NDC 62935-0163-60 — Fensolvi Leuprolide Acetate 45 mg/.375mL

🆔 Identity & classification

FDA NDC (as labeled) 62935-163-60

Product NDC 62935-163

11-digit billing NDC 62935016360

NCPDP billing unit EA — each (per item)

RxCUI 752884, 2371773

UNII 37JNS02E7V

Application # NDA213150

SPL Set ID 2c311700-edf4-4f2a-a468-9875489a6cc7

Established class (EPC) Gonadotropin Releasing Hormone Receptor Agonist

Mechanism of action Gonadotropin Releasing Hormone Receptor Agonists

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-03-06

Route SUBCUTANEOUS

Dosage form INJECTION, SUSPENSION, EXTENDED RELEASE

Substance LEUPROLIDE ACETATE

GPI-14 30080050256450

GCN Seq No 081002

GCN 47996

HICL code 021102

Ingredient (HICL) Leuprolide Acetate

HIC1 code P

Therapeutic class — broad (HIC1) Endocrine System

HIC2 code P1

Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones

HIC3 code P1P

Therapeutic class — specific (HIC3) Lhrh(Gnrh)Agnst Pit.sup-Central Precocious Puberty

AHFS code 10:00.00.00

AHFS class Antineoplastic Agents

FDB label name FENSOLVI 45 MG SYRINGE KIT

FDB brand name Fensolvi

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 62935-163-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62935-0163-60. 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 Gonadotropin Releasing Hormone Receptor Agonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Agonist

Drug family (ATC) Gonadotropin releasing hormone analogues

How it works Gonadotropin Releasing Hormone Receptor Agonists

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

LabelerTOLMAR Inc.

Application holderTOLMAR INTERNATIONAL LTD

FDA applicationNDA213150 (NDA)

Labeler code62935

First marketedMar 2023

Product typeHuman Prescription Drug

Portfolio14 products on file

🔎 All NDCs from TOLMAR Inc.

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 FENSOLVI 45 MG SYRINGE KIT Ingredient Leuprolide Acetate

📖 What it is MedlinePlus · NLM

Leuprolide injection is used to treat certain types of prostate cancer central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy, irregular bleeding) anemia (a lower-than-normal number of red blood cells) caused by uterine fibroids (growths i...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

That's a really common concern, and it's smart to ask. When you first start leuprolide, your testosterone levels actually spike for a week or two before the drug kicks in and bring...
Why does my doctor say my symptoms might get worse right after starting leuprolide?
Hot flashes are actually one of the most common side effects in men taking leuprolide — over half of men in clinical studies experienced them. Because leuprolide drops testosterone...
Will I get hot flashes? I thought that was just a women's issue.

📖 Read our full Leuprolide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

165 mg / 0.375 mL UNII JR9CE63FPM
Methyl pyrrolidone is a synthetic liquid solvent used in pharmaceutical formulations. It helps dissolve and deliver active ingredients in topical products and some oral medicines.
165 mg / 0.375 mL UNII 93PPD1S477
A synthetic polymer made from lactic and glycolic acid that breaks down in the body over time. It's used as a binder and matrix to control how and when a medicine is released into the bloodstream.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$25,703.14	$9,638.68 / 0.38 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1951	$145.311 / J1951 unit	—

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)62935-163-60

11-digit billing NDC62935-0163-60

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-codeJ1951

DescriptorInjection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg

Billing units / pkg180 units

Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Fensolvi 62935-0153-50	TOLMAR	1 kit	—	—	FDA listed	—
Fensolvi 45 mg/.375mLthis 62935-0163-60	TOLMAR	1 syringe	—	—	FDA listed	—
Eligard 62935-0453-45	TOLMAR	1 kit	—	—	FDA listed	—
Eligard 45 mg/.375mL 62935-0461-50	TOLMAR	1 syringe	—	—	FDA listed	—
Vabrinty 45 mg/.375mL 85043-0045-04	URONOVA	1 syringe	—	—	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

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 & generic status

🏛️

2020

First FDA approval

May 2020

📍

2026

Currently FDA-listed

6 years listed

🛡️

2041

Latest patent/protection listed

not a guaranteed launch date

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved May 1, 2020 RLD RS ⏳ ~15.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 12397120 — method of use (U-3611)

US 11931559 — drug substance

US 11771841 — drug substance

2020 2022 2024 2026 2028 2030 2032 2034 2036 2038 2040 2042

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)

Patent	Type	Use code	Expires
US 12397120 ↗	Method of use	U-3611	Dec 22, 2041
US 11931559 ↗	Drug substance	—	Dec 22, 2041
US 11771841 ↗	Drug substance	—	Dec 22, 2041

Common questions

Is there a generic version of FENSOLVI 45 MG SYRINGE KIT?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for FENSOLVI 45 MG SYRINGE KIT. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62935-0163-60, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

930

Units reimbursed last 4 qtrs

927

Gross reimbursed last 4 qtrs

$23.83M

Avg / prescription

$25,620.23

Avg / unit

$25,707.30

Latest quarter Q4 2025

262Rx

Fee-for-service vs managed care ⓘ

25% FFS 75% MCO

Fee-for-service · 228 Rx Managed care · 702 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.13.4

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Louisiana 3.4 /100k

2 Florida 1.3 /100k

3 North Carolina 1.2 /100k

4 Pennsylvania 0.6 /100k

5 Alabama 0.5 /100k

6 New York 0.5 /100k

7 Connecticut 0.4 /100k

8 California 0.2 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lupron Depot (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lupron Depot. CMS lists 5 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$71.92M

Claims incl. refills

11.6K

Beneficiaries

9.7K

Spend / beneficiary

$7,380.64

Spend / claim

$6,213.76

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Fatigue365

Hot Flush273

Fall272

Death263

Asthenia259

Pneumonia247

Prostate Cancer233

Age at onset

Neonate4

Child121

Adolescent19

Adult410

Elderly742

Reporter sex

Serious outcomes

Disabling213

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
62935-0163-60 You're viewing this	1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE	2023-03-06	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	✓ Available
Medicaid utilization (CMS SDUD)	✓ Available

“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 62935-163-60, 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: 62935-0163-60, written without dashes as 62935016360. 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 62935-0163-60, the first segment (62935) is the labeler code FDA assigned to TOLMAR Inc.; the middle segment (0163) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 TOLMAR Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

TOLMAR 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 J1951 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🎯 Indications and Usage 50 words ▾

1 INDICATIONS AND USAGE FENSOLVI ® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Must be administered by a healthcare provider. ( 2.1 ) The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. ( 2.1 ) Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics.

( 2.2 ) Measure height every 3 to 6 months and monitor bone age periodically. ( 2.2 ) See Full Prescribing Information for reconstitution and administration instructions. ( 2.3 , 2.4 )

2.1Dosing Information FENSOLVI must be administered by a healthcare provider. The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. Discontinue FENSOLVI treatment at the appropriate age of onset of puberty.

2.2Monitoring Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. Measure height (for calculation of growth velocity) every 3 to 6 months and monitor bone age periodically. Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process.

If the dose of FENSOLVI is not adequate, switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

2.3Reconstitution Instructions Use aseptic technique including gloves for reconstitution and administration. Allow the product to reach room temperature before reconstitution to allow for easier administration. Once reconstituted, the concentration is 45 mg/0.375 mL.

Administer the product within 30 minutes or discard. FENSOLVI is packaged in a carton containing: Tray containing pre-connected syringe system and desiccant pack Prescribing information Sterile safety needle and cap (located under the tray in carton) Follow the detailed instructions below to ensure correct preparation of FENSOLVI prior to administration: Step 1 On a clean field open the tray by tearing off the foil from the corner and remove the contents. Discard the desiccant pack.

Remove the pre-connected syringe system from the tray. Open the sterile safety needle package by peeling back the paper tab. Note: Syringe A and Syringe B should not be lined-up yet.

The product should only be administered with the co-packaged, sterile safety needle. Step 2 Grasp the latching button on the coupling device with your finger and thumb and press until you hear a snapping sound. The two syringes will be aligned.

Do not bend the pre-connected syringe system. Step 3 Holding the syringes in a horizontal position, transfer the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B. Thoroughly mix the product for 60 cycles by pushing the contents back and forth between both syringes to obtain a uniform suspension.

A cycle is one push of the Syringe A plunger and one push of the Syringe B plunger. When thoroughly mixed, the suspension will appear colorless to pale yellow. Note: Product must be mixed as described; shaking will NOT provide adequate mixing.

Do not bend. Step 4 After mixing, hold the syringes vertically (upright) with Syringe B (wide syringe) on the bottom. The syringes should remain securely coupled.

Transfer all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger. Step 5 While ensuring the Syringe A plunger is fully pushed down, hold the coupling device and unscrew Syringe B. This will disconnect Syringe B from the coup…

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS For injectable suspension, 45 mg of leuprolide acetate. Each FENSOLVI carton contains: Pre-connected syringe system consisting of syringe A and syringe B connected using a coupling device. Syringe A contains diluent for reconstitution (in situ polymeric extended release technology) in a prefilled syringe.

Syringe B contains 45 mg lyophilized leuprolide acetate powder in a single-dose prefilled syringe. Sterile safety needle and cap Desiccant Prescribing information For injectable suspension: 45 mg of leuprolide acetate. ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS Hypersensitivity to GnRH, GnRH agonists or any of the components of FENSOLVI. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported [see Adverse Reactions ( 6.2 )] . Pregnancy: FENSOLVI may cause fetal harm [see Use in Specific Populations ( 8.1 )] . Hypersensitivity reactions ( 4 ) Pregnancy ( 4 , 8.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Initial Rise of Gonadotropins and Sex Steroid Levels: During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty including vaginal bleeding may be observed during the first weeks of therapy or after subsequent doses. Instruct patients and caregivers to notify the physician if these symptoms continue beyond the second month after FENSOLVI administration.

( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms.

( 5.2 ) Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.3 ) Severe Cutaneous Adverse Reactions (SCARs): Have been reported in patients receiving GnRH agonists, including leuprolide products. Interrupt FENSOLVI if signs and symptoms of SCARs develop.

Permanently discontinue FENSOLVI if a SCAR is confirmed ( 5.4 ). Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including leuprolide acetate. Monitor patients for headache, papilledema, and blurred vision.

( 5.5 )

5.1Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug [see Clinical Pharmacology ( 12.2 )] . Therefore, an increase in clinical signs and symptoms of puberty including vaginal bleeding may be observed during the first weeks of therapy or after subsequent doses [see Adverse Reactions (6) ] . Instruct patients and caregivers to notify the physician if these symptoms continue beyond the second month after FENSOLVI administration.

5.2Psychiatric Events Psychiatric events have been reported in patients taking GnRH agonists, including leuprolide acetate. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with FENSOLVI [see Adverse Reactions (6.1 , 6.2) ] .

5.3Convulsions Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above [see Adverse Reactions (6.2) ] .

5.4Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) have been reported in patients receiving GnRH agonists, including leuprolide products [ see Adverse Reactions ( 6.2 )]. These reactions include Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts. Monitor patients for signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash or lymphadenopathy.

Advise patients and caregivers of the signs and symptoms of SCARs. If a SCAR is suspected, interrupt FENSOLVI. Consult a healthcare provider with expertise in the diagnosis and management of SCARs.

If a diagnosis of SCARs is confirmed, permanently discontinue FENSOLVI.

5.5 Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Pseudotumor cerebri (…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described here and elsewhere in the label: Initial rise in gonadotropin and sex steroid levels [see Warnings and Precautions ( 5.1 )] Psychiatric Events [see Warnings and Precautions ( 5.2 )] Convulsions [see Warnings and Precautions ( 5.3 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 )] The most common adverse reactions (≥5%) were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough, and hot flush.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tolmar at 1-844-4TOLMAR (1-844-486-5627) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies 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 trials of another drug and may not reflect the rates observed in practice. FENSOLVI was evaluated in an uncontrolled, open-label, single-arm clinical trial in which 64 pediatric patients with CPP received at least one dose of FENSOLVI. The age ranged from 4 to 9 years at start of treatment; 62 patients were female and 2 were male; 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; 2% Native Hawaiian or Other Pacific Islander.

56% of the subjects self-identified as Hispanic or Latino ethnicity. Adverse reactions that occurred in ≥ 5% of patients are shown in Table 1. Table 1: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial Adverse Reactions % of Patients (N=64) Injection site pain 31 Nasopharyngitis 22 Pyrexia 17 Headache 16 Cough 13 Abdominal pain 9 Injection site erythema 9 Nausea 8 Constipation 6 Vomiting 6 Upper respiratory tract infection 6 Bronchospasm 6 Productive cough 6 Hot flush 5 Other Adverse Reactions: Psychiatric Emotional disorder (2%) and irritability (2%)

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of FENSOLVI or GnRH agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions.

General : chest pain, weight increase, weight decrease, decreased appetite, fatigue. Laboratory Abnormalities: decreased WBC. Metabolic : diabetes mellitus.

Musculoskeletal and Connective Tissue : arthralgia, epiphysiolysis, muscle spasms, myalgia. Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial hypertension). Psychiatric: emotional lability, such as crying, irritability, impatience, anger and aggression, depression, including rare reports of suicidal ideation and attempt.

Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Skin and Subcutaneous Tissue : injection site reactions including induration and abscess, flushing, hyperhidrosis, erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Reproductive System: vaginal bleeding, breast enlargement.

Vascular : hypertension, hypotension. Respiratory: dyspnea.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary FENSOLVI is contraindicated in pregnancy [see Contraindications ( 4 )] . FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology ( 12.1 )]. The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose.

A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.

8.2Lactation Risk Summary There are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FENSOLVI and any potential adverse reactions on the breastfed infant from FENSOLVI or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Pregnancy Testing Exclude pregnancy in women of reproductive potential prior to initiating FENSOLVI if clinically indicated [see Use in Specific Populations ( 8.1 ) ] . Contraception Females FENSOLVI may cause embryo-fetal harm when administered during pregnancy. FENSOLVI is not a contraceptive.

If contraception is indicated, advise females of reproductive potential to use a non-hormonal method of contraception during treatment with FENSOLVI [see Use in Specific Populations ( 8.1 )] . Infertility Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased while on treatment with FENSOLVI. Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks [see Clinical Pharmacology ( 12.1 )] .

There is no evidence that pregnancy rates are affected following discontinuation of FENSOLVI. Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression.

8.4Pediatric Use The safety and effectiveness of FENSOLVI for the treatment of CPP has been established in pediatric patients 2 years of age and older. Use of FENSOLVI for this indication is supported by evidence from an adequate…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary FENSOLVI is contraindicated in pregnancy [see Contraindications ( 4 )] . FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology ( 12.1 )]. The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose.

A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data When administered on day 6 of pregnancy at test dosages of 0.00024 mg/kg, 0.0024 mg/kg, and 0.024 mg/kg (1/3255 to 1/33 of the human dose) to rabbits, leuprolide acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.

🧒 Pediatric Use 84 words ▾

8.4Pediatric Use The safety and effectiveness of FENSOLVI for the treatment of CPP has been established in pediatric patients 2 years of age and older. Use of FENSOLVI for this indication is supported by evidence from an adequate and uncontrolled open-label, single-arm study of 64 pediatric patients with CPP with an age range of 4 to 9 years [see Clinical Studies ( 14 )] . The safety and effectiveness of FENSOLVI have not been established in pediatric patients less than 2 years old.

🆘 Overdosage 16 words ▾

10 OVERDOSAGE No specific antidotes for FENSOLVI are known. Contact Poison Control (1-800-222-1222) for latest recommendations.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses. Following an initial stimulation of GnRH receptors, chronic administration of leuprolide acetate results in downregulation of GnRH receptors, reduction in release of LH, FSH and consequent suppression of ovarian and testicular production of estradiol and testosterone respectively. This inhibitory effect is reversible upon discontinuation of drug therapy.

12.2Pharmacodynamics In the clinical trial evaluating FENSOLVI in pediatric patients with CPP, there was a transient surge in circulating levels of LH, FSH, estradiol and testosterone following the first administration. A decrease in basal and GnRH agonist-stimulated LH and FSH levels along with reductions in basal estradiol and testosterone were observed after repeat administration.

12.3Pharmacokinetics Absorption After an initial subcutaneous injection of FENSOLVI 45 mg in pediatric patients 4 to 9 years of age with CPP, leuprolide levels peaked 4 hours postdose with a mean C max of 212.3 ng/mL. Absorption occurred in two phases, a burst phase followed by a plateau phase. The mean plateau serum leuprolide level from 4 to 48 weeks was approximately 0.37 ng/mL with a range of 0.18 to 0.63 ng/mL.

There was no accumulation of leuprolide after the second dose. Distribution The distribution of leuprolide following FENSOLVI administration was not evaluated in pediatric patients. The mean steady-state volume of distribution of leuprolide following intravenous bolus administration to healthy male volunteers was 27 L.

In vitro binding of leuprolide to human plasma proteins ranged from 43% to 49%. Elimination Metabolism In rats and dogs, administration of 14 C-labeled leuprolide was shown to be metabolized to smaller inactive peptides: a pentapeptide (Metabolite I), tripeptides (Metabolites II and III), and a dipeptide (Metabolite IV). These fragments may be further catabolized.

In healthy male volunteers, a 1 mg bolus of leuprolide administered intravenously revealed that the mean systemic clearance was

8.34L/h, with a terminal elimination half-life of approximately 3 hours based on a two-compartment model. Upon administration with different leuprolide acetate formulations, the major metabolite of leuprolide acetate is a pentapeptide (M-1) metabolite. Specific Populations The pharmacokinetics of FENSOLVI in hepatically and renally impaired pediatric patients have not been determined.

🧬 Mechanism of Action 76 words ▾

12.1Mechanism of Action Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses. Following an initial stimulation of GnRH receptors, chronic administration of leuprolide acetate results in downregulation of GnRH receptors, reduction in release of LH, FSH and consequent suppression of ovarian and testicular production of estradiol and testosterone respectively. This inhibitory effect is reversible upon discontinuation of drug therapy.

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING For injectable suspension, 45 mg of leuprolide acetate (NDC 62935-163-60) supplied in a carton that contains: Tray containing pre-connected syringe system and desiccant pack Prescribing information Sterile safety needle and cap (located under the tray in carton) Store refrigerated at 2°C to 8°C (36°F to 46°F). Once outside the refrigerator, this product may be stored in its original packaging at room temperature 15°C to 30°C (59°F to 86°F) for up to eight weeks prior to reconstitution and administration.

📋 Description 220 words ▾

11 DESCRIPTION FENSOLVI for injectable suspension is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous use. It is designed to deliver leuprolide acetate at a controlled rate over a six-month therapeutic period. Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone.

The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: FENSOLVI is supplied as a pre-connected syringe system. Immediately prior to administration, the content of the pre-connected syringe system are mixed until homogenous.

FENSOLVI is administered subcutaneously, where it forms a solid drug delivery depot. Syringe A contains the in situ polymeric extended release technology consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLG) polymer formulation dissolved in a biocompatible solvent, N -methyl-2pyrrolidone (NMP) and syringe B contains the leuprolide acetate. Refer to Table 2 for the delivery system composition and reconstituted product formulation for FENSOLVI product.

Table 2: FENSOLVI Delivery System Composition and Reconstituted Product Formulation In situ polymeric extended release technology Polymer PLG Polymer description Copolymer with hexanediol Polymer DL-lactide to glycolide molar ratio 85:15 Reconstituted Product Polymer delivered 165 mg NMP delivered 165 mg Leuprolide acetate delivered 45 mg Approximate leuprolide free base equivalent 42 mg Approximate administered formulation weight 375 mg Approximate injection volume 0.375 mL structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Symptoms After Initial FENSOLVI Administration Inform patients and caregivers that during the early phase of therapy with FENSOLVI, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty may be observed .

Instruct patients and caregivers to notify the physician if these symptoms continue beyond the second month after FENSOLVI administration [see Warnings and Precautions ( 5.1 )]. Psychiatric Events Inform patients and caregivers that psychiatric events have been reported in patients taking GnRH agonists, including leuprolide acetate. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression.

Instruct patients and caregivers to monitor for development or worsening of psychiatric symptoms including depression during treatment with FENSOLVI [see Warnings and Precautions ( 5.2 )] . Convulsions Inform patients and caregivers that reports of convulsions have been observed in patients receiving GnRH agonists, including leuprolide acetate. Patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions may be at increased risk [see Warnings and Precautions ( 5.3 )].

Severe Cutaneous Adverse Reactions Inform patients and/or caregivers that severe cutaneous adverse reactions (SCARs) may occur during treatment with FENSOLVI. Advise patients and/or caregivers to stop FENSOLVI and immediately contact their healthcare provider if they experience signs and symptoms of SCARs [see Warnings and Precautions ( 5.4 )]. Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Inform patients and caregivers that reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists, including leuprolide acetate.

Advise patients and caregivers to monitor for headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Advise patients and caregivers to contact their healthcare provider if the patient develops any these symptoms. [see Warnings and Precautions ( 5.5 )] . Injection Site Reactions Inform patients and caregivers that injection site related adverse reactions may occur such as transient burning/stinging, pain, bruising, and redness.

Advise patients to contact their healthcare provider if they experience rash or severe injection site reactions [see Adverse Reactions ( 6.1 )]. Pregnancy FENSOLVI is contraindicated in pregnancy. If the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )].

Compliance with the Dosing Schedule Inform caregivers about the importance of adherence to the FENSOLVI dosing schedule of one injection every 24 weeks [see Dosage and Administration ( 2.1 , 2.2 )]. Manufactured by: Tolmar, Fort Collins, CO 80526 ©2025 Tolmar. All rights reserved.

Tolmar, FENSOLVI, and associated logos, are trademarks of the Tolmar group. 04006226 Rev. 3 09/2025

💬 Medication Guide ~3 min read ▾

Medication Guide Medication Guide FENSOLVI ® (fen-SOL-vee) (leuprolide acetate) injectable suspension, for subcutaneous use What is the most important information I should know about FENSOLVI? FENSOLVI may cause serious side effects, including: In the first few weeks after your child receives their first FENSOLVI injection, FENSOLVI can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child including vaginal bleeding.

Call your child’s healthcare provider if signs of puberty continue after 2 months of receiving FENSOLVI. Some people taking gonadotropin releasing hormone (GnRH) agonists like FENSOLVI have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying irritability restlessness (impatience) anger acting aggressively Call your child’s healthcare provider right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.

Some people taking GnRH agonists like FENSOLVI have had seizures. The risk of seizures may be higher in people who: have a history of seizures have a history of epilepsy have a history of brain tumors or brain vessel (cerebrovascular) problems are taking a medicine that has been associated with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Seizures have also happened in people who have not had any of these problems. Call your child’s healthcare provider right away if your child has a seizure while taking FENSOLVI.

Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like FENSOLVI. Stop FENSOLVI and call your child’s healthcare provider right away if your child has any of the following signs or symptoms during treatment with FENSOLVI : skin rash or acne dry skin itching blisters on your skin redness or swelling of your face, hands, or soles of your feet blisters or sores in your mouth peeling of your skin fever muscle or joint aches swollen glands Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including FENSOLVI.

Call your child’s doctor right away if your child has any of the following symptoms during treatment with FENSOLVI: headache eye problems, including blurred vision, double vision and decreased eyesight eye pain ringing in the ears dizziness nausea What is FENSOLVI? FENSOLVI is a prescription gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP). It is not known if FENSOLVI is safe and effective in children younger than 2 years of age.

FENSOLVI should not be received if your child is: allergic to GnRH, GnRH agonist medicines, or any ingredients in FENSOLVI . See the end of this Medication Guide for a complete list of ingredients in FENSOLVI. Call your child’s healthcare provider or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction: • skin rashes, redness, or swelling • swelling of face, mouth, and tongue • trouble breathing or swallowing • hives • throat tightness, hoarseness • sweating • severe itching • dizziness or fainting • fast heartbeat pregnant or becomes pregnant .

FENSOLVI can cause birth defects or loss of the baby. If your child becomes pregnant, call your healthcare provider. Before your child receives FENSOLVI, tell your child’s healthcare provider about all of your child’s medical conditions, including if they: have a history of mental (psychiatric) problems. have a history of seizures. have a history of epilepsy. have a history of brain vessel (cerebrovascular) problems. have a history of brain or spinal cord (central nervous system) problems or tumors. are breastfeeding or plan to breastfeed.

It is not known if FENSOLVI passes into breastmilk. Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and he…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

aggression: Hostile or violent feelings or behavior directed toward other people.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

arthralgia: Joint pain.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bolus: A single dose given all at once, often as a quick push into a vein.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

convulsion: Uncontrolled, rapid shaking of the body caused by muscles rapidly tightening and relaxing, often during a seizure.

depot: An injection that forms a small reservoir in the body and releases medicine slowly over days or weeks.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diluent: The liquid used to dissolve or thin a medicine before it is given.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

fertility: The natural ability to become pregnant or to father a child.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

potency: How much of a medicine is needed to produce a given effect; a more potent medicine works at a smaller dose.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pyrexia: A raised body temperature; a fever.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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Fensolvi Leuprolide Acetate 45 mg/.375mL Injection, Suspension, Extended Release, 1 syringe

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