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Gonal-f RFF Redi-ject FOLLITROPIN 900 [iU]/1.5mL Injection, Solution, 1.5 mL — NDC 44087-1117-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gonal-f RFF Redi-ject FOLLITROPIN 900 [iU]/1.5mL Injection, Solution, 1.5 mL — NDC 44087-1117-1 (Billing 44087-1117-01)

by EMD Serono, Inc. · 1 PACKAGE in 1 CARTON / 1.5 mL in 1 PACKAGE

This is a package of 1.5 mL of Gonal-f RFF Redi-ject FOLLITROPIN 900 [iU]/1.5mL Injection, Solution from EMD Serono, Inc., marketed since Oct 2013 and currently FDA-listed. It is this product's only package size.

NDC 44087-1117-01
🏷️ FDA NDC (as labeled) 44087-1117-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 44087-1117-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
44087 labeler · 1117 product · 1 package
Package marketed since
Oct 16, 2013
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
2 mL per package
Barcode (UPC-A, from the NDC)
3 4408711171 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44087-1117-1
Product NDC 44087-1117
11-digit billing NDC 44087111701
NCPDP billing unit ML — per mL (volume)
RxCUI 1594334, 1594418, 1594432, 1654171, 1654179, 1654184
UNII 076WHW89TW
Application # BLA021684
SPL Set ID b6d11c45-b502-478e-bb28-2ff596ea259c
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 2013-10-16
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance FOLLITROPIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 3006203005D239
GPI class Gonal-f RFF Rediject
GCN Seq No 086435
GCN 56148
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 RFF REDI-JECT 900 UNIT
FDB brand name Gonal-F Rff Redi-Ject
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 086435
  • GCN: 56148
  • GPI-14 (Medi-Span): 3006203005D239
  • HICL (First Databank): 013308
  • AHFS class code: 68:18.08.00
  • RxCUI (RxNorm): 1594334
Why two NDCs? The FDA registers this code as 44087-1117-1 — 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 → 44087-1117-01. 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.

Clinical

Label name GONAL-F RFF REDI-JECT 900 UNIT 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.

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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44087-1117-01 You're viewing this Main listing 1 PACKAGE in 1 CARTON / 1.5 mL in 1 PACKAGE 2013-10-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gonal-f RFF Redi-ject 900 [iU]/1.5mLthis 44087-1117-01 EMD 1.5 ml — — 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

🏛️
2013
On the market since
Oct 2013
📍
2026
Currently FDA-listed
13 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.

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.

  • UNII GGO4Y809LO
    Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
  • 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.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.
  • 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.

6 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.

Manufacturer & labeler

LabelerEMD Serono, Inc.
FDA applicationBLA021684 (BLA)
Labeler code44087
First marketedOct 2013
Product typeHuman Prescription Drug
Portfolio18 products on file

More NDCs from EMD Serono, Inc. labeler code 44087

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 180 words ▾

1 INDICATIONS AND USAGE GONAL-f ® RFF Redi-ject ® is a prefilled gonadotropin-containing auto-injection device indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure ( 1.1 ) Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle ( 1.2 )

1.1Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation Exclude primary ovarian failure Exclude the possibility of pregnancy Demonstrate tubal patency Evaluate the fertility status of the male partner

1.2Development of Multiple Follicles in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle. Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility Exclude the possibility of pregnancy Evaluate the fertility status of the male partner

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Ovulation Induction ( 2.2 ) Initial starting dose of the first cycle - 75 International Units of GONAL-f ® RFF Redi-ject ® per day for 14 days, administered subcutaneously Individualization doses after 14 days Doses larger than 300 International Units of FSH per day are not recommended Assisted Reproductive Technology ( 2.3 ) Initial starting dose of the first cycle - 150 International Units per day, administered subcutaneously Dosage adjustments after 3-5 days and by 75-150 International Units at each adjustment Do not administer doses greater than 450 International Units per day

2.1General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GONAL-f ® RFF Redi-ject ® is a pre-filled disposable auto-injection device intended for multiple dose use. GONAL-f ® RFF Redi-ject ® can be set in

12.5International Units increments. Administer GONAL-f ® RFF Redi-ject ® subcutaneously in the abdomen as described in Instructions for Use Do not attempt to mix any other medications inside of the device with GONAL-f ® RFF Redi-ject ® . Instruct women to remove the GONAL-f ® RFF Redi-ject ® from the refrigerator at least 30 minutes prior to use in order to allow GONAL-f ® RFF Redi-ject ® to warm to room temperature and avoid the discomfort of a cold injection.

2.2Recommended Dosing for Ovulation Induction The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1) ] . Starting doses less than

37.5International Units have not been studied in clinical trials and are not recommended. A starting daily dose of 75 International Units of GONAL-f ® RFF Redi-ject ® is administered subcutaneously daily for 14 days in the first cycle of use. In subsequent cycles of treatment, the starting dose (and dosage adjustments) of GONAL-f ® RFF Redi-ject ® should be determined based on the history of the ovarian response to GONAL-f ® RFF Redi-ject ® .

The following should be considered when planning the woman's individualized dose: Appropriate GONAL-f ® RFF Redi-ject ® dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of GONAL-f ® RFF Redi-ject ® is 300 International Units per day. In general, do not exceed 35 days of treatment.

If indicated by the ovarian response after the initial 14 days, make an incremental adjustment in dose, up to

37.5International Units. If indicated by the ovarian response, make additional adjustments in dose, up to

37.5International Units, every 7 days. Treatment should continue until follicular growth and/or serum estradiol levels indicate an adequate ovarian response. When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.

Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of GONAL-f ® RFF Redi-ject ® therapy [see Warnings and Precautions (5.2 , 5.3 , 5.11) ] . Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent. Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2 , 5.3) ] .

2.3Recommended Dosing for Assisted Reproductive Technology The dosing scheme follows a stepwise approach and is individualized for each woman. Beginning on cycle day 2 or 3, a starting dose of 150 International Units of GONAL-f ® RFF Redi-ject ® is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 10 days.

In women under 35 years of age whose endogenous gonadotropin levels are suppressed, initiate GONAL-f ® RFF Redi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 127 words ▾

3 DOSAGE FORMS AND STRENGTHS GONAL-f® RFF Redi-ject is a clear and colorless to slightly yellow solution available as: • Injection: GONAL-f ® RFF Redi-ject ® 300 International Units per 0.48 mL in prefilled, single-patient-use pen • Injection: GONAL-f ® RFF Redi-ject ® 450 International Units per 0.72 mL in prefilled, single-patient-use pen • Injection: GONAL-f ® RFF Redi-ject ® 900 International Units per 1.44 mL in prefilled, single-patient-use pen Injection: GONAL-f ® RFF Redi-ject ® 300 International Units per 0.48 mL in prefilled, single-patient-use pen ( 3 ) Injection: GONAL-f ® RFF Redi-ject ® 450 International Units per 0.72 mL in prefilled, single-patient-use pen ( 3 ) Injection: GONAL-f ® RFF Redi-ject ® 900 International Units per 1.44 mL in prefilled single-patient-use pen ( 3 )

⛔ Contraindications 153 words ▾

4 CONTRAINDICATIONS GONAL-f ® RFF Redi-ject ® is contraindicated in women who exhibit: Prior hypersensitivity to recombinant FSH products 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) ] Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome GONAL-f ® RFF Redi-ject ® is contraindicated in women who exhibit ( 4 ): Hypersensitivity to recombinant FSH preparations 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 organ.

Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS GONAL-f ® RFF Redi-ject ® should only be used by physicians who are experienced in infertility treatment. GONAL-f ® RFF Redi-ject ® contains a gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications [see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5) ] and multiple births [see Warnings and Precautions (5.6) ] . Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.11) ] .

The lowest effective dose should be used. Careful attention should be given to the diagnosis of infertility and the selection of candidates for GONAL-f ® RFF Redi-ject ® therapy [see Indications and Usage (1.1 , 1.2) and Dosage and Administration (2.2 , 2.3) ]. Hypersensitivity Reactions and Anaphylaxis ( 5.1 ) Abnormal Ovarian Enlargement ( 5.2 ) Ovarian Hyperstimulation Syndrome ( 5.3 ) Pulmonary and Vascular Complications ( 5.4 ) Ovarian Torsion ( 5.5 ) Multi-fetal Gestation and Births ( 5.6 ) Congenital Malformation ( 5.7 ) Ectopic Pregnancy ( 5.8 ) Spontaneous Abortion ( 5.9 ) Ovarian Neoplasms ( 5.10 )

5.1Hypersensitivity Reactions and Anaphylaxis Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience with 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.

5.2Abnormal Ovarian Enlargement In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with GONAL-f ® RFF Redi-ject ® 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 ovarian stimulation [see Warnings and Precautions (5.11) ] . If the ovaries are abnormally enlarged on the last day of GONAL-f ® RFF Redi-ject ® therapy, hCG should not be administered in order to reduce the chance of developing Ovarian Hyperstimulation Syndrome (OHSS) [see Warnings and Precautions (5.3) ] .

Intercourse should be prohibited in women with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from rupture of ovarian cysts [see Warnings and Precautions (5.3) ] .

5.3Ovarian Hyperstimulation Syndrome (OHSS) 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, 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 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 evidence that OHSS may be developing prior to hCG administration [see Warni… [Excerpted — this section continues on DailyMed.]

🤒 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) ] Abnormal Ovarian Enlargement [see Warnings and Precautions (5.2) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.3) ] Atelectasis, acute respiratory distress syndrome and exacerbation of asthma [see Warnings and Precautions (5.4) ] Thromboembolic events [see Warnings and Precautions (5.4) ] Ovarian Torsion [see Warnings and Precautions (5.5) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.6) ] Congenital Malformations [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: headache, abdominal pain, ovarian hyperstimulation ( 6.1 ) The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, injection site bruising ( 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. The safety of GONAL-f ® RFF was examined in two clinical studies (one ovulation induction study and one ART study). Ovulation Induction In a multiple cycle (3), assessor-blind, multinational, multicenter, active comparator study vs. a recombinant FSH comparator, a total of 83 oligo-anovulatory infertile women were randomized and underwent ovulation induction with GONAL-f ® RFF.

Adverse reactions occurring in at least 2.0% of women receiving GONAL-f ® RFF are listed in Table 1. Table 1: Common Adverse Reactions Reported at a Frequency of ≥ 2% in an Ovulation Induction Study System Organ Class/Adverse Reactions GONAL-f ® RFF N=83 total number of women treated with GONAL-f ® RFF (176 treatment cycles up to 3 treatment cycles per woman ) n number of women with the adverse reaction (%) Central and Peripheral Nervous System Headache 22 (26.5%) Gastrointestinal System Abdominal Pain 10 (12.0%) Nausea 3 (3.6%) Flatulence 3 (3.6%) Diarrhea 3 (3.6%) Neoplasm Ovarian Cyst 3 (3.6%) Reproductive, Female Ovarian Hyperstimulation 6 (7.2%) Application Site Injection Site Pain 4 (4.8%) Injection Site Inflammation 2 (2.4%) Assisted Reproductive Technology In a single cycle, assessor-blind, multinational, multicenter, active comparator study vs. a recombinant FSH comparator, a total of 237 normal ovulatory infertile women were randomized and received GONAL-f ® RFF 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 2.0% of women are listed in Table 2. Table 2: Common Adverse Reactions Reported at a Frequency of ≥ 2% in an Assisted Reproductive Technologies Study System Organ Class/Adverse Reactions GONAL-f ® RFF N=237 total number of women treated with GONAL-f ® RFF n number of women with the adverse reaction (%) Gastrointestinal System Abdominal Pain 55 (23.2%) Nausea 19 (8.0%) Body as a Whole- General Abdomen Enlarged 33 (13.9%) Central and Peripheral Nervous System Headache 44 (18.6%) Application Site Disorders Injection Site Bruising 23 (9.7%) Injection Site Pain 13 (5.5%) Injection Site Inflammation 10 (4.2%) Injection Site Reaction 10 (4.2%) Application Site Edema 6 (2.5%) Reproductive, Female Ovarian Hyperstimulation 11 (4.6%)

6.2Postmarketing Experience The following adverse reactions have been reporte… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 10 words ▾

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

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Do not use GONAL-f ® RFF Redi-ject ® in pregnant women ( 4 , 8.1 ), Nursing Mothers: It is not known whether this drug is excreted in human milk. ( 8.3 ) Pediatric Use: Safety and efficacy not established. ( 8.4 ) Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of GONAL-f ® RFF Redi-ject ® in women with renal or hepatic insufficiency have not been established. ( 8.6 )

8.1Pregnancy Risk Summary GONAL-f ® RFF Redi-ject ® is not indicated in pregnant women. The incidence of congenital malformations after some Assisted Reproductive Technology (ART), procedures, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, 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 ® RFF Redi-ject ® ), 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 (including GONAL-f ® RFF Redi-ject ® ) 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 US general population, the estimated background risk of major birth defects and miscarriage after spontaneous 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 IU 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 IU 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 IU based on body surface area.

8.2Lactation There are no data on the presence of GONAL-F RFF 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 ® RFF Redi-ject ® .

8.3Females and Males of Reproductive Potential Since GONAL-f ® RFF Redi-ject ® is not indicated in pregnant women, verify a negative pregnancy test before administering GONAL-f ® RFF Redi-ject ® to a woman [see Dosage and Administration (2.2 , 2.3) ].

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

8.6Renal and Hepatic Insufficiency Safety, efficacy, and pharmacokinetics of GONAL-f ® RFF Redi-ject ® in women with renal or hepatic insufficiency have not been established.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary GONAL-f ® RFF Redi-ject ® is not indicated in pregnant women. The incidence of congenital malformations after some Assisted Reproductive Technology (ART), procedures, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, 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 ® RFF Redi-ject ® ), 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 (including GONAL-f ® RFF Redi-ject ® ) 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 US general population, the estimated background risk of major birth defects and miscarriage after spontaneous 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 IU 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 IU 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 IU based on body surface area.

🧒 Pediatric Use 13 words ▾

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

🆘 Overdosage 39 words ▾

10 OVERDOSAGE Aside from possible OHSS [see Warnings and Precautions (5.3) ] and multiple gestations [see Warnings and Precautions (5.6) ], there is no additional information on the consequences of acute overdosage with GONAL-f ® RFF Redi-ject ® .

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Follicle stimulating hormone (FSH), the active component in GONAL-f ® RFF Redi-ject ® , is required for normal follicular growth, follicular maturation, and gonadal steroid production. 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. GONAL-f ® RFF Redi-ject ® 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 GONAL-f ® RFF Redi-ject ® when monitoring of the woman indicates that appropriate follicular development parameters have been achieved. There is inter-woman variability in response to FSH administration.

12.3Pharmacokinetics Single-dose pharmacokinetics of follitropin alfa were determined following subcutaneous administration of 300 International Units of GONAL-f ® RFF Redi-ject ® to 21 pre-menopausal healthy female volunteers who were pituitary down-regulated with a GnRH agonist. The descriptive statistics for the pharmacokinetic parameters are presented in Table 3. Table 3: Pharmacokinetic parameters of FSH following administration of GONAL-f ® RFF Redi-ject ® (300 International Units subcutaneously in a single dose) Parameter Healthy Volunteers (N=21) Mean % CV Abbreviations are: C max : peak concentration (above baseline) t max : time of C max t 1/2 : elimination half life AUC last (IU hr/L) 884 20% C max (IU/L) 9.83 23% t max (hr) 15.5 43% t 1/2 (hr) 53 52% Absorption The absorption rate of GONAL-f ® RFF Redi-ject ® following subcutaneous administration is slower than the elimination rate.

Hence, the pharmacokinetics of GONAL-f ® RFF Redi-ject ® are absorption rate-limited. Distribution Human tissue or organ distribution of FSH has not been determined for GONAL-f ® RFF Redi-ject ® . Metabolism/Excretion FSH metabolism and excretion following administration of GONAL-f ® RFF Redi-ject ® have not been studied in humans.

🧬 Mechanism of Action 137 words ▾

12.1Mechanism of Action Follicle stimulating hormone (FSH), the active component in GONAL-f ® RFF Redi-ject ® , is required for normal follicular growth, follicular maturation, and gonadal steroid production. 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. GONAL-f ® RFF Redi-ject ® 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 GONAL-f ® RFF Redi-ject ® when monitoring of the woman indicates that appropriate follicular development parameters have been achieved. There is inter-woman variability in response to FSH administration.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection is a disposable, prefilled single-patient-use pen containing a clear and colorless to slightly yellow solution. Each Redi-ject ® is supplied in a carton containing 31G × 5/16 inch disposable needles to be used for administration. The following package presentations are available: NDC 44087-1115-1 - One GONAL-f ® RFF Redi-ject ® delivers 300 International Units per 0.48 mL and 5 single-use disposable 31G × 5/16" needles NDC 44087-1116-1 - One GONAL-f ® RFF Redi-ject ® delivers 450 International Units per 0.72 mL and 7 single-use disposable 31G × 5/16" needles NDC 44087-1117-1 - One GONAL-f ® RFF Redi-ject ® delivers 900 International Units per 1.44 mL and 14 single-use disposable 31G × 5/16" needles

16.2Storage and Handling Pharmacy Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until dispensed. Patient Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until the expiration date, or store at room temperature at 20° to 25°C (68°F to 77°F) for up to three months or until the expiration date, whichever occurs first. Store pen in the original carton to protect from light.

After the first injection, store refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 28 days. Keep the cap on the pen to protect from light. Do not freeze.

Discard unused material after 28 days.

📦 Storage and Handling 113 words ▾

16.2Storage and Handling Pharmacy Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until dispensed. Patient Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until the expiration date, or store at room temperature at 20° to 25°C (68°F to 77°F) for up to three months or until the expiration date, whichever occurs first. Store pen in the original carton to protect from light.

After the first injection, store refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 28 days. Keep the cap on the pen to protect from light. Do not freeze.

Discard unused material after 28 days.

📋 Description ~1 min read ▾

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 consisting of 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 ® RFF Redi-ject ® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use. Each GONAL-f ® RFF Redi-ject ® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP.

Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Each GONAL-f ® RFF Redi-ject ® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7.

Each GONAL-f ® RFF Redi-ject ® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7. Under current storage conditions, GONAL-f ® RFF Redi-ject ® may contain up to 10% of oxidized follitropin alfa.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use)

17.1Dosing and Use of GONAL-f ® RFF Redi-ject ® Instruct women on the correct usage and dosing of GONAL-f ® RFF Redi-ject ® [see Dosage and Administration (2.2 , 2.3) ] . Instruct women to view the dose display in bright light and to adjust the position of the GONAL-f ® RFF Redi-ject ® to minimize dose window glare. Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider.

Instruct women to remove the GONAL-f ® RFF Redi-ject ® from the refrigerator at least 30 minutes prior to use in order to allow GONAL-f ® RFF Redi-ject ® to warm to room temperature and avoid the discomfort of a cold injection.

17.2Duration and Necessary Monitoring in Women Undergoing Therapy with GONAL-f ® RFF Redi-ject ® Prior to beginning therapy with GONAL-f ® RFF Redi-ject ® , inform women about the time commitment and monitoring procedures necessary for treatment [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.11) ].

17.3Instructions Regarding a Missed Dose Inform the woman that if she misses or forgets to take a dose of GONAL-f ® RFF Redi-ject ® , the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.

17.4Ovarian Hyperstimulation Syndrome Inform women regarding the risks of OHSS [see Warnings and Precautions (5.3) ] and OHSS-associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.4) ] and ovarian torsion [see Warnings and Precautions (5.5) ] with the use of GONAL-f ® RFF Redi-ject ® .

17.5Multi-fetal Gestation and Birth Inform women regarding the risk of multi-fetal gestation and birth with the use of GONAL-f ® RFF Redi-ject ® [see Warnings and Precautions (5.6) ]

🧬 Pharmacokinetics 189 words ▾

12.3Pharmacokinetics Single-dose pharmacokinetics of follitropin alfa were determined following subcutaneous administration of 300 International Units of GONAL-f ® RFF Redi-ject ® to 21 pre-menopausal healthy female volunteers who were pituitary down-regulated with a GnRH agonist. The descriptive statistics for the pharmacokinetic parameters are presented in Table 3. Table 3: Pharmacokinetic parameters of FSH following administration of GONAL-f ® RFF Redi-ject ® (300 International Units subcutaneously in a single dose) Parameter Healthy Volunteers (N=21) Mean % CV Abbreviations are: C max : peak concentration (above baseline) t max : time of C max t 1/2 : elimination half life AUC last (IU hr/L) 884 20% C max (IU/L) 9.83 23% t max (hr) 15.5 43% t 1/2 (hr) 53 52% Absorption The absorption rate of GONAL-f ® RFF Redi-ject ® following subcutaneous administration is slower than the elimination rate.

Hence, the pharmacokinetics of GONAL-f ® RFF Redi-ject ® are absorption rate-limited. Distribution Human tissue or organ distribution of FSH has not been determined for GONAL-f ® RFF Redi-ject ® . Metabolism/Excretion FSH metabolism and excretion following administration of GONAL-f ® RFF Redi-ject ® have not been studied in humans.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of GONAL-f ® RFF were examined in two clinical studies (one ovulation induction study and one ART study).

14.1Ovulation Induction (OI) Ovulation induction was evaluated in a randomized, assessor-blind, multinational, multicenter, active-controlled, study in oligo-anovulatory infertile women. Women were randomized to either GONAL-f ® RFF (n=83), administered subcutaneously, or a comparator recombinant human FSH. The use of insulin-sensitizing agents was allowed during the study.

The study was designed to evaluate and compare mean ovulation rates in the first cycle of treatment. Results for GONAL-f ® RFF are presented in Table 4. Also presented in this table are secondary outcome results from cycle 1 through cycle 3.

The study was not powered to demonstrate differences in any of the secondary outcomes. Table 4: Cumulative Ovulation and Clinical Pregnancy Rates in Ovulation Induction Cycle GONAL-f ® RFF (n=83) Cumulative Cumulative rates were determined per woman over cycles 1, 2, and 3. Percent Ovulation Cumulative Clinical Pregnancy Clinical pregnancy was defined as a pregnancy for which a fetal sac (with or without heart activity) was visualized by ultrasound on day 34-36 after hCG administration.

Rate Cycle 1 72% Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis. 28% Secondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.

Cycle 2 89% 41% Cycle 3 92% 45%

14.2Assisted Reproductive Technology (ART) The efficacy of GONAL-f ® RFF was evaluated in a randomized, assessor-blind, multinational, multicenter, active controlled study in healthy normal ovulatory, infertile women treated for one cycle with controlled ovarian stimulation, as part of an ART [in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI)] cycle. Women were randomized to either GONAL-f ® RFF (n=237), administered subcutaneously, or a comparator recombinant human FSH. Randomization was stratified by insemination technique, (IVF vs.

ICSI). All women received pituitary down-regulation with a GnRH agonist before stimulation with recombinant FSH. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination.

The initial doses of GONAL-f ® RFF were 150 International Units per day for women less than 35 years of age and 225 International Units per day for women 35 years of age and older. The maximum dose given for both age groups was 450 International Units per day. Treatment outcomes for GONAL-f ® RFF are summarized in Table 5.

Table 5: Treatment Outcomes in ART Study Outcome value (n) Mean number of 2PN oocytes per woman 6.3 (237) Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis. Mean number of 2PN oocytes per subject receiving IVF 6.1 (88) Subgroup analyses. The study was not powered to demonstrate differences in subgroups.

Mean number of 2PN oocytes per subject receiving ICSI 6.5 (132) Clinical pregnancy A clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heart activity) was visualized by ultrasound on day 35-42 after hCG administration. rate per attempt 33.5% (218) Secondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes. Clinical pregnancy rate per embryo transfer 35.8% (204) Mean treatment duration in days (range) 9.7 [3-21] (230)

🧪 Nonclinical Toxicology 110 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of GONAL-f ® RFF Redi-ject ® . However, follitropin alfa showed no mutagenic activity in a series of tests performed to evaluate its potential genetic toxicity including, bacterial and mammalian cell mutation tests, a chromosomal aberration test and a micronucleus test. Impaired fertility has been reported in rats, exposed to pharmacological doses of follitropin alfa (greater than or equal to 40 International Units per kg per day, greater than or equal to 5 times the lowest clinical dose of 75 International Units) for extended periods, through reduced fecundity.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 107 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of GONAL-f ® RFF Redi-ject ® . However, follitropin alfa showed no mutagenic activity in a series of tests performed to evaluate its potential genetic toxicity including, bacterial and mammalian cell mutation tests, a chromosomal aberration test and a micronucleus test. Impaired fertility has been reported in rats, exposed to pharmacological doses of follitropin alfa (greater than or equal to 40 International Units per kg per day, greater than or equal to 5 times the lowest clinical dose of 75 International Units) for extended periods, through reduced fecundity.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION GONAL-f ® RFF Redi-ject ® (gon-AL-eff ar-eff-eff REH dee-jekt) (follitropin alfa) injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 03/2025 GONAL-f RFF* Redi-ject (follitropin alfa) injection for subcutaneous use Read this Patient Information before you start using GONAL-f RFF Redi-ject and each time you get a prescription refill. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is GONAL-f RFF Redi-ject? GONAL-f RFF Redi-ject is an injection Pen that delivers a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to: help healthy ovaries develop (mature) and release an egg cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program Who should not use GONAL-f RFF Redi-ject?

Do not use the GONAL-f RFF Redi-ject if you: are allergic to recombinant human FSH or any of the ingredients in GONAL-f RFF Redi-ject. See the end of this leaflet for a complete list of ingredients in GONAL-f RFF Redi-ject. have a high level of FSH in your blood that shows your ovaries no longer make eggs (primary ovarian failure) have uncontrolled thyroid, adrenal, or pituitary problems have a tumor in your female organs, including your ovaries, breast, or uterus that may get worse with high levels of estrogen have a tumor in your brain, such as a tumor in your pituitary or hypothalamus have abnormal bleeding from your uterus or vagina from an unknown cause have ovarian cysts or large ovaries from an unknown cause What should I tell my healthcare provider before using GONAL-f RFF Redi- ject?

Before you use GONAL-f RFF Redi-ject, tell your healthcare provider if you: have or have had asthma have been told by a healthcare provider that you have an increased risk for blood clots (thrombosis) have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot (thrombosis) have had stomach (abdominal) surgery have had twisting of your ovary (ovarian torsion) had or have a cyst on your ovary have polycystic ovarian disease have any other medical conditions are pregnant or think you may be pregnant.

GONAL-f RFF Redi-ject is not for pregnant women. Your healthcare provider will give you a pregnancy test before starting GONAL-f RFF Redi-ject. are breastfeeding. It is not known if GONAL-f RFF Redi-ject passes into your breast milk.

You and your healthcare provider should decide if you will take GONAL-f RFF Redi-ject or breastfeed. You should not do both. are not an adult. GONAL-f RFF Redi-ject is not for children.

It is not known if GONAL-f RFF Redi-ject is safe or works for children. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use GONAL-f RFF Redi-ject? Read the " Instructions for Use " that comes with GONAL-f RFF Redi-ject for information about the right way to use GONAL-f RFF Redi-ject.

GONAL-f RFF Redi-ject is given by injection under your skin. Do not inject GONAL-f RFF Redi-ject until your healthcare provider has taught you the correct way to use it. Change your injection site as your healthcare provider showed you.

Use GONAL-f RFF Redi-ject exactly as your healthcare provider tells you to use it. Do not change your dose of GONAL-f RFF Redi-ject unless your healthcare provider tells you to. Call your healthcare provider if you have any questions about your dose or how to use GONAL-f RFF Redi-ject What are the possible side effects of GONAL-f RFF Redi-ject GONAL-f RFF Redi-ject may cause serious side effects, including: severe allergic reactions.

Women who have used GONAL-f, GONAL-f RFF, or GONAL… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE GONAL-f® RFF Redi-ject® (follitropin alfa) injection for subcutaneous use GONAL-f® RFF Redi-ject® (follitropin alfa) injection Important Information Read this Instructions for Use before you start using GONAL-f RFF Redi-ject and each time you get a prescription refill. There may be new information . GONAL-f RFF Redi-ject (follitropin alfa) injection is for use under the skin only (subcutaneous).

Only use GONAL-f RFF Redi-ject if your healthcare provider trains you on how to use it correctly. Do not reuse needles. Do not share your pen or needles with anyone, because doing so can cause an infection.

Do not use the GONAL-f RFF Redi-ject if it has been dropped, or if the pen is cracked or damaged. This can cause an injury. The pen comes in 3 different IU amounts - For the 300 IU pen, the maximum dose you can dial is 300 IU. - For both the 450 IU and 900 IU pens, the maximum dose you can dial is 450 IU.

Use the attached treatment diary to make sure you take the correct dose. Consult your healthcare provider on proper use of your treatment diary. You might need to use more than one pen to give today's intended dose.

Contact your healthcare provider with any questions. The Dose Information Display is used for setting your dose, to confirm a completed dose, and to display the amount remaining to complete your intended dose. Gather your supplies ▯ Take the carton out of the refrigerator at least 30 minutes before you inject to let it warm to room temperature.

Do not use a microwave or other heating element to warm up the pen. ▯ Prepare a clean, flat surface, such as a table or countertop, in a well-lit area. ▯ Identify a firm, vertical surface, such as the side of your GONAL-f RFF Redi-ject carton or a wall. ▯ Fill in the first 5 columns of the treatment diary. Refer to the treatment diary for sample entries. ▯ You will also need a sharps disposal container, alcohol pads, and a writing utensil (not included). Step 1 Get ready ▯ Wash your hands with soap and water and dry them well.

Do not shake the pen. If you shake the pen, air bubbles may appear in the medicine. ▯ Remove the pen and a new needle from the carton using your hands. Do not use any tools (such as a knife, scissors or box cutters) to take the pen out of the carton because they may damage the pen. ▯ Check that the name on the pen says GONAL-f RFF Redi-ject. ▯ Check the expiration date on the pen label.

Do not use an expired pen. Get a new pen from your healthcare provider. Step 2 Choose and prepare your injection site Note: Your healthcare provider should show you the injection sites to use around your stomach area. ▯ Select your injection site and wipe the skin with an alcohol pad to clean the site.

Do not blow on or touch the injection site after cleaning. ▯ Choose a different injection site each time you give your injection to reduce redness, irritation, or other skin problems. Step 3 Attach your needle ▯ Pull off the pen cap. ▯ Make sure the plastic reservoir that holds the medicine is not cracked. Confirm the medicine is clear, colorless, and does not contain particles.

If the plastic is cracked or if the liquid is discolored or cloudy, get a new pen from your healthcare provider. This can cause an infection. ▯ Get a new needle. Only use the single-use needles supplied.

Re-using needles can cause infection. ▯ Check that the needle's peel-off seal tab is not broken. If it is, get a new needle. Do not use the needle if it is damaged, expired or if the outer needle cap or peel-off seal tab is damaged or loose.

This can lead to an infection. Throw it away in a sharps disposal container and get a new needle. ▯ Peel off the needle seal. ▯ Push the needle on the clear, plastic end of the pen, and twist the needle until you cannot twist it anymore. Do not attach the needle too tightly, the needle could be difficult to remove after the injection. ▯ Pull off the outer needle cap and save it for removing the needle after the injection. ▯ Keeping the needle p… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 159 words ▾

PRINCIPAL DISPLAY PANEL - 300 IU/0.48 mL Package Carton NDC 44087-1115-1 GONAL-f ® RFF Redi-ject ® 300 IU/0.48 mL (follitropin alfa) injection For subcutaneous injection Do not shake Rx only 1 Gonal-f ® RFF Redi-ject ® 5 needles for injection (31 gauge) EMD SERONO PRINCIPAL DISPLAY PANEL - 300 IU/0.48 mL Package Carton

PRINCIPAL DISPLAY PANEL - 450 IU/0.72 mL Package Carton NDC 44087-1116-1 GONAL-f ® RFF Redi-ject ® 450 IU/0.72 mL (follitropin alfa) injection For subcutaneous injection Do not shake Rx only 1 Gonal-f ® RFF Redi-ject ® 7 needles for injection (31 gauge) EMD SERONO PRINCIPAL DISPLAY PANEL - 450 IU/0.72 mL Package Carton

PRINCIPAL DISPLAY PANEL - 900 IU/1.44 mL Package Carton NDC 44087-1117-1 GONAL-f ® RFF Redi-ject ® 900 IU/1.44 mL (follitropin alfa) injection For subcutaneous injection Do not shake Rx only 1 Gonal-f ® RFF Redi-ject ® 14 needles for injection (31 gauge) EMD SERONO PRINCIPAL DISPLAY PANEL - 900 IU/1.44 mL Package Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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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.
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.
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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.