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Elliotts B Solution
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ELLIOTTS B® SOLUTION
(buffered intrathecal electrolyte/dextrose) injection

Status: U.S. FDA-Approved, U.S. Orphan Drug

 

About Chemotherapy Diluents and Neurotoxicity

Normal saline and water are the prevailing diluents for intrathecal chemotherapy drugs. However, both have pH, electrolyte composition, glucose content and osmalarity are inconsistent with cerebrospinal fluid.

Moreover, prolonged exposure to the anti-bacterial preservatives in normal saline has been shown to severely damage spinal nerve roots. Such damage results in neurotoxicities ranging from fever and nausea to seizures and paralysis, and force a premature cessation of chemotherapy treatment.

Synthetic Cerebrospinal Fluid

Elliotts B® Solution (EBS) is the only synthetic cerebrospinal fluid available, and is currently indicated for diluting methotrexate sodium and cytarabine for the prevention and treatment of pediatric meningeal leukemia and lymphocytic lymphoma.


Cerebrospinal FluidElliotts B® Solution
Na+
mEq/L		117-137149
K+
mEq/L		2.3-4.64.0
Ca++
mEq/L		2.22.7
Mg++
mEq/L		2.22.4
HCO3-
mEq/L		22.922.6
Cl-
mEq/L		113-127132
Phosphorus
mg/dL		1.2-2.12.3
Cl-
mEq/L		113-127132
Glucose
mg/dL		45-8080
pH
7.317.0-7.4
Osmalarity
mOsmol/L		281288
Source: Bauer, et al., 1974

Both the close chemical approximation with natural cerebrospinal fluid and the absence of toxic preservatives minimize the incidence of neurotoxicities and enable physicians to pursue extended, intensive chemotherapy with their patients, improving treatment outcomes.

Adverse Reaction
Specifically Reported		Five Studies
without EBS
(n=217),
%		Four Studies
with EBS
(n=1731),
%
Headache28-353
Fever10-201
Emesis9-423
Arachnoiditis442.4
Seizures1-51-6
Backache10-221
Paralysis30.15-1
Mucositis20Not reported
Source: Cradock JC, et al American Journal of Hospital Pharmacy (1978): 35:402

The use of EBS in enabling extended Triple Intrathecal Therapy (TIC) has also been shown to adequately prevent CNS leukemia in children older than one year of age with non-T, non-B acute lymphoblastic leukemia (ALL)1.

Over the last 30 years, the U.S. National Cancer Institute (NCI) has used over 200,000 ampoules of EBS involving over 3,000 children.

1 Source: Pullen et al, “Extended Triple Intrathecal Chemotherapy Trial for Prevention of CNS Relapse in Good-Risk and Poor-Risk Patients with B-Progenitor Acute Lymphoblastic Leukemia: A Pediatric Oncology Group Study,” Journal of Clinical Oncology, Vol. 11, No 5 (May), 1993: pp 839-849.
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