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Follistim AQ follitropin 300 [iU]/.36mL Injection, Solution, 1 kit — NDC 78206-0129-59 package photo

Follistim AQ follitropin 300 [iU]/.36mL Injection, Solution, 1 kit

by Organon LLC · 1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58)
NDC 78206-0129-59
🏷️ FDA NDC (as labeled) 78206-129-59 billing pads the product segment with a zero
This package
Contains1 kit Pack sizes2 compare ↓
Also comes in: 1 kit 78206-0129-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 78206-129-59
Product NDC 78206-129
11-digit billing NDC 78206012959
RxCUI 854787, 854788, 854790, 1361563, 1361569, 1361572
UNII 076WHW89TW
Application # BLA021211
SPL Set ID 48489027-e52b-4b10-ae74-4ba03839150c
Established class (EPC) Gonadotropin
Chemical class Gonadotropins
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-24
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance FOLLITROPIN
GCN Seq No 047557
GCN 12921
HICL code 012848
Ingredient (HICL) Follitropin Beta,Recomb
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P0
Therapeutic class — intermediate (HIC2) Ovulation Stimulants/Pregnancy Facilitators
HIC3 code P0E
Therapeutic class — specific (HIC3) Follicle-Stimulating Hormone (Fsh)
AHFS code 68:18.08.00
AHFS class Gonadotropins
FDB label name FOLLISTIM AQ 300 UNIT CARTRIDG
FDB brand name Follistim Aq
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 78206-129-59 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 78206-0129-59. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Gonadotropins class.

Drug family (ATC) Gonadotropins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerOrganon LLC
FDA applicationBLA021211 (BLA)
Labeler code78206
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio70 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FOLLISTIM AQ 300 UNIT CARTRIDG Ingredient Follitropin Beta,Recomb

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 3.6 mg / 0.36 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 0.18 mg / 0.36 mL UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • 0.072 mg / 0.36 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 18 mg / 0.36 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 4.64 mg / 0.36 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 kit
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Follistim AQ 300 [iU]/.36mLthis 78206-0129-59 Organon 1 kit — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2005
First FDA approval
Aug 2005
📍
2026
Currently FDA-listed
21 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Follistim AQ (this brand).

Top reported reactions

Headache96
Abdominal Distension62
Product Packaging Quantity Issue61
Product Quality Issue56
Poor Quality Device Used55
Fatigue52
Nausea48

Age at onset

Neonate2
Infant2
Adolescent1
Adult29
Elderly1

Reporter sex

0 reports

Serious outcomes

Hospitalization64
Life-threatening6
Disabling3
Death2
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 21 11
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
78206-0129-01 1 KIT in 1 CARTON (78206-129-01) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-99) 2023-07-24 Active
78206-0129-59 You're viewing this 1 KIT in 1 CARTON (78206-129-59) / 1 CARTRIDGE in 1 KIT / .36 mL in 1 CARTRIDGE (78206-129-58) 2023-07-24 Active

Pack size FAQ

What quantity is in NDC 78206-0129-59?
NDC 78206-0129-59 contains 1 kit — 1 kit in 1 carton / 1 cartridge in 1 kit / .36 ml in 1 cartridge.
What is the difference between NDC 78206-0129-59 and NDC 78206-0129-01?
Both are Follistim AQ follitropin 300 [iU]/.36mL Injection, Solution — the drug itself is identical. NDC 78206-0129-59 is the 1 kit package, while NDC 78206-0129-01 is the 1 kit package.
What NDC number is used to bill for this package of Follistim AQ follitropin 300 [iU]/.36mL Injection, Solution?
Bill NDC 78206-0129-59 — the 11-digit billing format is 78206012959. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 78206-129-59, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 78206-0129-59, written without dashes as 78206012959. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 78206-0129-59, the first segment (78206) is the labeler code FDA assigned to Organon LLC; the middle segment (0129) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (59) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Organon LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 kit (78206-0129-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Organon LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

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 )

1.1Induction 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.

1.2Pregnancy 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:

1.3Induction 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 and Administration ~3 min read ▾

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.

2.1General 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

2.2Recommended 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 ad…

💊 Dosage Forms and Strengths 100 words ▾

3 DOSAGE FORMS AND STRENGTHS FOLLISTIM AQ Cartridge is a clear and colorless solution available as: Injection: 300 international units per 0.36 mL in a single-patient-use cartridge Injection: 600 international units per 0.72 mL in a single-patient-use cartridge Injection: 900 international units per 1.08 mL in a single-patient-use cartridge Injection: FOLLISTIM AQ Cartridge 300 International Units per 0.36 mL in a single-patient-use cartridge ( 3 ) Injection: FOLLISTIM AQ Cartridge 600 International Units per 0.72 mL in a single-patient-use cartridge ( 3 ) Injection: FOLLISTIM AQ Cartridge 900 International Units per 1.08 mL in a single-patient-use cartridge ( 3 )

⛔ Contraindications 219 words ▾

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 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS FOLLISTIM AQ Cartridge should be used only by physicians who are experienced in infertility treatment. FOLLISTIM AQ Cartridge contains a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) [see Warnings and Precautions (5.2) ] with or without pulmonary or vascular complications [see Warnings and Precautions (5.3) ] and multiple births [see Warnings and Precautions (5.5) ] . Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.10) ] .

Careful attention should be given to the diagnosis of infertility and in the selection of candidates for FOLLISTIM AQ Cartridge therapy [see Indications and Usage (1.1 , 1.2 , 1.3) and Dosage and Administration (2.2 , 2.3 , 2.4) ] . Switching to FOLLISTIM AQ Cartridge from other brands (manufacturer), types (recombinant, urinary), and/or methods of administration (FOLLISTIM Pen, conventional syringe) may necessitate an adjustment of the dose [see Dosage and Administration (2) ] . Treatment with FOLLISTIM AQ may result in: Abnormal Ovarian Enlargement ( 5.1 ) Ovarian Hyperstimulation Syndrome (OHSS) ( 5.2 ) Pulmonary and Vascular Complications ( 5.3 ) Ovarian Torsion ( 5.4 ) Multi-fetal Gestation and Birth ( 5.5 ) Congenital Anomalies ( 5.6 ) Ectopic Pregnancy ( 5.7 ) Spontaneous Abortion ( 5.8 ) Ovarian Neoplasms ( 5.9 )

5.1Abnormal 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 [ see Dosage and Administration (2.2 , 2.3) ] . Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of overstimulation [see Warnings and Precautions (5.8) ] . 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 [see Warnings and Precautions (5.3) ] .

5.2Ovarian 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 [see Warnings and Precautions (5.3) ] . 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 [see Warnings and Precautions (5.1) ] , 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 con…

🤒 Adverse Reactions ~3 min read ▾

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 .

6.1Clinical 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 Org…

🔄 Drug Interactions 10 words ▾

7 DRUG INTERACTIONS No drug-drug interaction studies have been performed.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: It is not known whether this drug is excreted in human milk. ( 8.2 )

8.1Pregnancy 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 [see Warnings and Precautions (5.6) ] .

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 [see Warnings and Precautions (5.8) ] . In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FOLLISTIM AQ Cartridge and any potential adverse effects on the breastfed child from FOLLISTIM AQ Cartridge or from the underlying maternal condition.

8.4Pediatric Use FOLLISTIM AQ Cartridge is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

8.5Geriatric Use Clinical studies of FOLLISTIM AQ Cartridge have not been conducted in patients 65 years of age and older.

🤰 Pregnancy 168 words ▾

8.1Pregnancy 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 [see Warnings and Precautions (5.6) ] .

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 [see Warnings and Precautions (5.8) ] . In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use FOLLISTIM AQ Cartridge is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

🧓 Geriatric Use 21 words ▾

8.5Geriatric Use Clinical studies of FOLLISTIM AQ Cartridge have not been conducted in patients 65 years of age and older.

🆘 Overdosage 43 words ▾

10 OVERDOSAGE Aside from the possibility of Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2 , 5.3) ] and multiple gestations [see Warnings and Precautions (5.5) ] , there is no additional information concerning the consequences of acute overdosage with FOLLISTIM AQ Cartridge.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Women: Follicle-stimulating hormone (FSH), the active component in FOLLISTIM AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. FOLLISTIM AQ Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure.

In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with FOLLISTIM AQ Cartridge when patient monitoring indicates appropriate follicular development parameters have been reached. Men: FOLLISTIM when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of FOLLISTIM, is the pituitary hormone responsible for spermatogenesis.

12.3Pharmacokinetics Pharmacokinetic parameters for FOLLISTIM AQ Cartridge were evaluated in an open-label, single-center, randomized study in 20 healthy women. Serum FSH values from a single subcutaneous injection of reconstituted FOLLISTIM lyophilized powder administered by conventional syringe were compared to those values following a single subcutaneous injection of FOLLISTIM AQ Cartridge administered with the FOLLISTIM Pen injector. Administration of follitropin beta with the FOLLISTIM Pen resulted an 18% increase in AUC 0–∞ and C max .

The 18% difference in serum FSH concentrations resulting from administration of the two formulations was due to differences between the anticipated and actual volume delivered with the conventional syringe. The pharmacokinetic parameters for FOLLISTIM AQ Cartridge are as follows: Table 5: Mean (SD) Pharmacokinetic Parameters of a Single Subcutaneous Injection of 150 IU of FOLLISTIM AQ Cartridge (n=20) AUC 0–∞ (IU/L*h) C max (IU/L) t max (h) t ½ (h) CL app (L/h/kg) AUC 0–∞ Area under the curve C max Maximum concentration t max Time to maximum concentration t ½ Elimination half-life CL app Clearance FOLLISTIM AQ 215.1 3.4 12.9 33.4

0.01Cartridge (45.8) (0.7) (6.2) (4.2) (0.003) Absorption: Women: The bioavailability of FOLLISTIM following subcutaneous and intramuscular administration was investigated in healthy, pituitary-suppressed women given a single 300 international units dose. In these women, the area under the curve (AUC), expressed as the mean ± SD, was equivalent between the subcutaneous (455.6 ± 141.4 IU*h/L) and intramuscular (445.7 ± 135.7 IU*h/L) routes of administration. However, equivalence could not be established with respect to the peak serum FSH levels (C max ).

The C max achieved after subcutaneous administration and intramuscular administration was 5.41 ± 0.72 international units/L and 6.86 ± 2.90 international units/L, respectively. After subcutaneous or intramuscular injection the apparent dose absorbed was 77.8% and 76.4%, respectively. The pharmacokinetics and pharmacodynamics of a single, intramuscular dose (300 international units) of FOLLISTIM were also investigated in a group (n=8) of gonadotropin-deficient, but otherwise healthy women.

In these women, FSH (mean ± SD) AUC was 339 ± 105 international units*h/L, C max was 4.3 ± 1.7 international units/L. C max occurred at approximately 27 ± 5.4 hours after intramuscular administration. A multiple dose, dose proportionality, pharmacokinetic study of FOLLISTIM was completed in healthy, pituitary-suppressed, female subjects given subcutaneous doses of 75, 150, or 225 international units for 7 days.

Steady-state blood concentrations of FSH were reached with all doses after 5 days of treatment based on the trough concentrations of FSH just prior to dosing (C trough ). Peak blood concentrations with the 75, 150, and 225 international units dose were 4.30 ± 0.60 international un…

🧬 Mechanism of Action 145 words ▾

12.1Mechanism of Action Women: Follicle-stimulating hormone (FSH), the active component in FOLLISTIM AQ Cartridge, is required for normal follicular growth, maturation, and gonadal steroid production. In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. FOLLISTIM AQ Cartridge stimulates ovarian follicular growth in women who do not have primary ovarian failure.

In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with FOLLISTIM AQ Cartridge when patient monitoring indicates appropriate follicular development parameters have been reached. Men: FOLLISTIM when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of FOLLISTIM, is the pituitary hormone responsible for spermatogenesis.

📦 How Supplied / Storage and Handling 202 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING FOLLISTIM AQ Cartridge (follitropin beta) injection is a clear and colorless solution in a disposable, prefilled single-patient-use glass cartridge with grey rubber piston and an aluminum crimp-cap with grey rubber inlay supplied in a box containing disposable, 29 gauge, ultra-fine, ½-inch, sterile BD Micro-Fine™ Pen Needles (for use with FOLLISTIM Pen available separately) and in the following presentations: NDC 78206-129-01 FOLLISTIM AQ Cartridge 300 international units per 0.36 mL with silver crimp-caps and 5 BD Micro-Fine Pen Needles NDC 78206-130-01 FOLLISTIM AQ Cartridge 600 international units per 0.72 mL with gold crimp-caps and 7 BD Micro-Fine Pen Needles NDC 78206-131-01 FOLLISTIM AQ Cartridge 900 international units per 1.08 mL with blue crimp-caps and 10 BD Micro-Fine Pen Needles Pharmacy Storage: Store refrigerated 36°F to 46°F (2°C to 8°C) until dispensed.

Do not freeze. Patient Storage: Store unused cartridge refrigerated at 36°F to 46°F (2°C to 8°C) until the expiration date, or at room temperature at up to 77°F (25°C) for 3 months or until expiration date, whichever occurs first. After first use, store at 36°F to 77°F (2°C to 25°C) and discard after 28 days.

Store in the original carton to protect from light. Do not freeze.

📦 Storage and Handling 79 words ▾

Pharmacy Storage: Store refrigerated 36°F to 46°F (2°C to 8°C) until dispensed. Do not freeze. Patient Storage: Store unused cartridge refrigerated at 36°F to 46°F (2°C to 8°C) until the expiration date, or at room temperature at up to 77°F (25°C) for 3 months or until expiration date, whichever occurs first. After first use, store at 36°F to 77°F (2°C to 25°C) and discard after 28 days. Store in the original carton to protect from light. Do not freeze.

📋 Description ~1 min read ▾

11 DESCRIPTION Follitropin beta, a gonadotropin [human follicle-stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese hamster ovary (CHO) cell line. It has a dimeric structure containing two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from that of hFSH.

The molecular weight is approximately 40 kDa. FOLLISTIM AQ Cartridge (follitropin beta) injection is a sterile clear and colorless solution, containing either 300 International Units, 600 International Units, or 900 International Units of follitropin beta in disposable single-patient-use cartridges for subcutaneous use only with the FOLLISTIM Pen. Each cartridge delivers 300 International Units in 0.36 mL and the inactive ingredients: benzyl alcohol (3.6 mg; preservative), methionine (0.18 mg), polysorbate 20 (0.072 mg), sodium citrate (4.64 mg), sucrose (18 mg), and Water for Injection USP.

Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Each cartridge delivers 600 International Units in 0.72 mL and the inactive ingredients: benzyl alcohol (7.2 mg; preservative), methionine (0.36 mg), polysorbate 20 (0.144 mg), sodium citrate (9.3 mg), sucrose (36 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7.

Each cartridge delivers 900 International Units in 1.08 mL and the inactive ingredients: benzyl alcohol (10.8 mg; preservative), methionine (0.54 mg), polysorbate 20 (0.216 mg), sodium citrate (13.9 mg), sucrose (54 mg), and Water for Injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7. Under current storage conditions, FOLLISTIM AQ may contain up to 11% of oxidized follitropin beta.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Reactions and Anaphylaxis Advise patients to discontinue FOLLISTIM AQ Cartridge and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur [see Contraindications (4) and Adverse Reactions (6.2) ] . Dosing and Use of FOLLISTIM AQ Cartridge with Pen Instruct women and men on the correct usage and dosing of FOLLISTIM AQ Cartridge in conjunction with the FOLLISTIM Pen.

Make sure that individuals who have used other gonadotropin products delivered by a syringe are aware of differences arising from use of the pen. Women and men should read and follow all instructions in the FOLLISTIM Pen " Instructions for Use " Manual prior to administration of FOLLISTIM AQ Cartridge. Advise women and men of the number of doses which can be extracted from the full unused FOLLISTIM AQ Cartridge that you have prescribed.

Therapy Duration and Necessary Monitoring in Women and Men Undergoing Treatment Prior to beginning therapy with FOLLISTIM AQ Cartridge, inform women and men about the time commitment and monitoring procedures necessary to undergo treatment [see Dosage and Administration (2) , Warnings and Precautions (5.10) ] . Instructions on a Missed Dose Inform women and men that if they miss or forget to take a dose of FOLLISTIM AQ Cartridge, the next dose should not be doubled and they should call the healthcare provider for further dosing instructions.

Ovarian Hyperstimulation Syndrome Inform women regarding the risks with use of FOLLISTIM AQ Cartridge of Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] and associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.3) ] and ovarian torsion [see Warnings and Precautions (5.4) ] . Multi-fetal Gestation and Birth Inform women regarding the risk of multi-fetal gestations with the use of FOLLISTIM AQ Cartridge [see Warnings and Precautions (5.5) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.