Vitagon(TM) by Alpha Pharma – Human Chorionic Gonadotrophin(HCG)  for Injection (B.P.) 

5,000 IU multidose vials – 3 per Box (15,000 IU total) with (3) ampules of bacteriostatic water:

HCG mimics LH and can be used to re-start natural endogenous testosterone production after the body has stopped producing it from androgen therapy.  HCG also helps to restore the size and function of the testicles.

Typical Protocol:   Dosing 250-500 IU  – 3 times per week SQ during androgen therapy and from 2 to 3 weeks after cessation of therapy to maintain testicular function.

Presentation

Each carton contains 3 vials of 5000iu/vial + 3 x 1ml solvent.

FULL DESCRIPTION

Human Chorionic Gonadotrophin (HCG) is often used to stimulate endogenous testosterone production in hypogonadal male patients. HCG is an analogue for Luteinizing Hormone (LH) and can cause testicular Leydig cells to produce testosterone.  HCG and LH share a common structural subunit.  Testicular Leydig cell populations diminish with aging leading to reduced endogenous testosterone production.  As this course continues, LH and HCG may offer some improvement in testosterone production, but often is insufficient to replace the need for exogenous testosterone supplementation, particularly in the instance of men over 50.

In patients with reduced LH output (hypogonadotrophic hypogonadism), HCG acts as an effective substitute causing the Leydig cells to produce testosterone.  Leydig cell response may be delayed after long periods of testicular dysfunction and atrophy consequent to HPTA suppression from exogenous androgen use.

In some patient populations, HCG alone may be an effective option to increase serum testosterone levels, however most practitioners prefer HCG’s application for male hypogonadism with concomitant exogenous testosterone therapy.  HCG also serves to reduce testicular atrophy, increase testicular volume, and increase total ejaculate volume.

Traditional HCG protocol for HPTA suppressed male patients is 2000-4000 IU IM every 4 to 5 days for 2 to 3 weeks.  As research suggests a diminishing return on endogenous testosterone response to HCG with increasing dosages above 500 IU per day, many practitioners have begun lower dosing regiments spread over greater time ranging from daily to bi-weekly injections, often SQ.

HCG treatment for male hypogonadism is often in conjunction with SERM class medications such as clomiphene citrate and raloxifene citrate.  HCG treatments in hypogonadal men with functioning Leydig cells result in a bimodal response curve for serum testosterone with a surge several hours after the first injection and a secondary peak reaching maxima at 2 days.

PRESCRIBING INFORMATION:

HUMAN CHORIONIC GONADOTROPHIN (HCG) has been approved for:

Fertility applications both male and female

Treatment of cryptorchidism (testicular non-descent) in prepubescent males

DESCRIPTION

Human chorionic gonadotropin (hCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-units are of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The beta sub-units of these hormones differ in amino acid sequence.

Chorionic Gonadotropin is a water soluble glycoprotein derived from human pregnancy urine.

The sterile lyophilized powder is stable. When reconstituted, the solution should be refrigerated and used within (30) days.

Each vial, when reconstituted with provided diluent, will contain: Chorionic Gonadotropin 5,000 International Units (IU).

CLINICAL PHARMACOLOGY

The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. This descent is usually reversible when HCG is discontinued. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function.

During a normal pregnancy HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases supporting continued secretion of oestrogens and progesterone and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE, SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.

INDICATIONS

HCG HAS NOT BEEN DEMONSTRATED TO BE AN EFFECTIVE ADJUNCT THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG PRODUCES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to predict whether or not orchiopexy will be needed in the future. Although in some cases descent following HCG administration is permanent, in most cases the response is temporary. Therapy is usually instituted between the ages of 4 and 9.

Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.

Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and those who have been appropriately pretreated with human menotropins.

CONTRAINDICATIONS

Precocious puberty, prostatic carcinoma or other androgen-dependent neo-plasm. Prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare’s serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice in a dose-dependent manner. The potential extrapolation to humans has not been determined.

DOSAGE AND DIRECTIONS FOR USE

The dosage regimen employed in any particular case will depend upon the indication for use, the age and weight of the patient, and the physician’s discretion. The following regimens have been advocated by various authorities.

Prepubertal cryptorchidism not due to anatomical obstruction:

4,000 Units three times weekly for three weeks.

5,000 Units every second day for four injections.

15 injections of 500 to 1,000 Units over a period of six weeks.

500 Units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later, giving 1,000 Units per injection.

Selected cases of hypogonadotropic hypogonadism in males:

500 to 1,000 Units three times a week for three weeks, followed by the same dose twice a week for three weeks.

4,000 Units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 Units three times weekly for an additional three months.

Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who have been appropriately pre-treated with human menotropins (See prescribing information for menotropins for dosage and administration for that drug product):

5,000 to 10,000 Units one day following the last dose of menotropins.

(A dosage of 10,000 Units is recommended in the labeling for menotropins).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

WARNINGS

HCG should be used in conjunction with human menopausal gonadotropins (hMG) only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are:

Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion.

Enlargement of pre-existing ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum.

Multiple births.

Arterial thromboembolism.

The diluent used for reconstitution contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

General:

Induction of androgen secretion by HCG may induce precocious puberty in patients treated for cryptorchidism. Therapy should be discontinued if signs of precocious puberty occur.

Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

Drug/Laboratory test:

HCG can cross-react in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of cross-reactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

There have been sporadic reports of testicular tumors in otherwise healthy young men receiving HCG for secondary infertility. A causative relationship between HCG and tumor development in these men has not been established. Defects of the forelimbs and of the central nervous system as well as alterations in sex ratio have been reported in mice on combined gonadotropin and HCG regimens. The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans.

Fertility – see “INDICATIONS” and “DOSAGE AND DIRECTIONS FOR USE.”

Pregnancy: Teratogenic effects – Category X:

See “CONTRAINDICATIONS” section.

Combined HCG/PMS (pregnant mare’s serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 4 have not been established.

ADVERSE EFFECTS

May include headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.

PRESENTATION

Chorionic gonadotropin for injection is available in 3ml lyophilized multiple dose vial sets containing 5,000 Units per Vial with accompanying 2 ml ampule of bacteriostatic water for injection.

STORAGE

Store in a cool dry place (3 ºC – 8 ºC )

Protect from light.