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Sermorelin Growth Hormone Releasing Hormone Analog


Written by Dr. Chris Smith, Updated on March 10th, 2022
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Geref Sermorelin Acetate Therapy

Geref is one of the many forms of Sermorelin Acetate injection that have been released in the American market.

Sermorelin at a Glance

Sermorelin is a synthetic form of Growth Hormone-Releasing Hormone. GH-RH is composed of a chain of forty-four amino acids, whereas Sermorelin only contains twenty-nine amino acids.

Despite this fact, Sermorelin functions identically to GH-RH in the human body and is one of the most popular forms of GH-RH therapy.

One of the most common means by which Sermorelin is configured for human injection is by forming an acetate salt to which Sermorelin is attached.

Sermorelin Acetate Breakdown

Noted in molecular terms, Sermorelin Acetate is C149 H246 N44 O42 S1. Sermorelin acetate has a weight of 3,358 daltons.

Geref is sterilized and has been proven not to produce an inflammatory response when injected into the human body.

In unconstituted form, Geref is freeze-dried through sublimation, allowing it to be transported more effectively and stored for a longer period of time than its liquid form.

Before Geref is injected, it must be reconstituted, combining the lyophilized Sermorelin Acetate with a Sodium Chloride Solution. After reconstitution, the mixture has a pH of between 5 and 5.5.

How is Geref Distributed?

Geref is delivered to the patient via vials. The contents of the vial are as follows:

Each half milligram vial holds 0.5 milligrams of sermorelin acetate along with 5 milligrams of mannitol. The pH is fixated using a buffer of monobasic sodium phosphate and dibasic sodium phosphate.

Each one-milligram vial holds 1.0 milligram of sermorelin acetate along with 5 milligrams of mannitol. These contents have pH levels that are also fixated using monobasic sodium phosphate and dibasic sodium phosphate.

How does Geref Work?

Geref is an injectable form of Sermorelin Acetate which has the ability to boost plasma levels of Insulin-Like Growth Factor One and Human Growth Hormone by stimulating the endogenous production of HGH by the pituitary gland.

Geref functions in the body identically to endogenous GH-RH, stimulating HGH production in an identical manner in human beings.

How does Geref interact with the Human Body?

Distribution

After 0.25 to 1-milligram intravenous injection of Human Growth Hormone was delivered to twelve normal patients, the mean volume distribution had a range of 23.7 to 25.8 liters.

Absorption

After two milligrams of Sermorelin was subcutaneously injected into twelve normal patients, peak sermorelin saturation occurred between five and twenty minutes after injection. After this administration, the absolute mean bioavailability of sermorelin was around six percent.

Metabolism

There has been no human research regarding Geref.

Evacuation

Sermorelin leaves the body quite quickly after it has entered the bloodstream. In adults, Sermorelin is cleared from the body at a rate of around 2.6 liters per minute. Geref also has a short half-life of around eleven to twelve minutes after its initial subcutaneous or intravenous injection.

Among Individual Populations

Age/Gender: In healthy adults, Geref is evacuated from the body at a similar rate in both men and women. There is no clearance data as it relates to the age of the patient. There is also data that compares male and female pediatric clearance rates.

Hepatic/Renal Insufficiency: There is no available research data regarding how liver and kidney problems may affect clearance rates.

Clinical Evaluation of Geref

In one particular non-blind clinical research study performed across multiple medical centers, prepubescent adolescents suffering from idiopathic HGH Deficiency were given Geref injections of 30 micrograms per kilograms on a daily basis via SC injection.

After one year of treatment, 56 participants were available for an evaluation of efficacy after twelve months. Another 54 participants were not qualified for evaluation.

Twenty-four violated criteria eligibility, ten discontinued the required protocol for treatment, and twenty others did not meet the criteria for evaluation after the initial six months of the study.

56 of the total of 110 participants, including 47 of the 56 patients who were among the subset of participants who were qualified for evaluation and continued Sermorelin Acetate therapy over the course of an entire year, were shown to grow in height at a rate of two centimeters per year faster than their baseline rate of growth.

Among those 56 participants who qualified for evaluation, their height velocity changed at a rate of 4.1 centimeters per year after six months and increased at a rate of 7.2 centimeters per year after one year. The average patient grew taller at a rate of 3.1 centimeters per year. The bone age of these patients after one year of Geref therapy was in proportion to their height gains.

When should Geref be used?

Geref injections are intended for pediatric patients who suffer from HGH Deficiency with no discernible cause, which results in a failure to grow properly. The majority of these pediatric patients who suffer from HGH Deficiency still have active pituitary glands which respond readily to GH-RH.

Pediatric patients who use Geref should be prepubescent. Geref Therapy should be instituted at a bone age of eight in males and seven and a half in females.

Geref Contraindications

Geref should not be utilized by individuals which have been proven to have an allergy or sensitivity to Sermorelin. It should also be avoided by any patients that have a sensitivity or allergy to any of the other ingredients included in the product.

Geref Warning

It is vitally important to use Geref immediately after it is reconstituted with the accompanying diluent. The reconstituted solution will begin to degrade a short time after reconstitution.

If there is any solution that is left over after the injection is complete, it should be thrown away, and under no circumstances should you consider using it at a later time.

Geref Precautions

Geref should only be used with the express consent of a physician who specializes in either Growth Disorders or Anti-Aging Therapy, and when prescribed, hormone levels should be carefully monitored to ensure that proper hormone levels are restored.

Young patients who undergo Geref Hormone Replacement Therapy also need to be evaluated to ensure that Geref produces height gains.

Some patients will not respond to Geref or other GH-RH analogs even if they are not growing at a proper rate. Those pediatric patients who do not respond to Geref therapy will more than likely be fully served through the usage of Human Growth Hormone HRT.

It has been thoroughly proven that Geref produces positive changes in height following a single year of treatment; however, there has been no research as to the extent of the effect of Geref upon a patient's final height as an adult.

Geref and Hypothyroidism

In clinical research, 6.5% of participants were diagnosed with hypothyroidism as a result of Geref therapy. In the most significant Geref clinical trial, 8 participants among 110 who were enrolled were taking thyroid HRT before being administered Geref. 5 more participants began Thyroid Replacement HRT after treatment began.

If a patient suffers from undetected hypothyroidism it can negate or diminish the effects of Geref Hormone Replacement Therapy. For this reason, the administering physician should test for proper thyroid function before as well as periodically during Geref treatment.

If at any point before or during therapy, the patient begins to show signs of hypothyroidism, Thyroid Hormone HRT should be instituted as soon as possible to maximize the effectiveness of therapy and the health of the patient.

In addition to Thyroid Hormone testing, patients who are undergoing Geref Hormone Replacement Therapy should also be tested periodically for bone age. This is particularly important among patients who are currently undergoing puberty or are concurrently receiving Thyroid Hormone HRT.

In these particular patients, the epiphyseal plates can sometimes grow at a very fast rate. It is important to suspend Geref Sermorelin Acetate Therapy once the ephyseal plates close because at this point, the bones will no longer grow in length and Geref Therapy will no longer be needed.

Geref Hormone Replacement Therapy is not recommended for patients who suffer from an HGH Deficiency which resulted from an intracranial lesion. There has been no testing as to the safety of Sermorelin Acetate Therapy in this subset of patients.

Reactions to Geref

As is the case with the administration of any Hormone Replacement Therapy, systemic or local allergic responses can sometimes result. It is vital that the patient (and parent if applicable) be aware that such responses can potentially occur. If the patient suffers an allergic reaction as a result of Geref Therapy it is vital that they receive medical attention promptly.

Clinical Tests have shown that increased blood-serum levels of Insulin-Like Growth Factor One (IGF-1), Human Growth Hormone, alkaline phosphatase, and inorganic mineral phosphorus can occur as a result of Geref Sermorelin Acetate Therapy.

Drug Interactions

Taking glucocorticoid steroids in combination with Sermorelin Acetate Therapy maybe reduce the effectiveness of Geref.

In clinical studies of Geref Sermorelin Acetate Therapy, no pediatric patient who concomitantly took medications to treat normal youthful illnesses/problems had any problems as a result of combining their normal medications with Geref Hormone Replacement Therapy.

Though no evidence has been discovered, it is still important to note that there have been no clinical studies regarding formal medical interactions.

Fertility Impairment, Mutagenesis, Cancer risk

There has been no longitudinal animal research regarding fertility impairment or carcinogenicity risk regarding Geref Hormone Replacement Therapy. There has been absolutely no clinical research linking Geref Sermorelin Acetate Therapy to genetic abnormalities.

Pregnancy

There have been some animal research conducted regarding Geref Therapy. At a dosage somewhere between three and six times the normal daily dosage that a human patient receives adjusted for physical surface area, minor fetal changes occurred in rabbits and rats.

There have been no adequately controlled studies regarding the usage of Geref by women who are pregnant. Geref Sermorelin Acetate Therapy should only be administered to women that are pregnant if the likely benefits of the therapy outweigh the possible risk to the unborn child.

Nursing Women

It is unknown if Geref is produced in human milk. There are many medications that are released by the mother in the nursing process, and for this reason, mothers and physicians should exercise caution when using Geref Hormone Replacement Therapy while nursing.

Patient Information

All patients who are prescribed Geref (along with their parents, if applicable) should be adequately informed of the possible risks and benefits that are related to the therapy. If the prescribing physician has determined that Geref should be administered by either patient or parent at home, the physician must provide appropriate guidance regarding its use.

This includes verbally discussing the content of the Patient Information Booklet with the patient (and parent, if applicable). The Insert which accompanies the prescription is meant to assist the patient in the efficient and safe usage of Geref and does not provide complete and total disclosure of all potential effects whether intended or adverse.

Disposal Information

If the physician approves home usage, the patient should be provided with or directed to a location that provides SHARPS containers meant for the proper disposal of used needles and syringes accumulated as a result of Geref Therapy.

These containers are puncture-resistant and are a necessary safety measure to protect both patients and anyone who may come in contact with the used needles and syringes. It is vital that the patient (and parent, if applicable) be directed thoroughly as to the vital importance of proper needle disposal. Also, they should be informed of the dangers of reusing syringes and needles as well.

Side Effects

A significant portion of Geref Sermorelin Acetate HRT patients antibodies against Growth Hormone Factor during at least one point of therapy. There is no clear assessment of the significance of the presence of these antibodies, and the levels of these antibodies can change quickly from test to test.

A positive result at one juncture regularly turns into a negative result after the next test. The production of these antibodies does not seem to have any adverse effect on the patient.

Also, these antibodies do not seem to produce any change in the effectiveness of Geref therapy. There have been no reported general allergic responses to Geref Sermorelin Acetate Therapy.

The most common reaction to Geref Hormone Replacement Therapy which is related to treatment is local irritation around the injection site, which occurs in around one of every six patients. This irritation is characterized by redness, pain, or swelling. Though this side effect is relatively common, only a small minority of patients find the irritation bothersome enough to suspend therapy.

Out of a sample of 350 patients who underwent Geref Therapy in a clinical trial, only three suspended therapy as a result of injection-site irritation. There are other side effects that occurred in less than one percent of patients. These side effects include severe drowsiness, hives, vomiting, headache, nausea, difficulty swallowing, hyperactivity, chest tightness and pallor, distortion in the perception of taste, and flushing of the skin.

Geref Dependency and Abuse:

There is no evidence to suggest that the use of Geref for any period of time will result in any sort of dependency or proclivity toward abuse. The general pharmacology of Geref does not produce any addictive effect, and clinical trials have produced no evidence of such an effect.

Never Take More than Prescribed

It is not recommended to exceed the recommended dosage of Geref prescribed by your physician. Overdose will not provide better results. It will only increase the occurrence of side effects.

Administration and Dosage

The recommended dosage for Geref Sermorelin Acetate Therapy for pediatric patients is 0.03 milligrams per kilogram of body weight. This dosage should be administered every day before bed (unless otherwise advised by your physician) via subcutaneous injection. It is also that sites of injection be rotated periodically in order to reduce the risk of irritation.

In pediatric patients who are prescribed Geref Sermorelin Acetate Therapy, therapy should be discontinued after the epiphyseal plates have fused. Patients who do not respond to Geref Treatment should undergo further evaluation in order to discover the root cause of their unresponsiveness to therapy. Patients who do not experience increased levels of Human Growth Hormone as a result of therapy likely suffer from some other ailment or deficiency which prevents them from producing sufficient HGH levels.

Regular Height Assessment is Important

Pediatric patients should undergo a height assessment at least twice a year as they continue Geref Therapy. It is important that children who take Geref experience growth rates that are consistent with both their stage of development and their age.

If Geref Sermorelin Acetate Treatments is discovered to be inadequate, other forms of therapy should be considered. HGH Hormone Replacement Therapy is the most common consideration for patients who have a waning or poor response to Ger
ef Treatments.

Avoid Contamination of Geref Sermorelin Acetate Therapy

To avert contamination risk, clean the rubber stopper containing the reconstituted solution before piercing it with the needle. It is also strongly recommended that Geref be injected using disposable and sterile needles and syringes. The syringe should be small enough to where the proper dose of Geref can be drawn with reasonably high accuracy.

After the correct dose has been determined, the vial of Geref should be reconstituted using 0.5-1.0 milliliters of NaCl solution.

In order to reconstitute Geref Sermorelin Acetate, insert the diluent into the Geref vial via injection. Tilt the vial in a manner so that the liquid rolls down the wall of the vial onto the active ingredient below. Gently swirl the container in a circular motion until the solution has become completely dissolved.

IMPORTANT: Geref should not be administered if there are visible particles in the solution after reconstitution, nor should it be used if the resultant reconstitution is cloudy.

Before Geref Therapy is Reconstituted for use, it must be refrigerated at a temperature between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius). Expiration dates are also clearly shown on the label. If the Vial becomes unrefrigerated or becomes expired, the treatment should be discarded.

 

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