# Criteria for Use Checklist

# Non-Calcium, Non-Aluminum Phosphate Binders 

# (Lanthanum Carbonate, Sevelamer Carbonate, Sevelamer Hydrochloride) 

# for the Management of Hyperphosphatemia in Chronic Kidney Disease

# VHA Pharmacy Benefits Management Services and Medical Advisory Panel

*The following recommendations are based on current medical evidence and
expert opinion from clinicians. The content of the document is dynamic
and will be revised as new clinical data becomes available. The purpose
of this document is to assist practitioners in clinical decision-making,
to standardize and improve the quality of patient care, and to promote
cost-effective drug prescribing. The clinician should utilize this
guidance and interpret it in the clinical context of the individual
patient. The manufacturer's labeling and the national drug monographs
([www.pbm.va.gov](http://www.pbm.va.gov/) and
[http://vaww.pbm.va.gov](http://vaww.pbm.va.gov/)) should be consulted
for detailed information when prescribing lanthanum carbonate, sevelamer
carbonate, or sevelamer hydrochloride. Currently sevelamer hydrochloride
is listed on the VA National Formulary; lanthanum carbonate and
sevelamer carbonate may be obtained via the nonformulary process.*

+-----------------------------------------------------------------------+
| ########                                                              |
| INCLUSION CRITERIA FOR A NON-CALCIUM, NON-ALUMINUM PHOSHPHATE BINDER  |
|                                                                       |
| ######## (must fulfill the following to be eligible)                  |
+-----------------------------------------------------------------------+
| The non-calcium, non-aluminum phosphate binders (lanthanum carbonate, |
| sevelamer carbonate, sevelamer hydrochloride) are restricted to       |
| Nephrology Service^a^ and are to be used for the management of        |
| patients with chronic kidney disease (CKD) and hyperphosphatemia      |
| according to the criteria below:                                      |
|                                                                       |
| -   Diagnosis of Stage 5 CKD (defined as kidney failure with GFR \<   |
|     15 mL/min/1.73m^2^ or dialysis) and receiving kidney replacement  |
|     therapy (i.e., hemodialysis or peritoneal dialysis)               |
|                                                                       |
| OR                                                                    |
|                                                                       |
| -   Stage 3 to 5 CKD (refer to GFR range below) not receiving kidney  |
|     replacement therapy\*                                             |
|                                                                       |
|                                                                       |
|  ---------------------- ---------------------- ---------------------- |
|   Stage 3 CKD            Stage 4 CKD            Stage 5 CKD           |
|                                                                       |
|   30 to 59               15 to 29               \< 15 mL/min/1.73m^2^ |
|   mL/min/1.73m^2^        mL/min/1.73m^2^                              |
|                                                                       |
|  ---------------------- ---------------------- ---------------------- |
|                                                                       |
| \*Note: due to the risk for developing metabolic acidosis with        |
| sevelamer hydrochloride, patients with a serum bicarbonate level \<   |
| 22 mEq/l not on kidney replacement therapy should preferentially      |
| receive lanthanum carbonate or sevelamer carbonate if a non-calcium   |
| containing phosphate binder is indicated                              |
|                                                                       |
| AND                                                                   |
|                                                                       |
| -   Documented hyperphosphatemia                                      |
|                                                                       |
| AND one or more of the following:                                     |
|                                                                       |
| -   Serum phosphorus \> 6.0 mg/dl^b^ despite dietary restriction of   |
|     phosphate to \< 1gm/d AND adherence to maximally tolerated dose   |
|     of calcium based phosphate binders**^c^**                         |
|                                                                       |
| -   Total serum calcium (corrected for serum albumin)**^d^**          |
|     [\>]{.underline} 10.2 mg/dl (or maximum per lab/facility) on      |
|     conventional treatment with calcium based phosphate binding       |
|     therapy**^c^** and despite discontinuation of vitamin D           |
|     preparations for at least 1 month                                 |
|                                                                       |
| -   Intact plasma parathyroid hormone (PTH) level \< 2 times the      |
|     upper limit of normal (ULN) for PTH assay (K/DOQI Guideline       |
|     recommendations \< 150 pg/ml based on assay with ULN 75 pg/ml)    |
|     with normal or elevated serum calcium (corrected for serum        |
|     albumin;**^d^** elevated [\>]{.underline} 10.2 mg/dl or maximum   |
|     per lab/facility) associated with adynamic bone disease           |
|                                                                       |
| -   Calcium x phosphorus product \> 55 mg^2^/dl^2^ despite dietary    |
|     restriction of phosphate to \< 1 gm/d AND calcium based phosphate |
|     binders**^c^**                                                    |
|                                                                       |
| ^a^ Restricted to Nephrology for the initial prescription; if deemed  |
| appropriate, local P&T Committees may approve selected providers to   |
| renew prescriptions                                                   |
|                                                                       |
| ^b^ Kalantar-Zadeh K, et al. Survival predictability of time-varying  |
| indicators of bone disease in maintenance hemodialysis patients.      |
| Kidney Int 2006;70:771-80. Block GA, et al. Mineral metabolism,       |
| mortality, and morbidity in maintenance hemodialysis. J Am Soc        |
| Nephrol 2004;15:2208-18. Ganesh SK, et al. Association of elevated    |
| serum PO~4~, Ca, Ca X PO~4~ product, and parathyroid hormone with     |
| cardiac mortality risk in chronic hemodialysis patients. J Am Soc     |
| Nephrol 2001;12:2131-8. Block GA, et al. Association of serum         |
| phosphorus and calcium x phosphorus product with mortality risk in    |
| chronic hemodialysis patients: a national study. Am J Kidney Dis      |
| 1998;31:607-17.                                                       |
|                                                                       |
| ^c^ An aluminum containing phosphate binder should NOT be used for    |
| long-term management of hyperphosphatemia due to potential toxicity.  |
| K/DOQI Guideline recommendations are to limit elemental calcium       |
| intake from phosphate binders to \< 1500 mg/d, with the total daily   |
| intake (including dietary calcium) of elemental calcium not to exceed |
| 2,000 mg. In addition, use of 2.5mEq/L calcium dialysate or lower, if |
| indicated should be part of therapy to reduce hypercalcemia.          |
|                                                                       |
| ######### ^d^ Calculation for                                         |
| corrected total serum calcium=total calcium + 0.8 (4 - serum albumin) |
|                                                                       |
| #####                                                                 |
| #### \[4 gm/dl (normal serum albumin) -- most recent serum albumin\]  |
|                                                                       |
| Ex. Calcium 9.9 mg/dl; albumin 3.2 gm/dl                              |
|                                                                       |
| \[4 -- 3.2\] = 0.8; 0.8 X 0.8 = 0.64                                  |
|                                                                       |
| 9.9 + 0.64 = 10.54 (10.5 mg/dl is the corrected serum calcium)        |
+-----------------------------------------------------------------------+
| ###                                                                   |
| ##### EXCLUSION CRITERIA (if ONE is checked, patient is not eligible) |
+-----------------------------------------------------------------------+
| Lanthanum carbonate                                                   |
|                                                                       |
| -   Hypophosphatemia                                                  |
|                                                                       |
| Sevelamer carbonate or sevelamer hydrochloride                        |
|                                                                       |
| -   Hypophosphatemia                                                  |
|                                                                       |
| -   Bowel obstruction                                                 |
+-----------------------------------------------------------------------+
| **DOSING RECOMMENDATIONS**                                            |
+-----------------------------------------------------------------------+
| -   Lanthanum carbonate: initial recommended dose is 250 mg to 500 mg |
|     three times daily; doses may be increased by 750 mg every 2 to 3  |
|     weeks until serum phosphorus goal is achieved. Usual maintenance  |
|     dose (to achieve phosphorus \< 6.0 mg/dl in clinical trials) is   |
|     500 mg to 1000 mg three times daily (maximum dose studied 3750 mg |
|     daily in divided doses); doses should be administered with meals. |
|     The manufacturer recommends that medications that interact with   |
|     antacids should not be administered within 2 hours of lanthanum   |
|     carbonate.                                                        |
|                                                                       |
| -   Sevelamer carbonate or sevelamer hydrochloride: initial           |
|     recommended dose is 800 mg to 1600 mg three times daily; doses    |
|     may be increased by 800 mg three times daily every 2 weeks, based |
|     on response. Usual maintenance dose (to achieve phosphorus \< 5.0 |
|     mg/dl in clinical trials) is 2400 mg three times daily (maximum   |
|     dose studied are 14 gm daily for sevelamer carbonate and 13 gm    |
|     daily for sevelamer hydrochloride in divided doses); doses should |
|     be administered with meals. Patients receiving medications where  |
|     a reduction in bioavailability may result in a significant        |
|     clinical impact on the safety or efficacy of the medication       |
|     should be instructed to take the medication at least 1 hour       |
|     before or 3 hours after sevelamer carbonate or sevelamer          |
|     hydrochloride, or the provider should consider monitoring blood   |
|     levels of the medication                                          |
+-----------------------------------------------------------------------+
| **MONITORING**                                                        |
+-----------------------------------------------------------------------+
| -   Lanthanum carbonate: serum phosphorus levels should be monitored  |
|     as needed during titration and regularly once on maintenance dose |
|                                                                       |
| -   Sevelamer carbonate and sevelamer hydrochloride: phosphorus,      |
|     bicarbonate, chloride levels should be monitored. Rare cases of   |
|     increased TSH reported with concomitant levothyroxine; monitor    |
|     TSH in patients taking sevelamer carbonate or sevelamer           |
|     hydrochloride and levothyroxine                                   |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   If the patient does not respond adequately despite prescribing    |
|     the maximum studied doses, reevaluate adherence to the medication |
|     regimen and to dietary restrictions. Consider referral to         |
|     dietitian and reinforce importance of medication adherence        |
+-----------------------------------------------------------------------+
| **RECOMMENDATIONS FOR DISCONTINUATION OR DECREASE IN DOSE**           |
+-----------------------------------------------------------------------+
| -   Patient does not experience an improvement in serum phosphorus    |
|                                                                       |
| -   Patient experiences a significant drug related adverse event      |
+-----------------------------------------------------------------------+

Contact person: Elaine M. Furmaga, PharmD, Clinical Pharmacist
Specialist, VHA PBM Services