Cinnal-f®


(follitropin alfa)

The Right Choice for Fertility


Description

Cinnal-f® (follitropin alfa) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. Cinnal_f contains no luteinizing hormone (LH) activity.

Each Cinnal-f® Multi-Dose vial is filled with 75 IU (5.5 mcg) follitropin alfa. Multiple Dose vials are reconstituted with Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP.

Therapeutic Class: Infertility

Indication and Usage

Women

Cinnal-f® (follitropin alfa) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Cinnal-f® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.

Selection of Patients

  1. Before treatment with Cinnal-f® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Cinnal-f® only if enrolled in an in vitro fertilization program.
  2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
  3. Appropriate evaluation should be performed to exclude pregnancy.
  4. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Cinnal-f® therapy.
  5. Evaluation of the partner's fertility potential should be included in the initial evaluation.

Men

Cinnal-f® (follitropin alfa) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Selection of Patients

  1. Before treatment with Cinnal-f® is instituted for azoospermia, a thorough medical and endocrinologic evaluation must be performed.
  2. Hypogonadotropic hypogonadism should be confirmed, and primary testicular failure should be excluded by the determination of gonadotropin levels.
  3. Prior to Cinnal-f® therapy for azoospermia in patients with hypogonadotropic hypogonadism, serum testosterone levels should be normalized.

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).
more