Indications & Uses
Follitropin Alfa + Lutropin Alfa is an injection used to stimulate follicular development in adult women who have severe LH and FSH deficiency. In the clinical trials, these women were identified by an endogenous serum LH level below 1.2 IU/L.
Pharmacology
This injection contains recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH). Both are made in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Clinical trials have shown that the combination of follitropin alfa and lutropin alfa works in women with hypogonadotropic hypogonadism.
When follicular development is stimulated in anovulatory women who lack LH and FSH, the main effect of giving lutropin alfa is a rise in oestradiol secretion by the follicles. FSH stimulates the growth of these follicles. In the clinical trials, patients with severe FSH and LH deficiency were defined as those with an endogenous serum LH level below 1.2 IU/L, measured in a central laboratory. LH measurements can vary from one laboratory to another, so this should be taken into account. In these trials the ovulation rate per cycle was 70-75%.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
In women who lack LH and FSH (hypogonadotrophic hypogonadism), the aim of this injection is to develop a single mature Graafian follicle. The oocyte is released from that follicle after human chorionic gonadotrophin (hCG) is given. The injection is given as a course of daily injections. These women have no periods (amenorrhoeic) and produce little oestrogen of their own, so treatment can start at any time.
The treatment should be adjusted to each patient's response, which is checked by measuring follicle size on ultrasound and by the oestrogen response. A recommended regimen starts with one vial of this injection daily. If less than one vial a day is used, the follicles may not respond well, because the amount of lutropin alfa may not be enough.
If a higher FSH dose is thought to be appropriate, the dose should preferably be changed after intervals of 7 to 14 days, and preferably in steps of 37.5 to 75 IU, using a licensed follitropin alfa preparation. It may be acceptable to extend the stimulation in any one cycle to up to 5 weeks.
When the response is optimal, a single injection of 250 micrograms of r-hCG, or 5,000 IU to 10,000 IU of hCG, should be given 24 to 48 hours after the last injection of this medicine. The patient is advised to have intercourse on the day of hCG and on the day after. Intrauterine insemination (IUI) may be done instead.
Luteal phase support may be considered, because a lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to early failure of the corpus luteum.
If the response is excessive, treatment should be stopped and hCG withheld. In the next cycle, treatment should start again at a lower FSH dose than the one used in the previous cycle.
Side Effects
Side-effect information is not available for this brand yet.
Cautions & Contraindications
Warnings & Precautions
This injection (follitropin alfa with lutropin alfa) contains potent gonadotrophic substances. These can cause adverse reactions anywhere from mild to severe, so only physicians who are thoroughly familiar with infertility problems and their management should use it. Gonadotrophin therapy takes a certain time commitment from the physicians and the supporting health care professionals, and appropriate monitoring facilities must be available. In women, safe and effective use of this injection means checking the ovarian response regularly with ultrasound, either on its own or, preferably, together with measurement of serum oestradiol levels. Patients can differ in how they respond to FSH/LH, and some may have a poor response. In women, the lowest effective dose in relation to the treatment objective should be used.
Contraindications
This injection is contraindicated in patients with hypersensitivity to the active substances or to any of the excipients, tumours of the hypothalamus and pituitary gland, ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin, gynaecological haemorrhages of unknown origin, and ovarian, uterine or mammary carcinoma. This injection must not be used when an effective response cannot be obtained, such as primary ovarian failure, malformations of sexual organs incompatible with pregnancy, and fibroid tumours of the uterus incompatible with pregnancy.
Pregnancy & Breastfeeding
This injection has no use during pregnancy. A limited number of pregnancies have been exposed to follitropin alfa and lutropin alfa after controlled ovarian stimulation, and those data show no adverse effect on the pregnancy, on the development of the embryo or foetus, on delivery, or on development after birth. Animal studies have not reported any teratogenic effect of these gonadotropins. Still, if exposure happens during pregnancy, the clinical data are not enough to rule out a teratogenic effect of this injection. It is also not indicated during breast-feeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly: Follitropin Alfa + Lutropin Alfa injection has no relevant use in elderly people. Its safety and effectiveness in elderly patients have not been established.
Renal and hepatic impairment: The safety, efficacy and pharmacokinetics of Follitropin Alfa + Lutropin Alfa in patients with kidney or liver impairment have not been established.
Paediatric population: This injection has no relevant use in children.
Storage
Keep Follitropin Alfa + Lutropin Alfa at a temperature no higher than 25°C. Leave it in its original package so the light stays off it.
Drug Interactions
Common questions about Pergoveris 150 IU+75 IU
What is Pergoveris 150 IU+75 IU SC Injection?
Pergoveris 150 IU+75 IU SC Injection is a medicine that contains Follitropin Alfa + Lutropin Alfa. It is made by Janata Traders. It belongs to the Drugs for Infertility group of medicines.
What is Pergoveris used for?
Follitropin Alfa + Lutropin Alfa is an injection used to stimulate follicular development in adult women who have severe LH and FSH deficiency. In the clinical trials, these women were identified by an endogenous serum LH level below 1.2 IU/L.
Can I take Pergoveris during pregnancy or while breastfeeding?
This injection has no use during pregnancy. A limited number of pregnancies have been exposed to follitropin alfa and lutropin alfa after controlled ovarian stimulation, and those data show no adverse effect on the pregnancy, on the development of the embryo or foetus, on delivery, or on development after birth. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Pergoveris?
Keep Follitropin Alfa + Lutropin Alfa at a temperature no higher than 25°C. Leave it in its original package so the light stays off it.
Can I take other medicines with Pergoveris?
Some medicines can interact with Follitropin Alfa + Lutropin Alfa, for example: Follitropin Alfa. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Pergoveris?
Pergoveris is a prescription (Rx) medicine. Take it as your doctor advises.