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Anemia Management in Abdominal Transplant Recipients - Adult - Ambulatory [32]

Anemia Management in Abdominal Transplant Recipients - Adult - Ambulatory [32] - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Delegation/Practice Protocols, Ambulatory Delegation Protocols





Delegation Protocol Number: 32

Delegation Protocol Title:
Anemia Management in Abdominal Transplant Recipients – Adult – Ambulatory

Delegation Protocol Applies To:
University Hospital Transplant Clinic

Target Patient Population:
Adult patients treated or examined in the University Hospital Transplant Clinic who have received a solid organ
transplant, are not on dialysis and have been diagnosed with Chronic Kidney Disease (CKD) Stage III to V in
whom the purpose of using erythropoietin stimulating agents (ESAs) is to avoid the need for red blood cell
transfusion.

Delegation Protocol Champions:
Arjang Djamali, MD – Department of Medicine, Nephrology
David Foley, MD – Department of Surgery, Transplant

Delegation Protocol Reviewers:
Jillian Fose, PharmD – Pharmacy
Kimberly Holdener, PharmD - Pharmacy

Responsible Department:
Drug Policy Program
Department of Pharmacy

Purpose Statement:
To delegate authority from the patient’s Transplant Provider to the Pharmacists (RPhs) practicing in the
Transplant Clinic to manage the patient’s anemia therapy including initiation, patient assessment, dose
adjustment and monitoring.

Who May Carry Out This Delegation Protocol:
Pharmacists in the University Hospital Transplant Clinic who have completed training in the use of this
delegation protocol and demonstrated competence with an annual renewal.

Guidelines for Implementation:
1. This delegation protocol is initiated by a provider order for anemia management per pharmacist.
2. Initial patient assessment
2.1. The patient will qualify for ESA therapy if the following criteria are met for each patient group:
2.1.1.Kidney transplant recipients with delayed graft function less than 3 months posttransplant:
• Hemoglobin (Hgb) less than 9.5 g/dL or hematocrit (Hct) less than 28.5% and
• The use of transfusion is contraindicated and should be avoided.
2.1.2.Solid organ transplant recipients more than 3 months post-transplant:
• Hemoglobin (Hgb) less than 9.5 g/dL or hematocrit (Hct) less than 28.5% for at least 2
months and
• GFR less than 60 mL/min/1.73 m2 per the Modification of Diet in Renal Disease (MDRD)
Study equation.
2.2. A Transplant Clinic pharmacist will evaluate the patient and determine appropriate starting doses for
the ESA and iron supplementation based on the dosing guidelines below.
3. Clinic administration of ESAs by a transplant pharmacist is the preferred method of anemia management; however,
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org



home management may be considered for patients who qualify.
3.1. The patient will qualify for clinic management of anemia if the following criteria are met
3.1.1. The patient can attend Transplant Clinic at the frequency specified in 6.2
3.1.2. The patient’s insurance reimburses clinic administration of ESA therapy
3.1.3. The patient or caregiver cannot safely self-administer ESA therapy
3.2. The patient will qualify for home management of anemia if any of the following criteria are met:
3.2.1. Patient cannot attend Transplant Clinic at the frequency specified in 6.2.
3.2.2. The patient’s insurance does not reimburse clinic administration of ESA therapy
3.2.3. The patient is deemed competent to self-administer ESA therapy by a Transplant Clinic pharmacist
3.3. Patients enrolled in home management of anemia will be required to attend the initial visit with a pharmacist in
Transplant Clinic
3.4. Subsequent telephone assessments for patients enrolled in home management will be arranged with the patient
and Transplant Clinic pharmacist
4. Laboratory monitoring and goals
4.1. Hgb or Hct - Must be obtained prior to initiating ESA therapy unless results are available during
the previous 30 days.
4.1.1. target Hgb value = 9.5 – 11 g/dL
4.1.2. target Hct value = 28.5 – 33%
4.1.3. Must be checked at least monthly
4.2. Iron, total iron-binding capacity (TIBC), percent saturation (TSAT) and ferritin – Must be obtained
when initiating ESA therapy unless results are available during the previous 2 months
4.2.1. target ferritin value > 100 ng/mL
4.2.2. target TSAT value > 20%
4.2.3. All patients receiving iron supplementation will have iron studies checked at least every 3
months.
4.2.4. All patients receiving ESAs and not receiving iron supplementation will have iron studies checked
every month.
4.3. Serum creatinine – obtain prior to initiating ESA therapy unless result available during the
previous 30 days.
5. Blood pressure monitoring
5.1. Blood pressure will be checked at every clinic visit or prior to telephone assessment.
5.2. If a patient has a systolic blood pressure reading >180 mmHg, the darbepoetin dose will be held and the
provider contacted.
5.3. If a patient has a SBP <180 mmHg but >160 mmHg at 3 consecutive visits, the provider will be
contacted.
6. Initiating and maintaining iron therapy
6.1. Patients who do not qualify for darbepoetin therapy, but who do qualify for iron replacement based on
the criteria below will only have iron supplementation ordered.
6.2. Patients with ferritin < 100 ng/mL or TSAT < 20% will receive one of the following therapies:
6.2.1. Intravenous supplementation with up to two doses of iron sucrose 500mg in 250mL of 0.9%
sodium chloride infused intravenously over 3 hours will be recommended as a first-line option.
• IV iron may be given on consecutive days if desired. (Maximum of 500mg of iron
sucrose per day.)
• Patients who qualify for IV iron will be screened for active infection. IV iron will not be
administered to patients who have a significant active infection, e.g. bacteremia, any
infection requiring IV antibiotics, draining wounds, pneumonia, and cellulitis, even if on
oral antibiotics. IV iron may be given in the presence of minor infection, e.g. urinary
tract infections requiring short term (7-10 days) oral antibiotics. If any question exists
regarding use of IV iron therapy in the presence of minor infection the provider will be
contacted.
• Patients who are unable to receive IV iron supplementation, due to patient refusing or
inability to come to clinic, will receive ferrous sulfate 325 mg or similar oral iron
product by mouth one to three times daily.
6.3. Patients with ferritin > 800 ng/mL or TSAT > 40% will not receive iron supplementation.
6.4. All patient’s who are initiated on ESAs will receive ferrous sulfate 325 mg by mouth one to two
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org



times daily unless ferritin > 100 ng/mL and TSAT > 20% and expected duration of therapy with ESAs
is less than 4 months.
7. Initiation and maintenance of ESAs
7.1. Patients will be given a medication guide at initiation of ESA’s and at regular intervals as dictated by
both the UW Health guidelines and the Federal Drug Administration’s guidelines under the Risk
Evaluation and Mitigation Strategies (REMS) program.
7.2. Darbepoetin alfa
7.2.1. Darbepoetin is the preferred ESA for anemia therapy at UW Health.
7.2.2. General dosing guidelines
• Dose increases will not occur more than once a month.
• Syringes are available in the following dosages: 25 mcg, 40 mcg, 60 mcg, 100 mcg, 150
mcg, 200 mcg, 300 mcg, 500 mcg. Doses given to patients should use the entire syringe (no
partial wasting of a syringe should occur).
• The current dose will be continued if the Hgb is stable within the target range.
• The maximum dose that may be administered is 300 mcg every week or 500 mcg every 2
weeks.
• Other dosing regimens may be considered based on clinical assessment and the patient’s
response to therapy or per provider request.
7.2.3. Initial dosing
• The starting dose for patients weighing between 50 and 100 kg is 60 mcg subcutaneous
every week (or 100 mcg every 2 weeks).
• The starting dose for patients weighing greater than 100 kg is 100 mcg every week (or 200
mcg every 2 weeks).
• The starting dose for patients weighing less than 50 kg is 40 mcg every week (or 60 mcg
every 2 weeks).
7.2.4. Dose increases
• Dose increases are made by changing the dose to the next available higher syringe
strength.
• Alternatively a dose increase can be made by shortening the period between doses (e.g.
from every 2 weeks to every week). A frequency rather than syringe strength change may
be made based on patient convenience and current dose, e.g. the patient is already
receiving a 500 mcg dose.
• A dosage increase will be made if the Hgb/Hct is below the goal range and the increase in
Hgb is less than 1 g/dL (Hct less than 3%) in a 4 week period.
7.2.5. Dose decreases
• Dose decreases are made by changing the dose to the next lower syringe strength.
• Alternatively a dose decrease can be made by lengthening the period between doses. A
frequency rather than syringe strength change may be made based on patient
convenience and current dose, e.g. the patient is already receiving a 25 mcg dose.
• A dosage decrease will be made if the Hgb increase is greater than 1.5 g/dL in a 4 week
period.
7.2.6. Holding the dose of ESA
• The darbepoetin dose will be held if the Hgb is greater than 11 g/dL or Hct greater than or
equal to 33%.
• A follow up Hgb/Hct level will be checked in 2 to 4 weeks based on patient convenience and
Hgb trend.
• When the Hgb is less than 11 g/dL (Hct below 33%) the ESA will be resumed at the next
dosage lower than what was being given at the time the medication was held.
7.3. Epoetin alfa
7.3.1. Epoetin may be used in the following patients:
• Those who do not tolerate darbepoetin.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org



• Those who were previously receiving epoetin and prefer to continue anemia therapy with
their current ESA.
7.3.2. General dosing guidelines
• Doses may be given with a frequency of weekly to every 2 weeks.
• The current dose will be continued if the Hgb is stable within the target range.
• The starting dose is 10,000 units subcutaneous weekly.
7.3.3. Dose increases
• If the Hgb/Hct is below the goal range and the increase in Hgb is less than 1 g/dL (Hct less
than 3%) in a 4 week period increase the dose by 25%.
7.3.4. Dose decreases
• If the Hgb increase is greater than 1.5 g/dL (Hct increase greater than 6%) in a 4 week
period decrease the dose by 25%.
7.3.5. Holding the dose of ESA
• The epoetin dose will be held if the Hgb is greater than or equal to 11 g/dL (Hct greater
than 33%).
• A follow up Hgb level will be checked in 2 to 4 weeks based on patient convenience and
Hgb trend.
• When the Hgb is less than 11 g/dL (Hct below 33%) the ESA may be resumed at a dosage
25% lower than what was being given at the time the medication was held.
8. Discontinuing anemia therapy
8.1. If the Hgb remains above 10 g/dL (or hematocrit above 30%) for 12 weeks without an ESA dose
the medication will be discontinued.
8.2. Iron supplementation will be discontinued when any of the following occur:
8.2.1.Ferritin > 800 ng/mL
8.2.2. TSAT > 40%
8.1.3. Discontinuation of the ESA and iron studies are at goal (TSAT > 20% and ferritin > 100 ng/mL)
• If iron studies are not at goal when ESA therapy is discontinued, iron supplementation
will continue until iron studies are at goal levels.
9. Documentation
9.1. General documentation guidelines
9.1.3. Lab results from outside the UW Health system will be entered into the patient’s electronic
medical record as dictated by current Transplant Clinic practice (e.g. using the enter/edit results
function in HealthLink®).
9.1.4. If IV iron is ordered this must be documented in a note stating that the indication is anemia of
Chronic Kidney Disease (CKD) Stage III, IV or V with iron deficiency. The note should also state
whether or not the patient is receiving ESA therapy.
9.2. Upon initiation of the protocol the pharmacist will write a progress note in the electronic medical
record and include the following:
9.2.3. Indication for anemia therapy.
• For patients more than 3 months post-transplant this would be anemia due to CKD Stage III,
IV, or V.
• For deceased donor kidney recipients less than 3 months post-transplant this would be
anemia post-transplant with anemia due to CKD.
9.2.4. Initial Hgb or Hct.
9.2.5. Ferritin and TSAT results.
9.2.6. Whether or not iron supplementation is indicated and at what dose it was
initiated.
9.2.7. Whether or not ESA therapy is indicated and the initial ESA dose ordered.
9.3. The pharmacist will write a follow-up progress note in the electronic medical record anytime an ESA
or iron supplementation dosage adjustment is made and include the following:
9.3.3. Indication for anemia therapy.
• For patients more than 3 months post-transplant this would be anemia due to CKD Stage III,
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org



IV, or V.
• For deceased donor kidney recipients less than 3 months post-transplant this would
be anemia post-transplant due to CKD.
9.3.4. Most recent Hgb or Hct.
9.3.5. Most recent Ferritin and TSAT results.
9.3.6. Dose of ESA and if the dose is an increase or decrease from the previous dose.

Order Mode: Protocol/Policy, Without Cosign

References:
1. National Kidney Foundation. K/DOQI Clinical Practice Guidelines and Clinical Practice Recommendations for
Anemia of Chronic Kidney Disease in Adults. Am J Kidney Dis 2006; 47(suppl 3):S11-S145
2. National Kidney Foundation. K/DOQI Clinical Practice Recommendations for Anemia in Chronic Kidney
Disease in Transplant Recipients. Am J Kidney Dis 2006; 47(suppl 3): S110-S116
3. Djamali A, Becker YT, Simmons WD, Johnson CA, Premasathian N, Becker BN: Increasing hematocrit
reduces early posttransplant cardiovascular risk in diabetic transplant recipients. Transplantation
2003; 76:816-820
4. Khan S, Tighiouart H, Kalra A, Raman G, Rohrer RJ, Pereira BJ: Resource utilization among kidney
transplant recipients. Kidney Int 2003; 64:657-664
5. Singh AK, Szczech L, Tant L, et al. Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease. N Engl J
Med 2006; 335:2085-2098
6. Drueke TB, Locatelli F, Clyne N, et al. Normalization of Hemoglobin Level in Patients with Chronic Kidney
Disease and Anemia. N Engl J Med 2006; 355: 2071-2084
7. Monar MZ, Czira M, Ambrus C, et al. Anemia is Associated with Mortality and Kidney- Transplant Patients – A
Prospective Cohort Study. Am J Transpl 2007; 7:818-824
8. Winkelmayer WC, Chandraker A, Brookhart MA, et al. A Prospective Study of Anaemia and Long-term
Outcomes in Kidney Transplant Recipients. Nephrol Dial Transplant 2006; 21:3559-3566
9. Chandler F, Harchowal J, Macdougall IC. Intravenous Iron Sucrose: Establishing a Safe Dose. Am J Kidney
Dis 2001; 38(5): 988-991
10. Blaustein DA, Schwenk MH, Chattopadhyay J, et al. The Safety and Efficacy of an accelerated iron sucrose
dosing regimen in patients with chronic kidney disease. Kidney Int 2003; 64(suppl 87): S72-77
11. Blaustein DA, Schwenk MH, Chattopadhyay J, et al. Recent experience with high-dose intravenous iron
administration. Kidney Int 2006; 70:S26-29
12. Vikrant S. Optimum dosage regimen for iron sucrose. Kidney Int. 2007; 72:225

Collateral Documents/Tools:
Kidney Clinic – Anemia Managegment in Pre-dialysis Chronic Kidney Disease Patients – Adult – Ambulatory
[20] UW Health Delegation Protocol

Approved By:
UW Health Ambulatory Protocol Committee: November 2013; December 2015; *August 2017
UWHC Pharmacy & Therapeutics Committee: November 2013; January 2016; *August 2017
UWHC Medical Board: December 2013; January 2016; *August 2017
UW Health Chief Medical Officer: January 2014; January 2016; *August 2017

Effective: August 2017

Scheduled for Review: August 2020
* Expedited Review Process
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
11/2017CCKM@uwhealth.org