cligavyx
Cligavyx (Fulvestrant) is an estrogen receptor antagonist used to treat Breast Neoplasms.
Fulvestrant · by Avyxa Holdings
Available as a generic: Fulvestrant
Key facts
- Active ingredient
- Fulvestrant
- Drug class
- Estrogen Receptor Antagonist
- Form
- Injectable
- Strength
- Fulvestrant 250MG/5ML (50MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- breast neoplasms
- Manufacturer
- Avyxa Holdings
- FDA application
- NDA210063
- Availability
- Discontinued (per FDA)
What is Cligavyx?
From the FDA label: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
How to use
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 ) 2.1 Recommended 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. 2.2 Dosage 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…
Side effects
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. 6.1 Clinical 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…
Warnings
Important safety information
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 ) 5.1 Risk of Bleeding Because CLIGAVYX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use. 5.2 Injection 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) ] . 5.3 Embryo-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) ] . 5.4 Immunoassay 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.
Who should not take Cligavyx
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 )
Interactions
7.1 Interference 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) ] .
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Cligavyx treat?
- Cligavyx (Fulvestrant) may be used to treat breast neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Cligavyx?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cligavyx. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cligavyx?
- Cligavyx is marketed by Avyxa Holdings. You can see Avyxa Holdings's full profile, rating, and other products on pharmaranks.
- Is Cligavyx a brand-name or generic drug?
- Cligavyx is a brand-name product with the active ingredient Fulvestrant. Lower-cost generic equivalents containing Fulvestrant are available — ask your pharmacist.
- Is Cligavyx available over the counter?
- No. Cligavyx is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cligavyx come in?
- Cligavyx is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Cligavyx?
- Cligavyx is classified as estrogen receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Cligavyx FDA-registered?
- Cligavyx is on record with the U.S. FDA under application number NDA210063. You can verify this on its official FDA label.
- Is Cligavyx safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cligavyx. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cligavyx?
- Cligavyx's side effects are taken directly from its FDA label. From the label: 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 rea… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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