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Gonal-f follitropin alfa Kit — NDC 44087-9030-01 package photo

Gonal-f follitropin alfa Kit

by EMD Serono, Inc. · 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE
NDC 44087-9030-01
🏷️ FDA NDC (as labeled) 44087-9030-1 billing pads the package segment with a zero
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) 44087-9030-1
Product NDC 44087-9030
11-digit billing NDC 44087903001
NCPDP billing unit EA — each (per item)
RxCUI 351125, 351993
Application # BLA020378
SPL Set ID ae85b9c3-e7eb-4981-a5d9-346050e8f189
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-03-25
Route SUBCUTANEOUS
Dosage form KIT
GPI-14 30062030052140
GPI class Gonal-f
GCN Seq No 053207
GCN 20590
HICL code 013308
Ingredient (HICL) Follitropin Alfa, Recombinant
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 GONAL-F 450 UNITS VIAL
FDB brand name Gonal-F
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 44087-9030-1 — a 5-4-1 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 package segment → 44087-9030-01. 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

LabelerEMD Serono, Inc.
FDA applicationBLA020378 (BLA)
Labeler code44087
First marketedMar 2004
Product typeHuman Prescription Drug
Portfolio18 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 GONAL-F 450 UNITS VIAL Ingredient Follitropin Alfa, Recombinant

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer 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.
Medicare Part B allowsASP · J3490 No ASP payment limit on file for J3490 this quarter.
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.
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)44087-9030-1
11-digit billing NDC44087-9030-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ3490
DescriptorUNCLASSIFIED DRUGS
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gonal-fthis 44087-9030-01 EMD 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

🏛️
1997
First FDA approval
Sep 1997
📍
2026
Currently FDA-listed
29 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.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Gonal-ffollitropin alfa Gonal-f RFFfollitropin alfa Gonal-f RFF RediJectfollitropin alfa
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
44087-9030-01 You're viewing this 1 KIT in 1 CARTON (44087-9030-1) * 1 mL in 1 VIAL * 1 mL in 1 SYRINGE 2004-03-25 Active

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 44087-9030-1, 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: 44087-9030-01, written without dashes as 44087903001. 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 44087-9030-01, the first segment (44087) is the labeler code FDA assigned to EMD Serono, Inc.; the middle segment (9030) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 EMD Serono, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
EMD Serono, Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3490 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 👥 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 159 words ▾

1 INDICATIONS AND USAGE GONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. ( 1.1 ) Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles. ( 1.2 ) Men: Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure.

( 1.3 )

1.1Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.

1.2Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle.

1.3Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Induction of Ovulation ( 2.3 ) Initial starting dose of the first cycle - 75 International Units of GONAL-f per day for 14 days, administered subcutaneously Individualize doses after 14 days Do not administer doses greater than 300 International Units per day Development of Multiple Follicles in Assisted Reproductive Technology (ART) ( 2.3 ) Initial starting dose of the first cycle - 150 International Units per day, administered subcutaneously Dosage adjustments after 3 to 5 days and by 75 to 150 International Units at each adjustment Do not administer doses greater than 450 International Units per day Males with Hypogonadotropic Hypogonadism and Azoospermia ( 2.4 ) Use in conjunction with hCG.

Prior to concomitant therapy with GONAL-f and hCG, pretreat with 1,000 to 2,250 USP units of hCG alone two to three times per week to achieve normal serum testosterone levels, which may take 3 to 6 months. After normalization of serum testosterone, administer 150 International Units of GONAL-f subcutaneously three times a week and 1,000 USP units of hCG (or the dose required to maintain serum testosterone levels within the normal range) three times a week.

2.1Important Dosage and Administration Information Only physicians who are experienced in infertility treatment, should treat women with GONAL-f. GONAL-f is a gonadotropin product capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications [see Warnings and Precautions (5.2 , 5.3) ] and multiple births [see Warnings and Precautions (5.6) ] . Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.11) ] .

Use the lowest effective dose of GONAL-f. Give careful attention to the diagnosis of infertility and the selection of candidates for GONAL-f therapy [see Dosage and Administration (2.3 , 2.4) ] .

2.2Preparation of GONAL-f and Selection of Injection Site Store lyophilized multiple-dose vials refrigerated or at room temperature (2°-25°C /36°-77°F) and protected from light. Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Instruct women and men to use the accompanying syringes, calibrated in International Units FSH for administration.

The 27-gauge injection syringe (see figure below) has unit dose markings from

37.5International Units to 600 International Units FSH for use with GONAL-f Multi-Dose. Instruct women and men to take a specific dose of GONAL-f Multi-Dose. Show women and men how to locate the syringe marking that corresponds to the prescribed dose.

Each GONAL‑f Multi‑Dose Vial delivers 450 International Units or 1050 International Units of follitropin alfa, respectively Multi-Dose 450 International Units Vial: Dissolve the contents of one Multi-Dose vial (450 International Units) with 1 mL Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP. Resulting concentration will be 600 International Units/mL. Following reconstitution as directed, product will deliver the equivalent of six 75 International Units doses.

Multi-Dose 1050 International Units Vial: Dissolve the contents of one Multi-Dose vial (1050 International Units) with 2 mL Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP. Resulting concentration will be 600 International Units/mL. Following reconstitution as directed, product will deliver the equivalent of fourteen 75 International Units doses.

Discard unused reconstituted solution after 28 days. Administer GONAL-f subcutaneously in the abdomen, upper arm, or upper leg as described in Patient Information and Instructions for Use. Figure

2.3Dosing for Ovulation Induction Prior to initiation of treatment with GONAL-f: Perform a complete gynecologic and endocrinologic evaluation Exclude primary ovarian failure Exclude the possibility of pregnancy Demonstrate tubal patency Evaluate the fer…

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 450 International Units of white lyophilized powder in a multiple-dose vial For Injection: 1050 International Units of white lyophilized powder in a multiple-dose vial For Injection: 450 International Units in a multiple-dose vial.( 3 ) For Injection: 1050 International Units in a multiple-dose vial. ( 3 )

⛔ Contraindications 166 words ▾

4 CONTRAINDICATIONS GONAL-f is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant FSH products or one of their excipients. Reactions have included anaphylaxis [see Warning and Precautions (5.1) ] High levels of FSH indicating primary gonadal failure The presence of uncontrolled non-gonadal endocrinopathies (for example, thyroid, adrenal, or pituitary disorders) Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus GONAL-f is also contraindicated in women who exhibit: Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin GONAL-f is contraindicated in women and men who exhibit ( 4 ): Prior hypersensitivity to recombinant FSH products or one of their excipients High levels of FSH indicating primary gonadal failure Uncontrolled non-gonadal endocrinopathies Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus GONAL-f is also contraindicated in women who exhibit ( 4 ): Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions and Anaphylaxis: If occurs, initiate appropriate therapy including supportive measures, and discontinue GONAL-f ( 5.1 ) Ovarian Hyperstimulation Syndrome: If serious, stop gonadotropins, including hCG, and determine if the woman needs to be hospitalized. Treatment is primarily symptomatic and consists of bed rest, fluid and electrolyte management, and analgesics ( 5.2 ) Pulmonary and Vascular Complications: In women with recognized risk factors, the benefits of induction of ovulation and ART need to be weighed against the risks.

During or after use of GONAL-f, monitor for venous or arterial thromboembolic events ( 5.3 ) Ovarian Torsion: Early diagnosis and immediate detorsion limit damage to the ovary due to reduced blood supply ( 5.4 ) Abnormal Ovarian Enlargement: If the ovaries are abnormally enlarged on the last day of GONAL-f therapy, inform women not to administer hCG and to avoid intercourse ( 5.5 ) Multi-fetal Gestation and Births: The rate of multiple births is dependent on the number of embryos transferred. Advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy with GONAL-f ( 5.6 ) Embryofetal Toxicity: Inform women that the incidence of congenital malformations (birth defects) after some Assisted Reproductive Technology (ART) [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception.

There is no evidence that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations ( 5.7 ) Ectopic Pregnancy: Advise women who become pregnant following ART and have: abdominal/pelvic pain (particularly on one side); shoulder, neck or rectal pain; and nausea and vomiting to seek immediate medical attention. Confirm the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound ( 5.8 ) Spontaneous Abortion: The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, however, causality has not been established ( 5.9 ) Ovarian Neoplasm: Both benign and malignant ovarian neoplasms are reported in women who have had multiple drug therapy for controlled ovarian stimulation, however, causality has not been established ( 5.10 )

5.1Hypersensitivity Reactions and Anaphylaxis In the post-marketing experience, serious systemic hypersensitivity reactions, including anaphylaxis, have been reported with use of GONAL-f and GONAL-f RFF. Symptoms have included dyspnea, facial edema, pruritus, and urticaria. If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures if cardiovascular instability and/or respiratory compromise occur, and discontinue further use.

5.2Ovarian Hyperstimulation Syndrome (OHSS) Ovarian Hyperstimulation Syndrome (OHSS) is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. 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 development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain.

Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement [see Warnings and Precautions (5.6) ] , 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 (5.4) ] . Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy, have been reported in association w…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions and Anaphylaxis [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Pulmonary and Vascular Complication [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Abnormal Ovarian Enlargement [see Warnings and Precautions (5.5) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.6) ] Embryofetal Toxicity [see Warnings and Precautions (5.7) ] Ectopic Pregnancy [see Warnings and Precautions (5.8) ] Spontaneous Abortion [see Warnings and Precautions (5.9) ] Ovarian Neoplasms [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥5%) in ovulation induction include: ovarian cyst, headache, abdominal pain, OHSS, nausea, flatulence, pain and intermenstrual bleeding.

( 6.1 ) The most common adverse reactions (≥5%) in development of multiple follicles in ART include: headache, nausea, pelvic pain and abdominal pain. ( 6.1 ) The most common adverse reactions (>5%) in hypogonadotropic hypogonadal men participating in induction of spermatogenesis include: acne, injection site pain, fatigue, gynecomastia and seborrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088, Ext 5563 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 reaction 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. Women: The safety of GONAL-f was examined in four clinical trials that enrolled 691 women [two trials for ovulation induction (454 women) and two trials for ART (237 women)]. Induction of Ovulation In a randomized, open-labeled, multicenter, active-controlled trial in oligo-anovulatory infertile women, conducted in the U.S., a total of 118 oligo-anovulatory infertile women were randomized to and underwent ovulation induction with GONAL-f versus a comparator urofollitropin.

Adverse reactions occurring in at least 5.0% of women receiving GONAL-f are listed in Table 1. Table 1: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S. Ovulation Induction Trial System Organ Class/Adverse Reactions GONAL-f N=118 total number of women treated with GONAL-f (288 treatment cycles up to 3 treatment cycles per woman ) n number of women with the adverse reaction (%) Body as a Whole - General Pain 6 (5.1%) Central and Peripheral Nervous System Headache 12 (10.2%) Gastrointestinal System Abdominal Pain 9 (7.6%) Nausea 7 (5.9%) Flatulence 7 (5.9%) Reproductive, Female Intermenstrual Bleeding 6 (5.1) Ovarian Hyperstimulation 8 (6.8%) Ovarian Cyst 17 (14.4%) Development of Multiple Follicles as part of an Assisted Reproductive Technology (ART) Cycle In a randomized, open-labeled, active-comparator trial conducted in the U.S., a total of 56 normal ovulatory infertile women were randomized and received GONAL-f versus a urofollitropin comparator as part of an ART [in vitro fertilization (IVF) or intracytoplasmic sperm injection cycle (ICSI)] cycle.

All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring in at least 5.0% of women are listed in Table 2. Table 2: Common Adverse Reactions Reported at a Frequency of ≥ 5% in an U.S.

ART Trial System Organ Class/Adverse Reactions GONAL-f (N=56 total number of women treated with GONAL-f ) n number of women with the adverse reaction (%) Central and Peripheral Nervous System Headache 7 (12.5%) Gastrointestinal System Abdominal Pain 3 (5.4%) Nausea 4 (7.1%) Reproductive, Female Pelvic Pain 4 (7.1) Induction of Spermatogenesis: The safety of GONAL-f for induction of spermatogenesis in men with primary or secondary hypogonadotropic…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed ( 8.2 )

8.1Pregnancy Risk Summary GONAL-f is not indicated 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 GONAL-f) 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 gonadotropin products (including GONAL-f) to achieve pregnancy. In animal studies, the continuous administration of recombinant human FSH during pregnancy resulted in a decrease in the number of viable fetuses and difficult and prolonged delivery.

No teratogenic effect has been observed. In the U.S. 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. Data Human Data Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or fetal development, parturition or postnatal development following controlled ovarian stimulation.

Animal Data Embryofetal development studies with recombinant human FSH in rats, where dosing occurred during organogenesis, showed a dose dependent increase in difficult and prolonged parturition in dams, and dose dependent increases in resorptions, pre- and post-implantation losses, and stillborn pups at doses representing 5 and 41 times the lowest clinical dose of 75 International Units based on body surface area. Pre-/post-natal development studies with recombinant human FSH in rats, where dosing occurred from mid-gestation through lactation, showed difficult and prolonged parturition in all dams dosed at 41 times the lowest clinical dose of 75 International Units based on body surface area, along with maternal death and stillborn pups associated with the difficult and prolonged parturition.

This toxicity was not observed in dams and offspring dosed at a level 5 times the lowest clinical dose of 75 International Units based on body surface area.

8.2Lactation There are no data on the presence of GONAL-f in human milk, the effects on the breastfed infant, or the effects on milk production. Because the secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breast feed during treatment with GONAL-f.

8.3Females and Males of Reproductive Potential Because GONAL-f is not indicated in pregnant women, verify a negative pregnancy test before administering GONAL-f to a woman [see Dosage and Administration (2.3 , 2.4) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Safety and effectiveness of GONAL-f in postmenopausal women have not been established and it is not indicated in this population.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary GONAL-f is not indicated 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 GONAL-f) 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 gonadotropin products (including GONAL-f) to achieve pregnancy. In animal studies, the continuous administration of recombinant human FSH during pregnancy resulted in a decrease in the number of viable fetuses and difficult and prolonged delivery.

No teratogenic effect has been observed. In the U.S. 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. Data Human Data Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or fetal development, parturition or postnatal development following controlled ovarian stimulation.

Animal Data Embryofetal development studies with recombinant human FSH in rats, where dosing occurred during organogenesis, showed a dose dependent increase in difficult and prolonged parturition in dams, and dose dependent increases in resorptions, pre- and post-implantation losses, and stillborn pups at doses representing 5 and 41 times the lowest clinical dose of 75 International Units based on body surface area. Pre-/post-natal development studies with recombinant human FSH in rats, where dosing occurred from mid-gestation through lactation, showed difficult and prolonged parturition in all dams dosed at 41 times the lowest clinical dose of 75 International Units based on body surface area, along with maternal death and stillborn pups associated with the difficult and prolonged parturition.

This toxicity was not observed in dams and offspring dosed at a level 5 times the lowest clinical dose of 75 International Units based on body surface area.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 23 words ▾

8.5Geriatric Use Safety and effectiveness of GONAL-f in postmenopausal women have not been established and it is not indicated in this population.

🆘 Overdosage 25 words ▾

10 OVERDOSAGE Ovarian hyperstimulation syndrome (OHSS) and multiple gestations have been observed in women with GONAL-f overdosage [see Warnings and Precautions (5.2 , 5.6) ].

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action GONAL-f stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of GONAL-f, when monitoring of the patient indicates that sufficient follicular development is achieved. GONAL-f stimulates spermatogenesis in men with hypogonadotropic hypogonadism when administered with hCG.

12.2Pharmacodynamics Serum inhibin, estradiol, and total follicular volume responded as a function of time, with pronounced inter-woman variability in healthy volunteers administered GONAL-f. Pharmacodynamic effect lagged behind FSH serum concentration. Serum inhibin levels responded with the least delay and declined rapidly after discontinuation of GONAL-f.

Follicular growth was most delayed and continued even after discontinuation of GONAL-f, and after serum FSH levels had declined. Maximum follicular volume correlated better with inhibin and estradiol peak levels than with FSH concentration. Inhibin rise was an early index of follicular development.

FSH serum levels following fixed (during the first five days) and then adjusted doses of GONAL-f were found to be poor predictors of follicular growth rate. High pre-treatment serum FSH levels may predict lower follicular growth rates. Inhibin levels reached a plateau during the entire administration period and then returned to baseline despite high inter-male variation and the absence of down-regulation in healthy male volunteers administered GONAL-f.

12.3Pharmacokinetics Single dose and state-state pharmacokinetics of follitropin alfa were determined following subcutaneous administration of GONAL-f to healthy, down-regulated female volunteers, healthy adult male volunteers, and pituitary down-regulated women undergoing in vitro fertilization and embryo transfer (IVF/ET). The pharmacokinetic parameters of follitropin alfa following subcutaneous administration of GONAL-f are presented in Table 4. Table 4: Pharmacokinetic Parameters (mean ± SD) of Follitropin Alfa Population Female Male Healthy Female Volunteers IVF/ET Patients Healthy Male Volunteers Dose (IU) Single Dose (150 IU) Multiple Dose (7 × 150 IU) Multiple Dose (5 × 225 IU) , Single Dose (225 IU) Multiple Dose (7 × 225 IU) AUC=area under the concentration-time curve; CL/F=apparent clearance; C max =peak serum concentration; T max =time of C max ; t 1/2 =half-life; Vd=volume of distribution General Information AUC (IU*hr/L) 176 ± 87 187 ± 61 Steady-state AUC 144 hr-168 hr (after the 7th daily subcutaneous dose) --- 220 ± 109 186 ± 23 C max (IU/L) 3 ± 1 9 ± 3 --- 2.5 ± 0.8 8.3 ±

0.9Absorption Absolute Bioavailability (%) 66 ± 39 --- --- --- T max (hr) 16 ± 10 8 ± 6 --- 20 ± 14 10.7 ±

6.7Distribution Apparent Vd (L) ------ --- 10 ± 3 --- --- Elimination Follitropin alfa metabolism has not been studied in humans. t 1/2 terminal (hr) The elimination rate of follitropin alfa following subcutaneous administration is dependent on the absorption rate. 24 ± 11 24 ± 8 32 41 ± 14 32 ± 4 CL/F (L/hr) The apparent clearance was comparable to that in healthy volunteers. ------ --- 0.7 ± 0.2 0.86 ± 0.48 0.90 ±

0.12Specific Populations Body Weight The absorption rate of follitropin alfa lowers as body mass index (BMI) increases. Drug Interaction Studies No studies evaluating the drug interaction potential of follitropin alfa has been conducted.

🧬 Mechanism of Action 74 words ▾

12.1Mechanism of Action GONAL-f stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of GONAL-f, when monitoring of the patient indicates that sufficient follicular development is achieved. GONAL-f stimulates spermatogenesis in men with hypogonadotropic hypogonadism when administered with hCG.

📦 How Supplied / Storage and Handling 191 words ▾

16 How Supplied/Storage and Handling

16.1How Supplied GONAL-f (follitropin alfa) for injection is supplied as a sterile, white lyophilized powder in multiple-dose vials of either 450 International Units per vial or 1050 International Units per vial. The following package presentations are available: NDC 44087-9030-1 - One multiple-dose vial of GONAL-f 450 International Units, one-1 mL prefilled diluent syringe of Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), and six administration syringes calibrated in FSH Units (IU FSH) with a fixed 27-gauge × 0.5-inch needle.

NDC 44087-9070-1 - One multiple-dose vial GONAL-f of 1050 International Units, one-2 mL prefilled diluent syringe of Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), and ten administration syringes calibrated in FSH Units (IU FSH) with a fixed 27-gauge × 0.5-inch needle.

16.2Storage and Handling Store vials refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F). Store reconstituted solution refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F) and discard unused portion after 28 days. Protect from light [see Dosage and Administration (2.2) ] .

📦 Storage and Handling 64 words ▾

16.2Storage and Handling Store vials refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F). Store reconstituted solution refrigerated between 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F) and discard unused portion after 28 days. Protect from light [see Dosage and Administration (2.2) ] .

📋 Description 197 words ▾

11 DESCRIPTION Follitropin alfa, 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 those of human follicle stimulating hormone.

The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit). GONAL-f (follitropin alfa) for injection is a sterile, lyophilized powder intended for subcutaneous injection after reconstitution. Each multiple-dose vial of GONAL-f containing either 450 International Units (33 mcg) or 1050 International Units (77 mcg) follitropin alfa and the inactive ingredients dibasic sodium phosphate (0.89 mg), monobasic sodium phosphate (0.39 mg), and sucrose (30 mg).

Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment. After reconstitution with supplied 1 mL of with Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP, the resultant concentration is 600 IU/mL with a pH of approximately 6.5 to 7.5. Under current storage conditions, GONAL-f may contain up to 10% of oxidized follitropin alfa.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise women and men to read the FDA-approved patient labeling (Patient Information and Instructions for Use) Hypersensitivity Reactions and Anaphylaxis Advise women and men to discontinue GONAL-f and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.1) ]. Ovarian Hyperstimulation Syndrome Inform women regarding the risks of OHSS [see Warnings and Precautions (5.2 ] and OHSS-associated conditions including pulmonary and vascular complications [see Warnings and Precautions (5.3) ] and ovarian torsion [see Warnings and Precautions (5.4) ] with the use of GONAL-f.

Advise women to seek medical attention if any of these conditions occur. Abnormal Ovarian Enlargement Inform women regarding the hazards associated with abnormal ovarian enlargement that may occur with GONAL-f therapy. If the ovaries are abnormally enlarged on the last day of GONAL-f therapy, inform women not to administer hCG and to avoid intercourse [see Warnings and Precautions (5.5) ] .

Multi-fetal Gestation and Birth Advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy with GONAL-f [see Warnings and Precautions (5.6) ]. Embryofetal Toxicity Inform women that the incidence of congenital malformations (birth defects) after some Assisted Reproductive Technology [(ART) specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception [see Warnings and Precautions (5.7) ] .

Ectopic Pregnancy Inform women undergoing ART that the incidence of ectopic pregnancy may be increased with these procedures, particularly for women with tubal abnormalities. Advise women who become pregnant and have: abdominal/pelvic pain (particularly on one side); shoulder, neck or rectal pain; and nausea and vomiting to seek immediate medical attention [see Warnings and Precautions (5.8) ] . Spontaneous Abortion Inform women that the risk of spontaneous abortion (miscarriage) is increased with gonadotropin products (including GONAL-f).

However, causality has not been established. The increased risk may be a factor of the underlying infertility [see Warnings and Precautions (5.9) ] . Lactation Advise women not to breastfeed because the secretion of prolactin during lactation can result in inadequate response to ovarian stimulation with GONAL-f [see Use in Specific Populations (8.2) ] .

Dosing and Use of GONAL-f Multi Dose Instruct women and men on the correct usage and dosing of GONAL-f [see Dosage and Administration (2.3 , 2.4 , 2.5) ] . Caution against changing the dosage or the schedule of administration unless instructed to do so by a healthcare provider. Duration and Necessary Monitoring in Patients Undergoing Therapy with GONAL-f Prior to beginning therapy with GONAL-f, inform women and men about the time commitment and monitoring procedures necessary for treatment [see Dosage and Administration (2.3 , 2.4 , 2.5) and Warnings and Precautions (5.11) ].

Instructions Regarding a Missed Dose Inform women and men that if they miss or forget to take a dose of GONAL-f, they should not double the next dose and should call their healthcare provider for further dosing instructions.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 44087-8822-01 · EMD 44099-0011-01 · 21st →
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.