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Lucile Packard Children’s Hospital Clinical Protocol: Revised January 16, 2007 Post-Transplant Primary Immunosuppression Protocol 1) Induction Agents
a) Patients with low sensitization risk (peak PRA < 20%, first transplant). i) These patients will receive Zenapax [dacluzimab], administered as follows: (1) Steroid-Based: Zenapax® dose of 1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8. Patients receive a total of 5 doses until 2 months post-transplantation. (2) Steroid-Free: Zenapax® dose of 2 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11, 15, 19, and 23. Patients receive a total of 9 doses until 6 months post-transplantation. (3) If a transfusion >/= 15 mL/kg of packed red blood cells is required within the first 5 days post-transplant, give an additional 1 mg/kg dose of Zenapax. b) Patients with high sensitization risk (peak PRA > 20%, history of multiple blood transfusions, repeat transplant, history of pregnancy, selected deceased donor recipients requiring tacrolimus minimization). i) These patients will receive thymoglobulin, administered as follows. (1) Similar usage in Steroid-Free and Steroid-Based – minimum 3 days of (2) Pre-transplant dose 1.5mg/kg x1, post-transplant dose 1.5mg/kg q day for 3-7 (3) Titrate dose to target CD3 counts of 0 during treatment. 2) Prograf® (tacrolimus)
Oral Prograf® will be administered pre-operatively to recipients > 5 years of age at a starting
dose of 0.1 mg/kg/dose BID for living donor recipients and 0.1 mg/kg/dose QD for cadaveric
donor recipients. Recipients < 5 years of age will be dosed with 0.15 mg/kg/dose BID for living
donor recipients and 0.15 mg/kg/dose QD for cadaveric donor recipients. Post operatively, the
oral dose will be 0.07 mg/kg/dose BID adjusted subsequently to achieve target levels. Patients
should be NPO 1 hour before and after Prograf dosing.
Target trough tacrolimus levels:
Day 0 to Week 2 post transplant (day 0 to14 days) Day 15 to week 8 post transplant (days 15 to 56) After 12 weeks ( ≥85 days post transplant) If levels are persistently towards the lower end of the target range, consider 20% dose increase. If level is below target range, consider 1-time 50% dose increase and maintenance 20% dose increase and check levels (round up to the nearest 0.5mg increment if on pills). Lucile Packard Children’s Hospital Clinical Protocol: Revised January 16, 2007 If evidence of substantive tacrolimus toxicity is found on 12, or 24-month protocol biopsy (>20% tubular atrophy and interstitial fibrosis, medial hyalinosis, widespread isometric vacuolization, high Stanford DT score) consider reduction of tacrolimus target to 4-6ng/mL. 3) CellCept® (MMF)
CellCept® is administered intravenously at 1200 mg/m2/day in 2 divided doses. It should be
administered pre-operatively and continued IV for the first 48 hours. Following this, MMF at a
dose of 900 mg/m2/day in 2 divided doses should be administered until week 2, orally when
tolerated. The dose may be reduced to 600 mg/m2/day in 2 divided doses if full dose is not
tolerated. This dose may be reduced to 400 mg/m2/day transiently in 2 divided doses if full dose
is not tolerated, [diarrhea, persistent leucopenia despite GCSF treatment]. Oral MMF may be
taken with food to minimize GI toxicity. In patients who can take tablets, consider Myfortic
(180mg Myfortic = 250mg CellCept) if there is persistent GI toxicity.
Trough MPA levels between 2 to 4 mcg/mL in children >10 years old suggest drug efficacy. If
levels higher than 4mcg/mL are found, dose reduction may be considered. Children <10 years
old frequently have lower levels, and dosing in these patients should be based only on BSA.
4) Azathioprine (Imuran)
Persistent gastrointestinal symptoms in infant recipients immediately post-transplant may require temporary switch from CellCept to Imuran. Imuran is loaded at 3mg/kg x1 and then maintained at 2mg/kg q day. CellCept should be re-challenged in these patients at 3 months post-transplant. It is recommended to transition over 1-2 weeks from Imuran back to CellCept with 25% dose changes for both medications. Incremental changes to take place over 2-3 days each. 5) Rapamune® (sirolimus)
Sirolimus may be administered as an alternative to MMF, if subject re-challenge with MMF fails
due to MMF intolerance (usually due to bone marrow suppression or gastrointestinal side
effects), by the 6th post-transplant month. At this time, azathioprine will be replaced by
sirolimus. Sirolimus dosing will be stratified by subject’s age.
Loading dose: (give on first day of Sirolimus Rx, and then give maintenance dose)
Pt Weight (kg)
dose (mg, given po, once daily)
Maintenance dose (start on day #2 of Sirolimus Rx) Pt Weight (kg)
dose (mg, given po, once daily)
Lucile Packard Children’s Hospital Clinical Protocol: Revised January 16, 2007 a) Sirolimus Levels
After the first 5-7 days of sirolimus treatment, obtain blood level (24 hour trough level) and
adjust dose to achieve trough levels of 5-8 ng/dL for the first year post transplant. At 1 year
post transplant and thereafter, target sirolimus trough levels should be lowered to 3-5 ng/dL.
If patients are on sirolimus and tacrolimus, run tacrolimus targets towards the lower end of the target range to minimize tacrolimus nephrotoxicity. 6) Steroids
Prednisone 10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40 kg and
1.5 mg/kg/day in subjects weighing >40 kg.
The steroid dosing will be tapered as follows:
0.5 mg/kg/day 0.4mg/kg/day 0.3 mg/kg/day 0.2 mg/kg/day 0.15mg/kg/day 0.1 mg/kg/day a) Steroid Dosing
Consider maintaining all children >10 years old on no more than 5mg/day of Prednisone.
Steroid-Free patients will receive single doses of 10mg/kg intraoperatively.



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