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## Complete Summary

#### GUIDELINE TITLE

Guidelines for the diagnosis and therapy of adult myelodysplastic
syndromes.

#### BIBLIOGRAPHIC SOURCE(S)

Bowen D, Culligan D, Jowitt S, Kelsey S, Mufti G, Oscier D, Parker J, UK
MDS Guidelines Group. Guidelines for the diagnosis and therapy of adult
myelodysplastic syndromes. Br J Haematol 2003 Jan;120(2):187-200. \[89
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12542475)

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory information
has been released.

-   [July 31, 2008, Erythropoiesis Stimulating Agents
    (ESAs)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2):
    Amgen and the U.S. Food and Drug Administration (FDA) informed
    healthcare professionals of modifications to certain sections of the
    Boxed Warnings, Indications and Usage, and Dosage and Administration
    sections of prescribing information for Erythropoiesis Stimulating
    Agents (ESAs). The changes clarify the FDA-approved conditions for
    use of ESAs in patients with cancer and revise directions for dosing
    to state the hemoglobin level at which treatment with an ESA should
    be initiated.

-   [November 8, 2007 and January 3, 2008 Update, Erythropoiesis
    Stimulating Agents
    (ESAs)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#ESA2):
    The U.S. Food and Drug Administration (FDA) notified healthcare
    professionals of revised boxed warnings and other safety-related
    product labeling changes for erythropoiesis-stimulating agents
    (ESAs) stating serious adverse events, such as tumor growth and
    shortened survival in patients with advanced cancer and chronic
    kidney failure.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Adult myelodysplastic syndromes (MDS)

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Treatment

#### CLINICAL SPECIALTY

Hematology\
Oncology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To critically review individual therapeutic modalities designed to
improve the clinical problems specific to an individual patient with
myelodysplastic syndromes (MDS), and to provide recommendations for
management strategies driven by the patient\'s International Prognostic
Scoring System (IPSS) score and the overall clinical picture

#### TARGET POPULATION

Adults with myelodysplastic syndromes (MDS)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Exclusion of reactive causes of dysplasia

2.  Patient and family history

3.  Physical examination

4.  Full blood count

5.  Blood film

6.  Assay of serum ferritin, Vitamin B12 and folate levels

7.  Bone marrow aspirate

8.  Bone marrow trephine biopsy

9.  Bone marrow cytogenetic analysis

**Management/Treatment**

1.  Red cell transfusion

2.  Iron chelation therapy

    -   Desferrioxamine (with audiometry and ophthalmology review and
        vitamin C)

3.  Erythropoietin (EPO) +/-- granulocyte colony-stimulating factor
    (G-CSF)

4.  Immunosuppression therapy

    -   Anti-lymphocyte globulin (ALG)

5.  Thrombocytopenia therapy

    -   Antifibrinolytic agents

    -   Danazol

    -   Platelet transfusions

6.  Infection management

    -   Prophylactic (G-CSF)

    -   Therapeutic (intravenous antibiotics)

7.  Chronic myelomonocytic leukaemia therapy

    -   Hydroxyurea

8.  Intensive chemotherapy/stem cell transplantation

9.  Chemotherapy alone

10. Supportive care/investigational therapy

#### MAJOR OUTCOMES CONSIDERED

-   Response to therapy

-   Adverse effects of therapy

-   Quality of life

-   Survival

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Medline/Pubmed was systematically searched from 1982. The Cochrane
database was searched but contained no references to myelodysplastic
syndromes (MDS). Meeting abstracts were not included in the systematic
search strategy.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Levels of Evidence**

**Ia** Evidence obtained from meta-analysis of randomized controlled
trials.

**1b** Evidence obtained from at least one randomized controlled trial.

**IIa** Evidence obtained from at least one well-designed controlled
study without randomization.

**IIb** Evidence obtained from at least one other type of well-designed
quasi-experimental study

**III** Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies
and case studies.

**IV** Evidence obtained from expert committee reports or opinions
and/or clinical experiences of respected authorities.

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The guideline group was selected to include UK-based medical experts in
the clinical management of myelodysplastic syndromes (MDS) and to
include a representative from a District General Hospital. The drafting
group met on six occasions. Each group member was allocated
responsibility for preparation of a selected component of the first
draft.

The Chairman synthesized the draft components, which were revised by
consensus through meetings 3--6. No recommendations are included for
which full consensus was not achieved.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grades of Recommendations**

**Grade A, evidence level Ia, Ib**

Required - at least one randomised controlled trial of good quality and
consistency addressing specific recommendation.

**Grade B, evidence level IIa, IIb, III**

Required - availability of well-conducted studies but no randomised
controlled trials on the topic of recommendation.

**Grade C, evidence level IV**

Required - evidence obtained from expert committee reports or opinions
and/or clinical experiences of respected authorities.

Indicates absence of directly applicable clinical studies of good
quality.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The draft guideline was reviewed by the Sounding Board and by the
Committee of the British Committee for Standards in Haematology, and
comments incorporated where appropriate. Following further helpful
peer-review by the British Journal of Haematology, a final revision was
presented.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The levels of evidence **(I--IV)** and strength of recommendations
**(A--C)** are defined at the end of the \"Major Recommendations\"
field.

**Diagnosis**

The diagnosis and classification of myelodysplastic syndromes (MDS)
remain dependent on the morphological examination of blood and bone
marrow cells. Diagnostic criteria should ideally distinguish MDS from
reactive conditions causing dysplastic haematopoiesis and from other
clonal myeloid disorders. The minimum clinical assessment and laboratory
investigation required for the definitive diagnosis of cases of
suspected MDS is shown in the table below.

**Evaluation of suspected MDS**

+-----------------------------------------------------------------------+
| History                                                               |
|                                                                       |
| Prior exposure to chemotherapy/radiation                              |
|                                                                       |
| Family history of MDS/acute myeloid leukaemia (AML)                   |
|                                                                       |
| Recurrent infections or bleeding/bruising                             |
|                                                                       |
| Examination                                                           |
|                                                                       |
| Pallor/infection/bruising                                             |
|                                                                       |
| Splenomegaly                                                          |
|                                                                       |
| Full blood count                                                      |
|                                                                       |
| Macrocytosis, cytopenia(s), neutrophilia, monocytosis, thrombocytosis |
|                                                                       |
| Blood film\                                                           |
| \                                                                     |
| Assay of serum ferritin, vitamin B12 and folate levels\               |
| \                                                                     |
| Bone marrow aspirate\                                                 |
| \                                                                     |
| Bone marrow trephine biopsy\                                          |
| \                                                                     |
| Bone marrow cytogenetic analysis\                                     |
| \                                                                     |
| Exclusion of reactive causes of dysplasia                             |
|                                                                       |
| Megaloblastic anaemia                                                 |
|                                                                       |
| Human immunodeficiency virus infection                                |
|                                                                       |
| Alcoholism                                                            |
|                                                                       |
| Recent cytotoxic therapy                                              |
|                                                                       |
| Severe intercurrent illness                                           |
+-----------------------------------------------------------------------+

**Management of Myelodysplastic Syndromes**

Where possible, management decisions be based upon the patient\'s
International Prognostic Scoring System (IPSS) score. It is important
that the IPSS score is calculated during a stable clinical state, and
not, for example, during a florid infective initial presentation.
Management decisions should be taken with the informed involvement of
the patient and, to aid this, information booklets are available from
the Leukaemia Research Fund and the Myelodysplastic Syndromes
Foundation.

*Supportive Care: Principles*

For patients with good prognosis MDS, it is often feasible to undertake
a period of observation without needing to introduce specific therapy.
Where possible, this \'wait and watch\' approach to management may also
be useful for patients with more advanced MDS, allowing one to appraise
the stability of the disease process and to assess the need to introduce
treatment.

*Management of Anaemia*

*Red cell transfusion and iron chelation therapy*

Recommendations for iron chelation treatment in myelodysplasia are based
on limited data (**evidence grade B, level III**). Iron chelation should
be considered once a patient has received 5 g iron (approximately 25
units of red cells) but only in patients for whom long-term transfusion
therapy is likely, such as those with pure sideroblastic anaemia or the
5q^-^ syndrome. Desferrioxamine 20--40 mg/kg should be administered by
12 hour subcutaneous infusion 5--7 days per week. Audiometry and
ophthalmology review are essential prior to commencement of
desferrioxamine. The target ferritin concentration should be \< 1000
microg/L; if the ferritin concentration falls below \< 2000 microg/L,
the dose of desferrioxamine should be reduced and should not exceed 25
mg/kg. Vitamin C 100--200 mg daily should be commenced after 1 month of
desferrioxamine therapy. Vitamin C should be taken when the infusion is
set up. Repeat audiometry and ophthalmology review should be performed
at least annually. The use of twice daily subcutaneous bolus injections
of desferrioxamine may be considered where infusions are not tolerated,
but the common practice of adding a single dose of desferrioxamine at
each transfusion episode has no basis and should be discouraged.

*Erythropoietin (EPO) +/-- granulocyte colony-stimulating factor
(G-CSF)*

Many studies have clearly demonstrated that EPO ± G-CSF can increase
haemoglobin concentration and reduce/eliminate red cell transfusion in
selected MDS patients, and a summary outline of these is provided in
Tables IVA and B of the original guideline document. These studies were
small cohort studies (\< 120 patients in each) and only one (small)
placebo-controlled randomized study (of EPO therapy alone) has been
reported. Given the small size of this placebo-controlled trial of EPO
therapy alone (87 patients), the grade of recommendation for EPO therapy
alone should be considered as **grade A/B** (**level Ib/IIa**). The
evidence for efficacy of the combination of EPO + G-CSF therapy is
**grade B** (**level IIa/IIb**).

Overall there is sufficient evidence for the efficacy of EPO ± G-CSF
therapy in appropriately selected patients. It is recommended that those
patients with refractory anaemia (RA) and RA with excess blasts (RAEB,
not eligible for chemotherapy/stem cell transplantation \[SCT\]) who are
symptomatic of anaemia, with no/low transfusion requirement (\< 2
units/month) and a basal EPO level of less than 200 U/L (measured at the
haemoglobin nadir in transfusion-dependent patients) be considered for a
trial of EPO alone at a dose of 10,000 units daily for 6 weeks. For
non-responders, consideration should be given to either the addition of
daily G-CSF, doubling the dose of EPO, or both for a further 6 weeks.
The dose of G-CSF should be escalated weekly from 75 microg, to 150
microg to 300 microg (multiple sampling from single vials kept at 4°C)
to maintain the white blood cell count between 6 and 10 × 10^9^/L.

In responding patients, once the maximum response has been reached, the
G-CSF can be reduced to thrice weekly and the EPO to 5 days then 4 d to
3 days per week at 4 weekly intervals to the lowest dose that retains
response.

For patients with RA with ringed sideroblasts (RARS), symptomatic
anaemia, basal EPO levels of \< 500 U/L and a transfusion requirement of
less than 2 units per month, it is recommended that combined therapy
with EPO and G-CSF is used from the outset. Dosing recommendations are
as for RA/RAEB with consideration given to dose escalation of EPO at 6
weeks in non-responders for a further 6 weeks.

*Immunosuppression*

The data support a recommendation for a trial of immunosuppressive
therapy with anti-lymphocyte globulin (ALG) at least for patients with
hypoplastic MDS (**evidence grade B, level IIb**).

*Management of thrombocytopenia*

The role of platelet transfusions in MDS patients should be based on the
Royal College of Physicians of Edinburgh Consensus Conference Statement.
Antifibrinolytic agents (**grade C, level IV**) and Danazol (**grade B,
level IIb**) are occasionally useful but cannot be routinely
recommended.

*Management of infection*

*Prophylactic*

There are no published data to support the routine use of antibacterial
or antifungal prophylaxis in neutropenic MDS patients. Consideration may
be given to the use of prophylactic low-dose G-CSF therapy in severely
neutropenic patients to maintain the neutrophil count \> 1 × 10^9^/L
(**grade B, level IIb**)

*Therapeutic*

Neutropenic sepsis in MDS patients should be treated with intravenous
antibiotics as for other patients with neutropenia (e.g. post
chemotherapy).

*Chronic myelomonocytic leukaemia (CMML)*

CMML often has a myeloproliferative component, and cytoreductive
chemotherapy is frequently indicated. Hydroxyurea is considered the
standard treatment for CMML, in preference to oral etoposide (**evidence
grade A, level Ib**)

*Intensive chemotherapy/stem cell transplantation*

It is recommended that clinicians discuss all patients eligible for stem
cell transplantation with their local transplant unit.

*IPSS Low*

Neither intensive chemotherapy nor stem cell transplantation can
currently be recommended for this group whose median survival without
treatment is 4·8 (\> 60 years)-11·8 years (\< 60 years).

*IPSS INT-1*

All patients \< 65 years should be assessed for fitness/eligibility for
allogeneic SCT as soon as possible after diagnosis, as SCT outcome is
improved if performed early. If eligible and a sibling donor is
available, it is recommended that patients \< 50 years are offered
ablative allogeneic SCT (**evidence grade B, level IIb**) and patients
\> 50 \< 65 years are considered for non-ablative allogeneic SCT, within
clinical trials where available (**evidence grade C, level IV**).
Patients with no sibling donor, but with an unrelated donor should also
be considered for ablative unrelated-donor SCT (\< 40 years, **evidence
grade B, level III**) or non-ablative unrelated-donor SCT within
clinical trials (\> 40 years, **evidence grade C, level IV**), though
the transplant related mortality (TRM) from these procedures remains
high. Intensive cytoreductive chemotherapy prior to SCT is not
recommended for this group (**evidence grade B, level IIb**).

Patients \> 65 years or \< 65 years and not suitable for SCT should be
offered supportive care and/or considered for growth factor therapy
(e.g., EPO). Recommendations for the management of IPSS INT-1 MDS
patients [\<]{.underline} 65 years are outlined in Figure 2 of the
original guideline document.

*IPSS INT-2/High*

*Chemotherapy plus SCT*

All patients \< 65 years should again be considered as to
fitness/eligibility for stem cell transplantation early after diagnosis.
In this group of high-risk patients, stem cell transplantation should
only be considered for those responding to remission induction
chemotherapy (complete/good partial response) as the outcome for
non-responding patients is very poor (**evidence grade B, level IIb**).
For patients \< 65 years, eligible for SCT and responding to
chemotherapy, recommendations for SCT consolidation are outlined in
Figure 3 of the original guideline document.

*Chemotherapy alone*

Both patients \> 65 years and those \< 65 years who are ineligible for
stem cell transplantation should be considered for intensive
chemotherapy alone.

Cohort studies suggest that of all high-risk MDS patients
([\>]{.underline} INT-2), those with RAEB in transformation (20--30%
marrow blasts) and lacking an independent adverse risk factor
\[karyotype, age, performance status, length of antecedent
haematological disorder\] respond best to intensive \'AML-type\'
chemotherapy (**evidence grade B, level IIb**). Thus, intensive
chemotherapy alone is recommended for consideration in these patients.

In all other high-risk MDS patients (namely those for whom intensive
chemotherapy alone is not recommended), intensive remission-induction
chemotherapy (two courses) should be offered only if stem cell
transplantation is proposed as consolidation (Figure 3 of the original
guideline document).

*Supportive Care/Investigational Therapy*

If patients do not fall into any category for which chemotherapy ± SCT
is recommended they should be offered supportive care or investigational
therapies within clinical research protocols.

**[Definitions]{.underline}**:

**Levels of Evidence**

**Ia** Evidence obtained from meta-analysis of randomized controlled
trials.

**1b** Evidence obtained from at least one randomized controlled trial.

**IIa** Evidence obtained from at least one well-designed controlled
study without randomization.

**IIb** Evidence obtained from at least one other type of well-designed
quasi-experimental study

**III** Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies
and case studies.

**IV** Evidence obtained from expert committee reports or opinions
and/or clinical experiences of respected authorities.

**Grades of Recommendations**

**Grade A, evidence level Ia, Ib**

Required - at least one randomised controlled trial of good quality and
consistency addressing specific recommendation.

**Grade B, evidence level IIa, IIb, III**

Required - availability of well-conducted studies but no randomised
controlled trials on the topic of recommendation.

**Grade C, evidence level IV**

Required - evidence obtained from expert committee reports or opinions
and/or clinical experiences of respected authorities.

Indicates absence of directly applicable clinical studies of good
quality.

#### CLINICAL ALGORITHM(S)

Three clinical algorithms are provided in the original guideline
document:

-   Guidelines for the management of symptomatic anaemia in
    myelodysplastic syndromes (MDS) patients

-   Guidelines for the management of International Prognostic Scoring
    System (IPSS) INT-1 MDS patients aged [\<]{.underline} 65 years

-   Guidelines for stem cell transplantation (SCT) in the management of
    IPSS INT-2/high MDS patients aged [\<]{.underline} 65 years

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for most of the
recommendations (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Accurate diagnosis and appropriate management of myelodysplastic
syndromes (MDS), including control of disease, prevention of
complications, improved quality of life, and prolonged survival

#### POTENTIAL HARMS

-   Side effects of treatment

-   Transplant related mortality

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   It is important to stress that most recommendations are made on the
    basis of a very limited evidence base for the efficacy of
    interventional and non-interventional therapy in myelodysplastic
    syndromes (MDS). Most papers reporting interventional therapy
    describe relatively small cohorts of patients and only one (small)
    placebo-controlled trial is available. Criteria for defining
    therapeutic response are also highly variable between studies.

-   Supportive care remains the most important aspect of management for
    patients with good prognosis MDS and those with poor prognosis
    disease whose age or performance status precludes them from
    receiving more intensive forms of therapy. However, grade A and
    grade B evidence for the effectiveness of supportive care in
    patients with myelodysplasia is absent and is unlikely to ever be
    obtainable.

-   Whilst the advice and information contained in this guideline are
    believed to be true and accurate at the time of going to press,
    neither the authors nor the publisher can accept any legal
    responsibility or liability for any errors or omissions that may be
    made.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Bowen D, Culligan D, Jowitt S, Kelsey S, Mufti G, Oscier D, Parker J, UK
MDS Guidelines Group. Guidelines for the diagnosis and therapy of adult
myelodysplastic syndromes. Br J Haematol 2003 Jan;120(2):187-200. \[89
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12542475)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Jan

#### GUIDELINE DEVELOPER(S)

British Committee for Standards in Haematology - Professional
Association

#### SOURCE(S) OF FUNDING

British Committee for Standards in Haematology

#### GUIDELINE COMMITTEE

UK MDS Guidelines Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Group Members*: David Bowen, Molecular and Cellular Pathology,
Ninewells Hospital, Dundee; Dominic Culligan, Aberdeen Royal Infirmary,
Aberdeen; Simon Jowitt, Stepping Hill Hospital, Stockport; Stephen
Kelsey\*, Department of Oncology, St. Bartholomews and Royal London MDS,
London; Ghulam Mufti, Department of Haematological Medicine, King\'s
College of Medicine and Dentistry, London; David Oscier, Royal
Bournemouth Hospital, Bournemouth, UK; Jane Parker, Department of
Haematological Medicine, King\'s College of Medicine and Dentistry,
London

\*Present address: Genetech, Inc., South San Francisco, CA, USA

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Meeting expenses were covered by support from Janssen-Cilag. Dr Stephen
Kelsey became an employee of Pharmacia Upjohn during the guideline
preparation process. Dr Culligan and Professor Mufti are members of the
ROCHE Steering Group for the treatment of cancer-related anaemia.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [British Committee for Standards
in Haematology Web
site](http://www.bcshguidelines.com/publishedHO.asp?tf=Haemato-Oncology&status=).

Print copies: Available from Dr David Bowen, Consultant Haematologist,
Department of Hematology, Brotherton Wing D Floor, Leeds General
Infirmary, Great George Street, Leeds, LS1 3EX; Telephone: 44 113 392
5153; Fax: 44 113 392 6349; E-mail: <david.bowen@leedsth.nhs.uk>

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on September 28, 2006. The
information was verified by the guideline developer on October 25, 2006.
This summary was updated by ECRI on January 29, 2007, following the U.S.
Food and Drug Administration advisory on erythropoiesis stimulating
agents. This summary was updated by ECRI Institute on July 9, 2007,
following the FDA advisory on erythropoiesis stimulating agents. This
summary was updated by ECRI Institute on March 21, 2008 following the
FDA advisory on Erythropoiesis Stimulating Agents. This summary was
updated by ECRI Institute on August 15, 2008 following the U.S. Food and
Drug Administration advisory on Erythropoiesis Stimulating Agents
(ESAs).

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the British Committee for Standards in Haematology. For
more information, contact the BCSH Secretary, 100 White Lion Street,
London, UK, N1 9PF; Email: <bcsh@b-s-h.org.uk>

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008