Cinnal-f®

Description

Follitropin alfa is a recombinant protein of DNA-origin which is equivalent to follicle-stimulating hormone (FSH) produced by the pituitary gland. Cinnal-f^® is the brand name for follitropin alfa produced by CinnaGen Company with established comparable efficacy and safety to the reference product. Each pre-filled pen of Cinnal-f^® contains 450 IU/0.75 ml or 900 IU/1.5 ml of follitropin alfa.

Indications

• Cinnal-f^® (follitropin alfa) is indicated for multifollicular development during assisted reproductive technologies (ART), ovulation induction, and spermatogenesis induction.

Important safety information

• Cinnal-f^® is contraindicated in pregnancy and patients with:

high levels of FSH indicating primary gonadal failure (ovarian or testicular); sex hormone dependent tumors of the reproductive tract and accessory organs; intracranial lesions, uncontrolled thyroid, pituitary or adrenal dysfunction; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement of undetermined origin not due to polycystic ovary syndrome.

• Abortion: Risk of spontaneous abortion is increased with the use of gonadotropins; causal effect has not been established.
• Ectopic pregnancy: Risk for ectopic pregnancy may be increased in women with tubal abnormalities; intrauterine pregnancy should be confirmed early with hCG testing and transvaginal ultrasound.
• Ovarian enlargement: May be accompanied by abdominal distention or abdominal pain. If ovaries are abnormally enlarged on the last day of treatment, withhold hCG to reduce the risk of ovarian hyperstimulation syndrome (OHSS).
• Ovarian hyperstimulation syndrome (OHSS): This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy. Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting.
• Ovarian neoplasms: Benign and malignant neoplasms have been reported (infrequently) in women receiving multiple-drug therapy for controlled ovarian stimulation; causal effect has not been established.
• Ovarian torsion: Has been reported following gonadotropin treatment; may be related to OHSS, prior ovarian torsion, prior or current ovarian cyst, polycystic ovaries, pregnancy, or prior abdominal surgery. Early diagnosis and prompt detorsion may limit the extent of ovarian damage.
• Thromboembolic events: In association with and separate from OHSS, thromboembolic events have been reported.