Prolific Injection

Prolific Injection is used for: Anovulatory infertility, Adjunct to IVF procedures and other assisted conception techniques, Induction of Ovulation & Pregnancy

Adults Intramuscular Induction of Ovulation & Pregnancy 5,000-10,000 units 1 day following the last dose of menotropins Induction of Spermatogenesis Hypogonadotropic and hypogonadism in males: 1000-2000 units 2-3 times/week (may require 2-3 months of therapy); if needed, add follitropin alfa or menopausal gonadotropin to induce spermatogenesis; continue hCG therapy at the dose required to maintain testosterone levels Prepubertal cryptorchidism in males Adult: 500-4000 u injected 3 times wkly. Treatment should continue for 1-2 mth after testicular descent. Male infertility due to hypogonadotrophic hypogonadism Adult: 500-4000 u injected 2-3 times wkly. Anovulatory infertility Adult: Single dose of 5000-10,000 u. Up to 3 repeated injections of up to 5000 u each may be given within the following 9 days to prevent corpus luteum insufficiency. Delayed puberty associated with hypogonadism in males Adult: Male: Initially, 500-1500 u twice a wk titrated against plasma-testosterone concentration.

Child Intramuscular Prepubertal Cryptorchidism Not Caused By Anatomical Obstruction May institute therapy between ages of 4 and 9 4,000 units IM 3 times/week for 3 weeks 5,000 units IM every second day for 4 injections 15 injections of 500 to 1,000 units IM over a period of 6 weeks 500 units IM 3 times/week for 4-6 weeks; if course of treatment not successful, begin another 1 month later, giving 1,000 units/injection Male Hypogonadotropic Hypogonadism 500-1,000 units IM 3 times/week for 3 weeks, followed by same dose twice/week for 3 weeks 4,000 units IM 3 times/week for 6-9 months; following that dosage may be reduced to 2,000 units 3 times/week for an additional 3 months

Hypersensitivity to drug or components Precocious puberty Prostatic carcinoma or other androgen-dependent neoplasms High serum FSH, indicating primary gonadal failure in women Presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders) Tumors of hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males Malformations of reproductive organs incompatible with pregnancy Fibroid tumors of uterus incompatible with pregnancy Abnormal vaginal bleeding of undetermined origin

To be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in package insert for menotropins Use with caution in cardiovascular disease, asthma, history of migraines, renal impairment, seizure disorders Not effective in treatment of obesity May induce precocious puberty in children being treated for cryptorchidism (discontinue if signs of precocious puberty occur Safety and efficacy not established in children <4 years of age Anaphylaxis reported with urinary-derived HCG products Principal serious adverse reactions during this use are ascites with or without pain, and/or pleural effusion, rupture of ovarian cysts with resultant hemoperitoneum, multiple births, and arterial thromboembolism For pediatric use, induction of androgen secretion by HCG may induce precocious puberty in pediatric patients treated for cryptorchidism; therapy should be discontinued if signs of precocious puberty occur Incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions; this slightly higher incidence is thought to be related to differences in parental characteristics (eg, maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART; there are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations Infertile women undergoing assisted reproductive technologies (ART) have increased incidence of ectopic pregnancy; early ultrasound confirmation that a pregnancy is intrauterine is therefore important Risk of spontaneous abortion (miscarriage) is increased with gonadotropin products; however, causality has not been established; the increased risk may be a factor of the underlying infertility There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug therapy for ovarian stimulation; however, a causal relationship has not been established Induction of androgen secretion by hCG may cause fluid retention; use hCG with caution in patients with cardiac or renal disease, hypertension, epilepsy, migraine, or asthma Evaluate patients for uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal or pituitary disorders) and provide the appropriate specific treatment Gonadotropin therapy, including hCG, requires certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities; safe and effective induction of ovulation with use of this drug requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis Ovarian torsion has been reported after treatment; ovarian torsion may be related to other conditions, such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, and previous or current ovarian cysts; damage to ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion Ovarian hyperstimulation syndrome Ovarian hyperstimulation syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event; OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium The early warning signs of the development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain; abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions; transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy, reported in association with OHSS OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment; usually, OHSS resolves spontaneously with onset of menses If there is evidence that OHSS may be developing prior to hCG administration, withhold hCG; cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, assess women for development of OHSS for at least two weeks after hCG administration Pulmonary and vascular complications Serious pulmonary conditions (eg, atelectasis, acute respiratory distress syndrome) reported in women treated with gonadotropins; in addition, thromboembolic reactions both in association with and separate from OHSS reported following gonadotropin therapy Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities; women with generally recognized risk factors for thrombosis, such as a personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarction

Pregnancy Intrauterine death and impaired parturition observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times maximum human dose of 10,000 USP, based on body surface area Lactation Not known whether this drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution if hCG administered to a nursing woman The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

Interactions of Human chorionic gonadotrophin with other medicines have not been investigated; interactions with commonly used medicinal products cannot be excluded. Following administration, Human chorionic gonadotrophin may interfere for up to 10 days with the immunological determination of serum/urinary human chorionic gonadotropin (hCG), leading to a false positive pregnancy test. Incompatibilities: In the absence of compatibility studies, Pregnyl must not be mixed with other medicinal products.

Side effects of Chorionic Gonadotrophin : Frequency Not Defined Headache Irritability Depression Edema Restlessness Gynecomastia Precocious puberty Fatigue Arterial thrombus Ovarian hyperstimulation syndrome Overian cyst rupture

Chorionic Gonadotrophin is a polypeptide hormone produced by the human placenta. It stimulates the production of gonadal steroid hormones by inducing interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone. Obtained from the urine of pregnant women; stimulates production of gonadal steroid hornones by causing production of androgen by the testes Stimulates ovulation by acting as a substitute for luteinizing hormone

Prolific 5000 IU/vial Injection manufactured by Renata PLC.. Its generic name is Chorionic Gonadotrophin. Prolific is availble in Bangladesh. Farmaco BD drug index information on Prolific Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.