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CLIGAVYX fulvestrant 250 mg/5mL Injection — NDC 83831-0159-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLIGAVYX fulvestrant 250 mg/5mL Injection — NDC 83831-159-02 (Billing 83831-0159-02)

by Avyxa Pharma, LLC · 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS

This is a package of CLIGAVYX fulvestrant 250 mg/5mL Injection from Avyxa Pharma, LLC, marketed since Jul 2026 and currently FDA-listed. It is this product's only package size.

NDC 83831-0159-02
🏷️ FDA NDC (as labeled) 83831-159-02 billing pads the product 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
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 83831-159-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83831 labeler · 159 product · 02 package
Package marketed since
Jul 1, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8383115902 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83831-159-02
Product NDC 83831-159
11-digit billing NDC 83831015902
NCPDP billing unit ML — per mL (volume)
RxCUI 727762, 2745138
UNII 22X328QOC4
Application # NDA210063
SPL Set ID e20d8ca3-8837-4003-8b01-1ebec342062a
Established class (EPC) Estrogen Receptor Antagonist
Mechanism of action Estrogen Receptor Antagonists; Selective Estrogen Receptor Modulators
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-01
Route INTRAMUSCULAR
Dosage form INJECTION
Substance FULVESTRANT
Quick answers
  • RxCUI (RxNorm): 727762
Why two NDCs? The FDA registers this code as 83831-159-02 — 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 → 83831-0159-02. 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 Estrogen Receptor Antagonist class.

Pharmacologic class Estrogen Receptor Antagonist
Drug family (ATC) Anti-estrogens
How it works Estrogen Receptor Antagonists, Selective Estrogen Receptor Modulators
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

📗 Our plain-language guide HelloPharmacist
  • It treats HR-positive advanced or metastatic breast cancer, mainly in postmenopausal women. It can be used alone or with palbociclib, abemaciclib or ribociclib, depending on your s...
  • A healthcare professional injects it into the muscle of your buttocks, slowly over 1 to 2 minutes. You get doses closely spaced in the first month, then about once a month. Your cl...
  • The most common are pain where you were injected, nausea, bone or joint pain, headache, tiredness and hot flashes. Most are manageable, but tell your care team if they bother you....
  • The label lists no known drug interactions, and common enzyme-affecting drugs did not change its levels. Still, tell us about everything you take, especially blood thinners, becaus...
📖 Read our full Fulvestrant guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Fulvestrant — tap one for details:

DheaModerate
🌿 Every supplement checked against Fulvestrant (1 interactions) — ranked by severity →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
83831-0159-02 You're viewing this Main listing 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS 2026-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fulvestrant 50 mg/mL 00143-9022-02 Hikma 2 syringes — AO FDA listed —
Faslodex 50 mg/mL 00310-0720-10 AstraZeneca 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 00781-3532-12 Sandoz 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 00781-9055-12 Sandoz 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 16714-0070-02 Northstar 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 16729-0436-30 Accord 2 syringes — AO FDA listed —
fulvestrant 50 mg/mL 25021-0471-74 Sagent 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 43598-0262-02 Dr.Reddy's 2 syringes — AO Discontinued —
Fulvestrant 50 mg/mL 55150-0394-02 Eugia 2 syringes — — FDA listed —
Fulvestrant 50 mg/mL 62332-0650-05 Alembic 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 63323-0715-05 Fresenius 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 68001-0484-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 68001-0522-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 68001-0626-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 68462-0317-32 GLENMARK 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 70121-1463-02 Amneal 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70700-0284-98 Xiromed, 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70710-1688-08 Zydus 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70771-1626-08 Zydus 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70860-0211-74 Athenex 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 71288-0555-86 Meitheal 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 71731-6121-01 Chia 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 83634-0203-74 Avenacy, 2 syringes — AO FDA listed —
Cligavyx 250 mg/5mLthis 83831-0159-02 Avyxa 2 syringes — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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.

🧪 Avoiding an ingredient? See Fulvestrant inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII N762921K75
    A colorless, odorless gas that makes up most of the air we breathe. In medicines, it's used as a packaging gas or propellant to protect products from oxidation and maintain freshness.

5 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

LabelerAvyxa Pharma, LLC
Application holderAVYXA HOLDINGS LLC
FDA applicationNDA210063 (NDA)
Labeler code83831
First marketedJul 2026
Product typeHuman Prescription Drug
Portfolio29 products on file

More NDCs from Avyxa Pharma, LLC labeler code 83831

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 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 209 words ▾

1 INDICATIONS AND USAGE Monotherapy CLIGAVYX is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy CLIGAVYX is indicated for the treatment of: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.

HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. CLIGAVYX is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. ( 1 ) HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.

( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of CLIGAVYX is 500 mg intramuscularly into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter. ( 2.1 , 14 ) The dosage of CLIGAVYX for patients with moderate hepatic impairment is 250 mg intramuscularly into the buttock (gluteal area) slowly (1 to 2 minutes) as one 5 mL injection on Days 1, 15, 29, and once monthly thereafter. ( 2.2 , 8.6 )

2.1Recommended Dose The recommended dose of CLIGAVYX is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter [see Clinical Studies (14) ] . Pre/perimenopausal women who will receive CLIGAVYX plus palbociclib, abemaciclib, or ribociclib, should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards [see Clinical Studies (14) ] .

Refer to the respective Full Prescribing Information for each therapeutic agent administered in combination with CLIGAVYX for the recommended dosage information, as appropriate.

2.2Dosage in Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 250 mg to be administered intramuscularly into the buttock (gluteal area) slowly (1 to 2 minutes) as one 5 mL injection on Days 1, 15, 29, and once monthly thereafter. CLIGAVYX has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) [see Use in Specific Populations (8.6) ] . When CLIGAVYX is used in combination with palbociclib, abemaciclib, or ribociclib, refer to monotherapy dose modification instructions for CLIGAVYX.

Refer to the respective Full Prescribing Information for each therapeutic agent administered in combination with CLIGAVYX for dosage modifications in patients with hepatic impairment.

2.3Preparation and Administration Administer the injection according to the local guidelines for performing large volume intramuscular injections. NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering CLIGAVYX at the dorsogluteal injection site [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . The proper method of administration of CLIGAVYX for intramuscular use is described in the following instructions.

For each single-dose prefilled syringe: Remove glass syringe barrel from tray and check that it is not damaged. Remove perforated patient record label from syringe. Inspect drug product in glass syringe for any visible particulate matter or discoloration prior to use.

Discard if particulate matter or discoloration is present. Peel open the safety needle (SafetyGlide ™ ) outer packaging. Hold the syringe upright on the ribbed part (C).

With the other hand, take hold of the cap (A) and carefully TWIST THE CAP COUNTER-CLOCKWISE until the cap disconnects for removal (see Figure 1). 6. Pull the cap (A) off in a straight upward direction.

DO NOT TOUCH THE STERILE SYRINGE TIP (Luer-Lok) (B) (see Figure 2). 7. Attach the safety needle to the syringe tip (Luer-Lok).

Twist needle until firmly seated (see Figure 3). Confirm that the needle is locked to the Luer connector before moving or tilting the syringe out of the vertical plane to avoid spillage of syringe contents. For Administration: 8.

Pull shield straight off needle to avoid damaging needle point. 9. Remove needle sheath.

10. Expel excess gas from the syringe (a small gas bubble may remain). 11.

Administer intramuscularly slowly (1 to 2 minutes/injection) into the buttock (gluteal area). For user convenience, the needle 'bevel up' position is orientated to the lever arm, as shown in Figure 4. 12.

After injection, immediately activate the lever arm to deploy the needle shielding by applying a single-finger stroke to the activation assisted lever a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS CLIGAVYX, an injection for intramuscular administration, is supplied as two 5-mL single-dose prefilled syringes. Each syringe contains 250 mg/5 mL of fulvestrant, USP as a sterile, clear, colorless to yellow solution. CLIGAVYX, an injection for intramuscular administration, is supplied as 250 mg/5 mL of fulvestrant in a single-dose prefilled syringe ( 3 )

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS CLIGAVYX is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema, have been reported in association with CLIGAVYX [see Adverse Reactions (6.2) ] . Hypersensitivity. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. ( 5.1 ) Injection Site Reaction: Use caution while administering CLIGAVYX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. ( 5.2 ) Embryo-Fetal Toxicity: Can cause fetal harm.

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Immunoassay Measurement of Serum Estradiol: CLIGAVYX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels. ( 5.4 )

5.1Risk of Bleeding Because CLIGAVYX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use.

5.2Injection Site Reaction Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant. Caution should be taken while administering CLIGAVYX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve [see Dosage and Administration (2.3) and Adverse Reactions (6.1) ] .

5.3Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, fulvestrant can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus.

Advise females of reproductive potential to use effective contraception during treatment with CLIGAVYX and for one year after the last dose [see Use in Specific Populations (8.1) , (8.3) and Clinical Pharmacology (12.1) ] .

5.4Immunoassay Measurement of Serum Estradiol Due to structural similarity of fulvestrant and estradiol, fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Bleeding [see Warnings and Precautions (5.1) ] Injection Site Reaction [see Warnings and Precautions (5.2) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.3) ] The most common adverse reactions occurring in ≥5% of patients receiving fulvestrant 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, and constipation.

( 6.1 ) Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of fulvestrant-treated patients and were not dose-dependent. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. Monotherapy Comparison of Fulvestrant 500 mg and Fulvestrant 250 mg (CONFIRM) The following adverse reactions (ARs) were calculated based on the safety analysis of CONFIRM comparing the administration of fulvestrant 500 mg intramuscularly once a month with fulvestrant 250 mg intramuscularly once a month.

The most frequently reported adverse reactions in the fulvestrant 500 mg group were injection site pain (11.6% of patients), nausea (9.7% of patients), and bone pain (9.4% of patients); the most frequently reported adverse reactions in the fulvestrant 250 mg group were nausea (13.6% of patients), back pain (10.7% of patients), and injection site pain (9.1% of patients). Table 1 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from CONFIRM. Table 1: Adverse Reactions in CONFIRM (≥5% in Either Treatment Group) 1.

Including more severe injection site related sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. Adverse Reactions Fulvestrant 500 mg N=361 % Fulvestrant 250 mg N=374 % Body as a Whole Injection Site Pain 1 12 9 Headache 8 7 Back Pain 8 11 Fatigue 8 6 Pain in Extremity 7 7 Asthenia 6 6 Vascular System Hot Flash 7 6 Digestive System Nausea 10 14 Vomiting 6 6 Anorexia 6 4 Constipation 5 4 Musculoskeletal System Bone Pain 9 8 Arthralgia 8 8 Musculoskeletal Pain 6 3 Respiratory System Cough 5 5 Dyspnea 4 5 In the pooled safety population (N=1127) from clinical trials comparing fulvestrant 500 mg to fulvestrant 250 mg, post-baseline increases of ≥1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in >15% of patients receiving fulvestrant.

Grade 3-4 increases were observed in 1% to 2% of patients. The incidence and severity of increased hepatic enzymes (ALT, AST, ALP) did not differ between the 250 mg and the 500 mg fulvestrant arms. Comparison of Fulvestrant 500 mg and Anastrozole 1 mg (FALCON ) The safety of fulvestrant 500 mg versus anastrozole 1 mg was evaluated in FALCON.

The data described below reflect exposure to fulvestrant in 228 out of 460 patients with HR-positive advanced breast cancer in postmenopausal women not previously treated with endocrine therapy who received at least one (1) dose of treatment in FALCON. Permanent discontinuation associated with an adverse reaction occurred in 4 of 228 (1.8%) patients receiving fulvestrant and in 3 of 232 (1.3%) patients receiving anastrozole. Adverse reactions leading to discontinuation for those patients receiving fulvestrant included drug hypersensitivity (0.9%), injection site hypersensitivity (0.4%), and elevated liver enzymes (0.4%).

The most common adverse reactions (≥10%) of any grade reported in patients in the fulvestrant arm were arthralgia, hot flash, fatigue, and nausea. Adverse reactions reported in patients who received fulvestrant in FALCON at an incidence of ≥5% in either treatment… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 40 words ▾

7 DRUG INTERACTIONS

7.1Interference of Fulvestrant with Serum Estradiol Immunoassays Due to structural similarity of fulvestrant and estradiol, fulvestrant can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels [see Warnings and Precautions (5.4) ] .

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, CLIGAVYX can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicity, including skeletal malformations and fetal loss, at daily doses that were 6% and 30% of the maximum recommended human dose based on mg/m 2 , respectively [see Data] .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Administration of fulvestrant to rats prior to and up to implantation caused embryonic loss at daily doses that were 0.6% of the daily maximum recommended human dose based on mg/m 2 . When fulvestrant was administered to pregnant rats during the period of organogenesis, intramuscular doses ≥0.1 mg/kg/day (6% of the human recommended dose based on mg/m 2 ) caused effects on embryo-fetal development consistent with its antiestrogenic activity. Fulvestrant caused an increased incidence of fetal abnormalities in rats (tarsal flexure of the hind paw at 2 mg/kg/day; equivalent to the human dose based on mg/m 2 ) and non-ossification of the odontoid and ventral tubercle of the first cervical vertebra at doses ≥0.1 mg/kg/day.

Fulvestrant administered at 2 mg/kg/day caused fetal loss. When administered to pregnant rabbits during the period of organogenesis, fulvestrant caused pregnancy loss at an intramuscular dose of 1 mg/kg/day (equivalent to the human dose based on mg/m 2 ). Further, at 0.25 mg/kg/day (30% the human dose based on mg/m 2 ), fulvestrant caused increases in placental weight and post-implantation loss in rabbits.

Fulvestrant was associated with an increased incidence of fetal variations in rabbits (backwards displacement of the pelvic girdle, and 27 pre-sacral vertebrae at 0.25 mg/kg/day; 30% the human dose based on mg/m 2 ) when administered during the period of organogenesis.

8.2Lactation Risk Summary There is no information regarding the presence of fulvestrant in human milk, nor of its effects on milk production or breastfed infant. Fulvestrant can be detected in rat milk [see Data] . Because of the potential for serious adverse reactions in breastfed infants from CLIGAVYX, advise a lactating woman not to breastfeed during treatment with CLIGAVYX and for one year after the final dose.

Data Levels of fulvestrant were approximately 12-fold higher in milk than in plasma after exposure of lactating rats to a dose of 2 mg/kg. Drug exposure in rodent pups from fulvestrant-treated lactating dams was estimated as 10% of the administered dose. In a study in rats of fulvestrant at 10 mg/kg given twice or 15 mg/kg given once (less than the recommended human dose based on mg/m 2 ) during lactation, offspring survival was slightly reduced.

8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating CLIGAVYX. Contraception Females CLIGAVYX can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment and for one year after the last dose.

Infertility Based on animal studies, CLIGAVYX may impair fertility in females and males of reproductive potential. The effects of fulvestrant on fertility were reversible in female rats [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use Saf… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, CLIGAVYX can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicity, including skeletal malformations and fetal loss, at daily doses that were 6% and 30% of the maximum recommended human dose based on mg/m 2 , respectively [see Data] .

Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Administration of fulvestrant to rats prior to and up to implantation caused embryonic loss at daily doses that were 0.6% of the daily maximum recommended human dose based on mg/m 2 . When fulvestrant was administered to pregnant rats during the period of organogenesis, intramuscular doses ≥0.1 mg/kg/day (6% of the human recommended dose based on mg/m 2 ) caused effects on embryo-fetal development consistent with its antiestrogenic activity. Fulvestrant caused an increased incidence of fetal abnormalities in rats (tarsal flexure of the hind paw at 2 mg/kg/day; equivalent to the human dose based on mg/m 2 ) and non-ossification of the odontoid and ventral tubercle of the first cervical vertebra at doses ≥0.1 mg/kg/day.

Fulvestrant administered at 2 mg/kg/day caused fetal loss. When administered to pregnant rabbits during the period of organogenesis, fulvestrant caused pregnancy loss at an intramuscular dose of 1 mg/kg/day (equivalent to the human dose based on mg/m 2 ). Further, at 0.25 mg/kg/day (30% the human dose based on mg/m 2 ), fulvestrant caused increases in placental weight and post-implantation loss in rabbits.

Fulvestrant was associated with an increased incidence of fetal variations in rabbits (backwards displacement of the pelvic girdle, and 27 pre-sacral vertebrae at 0.25 mg/kg/day; 30% the human dose based on mg/m 2 ) when administered during the period of organogenesis.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. A multi-center, single-arm, open-label, study of fulvestrant was conducted in 30 girls with McCune-Albright Syndrome (MAS) associated with Progressive Precocious Puberty (PPP). The median age at informed consent was 6 years old (range: 1 to 8).

The first 10 patients initially received fulvestrant 2 mg/kg. Based on PK data from the first 6 patients, all 10 patients receiving 2 mg/kg were escalated to a dose of 4 mg/kg and all other patients received 4 mg/kg from study entry. Baseline measurements for vaginal bleeding days, bone age, growth velocity, and Tanner staging for at least 6 months prior to study entry were provided retrospectively by the parent, guardian, or local consultant.

All measurements during the study period were collected prospectively. Patients' baseline characteristics included the following: a mean ± SD chronological age of 5.9 ± 1.8 years; a mean rate of bone age advancement (change in bone age in years divided by change in chronological age in years) of 2.0 ± 1.03; and a mean growth velocity z-score of 2.4 ± 3.26. Twenty-nine of 30 patients completed the 12-month study period.

The following results were observed: 35% (95% CI: 16%, 57%) of the 23 patients with baseline vaginal bleeding experienced a complete cessation of vaginal bleeding on-treatment (month 0 to 12); a reduction in the rate of bone age advancement during the 12-month study period compared to baseline (mean change = -0.9 [95% CI: -1.4, -0.4]); and a reduction in mean growth velocity Z-score on-treatment compared to baseline (mean change = -1.1 [95% CI: -2.7, 0.4]). There were no clinically meaningful changes in median Tanner stage (breast or pubic), mean uterine volume, or mean ovarian volume, or predicted adult height (PAH) on-treatment compared to baseline.

The effect of CLIGAVYX on bone mineral density in children has not been studied and is not known. Eight patients (27%) experienced adverse reactions that were considered possibly related to fulvestrant. These included injection site reactions (inflammation, pain, hematoma, pruritus, rash), abdominal pain, contusion, tachycardia, hot flash, extremity pain, and vomiting.

Nine (30%) patients reported an SAE, none of which were considered related to fulvestrant. No patients discontinued study treatment due to an AE and no patients died. Pharmacokinetics The pharmacokinetics of fulvestrant was characterized using a population pharmacokinetic analysis with sparse samples per patient obtained from 30 female pediatric patients aged 1 to 8 years with PPP associated with MAS.

Pharmacokinetic data from 294 postmenopausal women with breast cancer who received 125 or 250 mg monthly dosing regimen were also included in the analysis. In these pediatric patients receiving 4 mg/kg monthly intramuscular dose of fulvestrant, the geometric mean (SD) CL/F was 444 (165) mL/min which was 32% lower than adults. The geometric mean (SD) steady state trough concentration (C min,ss ) and AUC ss was 4.19 (0.87) ng/mL and 3680 (1020) ng*hr/mL, respectively.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness of fulvestrant were observed between older and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol and downregulates the ER protein in human breast cancer cells. In vitro studies demonstrated that fulvestrant is a reversible inhibitor of the growth of tamoxifen-resistant, as well as estrogen-sensitive human breast cancer (MCF-7) cell lines.

In in vivo tumor studies, fulvestrant delayed the establishment of tumors from xenografts of human breast cancer MCF-7 cells in nude mice. Fulvestrant inhibited the growth of established MCF-7 xenografts and of tamoxifen-resistant breast tumor xenografts. Fulvestrant showed no agonist-type effects in in vivo uterotrophic assays in immature or ovariectomized mice and rats.

In in vivo studies in immature rats and ovariectomized monkeys, fulvestrant blocked the uterotrophic action of estradiol. In postmenopausal women, the absence of changes in plasma concentrations of FSH and LH in response to fulvestrant treatment (250 mg monthly) suggests no peripheral steroidal effects.

12.2Pharmacodynamics In a clinical study in postmenopausal women with primary breast cancer treated with single doses of fulvestrant 15 to 22 days prior to surgery, there was evidence of increasing down-regulation of ER with increasing dose. This was associated with a dose-related decrease in the expression of the progesterone receptor, an estrogen-regulated protein. These effects on the ER pathway were also associated with a decrease in Ki67 labeling index, a marker of cell proliferation.

12.3Pharmacokinetics Absorption: The single dose and multiple dose PK parameters for the 500 mg dosing regimen with an additional dose (AD) at Day 15 are reported in Table 11. The additional dose of CLIGAVYX given two weeks after the initial dose allows for steady state concentrations to be reached within the first month of dosing. Table 11: Summary of Fulvestrant Pharmacokinetic Parameters [gMean (CV%)] in Postmenopausal Advanced Breast Cancer Patients after Intramuscular Administration 500 mg + AD Dosing Regimen C max C min AUC (ng/mL) (ng/mL) (ng.hr/mL) 500 mg + AD 1 Single dose 25.1 (35.3) 16.3 (25.9) 11400 (33.4) Multiple dose steady state 2 28.0 (27.9) 12.2 (21.7) 13100 (23.4) 1.

Additional 500 mg dose given on Day 15 2. Month 3 Distribution: The apparent volume of distribution at steady state is approximately 3 to 5 L/kg. This suggests that distribution is largely extravascular.

Fulvestrant is highly (99%) bound to plasma proteins; VLDL, LDL, and HDL lipoprotein fractions appear to be the major binding components. The role of sex hormone-binding globulin, if any, could not be determined. Metabolism: Biotransformation and disposition of fulvestrant in humans have been determined following intramuscular and intravenous administration of 14 C-labeled fulvestrant.

Metabolism of fulvestrant appears to involve combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids, including oxidation, aromatic hydroxylation, conjugation with glucuronic acid and/or sulphate at the 2, 3, and 17 positions of the steroid nucleus, and oxidation of the side chain sulphoxide. Identified metabolites are either less active or exhibit similar activity to fulvestrant in antiestrogen models. Studies using human liver preparations and recombinant human enzymes indicate that cytochrome P-450 3A4 (CYP 3A4) is the only P-450 isoenzyme involved in the oxidation of fulvestrant; however, the relative contribution of P-450 and non-P-450 routes in vivo is unknown.

Excretion: Fulvestrant was rapidly cleared by the hepatobiliary route with excretion primarily via the feces (approximately 90%). Renal elimination was negligible (less than 1%). After an intramuscular injection of 250 mg, the clearance (Mean ± SD) wa… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 177 words ▾

12.1Mechanism of Action Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol and downregulates the ER protein in human breast cancer cells. In vitro studies demonstrated that fulvestrant is a reversible inhibitor of the growth of tamoxifen-resistant, as well as estrogen-sensitive human breast cancer (MCF-7) cell lines.

In in vivo tumor studies, fulvestrant delayed the establishment of tumors from xenografts of human breast cancer MCF-7 cells in nude mice. Fulvestrant inhibited the growth of established MCF-7 xenografts and of tamoxifen-resistant breast tumor xenografts. Fulvestrant showed no agonist-type effects in in vivo uterotrophic assays in immature or ovariectomized mice and rats.

In in vivo studies in immature rats and ovariectomized monkeys, fulvestrant blocked the uterotrophic action of estradiol. In postmenopausal women, the absence of changes in plasma concentrations of FSH and LH in response to fulvestrant treatment (250 mg monthly) suggests no peripheral steroidal effects.

📦 How Supplied / Storage and Handling 115 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING CLIGAVYX TM (fulvestrant) injection is supplied as two 5 mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of sterile, nonpyrogenic, clear, colorless to yellow CLIGAVYX solution for intramuscular injection and fitted with a luer lock connector. The rubber plunger is not made with natural rubber latex. NDC 83831-159-02 The single-dose prefilled syringes are presented in a tray with polystyrene plunger rod and safety needles (SafetyGlide ™ ) for connection to the barrel.

If a patient dose requires only one syringe, unused syringe should be stored as directed below. Storage: REFRIGERATE, 2°-8°C (36°-46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE .

📋 Description 123 words ▾

11 DESCRIPTION CLIGAVYX injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)-triene-3,17-beta-diol. The molecular formula is C 32 H 47 F 5 O 3 S and its structural formula is: Fulvestrant, USP is a white powder with a molecular weight of 606.77.

The sterile injection solution is a clear, colorless to yellow viscous liquid supplied in two 5 mL single-dose prefilled syringes each containing 250 mg/5 mL of fulvestrant, USP for intramuscular administration. CLIGAVYX contains the following inactive ingredients in each 5 mL syringe: benzyl alcohol 500 mg (10% w/v) and dehydrated alcohol 500 mg (10% w/v); castor oil 3000 mg (60% w/v), medium chain triglycerides q.s. to 5 mL (10.8% w/v), and nitrogen q.s. Image

💬 Information for Patients 174 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Bleeding: Because CLIGAVYX is administered intramuscularly, it should be used with caution in patients with bleeding disorders, decreased platelet count, or in patients receiving anticoagulants (for example, warfarin) [see Warnings and Precautions (5.1) ] . Embryo-Fetal Toxicity: Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with CLIGAVYX and for one year after the last dose.

Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) , (8.3) ] . Lactation: Advise women not to breastfeed during treatment with CLIGAVYX and for one year after the last dose [see Use in Specific Populations (8.2) ] . Combination Therapy When CLIGAVYX is used in combination with palbociclib, abemaciclib, or ribociclib, refer to the respective Full Prescribing Information for Patient Counseling Information.

Manufactured for: Avyxa Pharma, LLC New Jersey 07054, USA Made in China Image

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption: The single dose and multiple dose PK parameters for the 500 mg dosing regimen with an additional dose (AD) at Day 15 are reported in Table 11. The additional dose of CLIGAVYX given two weeks after the initial dose allows for steady state concentrations to be reached within the first month of dosing. Table 11: Summary of Fulvestrant Pharmacokinetic Parameters [gMean (CV%)] in Postmenopausal Advanced Breast Cancer Patients after Intramuscular Administration 500 mg + AD Dosing Regimen C max C min AUC (ng/mL) (ng/mL) (ng.hr/mL) 500 mg + AD 1 Single dose 25.1 (35.3) 16.3 (25.9) 11400 (33.4) Multiple dose steady state 2 28.0 (27.9) 12.2 (21.7) 13100 (23.4) 1.

Additional 500 mg dose given on Day 15 2. Month 3 Distribution: The apparent volume of distribution at steady state is approximately 3 to 5 L/kg. This suggests that distribution is largely extravascular.

Fulvestrant is highly (99%) bound to plasma proteins; VLDL, LDL, and HDL lipoprotein fractions appear to be the major binding components. The role of sex hormone-binding globulin, if any, could not be determined. Metabolism: Biotransformation and disposition of fulvestrant in humans have been determined following intramuscular and intravenous administration of 14 C-labeled fulvestrant.

Metabolism of fulvestrant appears to involve combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids, including oxidation, aromatic hydroxylation, conjugation with glucuronic acid and/or sulphate at the 2, 3, and 17 positions of the steroid nucleus, and oxidation of the side chain sulphoxide. Identified metabolites are either less active or exhibit similar activity to fulvestrant in antiestrogen models. Studies using human liver preparations and recombinant human enzymes indicate that cytochrome P-450 3A4 (CYP 3A4) is the only P-450 isoenzyme involved in the oxidation of fulvestrant; however, the relative contribution of P-450 and non-P-450 routes in vivo is unknown.

Excretion: Fulvestrant was rapidly cleared by the hepatobiliary route with excretion primarily via the feces (approximately 90%). Renal elimination was negligible (less than 1%). After an intramuscular injection of 250 mg, the clearance (Mean ± SD) was 690 ± 226 mL/min with an apparent half-life about 40 days.

Special Populations: Geriatric: In patients with breast cancer, there was no difference in fulvestrant pharmacokinetic profile related to age (range 33 to 89 years). Gender: Following administration of a single intravenous dose, there were no pharmacokinetic differences between men and women or between premenopausal and postmenopausal women. Similarly, there were no differences between men and postmenopausal women after intramuscular administration.

Race: In the advanced breast cancer treatment trials, the potential for pharmacokinetic differences due to race have been evaluated in 294 women including 87.4% Caucasian, 7.8% Black, and 4.4% Hispanic. No differences in fulvestrant plasma pharmacokinetics were observed among these groups. In a separate trial, pharmacokinetic data from postmenopausal ethnic Japanese women were similar to those obtained in non-Japanese patients.

Drug-Drug Interactions: There are no known drug-drug interactions. Fulvestrant does not significantly inhibit any of the major CYP isoenzymes, including CYP 1A2, 2C9, 2C19, 2D6, and 3A4 in vitro , and studies of co-administration of fulvestrant with midazolam indicate that therapeutic doses of fulvestrant have no inhibitory effects on CYP 3A4 or alter blood levels of drug metabolized by that enzyme. Although fulvestrant is partly metabolized by CYP 3A4, a clinical study with rifampin, an inducer of CYP 3A4, showed no effect on the pharmacokinetics of fulvestrant.

Also, results from a healthy volunteer study with ketoconazole, a potent inhibitor of CYP 3A4, indicated that ketoconazole had no effect on the pharmacokinetics of fulvestrant and dosage adjustment is not necessary in… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 75 words ▾

12.2Pharmacodynamics In a clinical study in postmenopausal women with primary breast cancer treated with single doses of fulvestrant 15 to 22 days prior to surgery, there was evidence of increasing down-regulation of ER with increasing dose. This was associated with a dose-related decrease in the expression of the progesterone receptor, an estrogen-regulated protein. These effects on the ER pathway were also associated with a decrease in Ki67 labeling index, a marker of cell proliferation.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of fulvestrant 500 mg versus fulvestrant 250 mg was compared in CONFIRM. The efficacy of fulvestrant 250 mg was compared to 1 mg anastrozole in Studies 0020 and 0021. The efficacy of fulvestrant 500 mg was compared to 1 mg anastrozole in FALCON.

The efficacy of fulvestrant 500 mg in combination with palbociclib 125 mg was compared to fulvestrant 500 mg plus placebo in PALOMA-3. The efficacy of fulvestrant 500 mg in combination with abemaciclib 150 mg was compared to fulvestrant 500 mg plus placebo in MONARCH 2. The efficacy of fulvestrant 500 mg in combination with ribociclib 600 mg was compared to fulvestrant 500 mg plus placebo in MONALEESA-3.

Monotherapy Comparison of Fulvestrant 500 mg and Fulvestrant 250 mg (CONFIRM) A randomized, double-blind, controlled clinical trial (CONFIRM, NCT00099437) was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease. This trial compared the efficacy and safety of fulvestrant 500 mg (n=362) with fulvestrant 250 mg (n=374). Fulvestrant 500 mg was administered as two 5 mL injections each containing fulvestrant 250 mg/5 mL, one in each buttock, on Days 1, 15, 29, and every 28 (+/- 3) days thereafter.

Fulvestrant 250 mg was administered as two 5 mL injections (one containing fulvestrant 250 mg/5 mL injection plus one placebo injection), one in each buttock, on Days 1, 15 (2 placebo injections only), 29, and every 28 (+/- 3) days thereafter. The median age of study participants was 61 years. All patients had ER+ advanced breast cancer.

Approximately 30% of subjects had no measurable disease. Approximately 55% of patients had visceral disease. Results of CONFIRM are summarized in Table 12.

The efficacy of fulvestrant 500 mg was compared to that of fulvestrant 250 mg. Figure 6 shows a Kaplan-Meier plot of the Progression Free Survival (PFS) data after a minimum follow-up duration of 18 months demonstrating statistically significant superiority of fulvestrant 500 mg vs. fulvestrant 250 mg. In the initial Overall Survival (OS) analysis after a minimum follow-up duration of 18 months, there was no statistically significant difference in OS between the two treatment groups.

After a minimum follow-up duration of 50 months, an updated OS analysis was performed. Figure 7 shows a Kaplan-Meier plot of the updated OS data. Table 12: Efficacy Results in CONFIRM (Intent-To-Treat (ITT) Population) 1.

PFS (Progression Free Survival) = the time between randomization and the earliest of progression or death from any cause. Minimum follow-up duration of 18 months. 2.

Hazard Ratio <1 favors fulvestrant 500 mg. 3. CI=Confidence Interval 4.

OS=Overall Survival 5. Minimum follow up duration of 50 months. 6.

Not statistically significant as no adjustments were made for multiplicity. 7. ORR (Objective Response Rate), as defined as number (%) of patients with complete response or partial response, was analyzed in the evaluable patients with measurable disease at baseline (fulvestrant 500 mg N=240; fulvestrant 250 mg N=261).

Minimum follow-up duration of 18 months. Endpoint Fulvestrant 500 mg N=362 Fulvestrant 250 mg N=374 PFS 1 6.5

5.4Median (months) Hazard Ratio 2 (95% CI 3 ) 0.80 (0.68 to 0.94) p-value 0.006 OS 4 Updated Analysis 5 261 (72.1%) 293 (78.3%) (% patients who died) Median OS (months) 26.4

22.3Hazard Ratio 2 (95% CI 3 ) 6 0.81 (0.69 to 0.96) ORR 7 (95% CI 3 ) 13.8% (9.7%, 18.8%) (33/240) 14.6% (10.5%, 19.4%) (38/261) Figure 6 Kaplan-Meier PFS: CONFIRM ITT Population Figure 7 Kaplan-Meier OS (Minimum Follow-up Duration of 50 Months): CONFIRM ITT Population Comparison of Fulvestrant 500 mg and Anastrozole 1 mg (FALCON) A randomized, double-blind, double-dummy, multi-center study (FALCON, NCT01602380) of fulvestrant 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive, HER2-negative l… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenesis studies were conducted in rats and mice. Positive findings were observed in both species. Rats were treated at intramuscular doses of 15 mg/kg/30 days, 10 mg/rat/30 days, and 10 mg/rat/15 days.

These doses correspond to 0.9-, 1.5-, and 3-fold (in females) and 0.8-, 0.8-, and 2-fold (in males) the systemic exposure [AUC 0-30 days ] achieved in women receiving the recommended dose of 500 mg/month. An increased incidence of benign ovarian granulosa cell tumors and testicular Leydig cell tumors was evident, in females dosed at 10 mg/rat/15 days and males dosed at 15 mg/rat/30 days, respectively. Mice were treated at oral doses of 0, 20, 150, and 500 mg/kg/day.

These doses correspond to 0-, 0.8-, 8.4-, and 18-fold (in females) and 0.8-, 7.1-, and 11.9-fold (in males), the systemic exposure (AUC 0-30 days ) achieved in women receiving the recommended dose of 500 mg/month. There was an increased incidence of sex cord stromal tumors (both benign and malignant) in the ovary of mice at doses of 150 and 500 mg/kg/day. Induction of such tumors is consistent with the pharmacology-related endocrine feedback alterations in gonadotropin levels caused by an antiestrogen.

Fulvestrant was not mutagenic or clastogenic in multiple in vitro tests with and without the addition of a mammalian liver metabolic activation factor (bacterial mutation assay in strains of Salmonella typhimurium and Escherichia coli , in vitro cytogenetics study in human lymphocytes, mammalian cell mutation assay in mouse lymphoma cells, and in vivo micronucleus test in rat). In female rats, fulvestrant administered at doses ≥0.01 mg/kg/day (0.6% the human recommended dose based on body surface area [BSA in mg/m 2 ]), for 2 weeks prior to and for 1 week following mating, caused a reduction in fertility and embryonic survival.

No adverse effects on female fertility and embryonic survival were evident in female animals dosed at 0.001 mg/kg/day (0.06% the human dose based on BSA in mg/m 2 ). Restoration of female fertility to values similar to controls was evident following a 29-day withdrawal period after dosing at 2 mg/kg/day (equivalent to the human dose based on BSA in mg/m 2 ). The effects of fulvestrant on the fertility of female rats appear to be consistent with its antiestrogenic activity.

The potential effects of fulvestrant on the fertility of male animals were not studied, but in a 6-month toxicology study, male rats treated with intramuscular doses of 15 mg/kg/30 days, 10 mg/rat/30 days, or 10 mg/rat/15 days fulvestrant showed a loss of spermatozoa from the seminiferous tubules, seminiferous tubular atrophy, and degenerative changes in the epididymides. Changes in the testes and epididymides had not recovered 20 weeks after cessation of dosing. These fulvestrant doses correspond to 1.3-, 1.2-, and 3.5-fold the systemic exposure [AUC 0-30 days ] achieved in women receiving the recommended dose of 500 mg/month.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenesis studies were conducted in rats and mice. Positive findings were observed in both species. Rats were treated at intramuscular doses of 15 mg/kg/30 days, 10 mg/rat/30 days, and 10 mg/rat/15 days.

These doses correspond to 0.9-, 1.5-, and 3-fold (in females) and 0.8-, 0.8-, and 2-fold (in males) the systemic exposure [AUC 0-30 days ] achieved in women receiving the recommended dose of 500 mg/month. An increased incidence of benign ovarian granulosa cell tumors and testicular Leydig cell tumors was evident, in females dosed at 10 mg/rat/15 days and males dosed at 15 mg/rat/30 days, respectively. Mice were treated at oral doses of 0, 20, 150, and 500 mg/kg/day.

These doses correspond to 0-, 0.8-, 8.4-, and 18-fold (in females) and 0.8-, 7.1-, and 11.9-fold (in males), the systemic exposure (AUC 0-30 days ) achieved in women receiving the recommended dose of 500 mg/month. There was an increased incidence of sex cord stromal tumors (both benign and malignant) in the ovary of mice at doses of 150 and 500 mg/kg/day. Induction of such tumors is consistent with the pharmacology-related endocrine feedback alterations in gonadotropin levels caused by an antiestrogen.

Fulvestrant was not mutagenic or clastogenic in multiple in vitro tests with and without the addition of a mammalian liver metabolic activation factor (bacterial mutation assay in strains of Salmonella typhimurium and Escherichia coli , in vitro cytogenetics study in human lymphocytes, mammalian cell mutation assay in mouse lymphoma cells, and in vivo micronucleus test in rat). In female rats, fulvestrant administered at doses ≥0.01 mg/kg/day (0.6% the human recommended dose based on body surface area [BSA in mg/m 2 ]), for 2 weeks prior to and for 1 week following mating, caused a reduction in fertility and embryonic survival.

No adverse effects on female fertility and embryonic survival were evident in female animals dosed at 0.001 mg/kg/day (0.06% the human dose based on BSA in mg/m 2 ). Restoration of female fertility to values similar to controls was evident following a 29-day withdrawal period after dosing at 2 mg/kg/day (equivalent to the human dose based on BSA in mg/m 2 ). The effects of fulvestrant on the fertility of female rats appear to be consistent with its antiestrogenic activity.

The potential effects of fulvestrant on the fertility of male animals were not studied, but in a 6-month toxicology study, male rats treated with intramuscular doses of 15 mg/kg/30 days, 10 mg/rat/30 days, or 10 mg/rat/15 days fulvestrant showed a loss of spermatozoa from the seminiferous tubules, seminiferous tubular atrophy, and degenerative changes in the epididymides. Changes in the testes and epididymides had not recovered 20 weeks after cessation of dosing. These fulvestrant doses correspond to 1.3-, 1.2-, and 3.5-fold the systemic exposure [AUC 0-30 days ] achieved in women receiving the recommended dose of 500 mg/month.

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2025 PATIENT INFORMATION CLIGAVYX TM (KLIG-uh-vicks ) (fulvestrant) injection What is CLIGAVYX ? CLIGAVYX is a prescription medicine used to treat advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic).

CLIGAVYX may be used alone, if you have gone through menopause, and your advanced breast cancer is: ● hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative and has not been previously treated with endocrine therapy or ● HR-positive and has progressed after endocrine therapy. CLIGAVYX may be used in combination with ribociclib, if you have gone through menopause, and your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has not been previously treated with endocrine therapy or has progressed after endocrine therapy.

CLIGAVYX may be used in combination with palbociclib or abemaciclib if your advanced or metastatic breast cancer is HR-positive and HER2-negative, and has progressed after endocrine therapy. When CLIGAVYX is used in combination with palbociclib, abemaciclib, or ribociclib, also read the Patient Information for the prescribed product. It is not known if CLIGAVYX is safe and effective in children.

It is not known if CLIGAVYX is safe and effective in people with severe liver problems. Who should not receive CLIGAVYX ? Do not receive CLIGAVYX if you have had an allergic reaction to fulvestrant or any of the ingredients in CLIGAVYX.

See the end of this leaflet for a list of the ingredients in CLIGAVYX. Symptoms of an allergic reaction to CLIGAVYX may include: ● itching or hives ● swelling of your face, lips, tongue, or throat ● trouble breathing What should I tell my healthcare provider before receiving CLIGAVYX ? Before receiving CLIGAVYX , tell your healthcare provider about all of your medical conditions, including if you: ● have a low level of platelets in your blood or bleed easily. ● have liver problems. ● are pregnant or plan to become pregnant.

CLIGAVYX can harm your unborn baby. Females who are able to become pregnant: ○ Your healthcare provider may perform a pregnancy test within 7 days before you start CLIGAVYX. ○ You should use effective birth control during treatment with CLIGAVYX and for one year after the last dose of CLIGAVYX. ○ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CLIGAVYX. ● are breastfeeding or plan to breastfeed. It is not known if fulvestrant passes into your breast milk.

Do not breastfeed during your treatment with CLIGAVYX and for one year after the final dose of CLIGAVYX. Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CLIGAVYX may affect the way other medicines work, and other medicines may affect how CLIGAVYX works. Especially tell your healthcare provider if you take a blood thinner medicine. How will I receive CLIGAVYX ? ● Your healthcare provider will give you Fulvestrant by injection into the muscle of each buttock. ● Your healthcare provider may change your dose of CLIGAVYX if needed.

What are the possible side effects of CLIGAVYX ? CLIGAVYX may cause serious side effects, including: ● Injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a CLIGAVYX: ○ numbness ○ tingling ○ weakness The most common side effects of CLIGAVYX include: ● injection site pain ● vomiting ● nausea ● loss of appetite ● muscle, joint, and bone pain ● weakness ● headache ● cough ● back pain ● shortness of breath ● tiredness ● constipation ● pain in arms, hands, legs, or feet ● increased liver enzymes ● hot flashes ● diarrhea CLIGAVYX may cause fertility… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 24 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CLIGAVYX (fulvestrant) injection -Container Label CLIGAVYX (fulvestrant) injection -Carton Label CLIGAVYX (fulvestrant) injection -Container Label CLIGAVYX (fulvestrant) injection -Carton Label

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

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

Medicare Part D (outpatient prescription) spending for Fulvestrant (matched by generic name) — the program that covers self-administered drugs. 12 manufacturers.
⚠️ 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 Fulvestrant. CMS lists 2 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
$1.52M
Claims incl. refills
3K
Beneficiaries
1.2K
Spend / beneficiary
$1,249.91
Spend / claim
$511.48
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.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Avyxa Pharma, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Avyxa Pharma, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83831-0153-01 · AVYXA 83831-0164-10 · Avyxa →
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.