• Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy (as monotherapy).
• HR-positive advanced breast cancer in postmenopausal women with progressive disease that has not responded to endocrine therapy (as monotherapy).
• HR-positive, HER2–negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy (in combination with palbociclib or abemaciclib).
• HR-positive, HER2–negative advanced or metastatic breast cancer in women as initial endocrine-based therapy or following disease progression on endocrine therapy (in combination with ribociclib).

Contraindicated in:

• Hypersensitivity
• Bleeding disorders, thrombocytopenia, concurrent anticoagulant therapy
• Severe hepatic impairment
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Moderate hepatic impairment
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CV: vasodilation (hot flushes), chest pain, edema.

Derm: rash, sweating.

EENT: pharyngitis.

GI: abdominal pain, constipation, diarrhea, nausea, vomiting, anorexia.

GU: ↓ fertility, pelvic pain, urinary tract infection.

Hemat: anemia.

Local: pain/inflammation at injection site .

MS: back pain, bone pain, arthritis.

Neuro: headache, weakness , anxiety, depression, dizziness, injection site-related neurological events (including sciatica and neuropathy), insomnia, paresthesia.

Resp: cough, dyspnea.

Misc: fever, flu syndrome.

Drug-Drug:

• None reported.

(Generic available)

• Solution for injection (prefilled syringes): 50 mg/mL;

Monotherapy

• IM (Adults): 500 mg on days 1, 15, and 29, and then once monthly (given as two injections of 250 mg (5 mL) each).

In Combination with Palbociclib, Abemaciclib, or Ribociclib

• IM (Adults): 500 mg on days 1, 15, and 29, and then once monthly (given as two injections of 250 mg (5 mL) each). Pre-/perimenopausal women should also be treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy.

Faslodex

• Competitively binds to estrogen receptors. Binding results in down-regulation of estrogen receptor protein in cancerous breast tissue.

• Decreased progression of hormone receptor-positive breast cancer.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: estrogen receptor antagonists

Absorption: Well absorbed following IM administration.

Distribution: Rapidly and extensively distributed.

Protein Binding: 99%.

Metabolism/Excretion: Mostly metabolized by the liver; negligible renal elimination.

Half-life: 40 days.

(effect on estrogen receptors)

• Inform patient that fulvestrant may cause mild pain and inflammation at injection site.
• Inform patient of potential for adverse reactions and advise her to notify health care professional.
• Advise patient to report an increase in pain so treatment with analgesics can be initiated.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: May cause fetal harm and death. Advise patient to use effective contraception during and for at least 1 yr after last dose of fulvestrant and to avoid breastfeeding during and for 1 year after last dose. May impair fertility in female and male patients of reproductive potential.

ful-VESS-trant

NDC Code^*

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-0720- FASLODEX
    • 0310-0720-10- 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) > 5 mL in 1 SYRINGE, GLASS

• 0310- AstraZeneca Pharmaceuticals LP
  • 0310-7720- Fulvestrant
    • 0310-7720-10- 2 SYRINGE, GLASS in 1 CARTON (0310-7720-10) > 5 mL in 1 SYRINGE, GLASS

• 0591- Actavis Pharma, Inc.
  • 0591-5019- Fulvestrant
    • 0591-5019-02- 2 SYRINGE, GLASS in 1 CARTON (0591-5019-02) > 5 mL in 1 SYRINGE, GLASS (0591-5019-11)

• 0781- Sandoz Inc
  • 0781-3079- Fulvestrant
    • 0781-3079-12- 2 SYRINGE, GLASS in 1 CARTON (0781-3079-12) > 5 mL in 1 SYRINGE, GLASS (0781-3079-01)

• 25021- Sagent Pharmaceuticals
  • 25021-462- fulvestrant
    • 25021-462-74- 2 SYRINGE in 1 CARTON (25021-462-74) > 5 mL in 1 SYRINGE

• 63323- Fresenius Kabi USA, LLC
  • 63323-715- Fulvestrant
    • 63323-715-05- 2 SYRINGE, GLASS in 1 CARTON (63323-715-05) > 5 mL in 1 SYRINGE, GLASS (63323-715-01)

• 67457- Mylan Institutional LLC
  • 67457-311- Fulvestrant
    • 67457-311-05- 2 SYRINGE, GLASS in 1 CARTON (67457-311-05) > 5 mL in 1 SYRINGE, GLASS (67457-311-00)

• 68001- BluePoint Laboratories
  • 68001-424- fulvestrant
    • 68001-424-85- 2 SYRINGE in 1 CARTON (68001-424-85) > 5 mL in 1 SYRINGE (68001-424-86)

• 68462- GLENMARK PHARMACEUTICALS INC., USA
  • 68462-317- Fulvestrant
    • 68462-317-32- 2 SYRINGE, GLASS in 1 CARTON (68462-317-32) > 5 mL in 1 SYRINGE, GLASS

• 70121- Amneal Pharmaceuticals LLC
  • 70121-1463- Fulvestrant
    • 70121-1463-2- 2 SYRINGE, GLASS in 1 CARTON (70121-1463-2) > 5 mL in 1 SYRINGE, GLASS

• 70534- HBT Labs, Inc.
  • 70534-002- fulvestrant
    • 70534-002-01- 2 SYRINGE, GLASS in 1 CARTON (70534-002-01) > 5 mL in 1 SYRINGE, GLASS