Overview
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- Prophylaxis of organ rejection in renal transplant
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- Hypersensitivity to sirolimus or any of the excipients
- Oral solution contains soya oil, patients allergic to peanut or soya should not take this medicine
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- Infection and malignancies (esp lymphoma, skin and cervical cancer)
- Bone marrow suppression, hypertension, hyperlipidaemia, delayed wound healing, lymphocoele, hypokalaemia, delayed recovery of renal function in delayed graft function
- Rarely HUS/TTP and interstitial lung disease
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- As in normal renal function. Not dialysed
- Sirolimus#2 mg#see prescribing section#PO#8
Sirolimus
- Prophylaxis of organ rejection in renal transplant
- Immunsuppressive agent. An inhibitor of mammalian target of rapamycin (mTOR inhibitor)
- Rapamune®: 0.5 mg, 1 mg and 2mg tablets; and 1 mg/ml oral solution
- 0.5 mg tablets are not fully bioequivalent to higher strengths, so 2 x 0.5 mg is not equivalent to 1 x 1 mg
- Hypersensitivity to sirolimus or any of the excipients
- Oral solution contains soya oil, patients allergic to peanut or soya should not take this medicine
- Monitor trough levels: initially 4-12 ng/ml if taken in combination with ciclosporin and 8-20 ng/ml if taken without ciclosporin
- Take blood levels no more frequently than every 5 days
- Hepatic impairment: in severe hepatic impairment, maintenance dose of sirolimus must be reduced by approximately one half and trough levels monitored
- In black-african patients a higher dose and trough levels may be required to acheive the same efficacy as in non-black patients
- Infection and malignancies (esp lymphoma, skin and cervical cancer)
- Bone marrow suppression, hypertension, hyperlipidaemia, delayed wound healing, lymphocoele, hypokalaemia, delayed recovery of renal function in delayed graft function
- Rarely HUS/TTP and interstitial lung disease
- 6 mg loading dose followed by 2 mg daily titrated according to trough blood levels (4-12ng/ml)
- If used without ciclosporin, a loading dose of 10-15 mg will be required followed by a daily dose of 3-6 mg titrated according to trough levels (8-20ng/ml)
- 0.5 mg tablets are not fully bioequivalent to higher strengths, so 2 x 0.5 mg is not equivalent to 1 x 1 mg
- If changing from tablet to liquid, give the same dose and check levels after 7 days
- Afro-Caribbean patients make require higher doses
- As in normal renal function. Not dialysed
- Levels ↑ by erythromycin, ketoconazole, clarithromycin, diltiazem, grapefruit juice, verapamil
- Levels ↓ by rifampicin
- Ciclosporin increases absorbtion of sirolimus – give sirolimus 4 hours after ciclosporin, St Johns Wort. Concomitant administration of mycophonolate results in increased levels of both sirolimus and mycophenolate
Sirolimus#2 mg#see prescribing section#PO#8
- There is an increased risk of infection and certain cancers (including skin and cervical). Avoid sunbathing, use high factor sun cream and women should attend for yearly cervical smears
- Avoid live vaccines – ask your pharmacist
- Food may affect absorption. So take at the same time in relation to food. Avoid grapefruit juice
- Women of childbearing age must use contraception during sirolimus therapy and for 12 weeks after stopping. Avoid if breastfeeding
- To minimise variability sirolimus should be taken at the same time in relation to ciclosporin, four hours after the ciclosporin dose, and consistently either with or without food
The information provided in this pdf is only a guideline. It should not be used as a basis for the diagnosis or treatment of any medical condition. Your patient may be different