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Puregon is a brand name for Follitropin Beta. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate. • Controlled ovarian hyperstimulation to induce the development of…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems. The first injection with Puregon should be performed under direct medical supervision. Posology Dosage in the female There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotrophins.
This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasound assessment of follicular development. The concurrent determination of serum oestradiol levels may also be useful.
When using the pen-injector, it should be realised that the pen is a precision device which accurately delivers the dose to which it is set. It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
This may be of particular relevance when switching between the pen-injector and a conventional syringe within one treatment cycle. Especially when switching from a syringe to the pen, small dose adjustments may be needed to prevent too high a dose being given.
1). Clinical experience with Puregon is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
4 • Anovulation A sequential treatment scheme is recommended starting with daily administration of 50 IU Puregon. The starting dose is maintained for at least seven days. If there is no ovarian response, the daily dose is then gradually increased until follicle growth and/or plasma oestradiol levels indicate an adequate pharmacodynamic response.
A daily increase of oestradiol levels of 40-100% is considered to be optimal. The daily dose is then maintained until pre-ovulatory conditions are reached. Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Usually, 7 to 14 days of treatment is sufficient to reach this state. The administration of Puregon is then discontinued and ovulation can be induced by administering human chorionic gonadotrophin (hCG). e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased.
Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature. 2% of all patients treated with follitropin beta).
Cases of anaphylactic reactions (including those requiring hospitalisation) have been reported in the post-marketing setting. 4). Adverse 8 reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.
The table below lists the adverse reactions with follitropin beta reported in clinical trials and post- marketing surveillance in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (cannot be estimated from available data).
SOC Frequency Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Gastrointestinal disorders Common Abdominal distension Abdominal pain Uncommon Abdominal discomfort Constipation Diarrhoea Nausea Reproductive system and breast disorders Common OHSS Pelvic pain Uncommon Breast complaints1 Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage General disorders and administration site conditions Common Injection site reaction2 Uncommon Generalised hypersensitivity reaction3 1.
Breast complaints include tenderness, pain and/or engorgement and nipple pain. 2. Local reactions at the site of injection include: bruising, pain, redness, swelling and itching. 3. Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus.
In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy. In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with other gonadotrophins.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Antibiotic hypersensitivity reactions • Puregon may contain traces of streptomycin and/or neomycin.
These antibiotics may cause hypersensitivity reactions in susceptible persons. Infertility evaluation before starting treatment • Before starting treatment, the couple's infertility should be assessed as appropriate. In particular, patients should be evaluated for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
In females 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, diarrhoea, 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, dyspnoea, oliguria, haematological 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 least two weeks after hCG administration.
1. • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus. • Primary gonadal failure. 5 Additionally for females • Undiagnosed vaginal bleeding. • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
• Malformations of the reproductive organs incompatible with pregnancy. • Fibroid tumours of the uterus incompatible with pregnancy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations. In that case hCG should be withheld and pregnancy should be avoided to prevent multiple gestations.
• Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied. A starting dose of 100-225 IU is recommended for at least the first four days. Thereafter, the dose may be adjusted individually, based upon ovarian response.
In clinical studies it was shown that maintenance dosages ranging from 75-375 IU for six to twelve days are sufficient, although longer treatment may be necessary. Puregon can be given either alone, or, to prevent premature luteinisation, in combination with a GnRH agonist or antagonist.
When using a GnRH agonist, a higher total treatment dose of Puregon may be required to achieve an adequate follicular response. Ovarian response is monitored by ultrasound assessment. The concurrent determination of serum oestradiol levels may also be useful.
When ultrasound assessment indicates the presence of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG.
Oocyte retrieval is performed 34-35 hours later. Dosage in the male Puregon should be given at a dosage of 450 IU/week, preferably divided in 3 dosages of 150 IU, concomitantly with hCG. Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
To assess the response, semen analysis is recommended 4 to 6 months after the beginning of treatment. If a patient has not responded after this period, the combination therapy may be continued; current clinical experience indicates that treatment for up to 18 months or longer may be necessary to achieve spermatogenesis.
Paediatric population There is no relevant use of Puregon in the paediatric population for the approved indication. Method of administration Puregon solution for injection in cartridges has been developed for use in the Puregon Pen and should be administered subcutaneously.
The injection site should be alternated to prevent lipoatrophy. Using the pen, injection of Puregon can be carried out by the patient, provided that proper instructions are given by the physician. Before using the pen, the instructions for use must be read carefully.
Treatment of males:
The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed) and post-marketing surveillance, according to system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from available data).
SOC Frequency1 Adverse reaction Immune system disorders Not known Anaphylactic reactions Nervous system disorders Common Headache Skin and subcutaneous tissue disorders Common Acne Rash Reproductive system and breast disorders Common Epididymal cyst Gynaecomastia General disorders and administration site conditions Common Injection site reaction2 1.
Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%. 2. Local reactions at the site of injection include induration and pain. 9 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment with Puregon. 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). Adherence to the recommended Puregon dose and treatment regimen and 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 oestradiol 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. If OHSS develops, standard and appropriate management of OHSS should be implemented and followed. 6 Multiple Pregnancy Multiple pregnancies and births have been reported for all gonadotropin treatments, including Puregon.
Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes. For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
The concurrent determination of serum oestradiol levels may also be useful. The patients should be advised of the potential risks of multiple births before starting treatment. In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
When used for an ovulation induction cycle, appropriate FSH dose adjustment(s) should prevent multiple follicle development. Ectopic Pregnancy Infertile women undergoing ART have an increased incidence of ectopic pregnancies. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Spontaneous Abortion Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population. Vascular Complications Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Puregon.
Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Puregon, may further increase this risk.
In these women the benefits of gonadotropin administration, including Puregon, need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. Congenital Malformations The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
, maternal age, sperm characteristics) and multiple gestations. Ovarian Torsion Ovarian torsion has been reported after treatment with gonadotropins, including Puregon. Ovarian torsion may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.
Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion. Ovarian and Other Reproductive System Neoplasms There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
It is not […]