Cinnal-f®


(follitropin alfa)

The Right Choice for Fertility


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.

FAQs

A

CinnaGen has sponsored four clinical trials with Cinnal-f® so far. In these clinical trials efficacy and safety of Cinnal-f® was compared with the reference product (Gonal-f®). In a randomized, phase III, triple-blind study that was conducted in patients referring to Vali-e-Asr Hospital (A referral infertility hospital, Tehran, Iran) Cinnal-f® proved to be non-inferior to Gonal-f® in terms of efficacy and safety.

 

A
  • Conventional (Fixed dose): I) Starting a constant daily dose of 75–150 IU of FSH from day 2-3. II) Monitoring USG and E2 levels. III) Continuing FSH until a follicle >18 mm is observed
  • Step-Up Protocol: I) Starting with 75–150 IU of FSH on day 2-3 and continuing that dose for 5–7 days. II) If the follicular and estradiol response are inadequate; the dose is increased by 37.5–75 IU for another 5–7 days. III) If necessary, another 37.5 IU incremental increase can be used until an appropriate response obtained.
  • Step-Down Protocol: I) beginning with 150 IU of FSH on day 2-3 which is continued for 2-3 days. II) The dose is reduced to 75 IU for another 3 days. III) Monitoring USG and E2 levels. If follicles >10 mm are observed on TVS, the dose is decreased in two steps. The last dose is then continued till the day of hCG injection
  • Chronic Low-Dose Step-Up (Low-Slow): I) Starting dose: 37.5–75 units/day of FSH and a stepwise increase in subsequent doses. II) Serum E2 and USG are monitored on day 7. If Serum E2>200 pg/ml or follicle size> 10 mm, the same dose is continued. III) Otherwise, if E2 and follicle size were lower than the above-mentioned cut-offs, the daily dose is increased by an increment of 37.5 units/week, till the serum E2 level rises adequately.
  • Sequential: I) start with 37.5–75 IU/day of FSH which is increased by 50 % or 37.5 IU after 14 days in case of no ovarian response. II) Thereafter, any further FSH increment is made by 37.5–75 IU at weekly intervals to a maximum of 225 IU/day. III) Once dominant follicle emerges and reaches a diameter of 14 mm, the dose is reduced by 50 %
A

Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Cinnal-f®. Deterioration or a first appearance of this condition may require cessation of treatment.

A

Cinnal-f® should be administered subcutaneously at a 90° angle. The best areas for administration of Cinnal-f® are:

  • Front of the thighs (at least 7.5 cm below the hip and above the knees).
  • Belly (below the ribs and above the hip bones, at least 5 cm away from the belly button).
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