Follistim AQ

Follistim AQ is an FDA-registered drug product whose active ingredient is FOLLITROPIN. It is labelled by Organon LLC taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 78206-129, application BLA021211, label effective 20260526. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing FOLLITROPIN are most often described in connection with: follistim cartridge, cause infertility, due primary, ovarian failure, hypogonadotropic hypogonadism, prior initiation, endocrinologic evaluation, fertility status. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE FOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle ( 1.2 ) 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 ( 1.3 ) 1.1 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. 1.2 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. The possibility of pregnancy should be excluded. The fertility status of the male partner should be evaluated. In Men for: 1.3 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.

2 DOSAGE AND ADMINISTRATION See Dose Conversion Table 1 for FOLLISTIM AQ Cartridge with Pen Injector ( 2.1 ) In Anovulatory Women Undergoing Ovulation Induction ( 2.2 ): Starting daily dose of 50 international units of FOLLISTIM AQ Cartridge is administered subcutaneously for at least the first 7 days. The dose is increased by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5,000 to 10,000 international units of urinary human chorionic gonadotropin (hCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent. In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycle ( 2.3 ): Starting dose of 200 international units (actual cartridge doses) of FOLLISTIM AQ Cartridge is administered subcutaneously for at least the first 7 days of treatment. Subsequent doses can be adjusted down or up based upon 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. Final oocyte maturation is induced with a dose of 5,000-10,000 international units of urinary hCG. Oocyte (egg) retrieval is performed 34 to 36 hours later. Induction of Spermatogenesis in Men ( 2.4 ): Pretreatment with urinary hCG alone (1,500 international units twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the dose may be increased to 3,000 international units twice a week. After normalization of serum testosterone levels, administer 450 international units per week (225 international units twice weekly or 150 international units three times weekly) of FOLLISTIM AQ Cartridge subcutaneously with the same pre-treatment hCG dose used to normalize testosterone levels. 2.1 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. 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 2.2 Recommended Dosing in Anovulatory Women Undergoing Ovulation Induction The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1) ] . A starting daily dose of 50 international units of FOLLISTIM AQ Cartridge is administered [see Dosage and Administration (2.1) ] 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 [see Warnings and Precautions (5.1 , 5.2 , 5.10) ] . 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 [see Warnings and Precautions (5.10) ] . 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. 2.3 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. A starting dose of 200 international units (actual cartridge doses) of FOLLISTIM AQ Cartridge is administered [see Dosage and Administration (2.1) ] subcutaneously daily for at least the first 7 days of treatment. 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. The maximum, individualized, daily dose of FOLLISTIM AQ Cartridge is 500 international units. For high responding women [those at particular risk of abnormal ovarian enlargement and/or ovarian hyperstimulation syndrome (OHSS)], decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response [see Warnings and Precautions (5.1 , 5.2 , 5.10) ] . 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. The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of FOLLISTIM AQ Cartridge therapy [see Warnings and Precautions (5.1 , 5.2 , 5.10) ] . Oocyte (egg) retrieval should be performed 34 to 36 hours following the administration of hCG. 2.4 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 [see Clinical Studies (14.3) ] . 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 [see Dosage and Administration (2.1) ], 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.

4 CONTRAINDICATIONS 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 [see Adverse Reactions (6.2) ] High levels of FSH indicating primary gonadal failure Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1.1 , 1.2 , 1.3) ] Hypersensitivity reactions to streptomycin or neomycin. FOLLISTIM AQ may contain traces of these antibiotics Tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland FOLLISTIM AQ Cartridge is also contraindicated in women who exhibit: Pregnancy [see Use in Specific Populations (8.1) ] Heavy or irregular vaginal bleeding of undetermined origin Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS) Women and men who exhibit: Prior hypersensitivity to recombinant hFSH products ( 4 ) High levels of FSH indicating primary gonadal failure ( 4 ) Presence of uncontrolled non-gonadal endocrinopathies ( 4 ) Hypersensitivity reactions related to streptomycin or neomycin ( 4 ) Tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland ( 4 ) Women who exhibit: Pregnancy ( 4 , 8.1 ) Heavy or irregular vaginal bleeding of undetermined origin ( 4 ) Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS) ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Atelectasis [see Warnings and Precautions (5.3) ] Thromboembolism [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5) ] Congenital Anomalies [see Warnings and Precautions (5.6) ] Ectopic Pregnancy [see Warnings and Precautions (5.7) ] Spontaneous Abortion [see Warnings and Precautions (5.8) ] Ovarian Neoplasms [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥2%) in women undergoing ovulation induction are ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. ( 6.1 ) The most common adverse reactions (≥2%) in women undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle are pelvic discomfort, headache, ovarian hyperstimulation syndrome, pelvic pain, nausea and fatigue. ( 6.1 ) The most common (≥2%) adverse reactions in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon USA LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 (105) 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 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) 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 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%) 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. Of the 49 men, 30 received weekly FOLLISTIM doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with FOLLISTIM. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with FOLLISTIM are listed in Table 4. Table 4: Common Adverse Reactions Reported at a Frequency of ≥2% in an Open-Label Clinical Trial in Men with Hypogonadotropic Hypogonadism 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) 6.2 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 [see Warnings and Precautions (5.3) ]

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Follistim AQ used for?
1 INDICATIONS AND USAGE FOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled …

Who makes Follistim AQ?
Organon LLC is the labeler of record for Follistim AQ.

What form does Follistim AQ come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Follistim AQ prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Follistim AQ been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.