Medicinal Products

PERGOVERIS 150 IU / 75 IU

Generic drug of the therapeutic class: Endocrinology
active ingredients: Follitropin alfa, Lutropin alfa
laboratory: Serono Europe Limited

Powder and solvent for solution for injection
Box of 10 vials of powder + 1 ml solvent vials
All forms

Indication

Pergoveris is indicated to stimulate follicular development in women with severe LH and FSH deficiency.
In clinical trials, these patients were defined by a plasma endogenous LH concentration <1.2 IU / L.

Dosage PERGOVERIS 150 IU / 75 IU Powder and solvent for solution for injection Box of 10 vials of powder + 1 ml solvent vials

- Any treatment with Pergoveris should be instituted under the supervision of a physician experienced in the treatment of fertility disorders.
- Pergoveris is administered subcutaneously. The powder must be reconstituted with the attached solvent immediately before use.
- In women with LH and FSH deficiency (hypogonadotropic hypogonadism), the goal of treatment with Pergoveris is to develop a single mature De Graaf follicle, from which the oocyte will be released after administration of human choriogonadotropin (hCG ). Pergoveris should be given as daily injections. Since these patients are amenorrheic and have low endogenous estrogen secretion, treatment can be started at any time during the cycle.
- The treatment should be adapted individually depending on the patient's response determined by the follicle size on ultrasound and by estrogen secretion. The recommended treatment begins with a bottle of Pergoveris a day. If less than one vial of Pergoveris per day is used, the amount of lutropin alfa may not be sufficient to ensure a satisfactory follicular response (see section 5.1).
- If an increase in the dose of FSH is necessary, it is preferable to adjust the dose at intervals of 7 or 14 days and in increments of 37.5 IU or 75 IU, using a follitropin alfa preparation with a clearance of marketing. It can be justified during a cycle to prolong stimulation up to 5 weeks.
- When an optimal response is obtained, a single injection of 5000 to 10000 IU hCG should be given 24 to 48 hours after the last Pergoveris injection. The patient will be advised to have sex the same day and the day after hCG administration.
Alternatively, intrauterine insemination (IUI) can be performed.
- Luteal phase support may be considered; indeed, the lack of substances with luteotropic activity (LH / hCG) after ovulation can lead to a qualitative deficiency of the corpus luteum.
- If an excessive response is obtained, treatment should be stopped and hCG should not be administered. Treatment should be resumed in the next cycle at a lower FSH dose than the discontinued cycle.
- In clinical trials, patients with severe FSH and LH deficiency were defined by a plasma endogenous LH concentration <1.2 IU / L (centralized dosages). Nevertheless, the existence of inter-laboratory variations for the determination of LH must be taken into account. In these trials, the ovulation rate per cycle was 70-75%.

Against indications

CONTRAINDICATED:
Pergoveris is contraindicated in patients with:
- hypersensitivity to the active substances, follitropin alfa or lutropin alfa, or to any of the excipients,
a hypothalamic or pituitary tumor,
- hypertrophy or ovarian cysts, not attributable to polycystic ovary syndrome,
- gynecological bleeding of unknown etiology,
- ovarian, uterine or mammary carcinoma.
NOT RECOMMENDED :
- Pergoveris should not be used when an effective response can not be obtained, for example:
. primary ovarian failure,
. a malformation of the genitals incompatible with a pregnancy,
. a uterine fibroid incompatible with a pregnancy.
- Pergoveris should not be used during pregnancy or lactation.

Pergoveris side effects

Within each group frequency, adverse effects should be presented in order of decreasing severity.
- disorders of the nervous system:
. Very common (> = 1/10) : Headache.
. Frequent (> = 1/100, <1/10) : Drowsiness.
- Respiratory, thoracic and mediastinal disorders:
Very rare (<1/10000) : Exacerbation or worsening of asthma.
- Gastrointestinal disorders:
Common (> = 1/100, <1/10) : Abdominal pain and gastrointestinal disturbances such as nausea, vomiting, diarrhea, abdominal cramps and bloating.
- Vascular disorders:
Very rare (<1/10000) : Thromboembolic stroke, often associated with severe ovarian hyperstimulation syndrome (OHSS).
- General disorders and anomalies at the site of administration:
Very common (> = 1/10) : Mild to severe reaction at the injection site (pain, redness, hematoma, edema and / or irritation at the injection site).
- Immune system disorders:
Very rare (<1/10000) : Slight systemic allergic reactions (eg mild erythema, rash, facial edema, urticaria, edema, respiratory discomfort). Serious cases of allergic reactions, especially of the anaphylactic type, have also been reported.
- Disorders of the reproductive organs and the breast:
. Very common (> = 1/10) : Ovarian cysts.
. Frequent (> = 1/100, <1/10) : Breast pain, pelvic pain, mild to moderate OHSS.
. Uncommon (> = 1/1000, <1/100) : severe OHSS.
. Rare (> = 1/10000, <1/1000) : Ovarian torsion, complication of OHSS.

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