Description
Latin name
Diphereline
Release form
Lyophilisate for solution for sc administration.
Packing
7 pcs
Indications
Female infertility. Ovarian stimulation together with gonadotropins (hMG, hCG, FSH) in in vitro fertilization and embryo transfer programs, as well as other assisted reproductive technologies.
Contraindications
Pregnancy
lactation period
hypersensitivity to GnRH, other GnRH analogues, to Diferelin ® and its components.
Use in pregnancy and lactation
Currently, GnRH analogues are used in combination with gonadotropins to stimulate ovulation and pregnancy.
Pregnancy is a contraindication to the use of the drug. However, practice has shown that after ovulation stimulated in the previous cycle, in some cases, pregnancy occurred without stimulation, and the further course of ovulation stimulation continued.
Two qualitatively performed experimental studies on animals did not reveal teratogenic effects of Diferelin.
Thus, when using the drug, the development of congenital anomalies in humans is not expected.
The results of clinical trials involving a small number of pregnant women who received GnRH analogue, showed the absence of fetal malformations or fetotoxicity. However, further study of the effects of the drug on pregnancy is needed.
Composition
1 vial contains:
Active substance: tryptorelin acetate, calculated on the basis of tryptorelin 100 mcg.
Excipients: mannitol – 10 mg.
Solvent: sodium chloride – 9 mg, water d / i – up to 1000 mg.
Dosage and administration of
Short course of treatment
Diferelin ® is administered subcutaneously at a dose of 100 mcg / day daily, starting from the 2nd day of the cycle (simultaneously starting stimulation of the ovaries), and the treatment is completed 1 day before the planned introduction of human chorionic gonadotropin. The course of treatment is 10-12 days.
Long-term course of treatment
Diferelin ® is administered subcutaneously at a dose of 100 mcg / day daily, starting from the 2nd day of the cycle. When the pituitary gland is desensitized (E2 is less than 50 pg / ml, i.e., approximately on the 15th day after the start of treatment), the ovaries are stimulated with gonadotropins and sc injection of Diferelin is continued at a dose of 100 μg / day, ending 1 day before the planned the introduction of human chorionic gonadotropin. The duration of treatment is determined by the doctor individually.
Rules for the preparation of
solution. The supplied solvent is introduced into the vial with lyophilisate and shaken until completely dissolved. Used needles should be placed in a container intended for sharp objects.
Side effects of
At the beginning of treatment with
From the reproductive system: when combined with gonadotropins, ovarian hyperstimulation is possible (an increase in ovarian size, abdominal pain).
During treatment
From the reproductive system: most often sudden flushing, vaginal dryness, decreased libido and dyspareunia associated with pituitary-ovarian blockade. From the digestive system: nausea, vomiting, increased activity of hepatic transaminases.
From the side of the central nervous system and peripheral nervous system: emotional lability, visual impairment, headache.
From the musculoskeletal system: muscle and joint pain. Prolonged use of GnRH analogues can lead to bone demineralization, risk of osteoporosis (this side effect was not observed with short-term use of the drug Diferelin ® 0.1 mg).
From the cardiovascular system: increased blood pressure.
Allergic reactions: urticaria, skin rash, itching rarely – Quincke’s edema.
Local reactions: pain at the injection site.
Other: weight gain.
Drug Interaction
No drug interaction has been described.
overdose
There are no known cases of overdose with Diferelin ®.
Storage conditions
Keep out of the reach of children at a temperature not exceeding 25 ° C.
Expiration
2 years.
Deystvuyuschee substances
Tryptorelyn
pharmacy leave with prescriptions
dosage form
dosage form
injection suspension
Ipsen Farma, France
