Genotropin Hgh Detailed Description

Genotropin Hgh Detailed Description


signs health and symptoms of low testosterone in males

Description:

Lyophilized Powdered Genotropincontains Recombinant-DNA [rDNA] derived somatropin. Somatropin is apolypeptide hormone comprised of a chain of 191 residues of aminoacid, and it has a molecular weight o 22,124 daltons. Somatropin'ssequence of amino acids is exactly the same as that of Human GrowthHormone which originates in the pituitary gland. Genotropin iscreated through a modification of a particular strain of E. coli toinclude the gene that is responsible for Human Growth Hormone.Genotropin comes in the form of a white, sterile powder,lyophilized and intended for injection subcutaneously.

Genotropin 1.5 milligram isadministered using a 2-chambered cartridge. The front compartmentholds 1.5 milligrams of rDNA-derived somatropin (about 4.5 IU),27.6 milligrams of glycine, 0.3 milligrams or anhydrous sodiumdihydrogen phosphate, and 0.3 milligrams of anhydrous disodiumphosphate. The rear compartment holds 1.13 milliliters of waterused for injection.

Genotropin 5.8 milligram isadministered using a 2-chambered cartridge. The front compartmentholds 5.8 milligrams of rDNA-derived somatropin (about 17.4 IU),2.2 milligrams of glycine, 1.8 milligrams of mannitol, 0.32milligrams of anhydrous sodium dihydrogen phosphate, and 0.31milligrams of anhydrous disodium phosphate. The rear compartmentholds 0.3 percent m-Cresol for use as a preservative, along with 45milligrams of mannitol and 1.14 milliliters of water to be used forinjection.

Genotropin 13.8 milligram isadministered using a 2-chambered cartridge. The front compartmentholds 13.8 milligrams of rDNA-derived somatropin (about 41.4 IU),2.3 milligrams of glycine, 14.0 milligrams of mannitol, 0.47milligrams of anhydrous sodium dihydrogen phosphate, and 0.46milligrams of anhydrous disodium phosphate. The rear compartmentholds 0.3 percent m-Cresol for use as a preservative, along with 32milligrams of mannitol and 1.13 milliliters of water to be used forinjection.

Genotropin Miniquick is administeredby a one-time use syringe device that holds a 2-chamberedcartridge. Genotropin Miniquick, canbe attained in single doses varying from 0.2 milligrams to 2.0milligrams in increments of 0.2 milligrams. The front compartmentholds 0.22 to 2.2 milligrams of rDNA-derived somatropin (about 0.66to 6.6 IU), 0.23 milligrams of glycine, 1.14 milligrams ofmannitol, 0.05 milligrams of anhydrous sodium dihydrogen phosphate,and 0.027 milligrams of anhydrous disodium phosphate. The rearcompartment holds 12.6 milligrams of mannitol in 12.6 millilitersof water to be used for injection 0.275 milliliters.

Genotropin is prepared in a highlypurified manner. The recombinant reconstituted solution ofsomatropin has an pH of about 6.7 and an osmolality of about 300mOsm/kg. Concentration of the somatropin solution is dependent uponthe presentation and strength (read more in the sectionHowSupplied).

ClinicalPharmacology

Clinical, preclinical, and in vitrotests show that Powdered Lyophilized Genotropin is equivalent toHuman Growth Hormone that originates naturally in the pituitary interms of therapeutic results.

The body reacts in a similar fashionto Genotropin as it does to the Human Growth Hormone createdinternally in the average adult. Genotropin therapy in childpatients who suffer from a growth hormone deficiency (GHD) succeedsin stimulating normal growth and balances concentrations ofSomatomedin-C/Insulin-like Growth Factor (IGF-1). Genotropintreatment in adults who are maligned with Growth Hormone Deficiencyoften results in a lower level of body fat, an increased amount oflean muscle mass, and changes in metabolism that include positivechanges in the metabolism of lipids and the balance ofconcentrations of IGF-1.

Also, many other results have beenshown through the administration of somatropin and/or Genotropin,including:

Tissue Growth

Skeletal SystemGrowth: Genotropin hasbeen shown to stimulate the growth of the skeletal system in youngpatients who suffer from Growth Hormone Disorder. There is asignificant increase in the length of the body through the use ofGenotropin that results from its effect upon the epiphyseal plateswhich develop inside the long bones. Serum levels of Insulin-LikeGrowth Factor-1, which likely play a part in the growth of theskeletal system, are found to usually be quite low in youngpatients suffering from Growth Hormone Disorder. These levelsincrease when the patient undergoes Growth Hormone ReplacementTherapy with Genotropin. Higher serum concentrations levels ofalkaline phosphatase also are seen with treatment.

Cell Growth: Research has shown that young, short-staturedchildren have a lesser number of skeletal muscle cells because theyhave an insufficient level of natural Growth Hormone in comparisonto the normal child population. Treatment with Genotropin leads toa boost in both the size and number of these musclecells.

Protein Metabolism

Linear, normal growth in childhoodis in part facilitated through an increase in the synthesis ofcellular proteins. Retention of nitrogen, which is shown through adecrease in the excretion of nitrogen through urination, as well asthrough blood test measurements of nitrogen in the urea, is one ofthe many physiological changes that occur through Genotropintherapy.

CarbohydrateMetabolism

Children who suffer fromhypopituitarism often also experience hypoglycemia when fasting,and this issue is also alleviated through Genotropin treatment,though excessive doses of Human Growth Hormone can lead to glucoseintolerance.

Lipid Metabolism

In those who are deficient in GrowthHormone, Genotropin therapy has been shown to result in themobilization of lipids, allowing for a reduction in storage of bodyfats and a higher level of fatty acid in the plasma.

Mineral Metabolism

Genotropin also can lead to aretention of phosphorus, potassium, and sodium. Concentrations ofinorganic phosphate in the blood stream are also increased in thosepatients maligned with Growth Hormone Disorder who go throughGenotropin Hormone Therapy. Levels of calcium in serum are notchanged in a significant manner through the use of Genotropin, andHuman Growth Hormone can lead to calciuria.

Body Composition

Adult patients who suffer fromGrowth Hormone Disorder that are treated with Genotropin at thesuggested adult dosage (view Dosage and Administration for moreinformation) show a decreased level of body fat and an increasedlevel of lean muscle mass. These changes occur at the same timethat the body begins to retain fluid more effectively. The resultof all of this is that Genotropin has the ability to positivelymodify the composition of the body, and these positive changes canbe sustained through continuing treatments.

Pharmakonetics

Absorption

After delivering a 0.03milligram/killigram subcutaneous (abbreviated SC) thigh injectionof 1.3 milligram/milliliter Genotropin to an adult patient withGrowth Hormone Disorder, around 80% of the total dose was availablefor usage by the body in comparison to that available to the bodythrough an intravenous dose. The results were similar in bothfemale and male hormone replacement therapy patients, and a similarlevel of bioavailability has been shown in healthy male adultsubjects as well.

In adult healthy males, after asubcutaneous thigh injection of 0.03 mg/kg, the extent of AUCabsorption of a 5.3 mg/ml concentration of Genotropin proved to be35% higher than that from 1.3 mg/mL Genotropin. The mean (plus orminus standard deviation) peak (max C) serum levels were 23.0 (plusor minus 9.4) ng/mL and 17.4 (plus or minus 9.2 ng/mL,respectively.

In another study of a similar kindwith pediatric Growth Hormone Deficiency patients, dosage of 5.3mg/mL Genotro
pin produced a mean area under the curve that happenedto be 17% higher than the mean AUC for 1.3 mg/mL Genotropin. Themean max C levels were 21.0 ng/mL and 16.3 ng/mLrespectively.

In yet another study, Adult GHDsufferers were administered two separate subcutaneous doses of 0.03mg/kg Genotropin at a 1.3 mg/mL concentration. There was a 1-4 weekperiod to washout between the injections. The mean max C levelswere 12.4 ng/mL for the first administration and 12.2 ng/mL for thesecond injection, and this was reached at around 6 hours after thedose was received.

No data exists regardingbioequivalence between the 12 mg/mL dosage and the 1.3 mg/mL or the5.3 mg/ml doses.

Distribution

The mean distribution volume ofGenotropin after it has been administrated to adults with GrowthHormone Deficiency was figured to be about 1.3 (plus or minus 0.8)L/kg.

Metabolism

Genotropin is metabolized in throughnormal protein catabolism which occurs in both the kidneys and theliver. In the kidney cells, some of the products of Genotropin'sbreakdown are filtered back into the circulation of the system. Theterminal mean half-life of Genotropin which is administeredintravenously in a normal adult is around 24 minutes, but whenGenotropin is administered subcutaneous, it has a half-life of 180minutes in adults with Growth Hormone Disorder. This significantdifference in half-life is due to the fact that when Genotropin isadministered subcutaneous it absorbs into the body at a much slowerrate.

Excretion

The mean of clearance or excretionof Genotropin which has been administered subcutaneously in a studyof 16 adult subjects with Growth Hormone Disorder was 0.3 (plus orminus 0.11) L/hrs/kg.

SpecialPopulations

Pediatric: Genotropin is broken down in adults in asimilar manner as it is broken down in children.

Gender:There have been no studies that attempt todifferentiate the difference in effect that Genotropin has betweenyoung boys and young girls, but it should be noted that Genotropinbioavailability has been found to be similar between adult female'sundergoing Growth Hormone Replacement Therapy and Male HormoneReplacement Therapy patients in regard to Growth HormoneDeficiency.

Race:No research has been conducted with regard towhether race plays a factor in the pharmacokinetic results ofGenotropin use.

Hepatic or renal insufficiency:There have been no research studies conducted in regard toGenotropin's effect on these particular populations ofpatients.

Table One

Average subcutaneous pharmacokineticparameters of adult patients who are deficient in GrowthHormone.

Bio-availability

(percentage)

(Number of participants = 15) MaxT

(Time [hours])

(Number of participants = 16)Clearance Rate

(Liters/hour ' kilogram)

(Number of participants = 16)Vol.Dis.

(Liters/kilogram)

(Number of participants = 16) T

(hours)

(Number of participants =16)

Average 80.5 / 5.9 / 0.3 / 1.3 /3.0

(St.Dev.) * ( 1.65)( 0.11) (0.80) ( 1.44)

95% CI 70.5 to 92 /. 5.0 to 6.7 /0.2 to 0.4 / 0.9 to 1.8 / 2.2 to 3.7

Max T= Time that has elapsed whenplasma concentration peaks

Clearance Rate = rate in whichGenotropin is excreted from the body

Vol/Dis = distributionvolume

T = timethat it takes the plasma concentration of Genotropin to reduce byhalf from its peak

St.Dev. = standarddeviation

Cl = interval ofconfidence

Absolute Genotropin bioavailabilityhas been estimated with the assumption that the data which has beentransformed by log will follow a normal, standard distribution. Thestandard deviation and mean of the transformed were a mean of 0.22and a standard deviation of plus or minus 0.241.

Clinical research with adult GrowthHormone Disorder patients

Lyophilized Genotropin Powder wastested along side a placebo in 6 clinical randomized trials whichinvolved 172 adult Growth Hormone Disorder patients in total. Thetrials featured a six month treatment period which was double-blindin nature. During this period, 85 participants were administeredGenotropin and 87 participants were administered a placebo. Afterthis, an open-label period of treatment followed. During thisperiod, patients who chose to participate were administeredGenotropin for a period of time as long as 24 months.

Genotropin was injectedsubcutaneously each day with a dosage of 0.04 mg/kg dose of 0.04mg/kg/wk during month one of treatment and in the subsequent monthsthereafter it was administered at 0.08 mg/kg/wk

After the six-month period oftreatment, researchers looked for changes that were beneficial tothe composition of the body for both the group that receivedGenotropin injections as well as the group which receivedinjections of placebo. It was found that in the Genotropin grouplean muscle mass, total water retention, and the ratio of lean/fatimproved, while circumference of the waist and total mass of bodyfat reduced to more healthy levels. The effects of Genotropin onthe composition of the body were retained with those who pursuedtreatment past the initial six month period. Mineral bone densitybegan to decline after six months of treatment, but after twelvemonths of treatment the density values returned tobaseline.

Usage andIndications

Lyophilized Genotropin Powder isdesigned for long-term therapy of pediatric patients that sufferfrom growth failure as a result of the inadequate production ofendogenous Human Growth Hormone. It is not recommended for othercauses of short stature.

Genotropin is also designed forlong-term Growth Hormone Replacement Therapy for adults that sufferfrom a Growth Hormone Deficiency that is of either adult orchildhood-onset in its etiology. Growth Hormone Disorder should bediagnosed through an appropriateGrowth Hormonestimulationtest.

Contraindictions

Lypophilized Genotropin Powdershould not be used if an individual shows any signs of neoplasticactivity. Intracranial spade occupying lesions must be inert andantitumor treatment must be complete before Genotropin therapybegins. If the tumor begins to grow again, Genottropin treatmentshould be discontinued immediately. Also,Growth Hormoneshould no beadministered as a means to promote growth in children who havefused epiphsys in the long bones.

Human Growth hormone treatmentsshould not be administered to provide therapy for individuals whohave an acutely critical illness stemming from abdominal or openheart surgery, multiple physical accidental trauma, or to those whohave suffered acute respiratory failure.

A pair of clinical research trialsinvolving 522 total adult participants that showed no signs ofGrowth Hormone Deficiency who suffered from these conditions wereconducted. The results of these two studies revealed that there wasa significantly higher incidence of mortality (41.9% vs. 19.3%)affecting those who were treated with somatropin (5.3 to 8 mg/daydosage) in comparison to those that merely received placebo(read Warningsfor more information).

Warnings

The 13.8 mg and 5.8 mg preparationsof Lyophilized Genotropin Powder contain the preservative m-Cresol.Those who have a sensitivity or allergy to this preservative shouldnot use these products. The Genotropin Miniquick and Genotropin 1.5mg preparations do not have m-Cresol, or any preservative (Readthe HowSupplied section for moreinformation).

Read the Contraindictions section for more information about increasedmortality risk in those who suffer from critical illnesses in ICUbecause of complications due to abdominal or open heart surgery,multiple trauma due to an accident, or those who are suffering fromacute respiratory failure. The proper research has not beenestablished regarding the safety of continuing to undergo GrowthHormone Replacement Therapy for those who would be eligible for thetreatment but also concurrently begin to suffer from the aboveailments. For this reason, the possible benefits of Growth HormoneReplacement Therap
y in those patients who are suffering fromcritical, acute injuries must be weighed against the possible risksof hormone treatment. The pros and cons of hormone replacement therapymust be properly evaluated.

Precautions: Is it time to thinkabout stopping hormone replacement therapy?

General

Therapy with Lyophilized GenotropinPowder, should be guided by HRT doctors who have experience in themanagement and diagnosis of patients with Growth Hormone Disorder,as should be the case with the usage of any Growth Hormonepreparation.

Caregivers and patients that willinject Genotropin in situations that are medically unsupervised aresternly advised to attain proper instruction and training about howto properly use Genotropin. This training should be given by aspecialized doctor or other properly trained healthprofessional.

Patients who suffer from GrowthHormone Disorder in addition to an intracranial lesion need tovisit their doctor with regularity to monitor the development orrecurrence of the underlying process of their disease. A survey ofreports regarding the use of somatotropin replacement therapy showsno correlation between somatropin replacement therapy and tumors ofthe central nervous system. Later in life, there has beeninsufficient research to discover is there is any sort of causalrelationship between the occurrence of Central Nervous Systemtumors and Somatropin Treatment

It is also vitally important thatpatients be carefully monitored for the formation of malignantlesions on the skin.

Caution is advised if Human GrowthHormone Therapy is administered to those that are already sufferingfrom diabetes mellitus, because the level of insulin intake mayneed to be changed as a result of the hormone therapy. Thoseundergoing Growth Hormone Replacement Therapy should be monitoredfor the development of a glucose intolerance because Growth Hormonecan sometimes give rise to a state where one is more resistant toinsulin. Those patients that have a glucose intolerance or diabetesmust be closely monitored while taking Genotropin. If majorcomplications begin to arise it may be time to think about stoppinghormone replacement therapy.

With those that have been diagnosedwith hypopituitarism (a disease that is the result of multipledeficiencies of the hormonal system), the normal regimen of HormoneReplacement Therapy should be closely monitored when Genotropintreatment commences. Hypothyroidism can develop as one is treatedwith Genotropin, and as a result, inadequate medical response tohypothyroidism can cause Genotropin to become less effective orineffective. For this reason, it is pertinent that patients gettested for proper thyroid function periodically, and if the thyroidbecomes less active, thyroid hormone should also be administered intandem with Genotropin.

Pediatric patients who have disorderof the endocrine system such as Growth Hormone Disorder have beenshown to have a greater risk of developing a slipped capitalfemoral epiphyses. Any young patient that develops a limp or beginsto complain of knee or hip pain as they undergo Growth HormoneTherapy needs to undergo evaluation.

Intracranial hypertension (IH) withnausea, vomiting, headache, visual disruption, and/or papilledemahas been shown to be a side effect in a small minority of patientsthat take Growth Hormone therapies. These issues occur usuallywithin the first two months after one begins GHT. In each reportedcase, and signs of Intracranial Hypertension are alleviated afterhormone therapy is terminated or the dosage is adjusted to a moreminute amount. Examination of the ocular fundus is recommended as apatient begins therapy, and it is also advised that they areexamined for Intracranial Hypertension periodically as he or shecontinues Therapy.

Before undergoing adult treatmentfor Growth Hormone Deficiency, a patient who has undergone pubertyand received GHRT in their childhood needs to be reevaluated in amanner that is recommended in the section Indications and Usage. If it is advisable to continue treatment,Genotropin therapy should continue at a lower level of dosage thatis more appropriate for adults who have Growth HormoneDisorder.

Drug Interactions

Undergoing treatment withglucocorticoids concomitantly with Growth Hormone can cancel outthe growth promotional effect of Hormone Therapy. Pediatric GrowthHormone deficiency patients that have a coexisting deficiency ofACTH aneed to have their dose adjusted carefully so that theglucocorticoid does not inhibit the effect of the Growth HormoneReplacement Therapy. For more information, see Precautions. Though there is limited published research onthe subject, it has been indicated that in humans, GHT increasesantipyrine evacuation mediated by CP450 (cytochrome P450). Theavailable data seems to suggest that Growth Hormone administrationcan alter the evacuation of the compounds that become metabolizedthrough the liver enzyme CP450. These compounds include sexualsteroids, cyclosporine, anticonvulsants, and corticosteroids. It isadvised that a patient undergo careful monitoring when Genotropinis injected in addition to other drugs that are metabolized by theliver enzyme CP450.

Mutagenesis, Carcinogenesis, andFertility Issues with Human Growth Hormone ReplacementTherapy

Studies of carcinogenicity have yetto be conducted in regard to bio identical Human Growth Hormone. Anumber of tests have shown no evidence of the mutagenicity of HumanGrowth Hormone. The tests conducted include the Ames Test in whichgene mutations are introduced to bacteria, mutation of genes inmammalian cellular cultures grown in vitro (L5178Y cells), anddamage to the chromosomes of intact animals (rat marrow cells). Tolearn more about issues regarding fertility, go to the sectionentitled Pregnancy.

Pregnancy CategoryB

Fertility studies enacted in regardto Genotropin at dosage levels of 0.3, 1, and 3.3 milligrams perkilogram per day delivered subcutaneously to rats and dosage levelsof 0.08, 0.3, and 1.3 milligrams per kilogram per day deliveredintramuscularly to rabbits resulted in a reduction in the bodyweight of the mother but the reduction was not teratogenic. Thehighest administered doses were about 24x and 19x the normal humanlevels for therapy, respectively, based upo the surface area of thebody.

Rats received subcutaneous doses ofGenotropin during gametogenesis and through the initial seven daysof pregnancy at a rate of 3.3 mg/kg/day. This level is about 24xhigher than the normal human dosage. This dosage produced extendedcycles of estrous in females (known as anestrus), and fewer, lessmotile sperm in male rats. When Genotropin was administered tofemale, pregnant rats during days one through seven of gestation at3.3 mg/kg/day, a modest increase of fetal mortality occurred. Whenadministered 1 mg/kg/day (which is around 7x the normal human dose)rats displayed estrus cycles which were only slightly extended. Ata dosage of 0.3 mg/kg/day there were no noted effects.

In postnatal and perinatal study ofrats, doses of Genotropin at 0.3, 1, and 3.3 mg/kg/day resulted inthe promotion of growth of the dams but not of the fetuses,themselves. Young rats exposed to 3.3 mg/kg/day were discovered tohave an increase in weight gain during the suckling period, butthese effects were no longer apparent at ten weeks old. There wereno negative effects observed during morphogenesis, gestation,lactation, parturition, postnatal continued development, or thefertility of the offspring as a result of Genotropin. It isimportant to note, however, that there have been no adequate,well-conducted studies of pregnant women in regard to Genotropin.Studies regarding animal reproduction do not always correctlypredict the equivalent human response to the same stimulus,therefore, Genotropin should only be used during pregnancy if it isclearly and absolutely needed.

Mothers who arenursing

No studies have been conducted withregard to Genotropin and nursing mothers. At this point it is notclear whether the drug is present in human milk
. Since it is a factthat a number of drugs are released in human milk, caution must beexercised with the administration of Genotropin to a nursingfemale.

Bioidentical hormone replacementtherapy side effects

As with all drugs that areprotein-derived, a small minority of patients can begin tomanufacture antibodies to the administered protein. Growth Hormoneantibody with a lower binding than 2 mg/L has not been shown to beassociated with the attenuation of growth. In those cases where thecapacity for binding is greater than 2 mg/L, antibodies sometimesinterfere with the desired results for growth.

In a survey of 419 pediatric GHTpatients which were administered Lyophilized Genotropin powder, 244were previously treated with Genotropin and 175 were undergoing GHTfor the first time. Baseline presence of Anti-Growth Hormoneantibodies had developed in 6 patients who were previously treatedwith Genotropin. 3 of those 6 once again tested negative foranti-Growth Hormone antibodies during six to twelve months ofGenotropin treatment. Out of the rest of the group (413 patients),8 (1.9% of the population) acquired detectable levels anti-GrowthHormone antibodies during Genotropin treatment. None of theseantibodies reached a binding capacity of greater than 2mg/L. As aresult, the patients who tested positive for Human Growth Hormoneantibodies experienced no hindrance to Genotropin's intended growthresponse.

Genotropin preparations do containtrace amounts of periplasmic E. coli peptides (abbreviated PECP).Antibodies resistant to PECP develop in a small minority of thosetreated with Genotropin, but these antibodies do not create anyissues of significance.

Clinical Genotropin studies withpediatric Growth Hormone Deficient patients uncommonly reported thefollowing side effects: burning and pain around the administrationsite, nodules, inflammation, fibrosis, rash, bleeding, or skinpigmentation. Other side effects include headache, hypothyroidism,lipoatrophy, hematuria, and mild hyperglycemia.

There have been a limited number ofreports of leukemia among young patients who have undergone GHTincluding pituitary-derived Growth hormone and Bio-Syntheticsomatropin. The correlation, if any, between GHT and leukemia isunclear at this time.

In a survey of clinical Genotropintrials in 1,145 adults with Growth Hormone Deficiency, the mostreported side-effect was mild or moderate fluid retention resultingin hypoesthesia, paresthesia, myalgia, peripheral edema, stiffnessand pain in the extremities, peripheral swelling, and arthralgia.The previous side effects were noted early in Genotropin Therapyand they often subsided with time or disappeared with a reductionin dosage.

Table 2 shows sideeffects reported by five percent ormore of adult patients with Growth Hormone Deficiency in a varietyof clinical trial settings and after a number of differentGenotropin treatment durations. Also corresponding rates of sideeffect incidence are listed for those who underwent placebotreatment during the six-month portion of double-blind clinicaltrials.

Table 2

Side effects reported by greaterthan or equal to 5 percent of a total of 1,145 Growth HormoneDeficient adult patients who participated in clinicaladministration of placebo and Genotropin, arranged by treatmentduration, double-blind, and open-label phase. Percentages arerounded to the nearest 0.5%

Genotropin

Side-effects

Placebo Patients

0-6 months

n = 572

# Genotropin Patients

0-6 months

number of participants =573

Percentage patients six-twelvemonths

n = 63

Percentage of patientstwelve-eighteen months

n = 63

Percentage of patientseighteen-twenty four months

n = 60

Percentage Patients Reporting SideEffect

Peripheral Swelling 5.0 / 17.5* /5.5 / 0 / 1.5

Infection of the upper respiratorytract 14.5 / 15.5 / 13.0 / 15.0 / 13.5

Arthralgia 4.0 / 17.0* / 7.0 / 6.5 /3.5

Extremity stiffness 6.0 / 15.0* /6.5 / 1.5 / 3.5

Tingling sensation 1.0 / 9.5* / 2.0/ 3.0 / 0

Peripheral edema 2.5 / 11.0* / 3.0 /0 / 0

Extremity Stiffness 1.5 / 8.0* / 2.5/ 1.5 / 0

Headache 8.0 / 10.0 / 6.0 / 00

Pain reported in back 4.5 / 3.0 /3.5 / 5.0 / 5.0

Muscle pain 1.5 / 5.0 * / 2.0 / 5.0/ 7.0

Fatigue 4.0 / 6.0 / 4.5 / 6.5 /1.5

* Significant increase in comparisonto those taking placebo. P n =

# of patients that receivedtreatment in the specific period.

% = Patient percentage whoexperienced the side effect in the specific period.

In expanded study which occurredpost-trial, diabetes was reported in twelve out of a total 3,031patients as they were treated with Genotropin, only 0.4$ of thepopulation. Each of the twelve patients showed risk factors fordiabetes such as significant obesity or high levels of glycatedhemoglocin, before beginning Genotropin Treatment. Out of that samepool of 3,031 Genotropin-receiving patients, only 2% (61) developedcarpal tunnel symptoms, and this number dropped by 52 aftertreatment interruption or dosage adjustment, and the other ninefound their symptoms alleviated by surgery. Other side effects thatwere reported in the study included hypoesthesia and generaledema.

Overdose

Little information is availableregarding chronic or acute overdosage of Lyophilized GenotropinPowder. Growth Hormone adminstered intravenously has shown evidencethat it results in a severe decrease in the plasma of the blood.For this reason, hyperglycemia sometime occurs as a result. It ishypothesized that this same issue could occur in the rare instancewhere a very high dose of Genotropin is administeredsubcutaneously. Overdosage over the long term could result inhormone imbalance symptoms and signs of acromegaly that areconsistent with the nature overproduction of Human Growth Hormone.Make sure to engage in safe hormone replacement therapy.

Administration andDosage

The appropriate dosage ofLyophilized Genotropin Powder is dependent upon the individualneeds of the patient. The dosage for the week ideally is dividedinto six or seven SC injections. The injection of Genotropin can beadministered to the abdomen, buttocks, or thigh. The area where thesubcutaneous injection occurs should change each day so thatlipoatrophy is averted.

For Pediatric Growth HormoneDeficiency patients, a dosage of 0.16 to 0.24 milligrams perkilogram of body weight per week is generally the recommendeddosage.

For Adult Growth Hormone DeficiencyPatients, the initial recommended dose when one begins therapy isgenerally not greater than 0.04 mg/kg/week. Every four to eightweeks, the dosage can be increased as needed for the patient up toa max of 0.08 mg/kg/week dependent upon the patient's tolerance forthe treatment. Response to the medicine, developed side effects,and levels of age-adjusted Insulin-Like Growth Factor-1 in serumcan all be used to provide a guide leading to a proper titration ofdosage. This regimen tends to lead to larger weight-adjustedtreatment for woman than men, and smaller weight-adjusted treatmentfor obese and older patients.

Do not inject Genotropinintravenously.

Genotropin is provided in atwo-chambered cartridge, with the lyophilized powder located in thefront compartment and a dilutant located in the rear compartment. Areconstitution device mixes the dilutant and the powder.

Each device has its own directionsto follow for proper reconstitution. It is vital that the medicineis not shaken, because shaking can lead to denaturation of theprimary ingredient.

Before injection, all parenteralmedicinal products need to be visually inspected for discolorationand particulate matter, if the container and solutionpermit. If the solutionhas become cloudy, it is vital that the contents are notinjected.

Caregivers and patients that willadminister the Genotropin in situations in situations where theyare not medically supervised are urged to visit one of manybioidentical hormone physicians other appropriately qualifiedhealth professionals in o
rder to acquire the appropriateinstruction and training regarding the proper administration ofGenotropin.

Storage andStability

Except in proceeding situation,store Lyophilized Genotropin Powder in refrigeration at 2-8 degreesCelsius (36-46 degrees Fahrenheit). Refrain from freezing. Store ina light-protected area.

The 1.5 mg Genotropin Cartridgecontains a dilutent without a preservative. After the drug isreconstituted, a cartridge can be stored safely for up to a day.Use it only once and throw away any solution thatremains.

The 13.8 and 5.8 mg Genotropincartridges contain a dilutent that is laced with a preservative.For this reason, these cartridges may be stored in refrigeration aslong as three weeks.

The Genotropin Miniquick GrowthHormone Delivery Device needs to be refrigerated before it isdispensed, but it can be placed in storage at a temperature of 25degrees Celsius (77 degrees Fahrenheit) or less for a period of aslong as 3 months after it is dispensed. The dilutent does notcontain preservative. After the Genotropin Miniquick has beenreconstituted, it may be placed in storage under refrigeration forup to one day before usage. After it is used one time it should bediscarded.

How Supplied

Lyophilized Genotropin Powder isavailable for purchase in the following configurations:

1.5 milligram two-chamberedcartridge (without preservative)

  • mg/mL concentration (about 4IU/mL)

  • Preconfigured in a GenotropinIntramix GH Reconstitution Device which is packaged with a singlepressure release needle

    Five Cartridge Package National DrugCode 0013-2606-94

    5.8 milligram two-chamberedcontainer (added preservative)

    5 mg/mL concentration (about 15IU/mL)

    Intended for usage with theGenotropin Mixer GH Reconstitution device and/or the Genotropin Pen5 GH Delivery Device

    Five Cartridge package National DrugCode 0013-2626-94

    One Cartridge package National DrugCode 0013-2626-81

    Preconfigured in a GenotropinIntramix GH Device for Reconstitution and packaged with one needlewhich functions through pressure release.

    Package of five National Drug Code0013-2616-94

    Package of one National Drug Code0013-2616-81

    13.8 milligram two-chamberedcontainer (added preservative)

    12 mg./mL concentration (about 36IU/mL)

    Intended for usage with theGenetropin Mixer GH Reconstitution device and/or the Genotropin Pen12 GH Delivery Device

    Box of Five National Drug Code0013-2646-94

    Box of One National Drug Code0013-2646-81

    Genotropin Miniquick GH DeliveryDevice contains a two-compartment cartridge containing atwo-chamber cartridge of GENOTROPIN (no preservative)

    After it is reconstituted, everyGenotropin Miniquick released a 0.25 mL fixed dose without regardto strength. It is available in the proceeding strengths inpackages of seven.

    0.2 milligram National Drug Code0013-2649-02

    0.4 milligram National Drug Code0013-2650-02

    0.6 milligram National Drug Code0013-2651-02

    0.8 milligram National Drug Code0013-2652-02

    1.0 milligram National Drug Code0013-2653-02

    1.2 milligram National Drug Code0013-2654-02

    1.4 milligram National Drug Code0013-2655-02

    1.6 milligram National Drug Code0013-2656-02

    1.8 milligram National Drug Code0013-2657-02

    2.0 milligram National Drug Code0013-2658-02

    Benefits Igf 1 Of Deer Antler Velvet