The Purpose of Sermorelin Acetate Therapy

The purpose of Sermorelin Acetate Therapy is to cause the pituitary gland to increase growth hormone production in humans. The purpose of adult Sermorelin growth hormone therapy is to reverse the effects of aging and secure the extensive treatment benefits described below.

What is Sermorelin Acetate GH-RH?

Sermorelin Acetate is a “growth hormone-releasing hormone” (GHRH). This prescription drug is compounded by U.S. pharmacies pursuant to a physician’s prescription and is patient self-injected subcutaneously. It stimulates the pituitary gland to naturally produce increased amounts of human growth hormone. Sermorelin Acetate is a truncated analog of a growth hormone releasing factor (GRF 1-44) that is naturally produced by the brain to stimulate pituitary production of human growth hormone. The increased volume of human growth hormone (hGH) produced by the pituitary gland causes an increase in the production of Insulin-Like Growth Factor-1 (IGF-1) by the liver and results in the benefits of treatment provided to the adult patient.

Sermorelin Growth Hormone (GHRH) Therapy

As a result of Sermorelin Growth Hormone (GHRH) Therapy, the increased volume of human growth hormone (hGH) secreted by the stimulated pituitary gland is converted by the liver into IGF-1. The increased amount of IGF-1 in the blood stream results an increase in metabolism and growth of new cells within the body’s organs and bones. This treatment is prescribed for unlabeled use in adults to increase lean muscle mass, reduce body fat, increase bone density, enhance the immune system, and strengthen the heart, as well as, other organs of the body. Since the increased volume of human growth hormone is produced by the body’s pituitary gland, the body’s endocrine system will not allow more growth hormone to be produced by the Sermorelin GH-RH stimulation of the pituitary than the body can safely process within the endocrine self-monitoring system.

Sermorelin Acetate Growth Hormone – Releasing Hormone has been specifically approved for medical use in increasing growth hormone levels in children deficient in growth hormone production. Its use to increase the growth hormone and IGF-1 levels in adults is an off-label use of this prescription drug.

Sermorelin Acetate Growth Hormone – Releasing Hormone Therapy causes the pituitary gland to increase the growth hormone and IGF-1 levels in humans. It is a prescription drug approved for one medical use that may be prescribed for adults for other unlabeled medical uses that are determined by the treating physician to be indicated and appropriate.

WHAT IS HGH OR HUMAN GROWTH HORMONE?

Human Growth hormone (hGH) is a protein-based peptide hormone, which stimulates growth, cell reproduction and regeneration in humans. Human growth hormone is a a 191-amino acid, single-chain polypeptide that is synthesized, stored, and secreted by the somatotroph cells within the pituitary gland.

‘Somatotropin’ refers to growth hormone produced naturally be the human pituitary gland. ‘Somatropin’ refers to genetically engineered growth hormone produced in a laboratory using recombinant DNA technology and is abbreviated “HGH”.

Human growth hormone or HGH is a prescription drug used to treat children’s growth disorders and very limited use in the treatment of other disorders when such treatment is expressly approved by the Secretary of Health and Human Services.

It is illegal and a felony under federal law for a physician to prescribe or distribute HGH for the purpose of anti-aging, enhancing athletic performance, building lean muscle mass, reducing body fat, to accelerate the recovery of a patient from surgery or injury, or to treat adult growth hormone deficiency in a healthy adult.

The U.S. Secretary of Health and Human Services has approved the medical use of HGH (Somatropin), the synthetic, genetically engineered human growth hormone produced in a laboratory using recombinant DNA technology, for the following uses only:

1. Treatment of short stature in children;
2. Treatment of AIDS wasting; and,
3. Treatment of Adult Growth Hormone Deficiency where the cause of such deficiency is a diagnosed pituitary disease or disorder evidenced by objective medical laboratory diagnostic testing.

COMPARISON OF HGH OR HUMAN GROWTH HORMONE THERAPY BENEFITS, COST AND PERMISSIBLE USES WITH THOSE OF SERMORELIN ACETATE GROWTH HORMONE RELEASING HORMONE

HGH or Human Growth Hormone Therapy and Sermorelin Acetate Growth Hormone Releasing Hormone Therapy Provide Similar Treatment Benefits

Human growth hormone therapy and Sermorelin growth hormone releasing hormone therapy have substantially the same treatment benefits because injected recombinant human growth hormone (somatropin) medication is genetically engineered to have the same DNA structure as human growth hormone produced by the pituitary gland when stimulated by Sermorelin acetate growth hormone releasing hormone injections. The benefits of Sermorelin therapy or recombinant human growth hormone therapy include the following:

• Increases the development of lean body mass through the development of new muscle cells
• Reduces body fat through lipolysis
• Increases energy and vitality
• Increases strength
• Increases endurance
• Accelerates healing from wounds or surgery
• Strengthens the heart
• Enhances the immune system
• Increases IGF-1 production
• Improves sleep quality
• Increases calcium retention, and strengthens and increases the mineralization of bone or bone density.
• Increases protein synthesis and stimulates the growth of all internal organs except the brain.

Sermorelin Growth Hormone Releasing Hormone (GH-RH) Therapy Costs Less Than Half the Cost of Recombinant Human Growth Hormone (Somatropin) Therapy

The cost of Sermorelin therapy is typically less than one half the cost of recombinant human growth hormone (somatropin) therapy due to the higher cost of the genetically engineered human growth hormone medication.

Federal Law Restricts the Use of HGH or Recombinant Human Growth Hormone (Somatropin) to Medical Uses Approved by the Secretary of Health and Human Services

Sermorelin acetate may be prescribed for an unlabeled use at the discretion of a treating physician, but HGH or recombinant human growth hormone may not be prescribed for any unapproved or unlabeled use.

The applicable law concerning the knowing possession or distribution of human growth hormone for any unapproved purpose is set forth in US Code Annotated, Title 21 Food and Drugs, Chapter 3 Subchapter III, Section 333. (e) (1). This statute provides in relevant part that “…whoever knowingly distributes, or possesses with the intent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 355 of this title pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, or both.

Recombinant human growth hormone (Somatropin) has not been approved for medical use in reversing the effects of aging, treating chronic fatigue, treating obesity or reducting body fat, increasing lean muscle, enhancing athletic performance, strengthening the immune system or accelerating healing of wounds following injury or surgery.