PREGNYL 10000 UNIT — DIN 02182904

What is PREGNYL?

PREGNYL 10000 UNIT contains CHORIONIC GONADOTROPIN : 10000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02182904, held by ORGANON CANADA INC., supplied as POWDER FOR SOLUTION ; KIT for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 06-Apr-2022. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is PREGNYL used for?

Pregnyl® (chorionic gonadotropin for injection, USP) is indicated for: 1) 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 predict whether or not orchiopexy will be needed in the future. 2) Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. 3) 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 has been appropriately pretreated with FSH-containing preparations. NOTE: hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or “normal” distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

FOR INTRAMUSCULAR USE ONLY after reconstitution of the dry powder with the sterile diluent. Although the dosage regimen will depend upon the indication, the patient's age and weight, and the prescriber's preference, the following regimens have been advocated by various authorities. Males: Prepubertal cryptorchidism not due to anatomical obstruction 4,000 USP units, 3 times weekly, for 2 to 3 weeks, or 1,000 USP units, 3 times weekly for 6 to 8 weeks. The dosage schedule may vary to some extent, depending upon the age when treatment is given. If the dosage is adequate, there will usually be some indication, following one such course of therapy, whether descent will occur or surgery be required. Selected cases of hypogonadotropic hypogonadism in males 4,000 to 5,000 USP units 3 times weekly for 6 to 8 weeks with a rest of period of 2 to 3 weeks between courses of therapy. Females: 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 has been appropriately pretreated with FSH-containing preparations (see prescribing information of FSH-containing preparations for dosage and administration for those drug products). 5,000 to 10,000 USP units one day following the last day of treatment with an FSH-containing preparation (a dosage of 10,000 USP units is recommended in the labeling of FSH-containing preparations).

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Pregnyl® (chorionic gonadotropin for injection, USP) is contraindicated for Prepubertal boys with signs of anatomical obstruction and for patients with: • Precocious puberty • Hypersensitivity to this drug or to any ingredient in the formulation or component of the container (see WARNINGS AND PRECAUTIONS). • Known or suspected sex hormone-dependent tumours, such as ovary, breast and uterine carcinoma in female and prostatic or breast carcinoma in the male. • Malformations of the reproductive organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy. • Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.

Warnings and precautions

HCG should be used in conjunction with FSH-containing preparations only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings and precautions, and adverse reactions described in the package insert for FSH-containing preparations. The drug substance of this product is manufactured from human urine. Although the risk is theoretical, and no case of transmission of an infectious agent linked to the use of urine-derived gonadotropins has ever been identified, the risk of transmitting infectious agents cannot be completely excluded. Anaphylaxis and other hypersensitivity reactions have been reported with urinary derived HCG products. Hypersensitivity reactions, both generalized and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontinue Pregnyl and assess for other potential causes for the event. Patients should be evaluated for uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders) and appropriate specific treatment given. Pregnyl should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite. In pregnancies occurring after induction of ovulation with gonadotropic preparations, there is an increased risk of multiple pregnancies. Infertile women undergoing Assisted Reproductive Technologies (ART) have an increased incidence of ectopic pregnancy. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. Rates of pregnancy loss in women undergoing assisted reproductive technologies (ART) are higher than in the normal population. Ovarian Hyperstimulation Syndrome (OHSS): OHSS is a medical event distinct from uncomplicated ovarian enlargement. Clinical signs and symptoms of mild and moderate OHSS are abdominal pain, nausea, diarrhea, mild to moderate enlargement of ovaries and ovarian cysts. Severe OHSS may be life-threatening. Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnea, oliguria, hematological abnormalities and weight gain. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS. Adherence to the recommended Pregnyl dose and treatment regimen is advised. Care should be taken with the administration of Pregnyl because OHSS may be triggered by administration of human Chorionic Gonadotropin (hCG). OHSS may also be triggered by pregnancy (endogenous hCG). Early OHSS usually occurs within 10 days after hCG administration and may be associated with an excessive ovarian response to gonadotropin stimulation. Late OHSS occurs more than 10 days after hCG administration, as a consequence of the hormonal changes with pregnancy. Because of the risk of developing OHSS, patients should be monitored for at least two weeks after hCG administration. Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Pregnyl. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, close observation for early signs and symptoms of OHSS is recommended. Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART). Careful monitoring of ovarian response is important to reduce the risk of OHSS. To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment, the concurrent determination of serum estradiol levels may also be useful. In ART, there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter. For patien