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SANDOZ CYCLOSPORINE is a brand name for Cyclosporine (also known as Ciclosporin), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Solid Organ Transplantation Sandoz Cyclosporine (cyclosporine) is indicated in the prevention of graft rejection following solid organ transplantation and in the treatment of transplant rejection in patients previously receiving other immunosuppressive agents. Bone Marrow Transplantation Sandoz Cyclosporine is…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The dose ranges of Sandoz Cyclosporine 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).
Smaller doses may require capsule strengths or dosage forms not available from Sandoz. 2 Recommended Dose and Dosage Adjustment Page 7 of 74 Sandoz Cyclosporine (cyclosporine capsules) Solid organ transplantation Treatment with Sandoz Cyclosporine 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 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, STRENGHTS, COMPOSITION AND PACKAGING section of the product monograph. • Sandoz Cyclosporine 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. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandoz 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 Sandoz Cyclosporine dosage, target trough levels of cyclosporine and, frequency of determination of these levels.
The attending physician should consult with the transplant centre when making Page 6 of 74 Sandoz Cyclosporine (cyclosporine capsules) 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.
2 Breast-Feeding 09/2023 TABLE OF CONTENT Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABELS CHANGES ..........................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics................................................................................................................... 2 Geriatrics ...................................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ........................................................................................................
11 5 OVERDOSAGE........................................................................................................... 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 12 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women ................................................................................................
• Patients who are hypersensitive to cyclosporine or any of its excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING section of the product monograph. • Sandoz Cyclosporine 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. Bone marrow transplantation The initial dose should be given on the day before transplantation.
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.
Higher doses of Sandoz Cyclosporine may be necessary in the presence of gastrointestinal disturbances which might decrease drug absorption. 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, Page 8 of 74 Sandoz Cyclosporine (cyclosporine capsules) followed by daily oral administration of the maintenance dose previously found to be satisfactory. Low doses of Sandoz Cyclosporine should be used to treat mild, chronic GVHD.
Non-transplantation When using Sandoz Cyclosporine 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 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 Sandoz Cyclosporine should be discontinued. 5 mg/kg/day given in two divided oral doses, 12 hours apart.
If there is no improvement after one month, the daily dose may be gradually increased. 0 mg/kg/day body weight per month and total daily dose, depending on monitoring of drug tolerance, should not exceed 5 mg/kg/day. 0 mg/kg/day, or in whom the effective dose is not compatible with the safety guidelines given below under Monitoring (see 7 WARNINGS AND PRECAUTIONS).
5- 1 mg/kg/day per month. Long-term Goals of Therapy Psoriasis generally recurs when Sandoz […]
Psoriasis/Rheumatoid Arthritis/Nephrotic Syndrome:
Careful monitoring of Sandoz Cyclosporine treated patients is mandatory. Sandoz Cyclosporine should only be prescribed for psoriasis, rheumatoid arthritis or nephrotic syndrome by physicians experienced with its use. 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 Sandoz Cyclosporine.
1 Dosing Considerations The dose ranges of Sandoz Cyclosporine 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
2 Breast-feeding ..................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics ............................................................................................................. 5 Renal impairment ................................................................................................
6 Hepatic impairment ............................................................................................ 23 Page 3 of 74 Sandoz Cyclosporine (cyclosporine capsules) 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................. 5 Post-Market Adverse Reactions..............................................................................
29 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview ....................................................................................
4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 37 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .......................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
41 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 44 PART II: SCIENTIFIC INFORMATION ......................................................................................
45 13 PHARMACEUTICAL INFORMATION ........................................................................... 45 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication .................................................................................. 46 Transplantation indications ..............................................................................................
46 Non-transplantation indications ....................................................................................... 3 Comparative Bioavailability Studies .................................................................... 55 15 MICROBIOLOGY .......................................................................................................
56 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 57 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 62 PATIENT MEDICATION INFORMATION .................................................................................
63 Page 4 of 74 Sandoz Cyclosporine (cyclosporine capsules) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Solid Organ Transplantation Sandoz Cyclosporine (cyclosporine) is indicated in the prevention of […]