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PUREGON is a brand name for Follitropin Beta, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In female: PUREGON® (follitropin beta) is indicated for: • Development of multiple follicles in ovulatory patients participating in an Assisted Reproduction Technology (ART) program. • Induction of ovulation and pregnancy in anovulatory infertile females in whom the cause of infertility is functional and not due to…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 02/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................
4 Administration ......................................................................................................... 5 Missed Dose ............................................................................................................
7 5 OVERDOSAGE............................................................................................................... 7
1 Adverse Reaction Overview The most frequently reported adverse drug reactions (≥1%) with Puregon in clinical trials were ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy, vaginal hemorrhage, miscarriage, abdominal pain and injection site pain.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
In Females:
The following adverse events, listed by body system, have been reported in clinical studies evaluating the efficacy and safety of PUREGON® in women. 2 † Related: definitely, probably, or possibly related to the study drug In Males: The safety of PUREGON® was examined in a clinical trial that enrolled 49 male patients for the indication of spermatogenesis, of whom 30 received PUREGON®.
Two subjects in the treatment period each reported one serious event, which were judged not related to study drug by the investigator. The events involved are pilonidal cyst and hemorrhoids. Both subjects recovered from these adverse events.
In the PUREGON® treatment phase, no patients discontinued due to an adverse event. In total, 21 patients in the treatment phase experienced at least one adverse event. Ten were reported by the investigator to be possibly related to study drug.
These include: two cases of acne, two cases of injection site bruising, two cases of injection site pain, and single cases of varicose veins, gynecomastia, injection site induration, and dermoid cyst. 3 Less Common Clinical Trial Adverse Reactions In Females: Body as a Whole, General Disorders: back pain, feeling unwell, influenza-like symptoms, face edema, lumbar pain, pain, sepsis, tooth disorder, Gastrointestinal: bloating, constipation, gastroesophageal reflux, vomiting, increased bilirubin, swollen abdomen.
, General). For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients PUREGON® (follitropin beta) Page 8 of 39 Description Solution for injection in cartridges is clear and colourless.
The cartridge is designed to be used in conjunction with a pen injector.
Composition of Solution for Injection in Cartridges:
Solution for injection in cartridges - 833 IU/mL. 23mL which is sufficient for a net dose of 900 IU. The net deliverable dose of 300 IU, 600 IU and 900 IU are based upon a maximum of six 50 IU injections, six 100 IU injections and nine 100 IU injections respectively.
When more injections are given, the net total dose may be lowered because each injection has to be preceded by an air shot.
Packaging:
Boxes of PUREGON® solution for injection contain 1 cartridge of PUREGON® and 6 (300 IU and 600 IU cartridges) or 9 (900 IU cartridges) needles to be used with the PUREGON PEN. The cartridges are of colourless hydrolytic (class 1) glass, with a rubber piston and an aluminium crimp-cap with a rubber inlay.
Cartridges contain 833 IU of FSH activity per mL aqueous solution. 230 mL. 08 mL at a concentration of 833 IU recFSH /mL benzyl alcohol, hydrochloric acid, L-methionine, polysorbate 20, sodium citrate, sodium hydroxide, sucrose, water for injection PUREGON® (follitropin beta) Page 9 of 39 PUREGON® is a potent gonadotropic agent that is capable of causing severe adverse effects.
It should be used only by physicians who are experienced in the management of fertility disorders and only when facilities for appropriate clinical and endocrinologic evaluations are available. PUREGON® may contain traces of streptomycin and/or neomycin.
For males and females: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Tumours of the ovary, breast, uterus, testis, pituitary gland or hypothalamus.
• A high circulating FSH level indicating primary gonadal failure. For females: • Patients who exhibit uncontrolled thyroid or adrenal dysfunction. • Patients who are pregnant or are breast-feeding. • Patients who exhibit heavy or irregular vaginal bleeding of undetermined origin.
• Patients who exhibit ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS). g. malformation of reproductive organs or PUREGON® (follitropin beta) Page 5 of 39 fibroid tumours of the uterus). PUREGON® is contraindicated in children.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Nervous System: hyperemesis, hot flashes, syncope Reproductive Disorder Women: premature labour, menorrhagia, ovarian disorder, vaginal discharge, vulvovaginitis, genital infection, genital herpes, hydatidiform mole. Respiratory System: dyspnea, otitis media Skin and Appendages: eczema, itching, rash, hematoma, abscess, Herpes zoster.
PUREGON® (follitropin beta) Page 18 of 39 Urinary System: dysuria, cystitis, frequent micturition. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings In Females: Post-treatment sera were analysed following three treatment cycles and no evidence of induction of anti-FSH or anti-CHO cell-derived […]
These antibiotics may cause hypersensitivity reactions in susceptible persons. Determination of serum gonadotropin concentrations should be obtained to rule out primary gonadal failure. For females The presence of early pregnancy should be ruled out by a biochemical pregnancy test.
A thorough gynecologic and endocrinologic evaluation must be performed prior to treatment with PUREGON®. These evaluations may assess uterine and tubal pathology, ovulatory cycle characteristics or an endometrial biopsy. Patients should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Medical conditions that contraindicate pregnancy should be evaluated before starting treatment with PUREGON®. Evaluation of the fertility potential of the male sexual partner should also be performed (a semen analysis) before starting PUREGON® therapy.
Overstimulation of the Ovary During Therapy:
To minimize the risk associated with abnormal ovarian enlargement in women receiving PUREGON® and human chorionic gonadotropin (hCG) for the induction of ovulation and pregnancy, the drugs should be administered at the lowest possible effective dosage.
Since PUREGON® may cause ovarian enlargement and/or hyperstimulation, patients should be assessed for signs of excessive ovarian stimulation during therapy and for a 2-week post- treatment period. Careful monitoring of ovarian response by ultrasound assessment (can minimize the risk of overstimulation.
The concurrent determination of serum estradiol levels may also be useful.
Abnormal Ovarian Enlargement:
Hemoperitoneum may occur from ruptured ovarian cysts. This is usually the result of sexual intercourse or a vigorous pelvic examination. Should this occur and be accompanied by bleeding to the extent that surgery is necessary, partial resection of the enlarged ovary or ovaries may be required.
Intercourse should be prohibited in those patients in whom significant ovarian enlargement occurs after ovulation due to the risk of hemoperitoneum resulting from ruptured ovarian cysts.
PUREGON® (follitropin beta) Page 10 of 39 Ovarian Hyperstimulation Syndrome:
Ovarian Hyperstimulation Syndrome (OHSS) is distinct from uncomplicated ovarian enlargement in that it rarely occurs unless hCG is administered or a pregnancy occurs. 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. OHSS may be caused by administration of human Chorionic Gonadotropin (hCG) and 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 […]