More from Puregon
Other strengths and forms by Healthcare Pharmaceuticals Ltd.
Indications & Uses
Follitropin Beta Cartridge is used in women for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. Prior checks are needed before starting treatment with Follitropin Beta Cartridge. The woman should have a complete gynecologic and endocrinologic evaluation. Primary ovarian failure should be excluded, and so should the possibility of pregnancy. Tubal patency should be demonstrated, and the fertility status of the male partner should be evaluated. It is also used for pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) cycle. Here too, prior evaluation is needed before treatment begins. Women should have a complete gynecologic and endocrinologic evaluation and a diagnosis of the cause of infertility. The possibility of pregnancy should be excluded, and the fertility status of the male partner should be evaluated. In men, Follitropin Beta Cartridge is used for induction of spermatogenesis in men with primary and secondary Hypogonadotropic Hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure. Before treatment starts, men should have a complete medical and endocrinologic evaluation. Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. Serum testosterone levels should be normalized with human chorionic gonadotropin (hCG) treatment. The fertility status of the female partner should also be evaluated.
Pharmacology
Women
Follicle-stimulating hormone (FSH) is the active component in Follitropin Beta Cartridge, and the body needs it for normal follicular growth, maturation and the production of gonadal steroids. In women, the FSH level matters a great deal for when follicular development starts and how long it lasts. That in turn decides the timing and the number of follicles that reach maturity. Follitropin Beta Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure. Final follicle maturation, the resumption of meiosis and the rupture of the follicle all need to happen, and without an endogenous LH surge they won't happen on their own. So human chorionic gonadotropin (hCG) must be given after treatment with Follitropin Beta Cartridge, once patient monitoring shows that the right follicular development parameters have been reached.
Men
When Follitropin Beta is given together with hCG, it stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of Follitropin Beta, is the pituitary hormone responsible for spermatogenesis.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
In Anovulatory Women Undergoing Ovulation Induction
The starting dose is 50 international units of Follitropin Beta Cartridge once a day, given subcutaneously, for at least the first 7 days. After that, the dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels show an adequate response. When an acceptable pre-ovulatory state is reached, final oocyte maturation is brought about with 5,000 to 10,000 international units of urinary human chorionic gonadotropin (hCG). The woman and her partner should have intercourse daily, starting on the day before hCG is given and continuing until ovulation becomes apparent.
In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle
The starting dose is 200 international units (actual cartridge doses) of Follitropin Beta Cartridge, given subcutaneously for at least the first 7 days of treatment. Later doses can be adjusted down or up depending on ovarian response, as judged by ultrasound evaluation of follicular growth and serum estradiol levels. For high responders, the dose can be reduced from the 6th day of treatment onward, according to individual response. Final oocyte maturation is induced with 5,000 to 10,000 international units of urinary hCG. Oocyte (egg) retrieval is done 34 to 36 hours later.
Induction of Spermatogenesis in Men
Pretreatment with urinary hCG alone (1,500 international units twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the dose may be increased to 3,000 international units twice a week. Once serum testosterone levels have normalized, Follitropin Beta Cartridge is given at 450 international units per week (225 international units twice weekly or 150 international units three times weekly).
Side Effects
In women having ovulation induction with Follitropin Beta, the most common side effects (seen in 2% or more) are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. For women having controlled ovarian stimulation as part of an IVF or ICSI cycle, the most common side effects (again 2% or more) are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue. In men having induction of spermatogenesis, the most common side effects (2% or more) are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst.
Cautions & Contraindications
Warnings & Precautions
Treatment with Follitropin Beta may lead to abnormal enlargement of the ovaries, ovarian hyperstimulation syndrome (OHSS), and pulmonary and vascular complications. It may also cause ovarian torsion, multi-fetal gestation and birth, congenital anomalies, ectopic pregnancy, spontaneous abortion and ovarian neoplasms.
Contraindications
Follitropin Beta is contraindicated in women and men who exhibit prior hypersensitivity to recombinant hFSH products, high levels of FSH indicating primary gonadal failure, the presence of uncontrolled non-gonadal endocrinopathies, hypersensitivity reactions related to streptomycin or neomycin, or tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland. In women, there are a few more reasons not to use Follitropin Beta. These are pregnancy, heavy or irregular vaginal bleeding of undetermined origin, and ovarian cysts or enlargement not due to polycystic ovary syndrome.
Pregnancy & Breastfeeding
Pregnancy: Follitropin Beta Cartridge must not be used in pregnant women, and it gives no benefit during pregnancy.
Lactation: Doctors don't know whether this medicine passes into human milk. So the benefits of breastfeeding for the baby's development and health should be weighed against the mother's clinical need for Follitropin Beta Cartridge. Any possible side effects on the breastfed child, whether from the medicine or from the mother's underlying condition, should be considered as well.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: Follitropin Beta Cartridge isn't indicated for children. No clinical studies have been done in the pediatric population.
Geriatric use: No clinical studies of Follitropin Beta Cartridge have been done in patients 65 years of age and older.
Storage
Keep an unused Follitropin Beta cartridge in the refrigerator at 2°C to 8°C until its expiration date. You can also keep it at room temperature, up to 25°C, for 3 months or until the expiration date, whichever comes first. Once you have started using a cartridge, store it at 2°C to 25°C and throw it away after 28 days. Keep it in its original carton so light doesn't reach it. Do not freeze it.
Common questions about Puregon 100 IU
What is Puregon 100 IU Injection?
Puregon 100 IU Injection is a medicine that contains Follitropin Beta. It is made by Healthcare Pharmaceuticals Ltd. It belongs to the Drugs for Infertility group of medicines.
What is Puregon used for?
Follitropin Beta Cartridge is used in women for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure. Prior checks are needed before starting treatment with Follitropin Beta Cartridge.
What are the side effects of Puregon?
In women having ovulation induction with Follitropin Beta, the most common side effects (seen in 2% or more) are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. For women having controlled ovarian stimulation as part of an IVF or ICSI cycle, the most common side effects (again 2% or more) are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue.
Can I take Puregon during pregnancy or while breastfeeding?
Pregnancy: Follitropin Beta Cartridge must not be used in pregnant women, and it gives no benefit during pregnancy. Lactation: Doctors don't know whether this medicine passes into human milk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Puregon?
Keep an unused Follitropin Beta cartridge in the refrigerator at 2°C to 8°C until its expiration date. You can also keep it at room temperature, up to 25°C, for 3 months or until the expiration date, whichever comes first.
Do I need a prescription for Puregon?
Puregon is a prescription (Rx) medicine. Take it as your doctor advises.