Compendium of Pharmaceuticals and Specialties Information - Health Research Library

As listed in the Compendium of Pharmaceuticals and Specialties (CPS)
Immunocal®
Whey protein isolate
Glutathione Precursor
Immunotec
NPN(s): 80004370

Pharmacology

IMMUNOCAL is a natural source of the glutathione precursor cysteine for the maintenance of a strong immune system. It is fat-free and contains less than 1% lactose and has a high protein biological value (>110 BV) providing all essential amino acids.
The systemic availability of oral glutathione is negligible; the vast majority of it must be manufactured intracellularly from precursors. Glutathione is a tripeptide made intracellularly from its constituent amino acids L-glutamate, L-cysteine and glycine. The sulfhydryl (thiol) group (SH) of cysteine serves as a proton donor and is responsible for the biological activity of glutathione. Provision of this amino acid is the rate-limiting factor in glutathione synthesis by the cells since bioavailable cysteine is relatively rare in foodstuffs. Furthermore, cysteine if ingested as the free amino acid L-cysteine, has toxic potential and is spontaneously catabolized in the gastrointestinal tract and blood plasma. Toxicity is avoided when cysteine is integrated into larger proteins such as serum albumin, alpha lactalbumin and lactoferrin.
IMMUNOCAL is an undenatured bovine whey protein isolate specially prepared to provide a rich source of bioavailable cysteine. Following digestion, the cysteine remains as the stable form cystine (2 molecules of cysteine linked by a disulfide bond) and glutamylcystine. After absorption, these dipeptides travel safely in the blood stream and readily enter the cells to release free cysteine for intracellular glutathione synthesis. IMMUNOCAL is a cysteine delivery system.
The disulphide bond in cystine is pepsin and trypsin resistant but may be split by heat, low pH or mechanical stress, releasing free cysteine. When subject to heat or shearing forces (inherent in most extraction processes), the fragile disulfide bonds within the peptides are broken and the bioavailability of cysteine is greatly diminished.

Glutathione has multiple functions:

1. It is the major endogenous antioxidant produced by the cells, participating directly in
the neutralization of free radicals and reactive oxygen compounds, as well as the
maintenance of exogenous antioxidants such as vitamins C and E in their reduced
(active) forms.
2. Through direct conjugation, it detoxifies many xenobiotics (foreign compounds) and
carcinogens, both organic and inorganic such as heavy metals, aromatic hydrocarbons,
nitrosamines, benzopirines and others including pharmacological agents such as
acetaminophen.
3. It is essential for the immune system to exert its full potential, e.g. (1) modulating
antigen presentation to lymphocytes, thereby influencing cytokine production and the
type of response (cellular or humoral) that develops, (2) enhancing proliferation of
lymphocytes thereby increasing magnitude of response, (3) enhancing killing activity of
cytotoxic T cells and NK cells, and (4) regulating apoptosis, thereby maintaining control
of the immune response.
4. It plays a fundamental role in numerous metabolic and biochemical reactions such as
DNA synthesis and repair, protein synthesis, prostaglandin synthesis, amino acid
transport and enzyme activation. Many systems in the body are adversely affected by
low glutathione levels, including the immune system, the nervous system, the
gastrointestinal system and the cardiovascular-pulmonary system.

Health Claim

Glutathione augmentation is a strategy developed to address states of glutathione deficiency,
high oxidative stress, immune deficiency, and xenobiotic overload in which glutathione plays a
part in the detoxification of the xenobiotic in question. Many clinical pathologies are associated
with glutathione deficiency and oxidative stress and are elaborated upon in numerous medical
references. Low glutathione is also strongly implicated in cachexia and negative nitrogen
balance seen in muscle wasting. Immunocal has been demonstrated to improve muscle
function and it is clinically proven to raise glutathione.

Contraindications

In individuals who develop or have known hypersensitivity to specific milk proteins (this does
not include lactose intolerance).

Warnings

Patients undergoing immunosuppressive therapy should discuss the use of this product with
their health care practitioner.
Heating or adding IMMUNOCAL to a hot liquid or use of a high-speed blender to reconstitute it
will significantly decrease the effectiveness of the product.

Precautions

Each pouch of IMMUNOCAL provides 9 g of protein. Patients on a protein-restricted diet need
to take this into account when calculating their daily protein load. Although a bovine milk
derivative, IMMUNOCAL is well tolerated by lactose-intolerant individuals. IMMUNOCAL is
contraindicated in individuals who develop or have known hypersensitivity to specific milk
proteins (this does not include lactose intolerance).
Individuals with the autosomal-recessive metabolic disorder cystinuria, are at higher risk of
developing cysteine nephrolithiasis (1-2% of renal calculi).
Pregnancy - No adverse effects have been reported. A health care practitioner should be
consulted prior to use if the patient is pregnant or has reason to believe she is.
Lactation – No adverse effects have been reported. A health care practitioner should be
consulted prior to use if the patient breast feeds.
Geriatrics - Glutathione levels drop with age. Dosage recommendations may rise with
increasing age.

Adverse Effects

IMMUNOCAL is a natural source of protein classified as a Natural Health Product and has not
been statistically assessed for adverse effects. Gastrointestinal bloating and cramps are possible
if the product is not sufficiently rehydrated. Transient urticarial-like skin rash has been reported
in rare individuals undergoing severe detoxification reaction. Skin rash abates when the intake
is stopped or reduced.

Overdose

Symptoms and Treatment - There have been no reports of toxicity from overdosing on
IMMUNOCAL. Glutathione is a tightly regulated intracellular constituent and is limited in its
production by negative feedback inhibition of its own synthesis through the enzyme gammaglutamylcysteine
synthetase.
For management of a suspected drug overdose, CPhA recommends that you contact your
regional Poison Control Centre. See the eCPS Directory section for a list of Poison Control
Centres.

Dosage

As a natural source of the glutathione precursor cysteine for the maintenance of a strong
immune system, 20 g per day is recommended. 30-40 g per day has been used in clinical trials
without ill effects.
IMMUNOCAL is best administered on an empty stomach or with a light meal. Concomitant
intake of another high protein load may adversely affect absorption.

Supplied

Each individually-sealed foil pouch contains: 10 g of powder, 9 g of which is protein. The other is
represented by naturally occurring ingredients including ash, trace minerals and trace amounts
of vitamins. Boxes of 30 pouches.
IMMUNOCAL is a dehydrated powdered whey protein isolate. It must be appropriately
rehydrated before use. Remains bioactive up to 12 hours after mixing. Ideally, it should be
consumed immediately after mixing. Should the product be premixed for later consumption, it
should be refrigerated and consumed within a short period after mixing. Do not heat or use a
hot liquid to rehydrate the product or use a high-speed blender for reconstitution. These
methods will decrease the effectiveness of the product. Proper mixing is imperative. Consult
instructions included in packaging. Store in a cool dry environment. Avoid excessive heat.
Refrigeration is not necessary.
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