
The following table outlines the recommended steady state therapeutic ranges of NEORAL® (Cyclosporine) capsules, oral solution for microemulsion SANDIMMUNE® (Cyclosporine) concentrate for solution for infusion Page 7 of 73 cyclosporine 12 hour trough levels (the level immediately before the next dose).
Table 1 Target Trough Levels RIA METHOD Blood ng/mL Plasma/serum ng/mL Monoclonal specific1 Polyclonal non-specific2 100-400 150-1500 50-200 50-300 1Values are based on HPLC data and the results of a multi -centre comparison of the monoclonal specific RIA with the polyclonal RIA kit.
). 4 Geriatrics). 2 CONTRAINDICATIONS • Patients who are hypersensitive to cyclosporine or any of its excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • NEORAL is also contraindicated in the treatment of psoriasis and rheumatoid arthritis patients under the following circumstances: abnormal renal function; uncontrolled hypertension; malignancy (except non-melanoma skin cancer); uncontrolled infection; primary or secondary immunodeficiency excluding autoimmune disease.
• Co-administration of cyclosporine together with bosentan is contraindicated. V. (cyclosporine). Patients receiving the drug should be managed in centres staffed with professionals experienced in transplantation and the use of immunosuppressants and equipped with adequate laboratory facilities to monitor cyclosporine levels.
The ability to measure cyclosporine blood levels facilitates the management of the patient. The radioimmunoassay (RIA) method has been used most often in clinical trials. For long-term follow-up, the attending physician should receive complete information from the transplant centre on the patient, to include recommended NEORAL dosage, target trough levels of cyclosporine and, frequency of determination of these levels.
The attending physician should consult with the transplant centre when making dose adjustments to ensure that toxicity is minimized while maintaining adequate immunosuppression. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
NEORAL® (Cyclosporine) capsules, oral solution for microemulsion SANDIMMUNE® (Cyclosporine) concentrate for solution for infusion Page 6 of 73 Psoriasis/Rheumatoid Arthritis/Nephrotic Syndrome: Careful monitoring of NEORAL treated patients is mandatory.
NEORAL should only be prescribed for psoriasis, rheumatoid arthritis or nephrotic syndrome by physicians experienced with its use. V. given below are intended to serve as guideline only. Routine monitoring of cyclosporine blood levels is required; this can be carried out by means of an RIA method based on monoclonal antibodies.
2 Breast Feeding 02/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 4 Administration...................................................................................................
11 5 OVERDOSAGE ............................................................................................................. 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 13 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ............................................................................................ 25 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 5 Post-Market Adverse Reactions..........................................................................
31 9 DRUG INTERACTIONS.................................................................................................. 2 Drug Interactions Overview................................................................................ 4 Drug-Drug Interactions ......................................................................................
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 39 10 CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics .........................................................................................
• Patients who are hypersensitive to cyclosporine or any of its excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph. • NEORAL is also contraindicated in the treatment of psoriasis and rheumatoid arthritis patients under the following circumstances: abnormal renal function; uncontrolled hypertension; malignancy (except non-melanoma skin cancer); uncontrolled infection; primary or secondary immunodeficiency excluding autoimmune disease.
• Co-administration of cyclosporine together with bosentan is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Plasma serum values are based on separation at 37oC. These values will be lower if plasma/serum is separated at room temperature. 2Whole blood values are based on a multiplication factor of 3 -5x concentration obtained using plasma/serum values.
Plasma/serum values are based on separation at 22oC. g. g. 3 to 6 mg/kg given in two divided doses 12 hours apart for the initial treatment) may be used. V. at one-third the oral dose. V. is 3 to 5 mg/kg/day. This daily dose is continued post- operatively for up to 2 weeks until the patient can tolerate the NEORAL soft gelatin capsules or oral solution.
Patients should be switched to NEORAL as soon as possible after surgery. In pediatric usage, the adult dose and dosing regimen have been used initially and adjusted to target blood levels (see 7 WARNINGS AND PRECAUTIONS). Bone marrow transplantation The initial dose should be given on the day before transplantation.
) infusion of SANDIMMUNE is preferred for this purpose (please refer to previous Section). 5 mg/kg given in two divided doses, 12 hours apart, and should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by one year after transplantation.
5 to 15 mg/kg given in two divided doses, starting on the day before transplantation. v. therapy, may be necessary in the presence of gastrointestinal disturbances which might decrease drug absorption. NEORAL® (Cyclosporine) capsules, oral solution for microemulsion SANDIMMUNE® (Cyclosporine) concentrate for solution for infusion Page 8 of 73 In some patients, GVHD occurs after discontinuation of cyclosporine treatment, but usually responds favourably to re-introduction of therapy.
5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory. Low doses of NEORAL should be used to treat mild, chronic GVHD. Non-transplantation When using NEORAL in any of the established non-transplant indications, the following general rules should be adhered to: • Before initiation of treatment a reliable baseline level of serum creatinine should be established by at least two measurements, and renal function must be assessed regularly throughout therapy to allow dosage adjustment (see 7 WARNINGS AND PRECAUTIONS).
• The only accepted route of administration is by the mouth (the concentrate for intravenous infusion must not be used), and the daily dose should be given in two divided doses. • Except in children with nephrotic syndrome, the total daily dose must never exceed 5 mg/kg.
• For maintenance, the lowest effective and well tolerated dosage should be determined individually. • In patients in whom within a given time no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with NEORAL should be discontinued.
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Routine monitoring of cyclosporine blood levels is also required when switching a patient from one oral cyclosporine formulation to another. The results obtained will serve as a guide for determining the actual dosage required to achieve the desired target concentration in individual patients.
Because of considerable inter- and intra-individual variations in absorption and elimination and the possibility of pharmacokinetic drug interactions (see
43 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 45 PART II: SCIENTIFIC INFORMATION ........................................................................................
47 13 PHARMACEUTICAL INFORMATION.............................................................................. 47 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trials by Indication............................................................................ 53 15 MICROBIOLOGY ..........................................................................................................
57 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 57 PATIENT MEDICATION INFORMATION ...................................................................................
V. (cyclosporine) are indicated in the prevention of graft […]