SANDIMMUN CONCENTRATE FOR INFUSION 50 MG/ML [SIN00520P]

Product Info

SANDIMMUN CONCENTRATE FOR INFUSION 50 MG/ML

[SIN00520P]

INDICATIONS

Solid organ transplantation

Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations.

Treatment of transplant rejection in patients previously receiving other immunosuppressive agents.

Bone marrow transplantation

Prevention of graft rejection following bone marrow transplantation.

Prevention or treatment of graft-versus-host disease (GVHD).

DOSAGE REGIMEN AND ADMINISTRATION

Dosage Regimen

The dose ranges given are intended to serve as guidelines only. The recommended dose of Sandimmun concentrate for solution for infusion is approximately one third of the appropriate oral dose.

In transplant patients, routine monitoring of ciclosporin blood levels is required to avoid adverse effects due to high levels and to prevent organ rejection due to low levels (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The results obtained will serve, as a guide for determining the actual dosage required to achieve the desired target concentrations in individual patients.

Because of the risk of anaphylaxis, Sandimmun concentrate for solution for infusion should be reserved for patients who are unable to take the drug orally (e.g. shortly after surgery) or in whom the absorption of the oral form might be impaired during episodes of gastrointestinal disorders. In such cases, it is recommended to change to oral administration as soon as feasible.

General target population

Solid organ transplantation

Treatment with Sandimmun concentrate for solution for infusion should be initiated within 12 hours before surgery at a dose of 3 to 5 mg/kg. This dose should be maintained as the daily dose for 1 to 2 weeks post-operatively before being gradually reduced in accordance with blood levels until a maintenance dose of about 0.7 to 2 mg/kg is reached.

When Sandimmun concentrate for solution for infusion is given with other immunosuppressants (e.g. with corticosteroids or as part of a triple or quadruple drug therapy), lower doses (e.g. 1 to 2 mg/kg for the initial treatment) may be used.

The recommended dose of Sandimmun concentrate for solution for infusion is approximately one third of the appropriate oral dose. It is recommended that patients be put on oral therapy as soon as possible.

Bone marrow transplantation

The initial dose should be given on the day before transplantation. For the initiation of Sandimmun therapy the preferred route of administration is by intravenous infusion The recommended i.v. dose is 3 to 5 mg/kg per day. Infusion is continued at this dose level during the immediate post-transplant period of up to 2 weeks, before a change is made to oral maintenance therapy.

Maintenance treatment should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation. Continuation of ciclosporin treatment via i.v. therapy may be necessary in the presence of oral ciclosporin induced gastrointestinal disturbances which might decrease drug absorption.

In some patients, GVHD occurs after discontinuation of ciclosporin treatment, but usually responds favorably to re-introduction of therapy. Low doses of ciclosporin should be used to treat mild, chronic GVHD.

Special populations

Renal impairment

Ciclosporin undergoes minimal renal elimination, and its pharmacokinetics is not significantly affected by renal impairment (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, due to its nephrotoxic potential (see section ADVERSE DRUG REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), a careful monitoring of the renal function is recommended (see section WARNINGS AND PRECAUTIONS subsection all indications – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Ciclosporin is extensively metabolized by the liver. The terminal half-life varied between 6.3 hours in healthy volunteers to 20.4 hours in severe liver disease patients (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Dose reduction may be necessary in patients with severe liver impairment to maintain blood levels within the recommended target range (see section WARNINGS AND PRECAUTIONS and section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

Experience with ciclosporin in children is still limited. However, children from 1 year of age have received Sandimmun in standard dosage with no particular problems. In several studies, pediatric patients required and tolerated higher doses of ciclosporin per kg body weight than those used in adults.

Geriatrics (65 years of age or above)

Experience with ciclosporin in the elderly is limited, but no particular problems have been reported following the use of the drug at the recommended dose.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Method of administration

The types of container suitable for the infusion solution are mentioned in section INSTRUCTIONS FOR USE AND HANDLING – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The concentrate for solution for infusion should be diluted 1:20 to 1:100 with normal saline or 5% glucose, and given as a slow i.v. infusion over approximately 2 to 6 hours.

Once an ampoule is opened, the content should be used immediately. Diluted infusion solutions must be discarded after 24 hours.

CONTRAINDICATIONS

Hypersensitivity to ciclosporin or to any of the excipients of Sandimmun concentrate for solution for infusion including polyoxyl castor oil (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).