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Drug overview for FASLODEX (fulvestrant):
Generic name: FULVESTRANT (ful-VES-trant)
Drug class: Antiestrogen
Therapeutic class: Antineoplastics
Fulvestrant, an estrogen antagonist, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: FULVESTRANT (ful-VES-trant)
Drug class: Antiestrogen
Therapeutic class: Antineoplastics
Fulvestrant, an estrogen antagonist, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
FASLODEX 250 MG/5 ML SYRINGE
The following indications for FASLODEX (fulvestrant) have been approved by the FDA:
Indications:
Hormone receptor (HR)-positive, HER2-negative advanced female breast cancer
Hormone receptor positive postmenopausal advanced breast cancer
Professional Synonyms:
Hormone receptor (HR)-positive, HER2-negative metastatic female breast cancer
HR+, human epidermal growth factor receptor 2 (HER2)- advanced breast cancer in woman
HR+, human epidermal growth factor receptor 2 (HER2)- metastatic female breast
Indications:
Hormone receptor (HR)-positive, HER2-negative advanced female breast cancer
Hormone receptor positive postmenopausal advanced breast cancer
Professional Synonyms:
Hormone receptor (HR)-positive, HER2-negative metastatic female breast cancer
HR+, human epidermal growth factor receptor 2 (HER2)- advanced breast cancer in woman
HR+, human epidermal growth factor receptor 2 (HER2)- metastatic female breast
The following dosing information is available for FASLODEX (fulvestrant):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FASLODEX 250 MG/5 ML SYRINGE | Maintenance | Adults inject 10 milliliters (500 mg) as 2 equally divided injections, one in each buttock, over 1-2 minute(s) by intramuscular route once a month |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FULVESTRANT 250 MG/5 ML SYRING | Maintenance | Adults inject 10 milliliters (500 mg) as 2 equally divided injections, one in each buttock, over 1-2 minute(s) by intramuscular route once a month |
The following drug interaction information is available for FASLODEX (fulvestrant):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Fluoroestradiol F-18/Estrogen Receptor Blockers (ERBs) SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Drugs that bind to the estrogen receptor (ER) may compete with the binding of radioactive diagnostic agent fluoroestradiol F-18.(1) CLINICAL EFFECTS: Concurrent use of estrogen receptor blockers such as selective estrogen receptor modulators (SERMs) and selective estrogen receptor down-regulators (SERDs) may reduce the detection of ER-positive lesions with fluoroestradiol F-18.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Before administering fluoroestradiol F-18, discontinue drugs that bind to the ER, such as SERMs and SERDs, for at least 5 biological half-lives.(1) The following washout periods apply when discontinuing ERBs, prior to fluoroestradiol F-18 administration: - Bazedoxifene = 7 days - Clomiphene = 25 days - Elacestrant = 11 days - Fulvestrant = 28 weeks - Ospemifene = 5 days - Raloxifene = 7 days - Tamoxifen = 8 weeks - Toremifene = 5 weeks DISCUSSION: The following ERBs are linked to this monograph: SERDs: elacestrant and fulvestrant. SERMs: bazedoxifene, clomiphene, ospemifene, raloxifene, tamoxifen and toremifene. |
CERIANNA |
There are 0 moderate interactions.
The following contraindication information is available for FASLODEX (fulvestrant):
Drug contraindication overview.
Known hypersensitivity to fulvestrant, benzyl alcohol, or any ingredient in the formulation.
Known hypersensitivity to fulvestrant, benzyl alcohol, or any ingredient in the formulation.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Child-pugh class B hepatic impairment |
| Disease of liver |
| Increased risk of bleeding due to coagulation disorder |
| Pregnancy |
| Thrombocytopenic disorder |
There are 0 moderate contraindications.
The following adverse reaction information is available for FASLODEX (fulvestrant):
Adverse reaction overview.
The most common adverse effects of fulvestrant are adverse GI effects (e.g., nausea, vomiting, constipation, diarrhea, abdominal pain ), headache, back pain, vasodilation (hot flushes), and pharyngitis, which occurred in approximately 52, 15, 14, 18, and 16% of patients, respectively, who received the drug in clinical studies. Other adverse effects occurring in 5-23% of patients receiving fulvestrant (in order of descending frequency) include asthenia, pain, nutritional disorders, bone pain, dyspnea, injection site pain, increased cough, pelvic pain, anorexia, peripheral edema, rash, chest pain, flu syndrome, dizziness, insomnia, fever, paresthesia, urinary tract infection, depression, anxiety, and sweating. Injection site reactions with mild transient pain and inflammation were reported in 7% of patients receiving a single 5-mL injection of fulvestrant in one study and in 27% of those who received two 2.5-mL
injections of the drug in another study. Vaginal bleeding has been reported infrequently (less than 1%), usually during the first 6 weeks of changing from existing hormonal therapy to fulvestrant; however, if bleeding persists, the manufacturer states that further clinical evaluations may be necessary.
The most common adverse effects of fulvestrant are adverse GI effects (e.g., nausea, vomiting, constipation, diarrhea, abdominal pain ), headache, back pain, vasodilation (hot flushes), and pharyngitis, which occurred in approximately 52, 15, 14, 18, and 16% of patients, respectively, who received the drug in clinical studies. Other adverse effects occurring in 5-23% of patients receiving fulvestrant (in order of descending frequency) include asthenia, pain, nutritional disorders, bone pain, dyspnea, injection site pain, increased cough, pelvic pain, anorexia, peripheral edema, rash, chest pain, flu syndrome, dizziness, insomnia, fever, paresthesia, urinary tract infection, depression, anxiety, and sweating. Injection site reactions with mild transient pain and inflammation were reported in 7% of patients receiving a single 5-mL injection of fulvestrant in one study and in 27% of those who received two 2.5-mL
injections of the drug in another study. Vaginal bleeding has been reported infrequently (less than 1%), usually during the first 6 weeks of changing from existing hormonal therapy to fulvestrant; however, if bleeding persists, the manufacturer states that further clinical evaluations may be necessary.
There are 16 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Increased alanine transaminase Increased alkaline phosphatase Increased aspartate transaminase Infection |
Deep venous thrombosis Neutropenic disorder Pulmonary thromboembolism |
| Rare/Very Rare |
|---|
|
Angioedema Cerebral thrombosis Hepatic failure Hepatitis Hyperbilirubinemia Hypersensitivity drug reaction Leukopenia Thromboembolic disorder |
There are 46 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Anorexia Arthralgia Back pain Bone pain Chest pain Constipation Cough Depression Diarrhea Dizziness Drug-induced hot flash Dyspnea Fatigue Fever Flu-like symptoms General weakness Headache disorder Injection site sequelae Insomnia Musculoskeletal pain Nausea Pain Paresthesia Pelvic pain Peripheral edema Pharyngitis Pruritus of skin Skin rash Vasodilation of blood vessels Vomiting |
Accidental injury Anemia Arthritis Hyperhidrosis Symptoms of anxiety Urinary tract infection |
| Rare/Very Rare |
|---|
|
Abnormal vaginal bleeding Myalgia Neuralgia Neuropathic pain Pain in extremities Peripheral neuropathy Sciatica Urticaria Vertigo |
The following precautions are available for FASLODEX (fulvestrant):
Safety and efficacy of fulvestrant have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category D. (See Users Guide for a definition and see Warnings: Fetal/Neonatal Morbidity and Mortality, in Cautions for additional information.)
Fulvestrant is distributed into milk in rats; not known whether the drug is distributed into human milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Objective response rates reported in patients 65 years of age and older (11-16%) appear to be slightly lower than those reported in younger adults (22-24%). The pharmacokinetics of fulvestrant are not altered substantially by age; therefore, the manufacturer states that dosage adjustment is not necessary in geriatric patients.
The following prioritized warning is available for FASLODEX (fulvestrant):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FASLODEX (fulvestrant)'s list of indications:
| Hormone receptor + postmenopausal advanced breast cancer | |
| C50.11 | Malignant neoplasm of central portion of breast, female |
| C50.111 | Malignant neoplasm of central portion of right female breast |
| C50.112 | Malignant neoplasm of central portion of left female breast |
| C50.119 | Malignant neoplasm of central portion of unspecified female breast |
| C50.21 | Malignant neoplasm of upper-inner quadrant of breast, female |
| C50.211 | Malignant neoplasm of upper-inner quadrant of right female breast |
| C50.212 | Malignant neoplasm of upper-inner quadrant of left female breast |
| C50.219 | Malignant neoplasm of upper-inner quadrant of unspecified female breast |
| C50.31 | Malignant neoplasm of lower-inner quadrant of breast, female |
| C50.311 | Malignant neoplasm of lower-inner quadrant of right female breast |
| C50.312 | Malignant neoplasm of lower-inner quadrant of left female breast |
| C50.319 | Malignant neoplasm of lower-inner quadrant of unspecified female breast |
| C50.41 | Malignant neoplasm of upper-outer quadrant of breast, female |
| C50.411 | Malignant neoplasm of upper-outer quadrant of right female breast |
| C50.412 | Malignant neoplasm of upper-outer quadrant of left female breast |
| C50.419 | Malignant neoplasm of upper-outer quadrant of unspecified female breast |
| C50.51 | Malignant neoplasm of lower-outer quadrant of breast, female |
| C50.511 | Malignant neoplasm of lower-outer quadrant of right female breast |
| C50.512 | Malignant neoplasm of lower-outer quadrant of left female breast |
| C50.519 | Malignant neoplasm of lower-outer quadrant of unspecified female breast |
| C50.61 | Malignant neoplasm of axillary tail of breast, female |
| C50.611 | Malignant neoplasm of axillary tail of right female breast |
| C50.612 | Malignant neoplasm of axillary tail of left female breast |
| C50.619 | Malignant neoplasm of axillary tail of unspecified female breast |
| C50.81 | Malignant neoplasm of overlapping sites of breast, female |
| C50.811 | Malignant neoplasm of overlapping sites of right female breast |
| C50.812 | Malignant neoplasm of overlapping sites of left female breast |
| C50.819 | Malignant neoplasm of overlapping sites of unspecified female breast |
| C50.91 | Malignant neoplasm of breast of unspecified site, female |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
| C50.912 | Malignant neoplasm of unspecified site of left female breast |
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
| Z17.0 | Estrogen receptor positive status [Er+] |
| Z19.1 | Hormone sensitive malignancy status |
| Hr(+), HEr2(-) advanced female breast cancer | |
| C50 | Malignant neoplasm of breast |
| C50.1 | Malignant neoplasm of central portion of breast |
| C50.11 | Malignant neoplasm of central portion of breast, female |
| C50.111 | Malignant neoplasm of central portion of right female breast |
| C50.112 | Malignant neoplasm of central portion of left female breast |
| C50.119 | Malignant neoplasm of central portion of unspecified female breast |
| C50.2 | Malignant neoplasm of upper-inner quadrant of breast |
| C50.21 | Malignant neoplasm of upper-inner quadrant of breast, female |
| C50.211 | Malignant neoplasm of upper-inner quadrant of right female breast |
| C50.212 | Malignant neoplasm of upper-inner quadrant of left female breast |
| C50.219 | Malignant neoplasm of upper-inner quadrant of unspecified female breast |
| C50.3 | Malignant neoplasm of lower-inner quadrant of breast |
| C50.31 | Malignant neoplasm of lower-inner quadrant of breast, female |
| C50.311 | Malignant neoplasm of lower-inner quadrant of right female breast |
| C50.312 | Malignant neoplasm of lower-inner quadrant of left female breast |
| C50.319 | Malignant neoplasm of lower-inner quadrant of unspecified female breast |
| C50.4 | Malignant neoplasm of upper-outer quadrant of breast |
| C50.41 | Malignant neoplasm of upper-outer quadrant of breast, female |
| C50.411 | Malignant neoplasm of upper-outer quadrant of right female breast |
| C50.412 | Malignant neoplasm of upper-outer quadrant of left female breast |
| C50.419 | Malignant neoplasm of upper-outer quadrant of unspecified female breast |
| C50.5 | Malignant neoplasm of lower-outer quadrant of breast |
| C50.51 | Malignant neoplasm of lower-outer quadrant of breast, female |
| C50.511 | Malignant neoplasm of lower-outer quadrant of right female breast |
| C50.512 | Malignant neoplasm of lower-outer quadrant of left female breast |
| C50.519 | Malignant neoplasm of lower-outer quadrant of unspecified female breast |
| C50.6 | Malignant neoplasm of axillary tail of breast |
| C50.61 | Malignant neoplasm of axillary tail of breast, female |
| C50.611 | Malignant neoplasm of axillary tail of right female breast |
| C50.612 | Malignant neoplasm of axillary tail of left female breast |
| C50.619 | Malignant neoplasm of axillary tail of unspecified female breast |
| C50.8 | Malignant neoplasm of overlapping sites of breast |
| C50.81 | Malignant neoplasm of overlapping sites of breast, female |
| C50.811 | Malignant neoplasm of overlapping sites of right female breast |
| C50.812 | Malignant neoplasm of overlapping sites of left female breast |
| C50.819 | Malignant neoplasm of overlapping sites of unspecified female breast |
| C50.9 | Malignant neoplasm of breast of unspecified site |
| C50.91 | Malignant neoplasm of breast of unspecified site, female |
| C50.911 | Malignant neoplasm of unspecified site of right female breast |
| C50.912 | Malignant neoplasm of unspecified site of left female breast |
| C50.919 | Malignant neoplasm of unspecified site of unspecified female breast |
| Z17.0 | Estrogen receptor positive status [Er+] |
| Z19.1 | Hormone sensitive malignancy status |
Formulary Reference Tool