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09-J1000-43

Original Effective Date: 01/01/12

Reviewed: 02/08/17

Revised: 03/15/17

Subject: Dasatinib (Sprycel®) Tablets

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Dasatinib (Sprycel®), a second-generation tyrosine kinase inhibitor (TKI), was approved by the US Food and Drug Administration (FDA) in June 2006 for the treatment of all phases of chronic myelogenous leukemia (CML) resistant to or intolerant of prior therapy and for Philadelphia chromosome-positive (Ph+) acute lymphocytic leukemia (ALL) resistant or intolerant of prior therapy. The approval was expanded in October 2010 to include treatment of newly diagnosed Ph+ CML in chronic phase. The FDA had previously granted dasatinib orphan designation status for the treatment of CML and the treatment of Ph+ ALL in 2005.

Chronic myelogenous leukemia (CML) is a hematopoietic stem cell disease characterized by a reciprocal translocation between chromosomes 9 and 22, resulting in the formation of the Philadelphia (Ph) chromosome. CML occurs in three different phases (chronic, accelerated, and blast phase) and is usually diagnosed in the chronic phase. The median age of disease onset is 67 years, but CML occurs in all age groups. Untreated chronic phase CML will eventually progress to advanced phase disease in 3 to 5 years. The introduction of small molecule tyrosine kinase inhibitors (TKIs) changed the treatment armamentarium and this “targeted” approach has dramatically altered the natural history of the disease and improved 10-year overall survival from approximately 20% to 80 to 90%.

The National Comprehensive Cancer Network (NCCN) guidelines for CML (Version 2.2017) list imatinib (Gleevec®), nilotinib (Tasigna®), or dasatinib as category 1 options for the treatment of chronic phase CML in patients with a low-risk Sokal or Hasford score. For patients with an intermediate- or high-risk score, the three TKIs are all listed as category 2A options; however, dasatinib and nilotinib are labeled as preferred. Age, tolerance of adverse effects, and comorbid conditions also may affect initial choice of treatment. For example, nilotinib may be preferred in in individuals prone to fluid retention; dasatinib may be preferred in persons with liver disease. Subsequent treatment for chronic phase CML is determined by assessment of response every 3 months. The efficacy of CML therapy is assessed by monitoring hematologic, cytogenetic, and molecular responses.

Despite positive outcomes observed with TKIs in the treatment of CML, drug resistance has been identified. One of the most common mechanisms of resistance involves point mutations in the kinase domain of BCR-ABL, which impairs the activity of TKIs. One important mutation, the T315I, is known as the “gatekeeper” mutation, as it displays resistance to all TKIs, with the exception of ponatinib (Iclusig®). Current guidelines recommend checking mutational analysis in the following situations: if there is inadequate initial response, any sign of loss of response, and in disease progression to accelerate-phase or blast-phase CML (CML-AP and CML-BP, respectively). In vitro studies have shown that some mutations confer resistance specifically to one second generation TKI and not the other. For example, T315A, V299L, and F359V confer resistance to dasatinib only, whereas Y253H, E255K/V, L273M, and F359V specifically to nilotinib.

Acute lymphoblastic leukemia (ALL) is a heterogeneous hematologic disease characterized by the proliferation of immature lymphoid cells in the bone marrow, peripheral blood and other organs. ALL represents approximately 20% of all leukemias among adults. The long-term prognosis for adults with ALL remains poor, with cure rates of only 30% to 40%. The treatment approach to ALL represents one of the most complex and intensive programs in cancer therapy. In general, treatment phases can be largely grouped into induction, consolidation, and maintenance. All phases of treatment also include central nervous system (CNS) prophylaxis and/or treatment to clear leukemic cells within sites that cannot be readily accessed with systemic chemotherapy due to the blood-brain barrier.

During the past decade, the advent of novel agents targeted to specific genetic abnormalities, such as those associated with Ph+ ALL, or to specific cell antigens, has contributed to improvements in outcomes in some subtypes of ALL. These agents include BCR-ABL selective TKIs for Ph+ ALL. NCCN guidelines for ALL list dasatinib and imatinib as the preferred TKIs for induction and maintenance regimens for newly diagnosed Ph+ ALL. Dasatinib, ponatinib (for patients with a Y253H, E255K/V, or F359V/C/I mutation), and imatinib are listed as preferred options for relapsed or refractory ALL. Nilotinib is also listed as an option but is not preferred and should be reserved for patients with a F317L/V/I/C, T315A, or V299L mutation. Dasatinib has greater blood-brain barrier penetration than imatinib, and may provide an advantage when treating ALL with CNS involvement.

POSITION STATEMENT:

Comparative Effectiveness

The FDA has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of dasatinib (Sprycel®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is NOT taking another tyrosine kinase inhibitor (TKI) (i.e., imatinib, nilotinib, bosutinib, or ponatinib) or omacetaxine mepesuccinate (Synribo®) concurrently with dasatinib.

2. Dosage of dasatinib does not exceed 180 mg daily and will be achieved using the fewest number of tablets per day.

3. The member is receiving treatment for ANY of the following conditions and ALL associated criteria are met:

a. Chronic-, accelerated-, or blast-phase Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) (including post-transplant relapse),

i. Member does NOT have a F317L/V/I/C, T315A, V299L, or T315I mutation (only applicable if a BCR-ABL kinase domain mutation analysis has been performed)

ii. EITHER of the following (“a” or “b”):

a. Member has an intermediate- or high-risk Sokal or Hasford score as determined prior to treatment initiation (at least one calculated score must be provided)

b. Member has previously tried imatinib treatment and EITHER failed (i.e., inadequate initial treatment response or relapse during treatment – see definitions) OR had persistent intolerable adverse effects despite appropriate dose modification (the specific adverse effect must be provided), UNLESS either of the following apply:

• Member has documented genetic resistance to imatinib (lab documentation of Y253H, E255K/V, or F359V/C mutation must be submitted)

• Member has an FDA-labeled contraindication to imatinib (the specific contraindication must be provided)

b. Ph-positive acute lymphoblastic leukemia (ALL) (induction, consolidation, and/or maintenance therapy)

i. Member does NOT have a F317L/V/I/C, T315A, V299L, or T315I mutation (only applicable if a BCR-ABL kinase domain mutation analysis has been performed).

ii. EITHER of the following (“a” or “b”):

a. The member has Ph-positive ALL with central nervous system (CNS) involvement

b. Member has previously tried imatinib treatment and EITHER failed (i.e., inadequate initial treatment response or relapse during treatment) OR had persistent intolerable adverse effects despite appropriate dose modification (the specific adverse effect must be provided), unless either of the following apply:

• Member has documented genetic resistance to imatinib (lab documentation of Y253H, E255K/V, or F359V/C mutation must be submitted)

• Member has an FDA-labeled contraindication to imatinib (the specific contraindication must be provided)

c. Progressive gastrointestinal stromal tumors (GIST),

i. Member has a documented platelet derived growth factor receptor alpha (PDGFRA) D842V mutation (lab documentation of mutation must be submitted),

ii. Member meets any of the following in reference to at least TWO first-line GIST treatments [i.e., imatinib, sunitinib (Sutent®), or regorafenib (Stivarga®)] one of which must be imatinib:

1) Did not achieve recommended initial treatment goals or experienced disease relapse during treatment

2) Had persistent intolerable adverse effects despite appropriate dose modification (the specific adverse effect must be provided)

3) Has documented genetic resistance (lab documentation must be submitted)

4) Has an FDA-labeled contraindication (the specific contraindication must be provided)

Approval duration: 6 months

Continuation of dasatinib (Sprycel®) meets the definition of medical necessity when ALL of the following criteria are met:

1. The member has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of CML, ALL, or GIST, OR the member has previously met all indication-specific criteria.

2. Member does NOT have a F317L/V/I/C, T315A, V299L, or T315I mutation (only applicable if a BCR-ABL kinase domain mutation analysis has been performed and does NOT apply if dasatinib is being used for treatment of GIST).

3. Member’s disease has not progressed during treatment with dasatinib.

4. Member is NOT taking another TKI (i.e., imatinib, nilotinib, bosutinib, or ponatinib) or omacetaxine concurrently with dasatinib.

5. Dosage of dasatinib does not exceed 180 mg daily and will be achieved using the fewest number of tablets per day.

Approval duration: 1 year

NOTE: Quest Diagnostics® can perform the BCR-ABL kinase domain mutation test and the c-KIT mutations with reflex to PDGFRA mutations for GIST test (to detect D842V mutation). Current guidelines recommend checking mutational analysis in the following situations: if there is inadequate initial response, any sign of loss of response, and in disease progression to accelerate-phase or blast-phase CML (CML-AP and CML-BP, respectively).

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: dasatinib is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase; adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy with imatinib; and adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Dasatinib is administered orally and can be taken with or without food. The tablets should not be crushed or chewed. The recommended dose for treatment of chronic phase CML is 100 mg once daily. The recommended dose for the other FDA-approved indications is 140 mg once daily. In clinical studies, treatment was continued until disease progression or until no longer tolerated by the patient.

Dose Modifications

Dose Escalation: Dose escalation to 140 mg once daily in persons with chronic phase CML or 180 mg daily in persons with advanced phase CML and Ph+ ALL is an option in persons who do not achieve a hematologic or cytogenetic response at the recommended starting doses.

Concomitant Strong CYP3A4 Inducers: Use of concomitant strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital, St. John’s Wort) may decrease dasatinib plasma concentrations and should be avoided. If co-administration cannot be avoided, a dasatinib dose increase should be considered with subsequent careful monitoring for toxicity.

Concomitant Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase dasatinib plasma concentrations and should be avoided. Avoid grapefruit products since they may also increase serum concentrations of dasatinib. If co-administration cannot be avoided, consider a decrease in the dasatinib dose. Based on pharmacokinetic studies, a dose decrease to 20 mg daily should be considered for patients taking 100 mg daily. For patients taking 140 mg daily, a dose decrease to 40 mg daily should be considered. There are no clinical data with these dose adjustments. If not tolerated after a dose reduction, either the strong CYP3A4 inhibitor must be discontinued, or dasatinib should be stopped until treatment with the inhibitor has ceased. When the strong inhibitor is discontinued, a washout period of approximately 1 week should be allowed before the dasatinib dose is increased.

Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment; however, caution is recommended.

Myelosuppression: Myelosuppression can be managed by dose interruption, dose reduction, or discontinuation of therapy. Hematopoietic growth factor has been used in persons with resistant myelosuppression. The Table describes guidelines for dose modifications.

Table: Dose Adjustments for Neutropenia and Thrombocytopenia

Chronic Phase CML

(starting dose 100 mg once daily)

ANC <0.5 × 109/L

or

Platelets <50 × 109/L

1. Stop dasatinib until ANC ≥1 × 109/L and platelets ≥50 × 109/L

2. Resume treatment with dasatinib at the original starting dose if recovery occurs in ≤7 days.

3. If platelets <25 × 109/L or recurrence of ANC <0.5 × 109/L for >7 days, repeat Step 1 and resume dasatinib at a reduced dose of 80 mg once daily for second episode. For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue (for patients resistant or intolerant to prior therapy including imatinib).

Accelerated and Blast Phase CML and Ph+ ALL

(starting dose 140 mg once daily)

ANC <0.5 × 109/L

or

Platelets <10 × 109/L

1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy).

2. If cytopenia is unrelated to leukemia, stop dasatinib until ANC ≥1 × 109/L and platelets ≥20 × 109/L and resume at the original starting dose

3. If recurrence of cytopenia, repeat Step 1 and resume dasatinib at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).

4. If cytopenia is related to leukemia, consider dose escalation to 180 mg once daily.

ANC = absolute neutrophil count

Drug Availability: dasatinib is available as a 20-, 50-, 70-, 80-, 100-, and 140 mg tablet.

PRECAUTIONS:

CONTRAINDICATIONS

• None

WARNINGS

Myelosuppression: Treatment with dasatinib is associated with severe thrombocytopenia, neutropenia, and anemia and may require dose interruption or reduction. Perform complete blood counts weekly for the first 2 months and then monthly thereafter, or as clinically indicated.

Bleeding Events: In addition to causing thrombocytopenia, dasatinib can cause platelet dysfunction. CNS and gastrointestinal hemorrhages, including fatalities have occurred, and are usually associated with severe thrombocytopenia. Severe hemorrhage may require treatment interruptions and transfusions. Use with caution in persons requiring medications that inhibit platelet function or anticoagulants.

Fluid retention: Dasatinib is associated with fluid retention, sometimes severe, including ascites, edema, pleural effusions, and pericardial effusions. Manage with appropriate supportive care measures (e.g., diuretics, short-term steroids). Fluid retention events are less frequently with once daily dosing than with other dosing regimens.

QT prolongation: Use with caution in persons who have or may develop QT prolongation (e.g., hypokalemia or hypomagnesemia, congenital long QT syndrome, or concomitant medications know to prolong the QT interval). Correct hypokalemia or hypomagnesemia prior to administration.

Cardiovascular events: Monitor members for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pulmonary Arterial Hypertension: Dasatinib may increase the risk of developing pulmonary arterial hypertension (PAH) which may occur any time after initiation, including after more than 1 year of treatment and may be reversible on discontinuation. Evaluate members for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib and during treatment. If PAH is confirmed, permanently discontinue dasatinib.

Severe dermatologic reactions: Individual cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported.

Tumor Lysis Syndrome: Tumor lysis syndrome has been reported. Maintain adequate hydration and correct uric acid levels prior to initiating therapy with dasatinib.

Embryo-fetal toxicity: Dasatinib can cause fetal harm when administered to a pregnant woman. Women should be advised of the potential hazard to the fetus and avoid becoming pregnant.

BILLING/CODING INFORMATION:

HCPCS Coding

J8999

Prescription drug, oral, chemotherapeutic, NOS

ICD-10 Diagnoses Codes That Support Medical Necessity

C49.A0 - C49.A9

Gastrointestinal stromal tumor

C91.00

Acute lymphoblastic leukemia not having achieved remission

C91.01

Acute lymphoblastic leukemia, in remission

C91.02

Acute lymphoblastic leukemia, in relapse

C92.10

Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission

C92.11

Chronic myeloid leukemia, BCR/ABL-positive, in remission

C92.12

Chronic myeloid leukemia, BCR/ABL-positive, in relapse

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Acute lymphoblastic leukemia: an aggressive (fast-growing) type of leukemia (blood cancer) in which too many immature white blood cells are found in the blood and bone marrow. Also called acute lymphocytic leukemia and ALL.

Chronic myelogenous leukemia: also known as chronic granulocytic leukemia (CGL), is a cancer of the white blood cells. It is a form of leukemia characterized by the increased and unregulated growth of predominantly myeloid cells in the bone marrow and the accumulation of these cells in the blood

Inadequate chronic-phase CML treatment response: BCR-ABL1 transcript levels >10% or lack of partial cytogenetic response (i.e., >35% Ph-positive metaphases) at 3 or 6 months; or lack of a complete response (i.e., Ph-positive metaphases are detectable), BCR-ABL1 transcript levels >1%, or cytogenetic relapse at 12 months

Ph+ ALL complete response criteria to induction chemotherapy:

1. No circulating blasts or extramedullary disease

2. Trilineage hematopoiesis (TLH) and less than 5% blasts

3. ANC greater than 1,000/microL

4. Platelet count greater than 100,000/microL

5. No recurrence for 4 weeks

Philadelphia chromosome or Philadelphia translocation: is a specific chromosomal abnormality that is associated CML or ALL.

Relapse: the return of a disease or the signs and symptoms of a disease after a period of improvement. Specifically for CML a relapse is defined as “any sign of loss response” (defined as hematologic or cytogenic relapse). A 1-log increase in BCR-ABL transcript levels with loss of MMR should prompt bone marrow evaluation for loss of complete cytogenic response is not itself defined as relapse.

Refractory: cancer that does not respond to treatment; the cancer may be resistant at the beginning of treatment or it may become resistant during treatment. Also called resistant cancer.

RELATED GUIDELINES:

Allogeneic Bone Marrow and Stem Cell Transplantation, 02-38240-01
Autologous Bone Marrow and Stem Cell Transplantation, 02-38241-01

Azacitidine (Vidaza®) Injection, 09-J0000-84

Bosutinib (Bosulif) Tablets, 09-J1000-84

Cytogenetic Studies (Chromosomal Studies), 05-82000-18

Erythropoiesis Stimulating Agents, 09-J0000-31

Immune Globulin Therapy, 09-J0000-06

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

Interferons for Oncology Use, 09-J1000-37

Imatinib (Gleevec®) Tablets, 09-J1000-46

Nilotinib (Tasigna®) Capsules, 09-J1000-48

Sunitinib Malate (Sutent®) Capsules, 09-J1000-51

Regorafenib (Stivarga®), 09-J1000-83

Ponatinib (Iclusig®) Tablet, 09-J1000-89

Omacetaxine (Synribo®) Injection, 09-J1000-87

OTHER:

CML Risk Scores

Study

Calculation

Risk Definition by Calculation

Sokal et al, 1984

Exp 0.0116 x (age in years – 43.4) + (spleen – 7.51) + 0.188 x [(platelet count/700)2 – 0.562] + 0.0887 x (blast cell -2.10)

• Low: <0.8

• Intermediate: 0.8 to 1.2

• High: >1.2

Hasford et al, 1998

0.666 when age ≥50 years + (0.042 x spleen) + 1.0956 when platelet count >1,500 x 103/L + (0.0584 x blast cells) + 0.20399 when basophils >3% + (0.0413 X eosinophils) x 100

• Low: ≤780

• Intermediate: 781 to 1,480

• High: >1,480

Age is in years. Spleen is in centimeters below the costal margin (maximum distance). Blast cells, eosinophils, and basophils are in percents of peripheral blood differential. All factors must be collected prior to any treatment.

Online risk calculator can be found at: http://www.icsg.unibo.it/rrcalc.asp

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2016. Available at: www.clinicalpharmacilogy-ip.com. Accessed 1/12/17.
  2. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 1/12/17.
  3. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 1/12/17.
  4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2016.Acute Lymphoblastic Leukemia. Available at http://www.nccn.org/professionals/physician_gls/PDF/all.pdf. Accessed 1/25/17.
  5. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 2.2017. Chronic Myelogenous Leukemia. Available at http://www.nccn.org/professionals/physician_gls/PDF/cml.pdf. Accessed 11/29/16. Accessed: 1/25/17
  6. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology Version 1.2017. Soft Tissue Sarcoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/sarcoma.pdf. Accessed 1/25/17.
  7. Porkka K, Koskenvesa P, Lundán T, et al. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12.
  8. Sprycel (dasatinib) [package insert]. Bristol-Myers Squibb Company. Princeton (NJ): September 2016.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 02/08/17.

GUIDELINE UPDATE INFORMATION:

01/01/12

New Medical Coverage Guideline.

11/15/12

Review and revision to guideline; consisting of reformatting position statement, added contraindications, added warnings, updated coding, program exceptions, related guidelines and references.

03/15/13

Review and revision to guideline; consisting of revising and reformatting position statement, revising and reformatting description, dosage/administration, and precautions section; adding pertinent definitions and related guidelines; updating references and coding.

03/15/14

Review and revision to guideline; consisting of reformatting and revising position statement; updating references, coding, and program exceptions.

03/15/15

Review and revision to guideline; consisting of revising position statement and decision tree, and updating the description, dosage/administration, warnings, and references.

11/01/15

Revision: ICD-9 Codes deleted.

03/15/16

Review and revision to guideline consisting of description, position statement, definitions, and references.

09/15/16

Revision to guideline consisting of updating the position statement and definitions.

10/01/16

Revision: ICD-10 code updates

01/15/17

Revision to guideline consisting of updating the description section, position statement, and references based on updated NCCN guidelines.

03/15/17

Review and revision to guideline consisting of updating the position statement, description section, dosage/administration section, precautions section, and references.

Date Printed: August 22, 2017: 07:01 AM