Follistim AQ 900 [iU]/1.08mL
follitropin · INJECTION, SOLUTION · Organon LLC
Follistim AQ is a injection, solution containing follitropin at 900 [iU]/1.08mL, taken subcutaneous. Manufactured by Organon LLC.
Key Facts
- Brand Name
- Follistim AQ
- Generic Name
- follitropin
- NDC Code (Product)
78206-131- Manufacturer
- Organon LLC
- Strength
- 900 [iU]/1.08mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA021211
- Drug Class
- Gonadotropin [EPC]
- Marketing Start
- 07/24/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 Pregna…
Dosage & Administration
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 b…
Contraindications
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 …
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been performed.
Adverse Reactions
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 inductio…
Frequently Asked Questions
What is Follistim AQ used for?
Follistim AQ contains follitropin. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Follistim AQ a controlled substance?
Follistim AQ is not classified as a controlled substance by the DEA.
What is the generic name for Follistim AQ?
The generic name for Follistim AQ is follitropin. There are 4 other brand versions of follitropin.
What is the NDC code for Follistim AQ 900 [iU]/1.08mL?
The NDC (National Drug Code) for Follistim AQ 900 [iU]/1.08mL is 78206-131, listed by Organon LLC.