Follistim Aq Drug Information
Generic name: FOLLITROPIN
Gonadotropin [EPC]
Uses of Follistim Aq
Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Women should have a complete gynecologic and endocrinologic evaluation. Primary ovarian failure should be excluded. The possibility of pregnancy should be excluded.
Tubal patency should be demonstrated. The fertility status of the male partner should be evaluated.
Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. In Men for:
Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Men should have a complete medical and endocrinologic evaluation. Hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. Serum testosterone levels should be normalized with human chorionic gonadotropin (hCG) treatment.
The fertility status of the female partner should be evaluated.
Dosage & Administration of Follistim Aq
General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is not clear and colorless or has particles in it, the solution should not be used. Do not add any other medicines into the FOLLISTIM AQ Cartridge.
FOLLISTIM AQ Cartridge with the pen injector device delivers on average an 18% higher amount of follitropin beta when compared to reconstituted FOLLISTIM delivered with a conventional syringe and needle. When administering FOLLISTIM AQ Cartridge, a lower starting dose and lower dose adjustments (as compared to reconstituted FOLLISTIM) should be considered. For that purpose the following Dose Conversion Table is provided: Table 1: FOLLISTIM AQ Cartridge Administered Subcutaneously with the FOLLISTIM Pen Dose Conversion Table Each value represents an 18% difference rounded to the nearest 25 IU increment.
Recommended Dosing in Anovulatory Women Undergoing Ovulation Induction The dosing scheme is stepwise and is individualized for each woman. A starting daily dose of 50 international units of FOLLISTIM AQ Cartridge is administered subcutaneously daily for at least the first 7 days. Subsequent dosage adjustments are made at weekly intervals based upon ovarian response.
If an increase in dose is indicated by the ovarian response, the increase should be made by 25 or 50 international units of FOLLISTIM AQ Cartridge at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response. The following should be considered when planning the woman's individualized dose: Appropriate FOLLISTIM AQ Cartridge dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of FOLLISTIM AQ Cartridge is 250 international units.
Treatment should continue until ultrasonic visualizations and/or serum estradiol determinations approximate the pre-ovulatory conditions seen in normal individuals. When pre-ovulatory conditions are reached, 5,000 to 10,000 international units of urinary hCG are used to induce final oocyte maturation and ovulation. The administration of hCG must be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of FOLLISTIM AQ Cartridge therapy.
The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent. During treatment with FOLLISTIM AQ Cartridge and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation. It is recommended that FOLLISTIM AQ Cartridge administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs.
Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.
Recommended Dosing in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle The dosing scheme follows a stepwise approach and is individualized for each woman. Subsequent to the first 7 days of treatment, the dose can be adjusted down or up based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Dosage reduction in high responders can be considered from the 6th day of treatment onward according to individual response.
The following should be considered when planning the woman's individualized dose: For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved (seven to twelve days). For low or poor responding women, the daily dose should be increased according to the ovarian response. For high responding women, decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response.
When a sufficient number of follicles of adequate size are present, dosing of FOLLISTIM AQ Cartridge is stopped and final maturation of the oocytes is induced by administering urinary hCG at a dose of 5,000 to 10,000 international units. Oocyte (egg) retrieval should be performed 34 to 36 hours following the administration of hCG.
Recommended Dosing for Induction of Spermatogenesis in Men Pretreatment with hCG is required prior to concomitant therapy with FOLLISTIM AQ Cartridge and hCG. An initial dosage of 1,500 international units of urinary hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the urinary hCG dose can be increased to 3,000 international units twice weekly.
After normal serum testosterone levels have been reached, FOLLISTIM AQ Cartridge should be administered by subcutaneous injection concomitantly with hCG treatment. FOLLISTIM is given at a dosage of 450 international units per week, as either 225 international units twice weekly or 150 international units three times per week, in combination with the same hCG dose used to normalize testosterone levels. Based on delivery of a higher dose of follitropin beta with the FOLLISTIM AQ Cartridge and pen injector, a lower dose of FOLLISTIM AQ Cartridge may be considered.
The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.
| Lyophilized recombinant FSH dosing with ampules or vials, using conventional syringe | FOLLISTIM AQ Cartridge dosing with the FOLLISTIM Pen |
|---|---|
| 75 IU | 50 IU |
| 150 IU | 125 IU |
| 225 IU | 175 IU |
| 300 IU | 250 IU |
| 375 IU | 300 IU |
| 450 IU | 375 IU |
Side Effects of Follistim Aq
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. Ovulation Induction In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with FOLLISTIM or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.
Table 2: Common Adverse Reactions Reported at a Frequency of ≥2% in an Assessor-Blind, Comparative Study of Anovulatory Women Receiving Ovulation Induction 0 2 Adverse reactions reported commonly (greater than or equal to 2% of women treated with FOLLISTIM) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction. In Vitro Fertilization/Intracytoplasmic Sperm Injection In a single cycle, multi-center, double-blind, parallel group, comparative study, a total of 1509 women were randomized to receive controlled ovarian stimulation with either FOLLISTIM AQ Cartridge (751 women were treated with FOLLISTIM AQ Cartridge) or a comparator and pituitary suppression with a gonadotropin releasing hormone (GnRH) antagonist as part of an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Table 3 lists adverse reactions with an incidence of greater than 2% in the group of women treated with FOLLISTIM AQ Cartridge.
Table 3: Common Adverse Reactions Reported at a Frequency of ≥2% in a Randomized, Double-blind, Active-controlled, Comparative Study of Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle Induction of Spermatogenesis In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to receive pretreatment with hCG, followed by combination therapy with hCG and FOLLISTIM for induction of spermatogenesis. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with FOLLISTIM are listed in Table 4.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of FOLLISTIM and/or FOLLISTIM AQ Cartridge. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal disorders Abdominal distension, abdominal pain, constipation, diarrhea General disorders and administration site conditions Injection site reaction Immune system disorders Hypersensitivity reactions including anaphylaxis, pruritus, rash, and urticaria Reproductive system and breast disorders Breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage Skin and subcutaneous tissue disorders Rash Vascular disorders Thromboembolism
| System Organ Class/Adverse Reactions | Treatment Number (%) of Women | |
|---|---|---|
| FOLLISTIM N=105 n (%) | Comparator N=67 n (%) | |
| Gastrointestinal disorders | ||
| Abdominal discomfort | 3 (2.9) | 1 (1.5) |
| Abdominal pain | 3 (2.9) | 2 (3.0) |
| Abdominal pain lower | 3 (2.9) | 1 (1.5) |
| Reproductive system and breast disorders | ||
| Ovarian cyst | 3 (2.9) | 2 (3.0) |
| Ovarian hyperstimulation syndrome | 8 (7.6) | 3 (4.5) |
| General disorders and administration site conditions | ||
| Pyrexia | 0 (0.0) | 2 (3.0) |
| System Organ Class/Adverse Reactions | FOLLISTIM AQ Cartridge Treatment N = 751 n n a = number of women with the adverse reaction. (%) |
|---|---|
| Nervous System disorders | |
| Headache | 55 (7.3%) |
| Gastrointestinal disorders | |
| Nausea | 29 (3.9%) |
| Reproductive system and breast disorders | |
| Ovarian Hyperstimulation Syndrome | 48 (6.4%) |
| Pelvic discomfort | 62 (8.3%) |
| Pelvic Pain | 41 (5.5%) |
| General disorders and Administration site conditions | |
| Fatigue | 17 (2.3%) |
| System Organ Class/Adverse Reactions | FOLLISTIM Treatment N=30 n (%) |
|---|---|
| Nervous system disorders | |
| Headache | 2 (6.7) |
| General disorders and administration site disorders | |
| Injection site reaction | 2 (6.7) |
| Injection site pain | 2 (6.7) |
| Skin and cutaneous tissue disorders | |
| Acne | 2 (6.7) |
| Rash | 1 (3.3) |
| Reproductive system and breast disorders | |
| Gynecomastia | 1 (3.3) |
| Neoplasms benign, malignant and unspecified | |
| Dermoid cyst | 1 (3.3) |
Warnings & Cautions for Follistim Aq
Abnormal Ovarian Enlargement
In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with FOLLISTIM AQ therapy, treatment should be individualized and the lowest effective dose should be used. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of overstimulation. If the ovaries are abnormally enlarged on the last day of FOLLISTIM AQ therapy, hCG should not be administered in order to reduce the chances of developing Ovarian Hyperstimulation Syndrome (OHSS).
Intercourse should be prohibited in patients with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from ruptured ovarian cysts.
Ovarian Hyperstimulation Syndrome (OHSS) OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical condition. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of OHSS developing are severe pelvic pain, nausea, vomiting, and weight gain.
Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
OHSS occurs after gonadotropin treatment has been discontinued, and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is a risk for OHSS evident prior to hCG administration, the hCG must be withheld.
Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the patient needs to be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed).
Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows: Acute Phase: Management should be directed at preventing hemoconcentration due to loss of intravascular volume to the third space and minimizing the risk of thromboembolic phenomena and kidney damage. Fluid intake and output, weight, hematocrit, serum and urinary electrolytes, urine specific gravity, BUN and creatinine, total proteins with albumin: globulin ratio, coagulation studies, electrocardiogram to monitor for hyperkalemia, and abdominal girth should be thoroughly assessed daily or more often based on the clinical need.
Treatment, consisting of limited intravenous fluids, electrolytes, and human serum albumin is intended to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume. Full correction of the intravascular volume deficit may lead to an unacceptable increase in the amount of third space fluid accumulation. Chronic Phase: After the acute phase is successfully managed as above, excessive fluid accumulation in the third space should be limited by instituting severe potassium, sodium, and fluid restriction.
Resolution Phase: As third space fluid returns to the intravascular compartment, a fall in hematocrit and increasing urinary output are observed in the absence of any increase in intake. Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized. Diuretics may be indicated during the resolution phase, if necessary, to combat pulmonary edema.
OHSS increases the risk of injury to the ovary. The ascitic, pleural, and pericardial fluid should not be removed unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade. Pelvic examination may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should therefore be avoided.
If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible. During clinical trials with FOLLISTIM or FOLLISTIM AQ Cartridge therapy, OHSS occurred in 7.6% of 105 women (OI) and 6.4% of 751 women (IVF or ICSI) treated with FOLLISTIM and FOLLISTIM AQ Cartridge, respectively.
Pulmonary and Vascular Complications
Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome) have been reported in women treated with gonadotropins. In addition, thromboembolic reactions both in association with, and separate from OHSS have been reported following gonadotropin therapy. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities.
Women with generally recognized risk factors for thrombosis, such as a personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarction. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death.
In women with recognized risk factors, the benefits of ovulation induction, in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment need to be weighed against the risks. It should be noted that pregnancy itself also carries an increased risk of thrombosis.
Ovarian Torsion
Ovarian torsion has been reported after treatment with FOLLISTIM AQ Cartridge and after intervention with other gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multi-fetal Gestation and Birth
Multi-fetal gestation and births have been reported with all gonadotropin treatments including FOLLISTIM AQ Cartridge treatment. The woman and her partner should be advised of the potential risk of multi-fetal gestation and births before starting treatment.
Congenital Anomalies
The incidence of congenital malformations after IVF or ICSI may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.
Ectopic Pregnancy
Since infertile women undergoing IVF or ICSI often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early confirmation of an intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.
Spontaneous Abortion
The risk of spontaneous abortions (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility.
Ovarian Neoplasms There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for controlled ovarian stimulation; however, a causal relationship has not been established.
Laboratory Tests For Women
In most instances, treatment with FOLLISTIM AQ Cartridge will result only in follicular growth and maturation. In order to complete the final phase of follicular maturation and to induce ovulation, hCG must be given following the administration of FOLLISTIM AQ Cartridge or when clinical assessment indicates that sufficient follicular maturation has occurred. The degree of follicular maturation and the timing of hCG administration can both be determined with the use of sonographic visualization of the ovaries and endometrial lining in conjunction with measurement of serum estradiol levels.
The combination of transvaginal ultrasonography and measurement of serum estradiol levels is also useful for minimizing the risk of OHSS and multi-fetal gestations. The clinical confirmation of ovulation is obtained by the following direct or indirect indices of progesterone production as well as sonographic evidence of ovulation. Direct or indirect indices of progesterone production are: Urinary or serum luteinizing hormone (LH) rise A rise in basal body temperature Increase in serum progesterone Menstruation following the shift in basal body temperature The following provide sonographic evidence of ovulation: Collapsed follicle Fluid in the cul-de-sac Features consistent with corpus luteum formation Sonographic evaluation of the early pregnancy is also important to rule out ectopic pregnancy.
For Men: Clinical monitoring for spermatogenesis utilizes the following indirect or direct measures: Serum testosterone level Semen analysis
FOLLISTIM Pen The FOLLISTIM Pen is intended only for use with FOLLISTIM AQ Cartridge. The FOLLISTIM Pen is not recommended for the blind or visually impaired without the assistance of an individual with good vision who is trained in the proper use of the injection device.
Drug Interactions with Follistim Aq
No drug-drug interaction studies have been performed.
Pregnancy Safety for Follistim Aq
Pregnancy Risk Summary FOLLISTIM AQ Cartridge is contraindicated for use in pregnant women. The incidence of congenital malformations after some Assisted Reproductive Technology, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], may be slightly higher than that after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to a higher incidence of multi-fetal gestations after IVF or ICSI.
There is no human data that the use of gonadotropins (including FOLLISTIM AQ Cartridge) alone or as part of IVF or ICSI cycles, increases the risk of congenital malformations. The risk of spontaneous abortion (miscarriage) is increased in women who have used gonadotropins products to achieve pregnancy. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively.
Pediatric Use of Follistim Aq
Pediatric Use FOLLISTIM AQ Cartridge is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.
Contraindications for Follistim Aq
FOLLISTIM AQ Cartridge is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant hFSH products or any component of FOLLISTIM AQ Cartridge. Reactions including anaphylaxis have been reported High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) Hypersensitivity reactions to streptomycin or neomycin.
Overdosage Information for Follistim Aq
Aside from the possibility of Ovarian Hyperstimulation Syndrome and multiple gestations, there is no additional information concerning the consequences of acute overdosage with FOLLISTIM AQ Cartridge.
Clinical Studies of Follistim Aq
Ovulation Induction
The efficacy of FOLLISTIM for ovulation induction was evaluated in a randomized, assessor-blind, parallel-group comparative, multicenter safety and efficacy study of 172 chronic anovulatory women (105 subjects on FOLLISTIM) who had previously failed to ovulate and/or conceive during clomiphene citrate treatment. The study results for ovulation rates are summarized in Table 6 and those for pregnancy rates are summarized in Table 7. Table 6: Cumulative Ovulation Rates Table 7: Cumulative Ongoing All ongoing pregnancies were confirmed after at least 12 weeks after the hCG injection., Study was not powered to demonstrate this outcome.
Pregnancy Rates
Controlled Ovarian
Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle The efficacy of FOLLISTIM AQ Cartridge was evaluated in a randomized, double-blind, active-controlled study of 1,509 healthy normal ovulatory women (mean age, body weight, and body mass index of 32 years, 68 kg and 25 kg/m 2, respectively) treated for one cycle with controlled ovarian stimulation and pituitary suppression with a GnRH antagonist as part of an in vitro fertilization or intracytoplasmic sperm injection cycle. This 2008 study was conducted in Europe and North America (United States and Canada). Approximately 54% of the subjects were from North America.
The overall results, as well as the results from North America only, for clinical pregnancy are summarized in Table 8. Table 8: Pregnancy Results from Treatment With FOLLISTIM AQ Cartridge and a GnRH Antagonist in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle. Single treatment cycle results.
Intent-to-Treat Population (ITT)
Induction of Spermatogenesis
The safety and efficacy of FOLLISTIM administered by subcutaneous injection concomitantly with chorionic gonadotropin for injection (hCG) has been examined in a multicenter, open-label, non-comparator clinical study for induction of spermatogenesis in hypogonadotropic hypogonadal men. The study compared the effects of two different FOLLISTIM dosing schedules on semen parameters and serum levels of follicle stimulating hormone (FSH). The multicenter study involved a 16-week pretreatment phase with urinary hCG at a dosage of 1,500 international units twice a week to normalize serum testosterone levels.
If serum testosterone levels did not normalize after 8 weeks of hCG treatment, the urinary hCG dose could have been increased to 3,000 international units twice a week. This phase was followed by a 48-week treatment phase. Men who were still azoospermic after the pretreatment phase were randomized to receive either 225 international units FOLLISTIM together with 1,500 international units urinary hCG twice a week or 150 international units FOLLISTIM three times a week together with 1,500 international units urinary hCG twice weekly.
Men who required 3,000 international units of urinary hCG twice a week in the pretreatment phase were continued on that dosage during the treatment phase. The mean age of patients in both treatment groups was approximately 30 years (range 18 to 47 years). The primary efficacy endpoint was the FOLLISTIM percentage of patients with a mean sperm density of ≥1 × 10 6 /mL on their last two treatment assessments.
The outcomes of treatment in the 30 men enrolled in the treatment phase are summarized in Table 9. No pregnancy data were collected during the trial. The local tolerance data were comparable between the two treatment groups.
The mean percentage of days without pain calculated for all subjects in the treatment period was 91.3% for patients in the 150 international units (three times a week) and 76.0% for patients in the 225 international units (two times a week) FOLLISTIM treatment groups. No patient discontinued treatment due to injection site reaction or injection site pain.
| Cycle | FOLLISTIM (n=105) |
|---|---|
| First treatment cycle | 72% |
| Second treatment cycle | 82% |
| Third treatment cycle | 85% |
| Cycle | FOLLISTIM (n=105) |
|---|---|
| First treatment cycle | 14% |
| Second treatment cycle | 19% |
| Third treatment cycle | 23% |
| Parameter | FOLLISTIM AQ Cartridge Overall data (n=750) | FOLLISTIM AQ Cartridge North American data (n=403) |
|---|---|---|
| Clinical pregnancy rate/cycle initiation Clinical pregnancy was assessed ≥6 weeks after transfer of one or two embryos. | 41.1% | 48.9% |
| FOLLISTIM 150 international units three times a week (n=15) | FOLLISTIM 225 international units twice a week (n=15) | Overall (n=30) | ||||
|---|---|---|---|---|---|---|
| Sperm Density of ≥10 6 /mL | n | % | n | % | n | % |
| Yes | 6 | 40 | 7 | 47 | 13 | 43 |
| No | 9 | 60 | 8 | 53 | 17 | 57 |
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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