300 mg/4mL (75 mg/mL)
ready-to-use solution
for intramuscular use only
A branded alternative
for your fulvestrant patients
FAZDI is NOT substitutable on a mg-to-mg basis with other fulvestrant products.
NDC 42367-225-28 (carton containing 2 single-dose vials). See full contents below.
Move forward, with FAZDI™:
FAZDI (fulvestrant) injection is the first fulvestrant that delivers the labeled dosage in
20%
lower volume1,2
Move forward, with room-temperature storage:
FAZDI is stored at controlled room temperature (20°C to 25°C [68°-77°F]) with excursions permitted between 15°C and 30°C (59°F and 86°F).
Do not refrigerate or freeze.1
- After preparation, FAZDI may be stored in the syringe at controlled room temperature for up to 24 hours.1
Everything needed to administer FAZDI is included in a self-contained kit:
FAZDI is supplied in a carton (NDC 42367-225-28) containing the following:
- Two single-dose vials of FAZDI: 300 mg/4 mL (75 mg/mL) each
- Two SmartSite® vented vial access devices
- Two 21G injection safety needles (SafetyGlide™) for administration
- Two 5 mL syringes
Local, dedicated field reimbursement support
Contact your regional Field Reimbursement Manager for assistance at
Resources
Helpful resources for healthcare providers
Ordering
For the latest ordering information, contact Eagle Pharmaceuticals Customer Service at 855-318-2170 from 9:00 AM-5:00 PM ET
References:
- FAZDI (prescribing information) Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc: 2026
- FASLODEX (prescribing information). Wilmington, DE: AstraZeneca Pharmaceuticals LP: 2021
INDICATIONS AND IMPORTANT SAFETY INFORMATION
Indications
FAZDI 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.
- HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
- 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.
Important Safety Information
Contraindication
FAZDI 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 fulvestrant.
Risk of Serious Adverse Reactions or Reduced Effectiveness Due to Medication Errors
Fulvestrant is available in different formulations, and strengths. Recommended dosages depends on the specific fulvestrant product prescribed. FAZDI is NOT substitutable on a mg-to-mg basis with other fulvestrant products. Inappropriate substitution or incorrect conversion of FAZDI for another fulvestrant product can:
- Increase the risk of adverse reactions to FAZDI, or.
- Reduce FAZDI effectiveness.
Confirm that the intended fulvestrant product at the intended dose and strength is being prescribed and dispensed.
Risk of Bleeding
Because FAZDI is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use.
Injection Site Reaction
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection. Caution should be taken while administering FAZDI at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve.
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. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with FAZDI and for one year after the last dose.
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.
Adverse Reactions
The most common 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.
Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of patients and were not dose-dependent.
To report SUSPECTED ADVERSE REACTIONS, contact Eagle Pharmaceuticals, Inc. at 1-855-318-2170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in Specific Populations
Pregnancy
There are no available data in pregnant women to inform the drug-associated risk.
Lactation
There is no information regarding the presence of fulvestrant in human milk, nor of its effects on milk production or breastfed infant. Because of the potential for serious adverse reactions in breastfed infants from fulvestrant, advise a lactating woman not to breastfeed during treatment with FAZDI and for one year after the final dose.
Females and Males of Reproductive Potential
Pregnancy testing is recommended for females of reproductive potential within seven days prior to initiating FAZDI.
FAZDI can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment and for one year after the last dose.
Based on animal studies, FAZDI may impair fertility in females and males of reproductive potential.
Pediatric Use
The safety and effectiveness of FAZDI have not been established in pediatric patients.
The safety and efficacy were assessed, but not established in a single multi-center, open-label trial of fulvestrant in 30 pediatric females with McCune-Albright Syndrome (MAS) associated with Progressive Precocious Puberty (PPP) aged 1 to 8 years.
No new safety signals were observed in these pediatric patients. Eight patients (27%) experienced adverse reactions including injection site reactions (inflammation, pain, hematoma, pruritus, rash), abdominal pain, contusion, tachycardia, hot flash, extremity pain, and vomiting. The mean CL/F in these pediatric patients is 32% lower than that observed in postmenopausal women with breast cancer receiving similar dose based on body weight.
Geriatric Use
No overall differences in safety or effectiveness of FAZDI were observed between older and younger patients.
Hepatic Impairment
Reduce the dose of FAZDI in patients with moderate hepatic impairment (Child-Pugh Class B).
No dosage modification is recommended in patients with mild hepatic impairment (Child-Pugh Class A). Fulvestrant has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Please click here to see the Full Prescribing Information for FAZDI.