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Faslodex

Faslodex

SIDE EFFECTS

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.

Comparison of FASLODEX 500 mg and FASLODEX 250 mg

The following frequency categories for adverse reactions (ARs) were calculated based on the safety analysis of Study 1 that compared FASLODEX 500 mg with FASLODEX 250 mg. 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 the controlled clinical trial Study 1 comparing the administration of FASLODEX 500 mg intramuscularly once a month with FASLODEX 250 mg intramuscularly once a month.

Table 1: Summary of Most Commonly Reported Adverse Reactions in Study 1 ( ≥ 5% in either treatment group): Safety Population

Body System and Adverse Reaction Number (%) of Patients
Fulvestrant 500 mg
N=361
Fulvestrant 250 mg
N=374
Body as a Whole
  Injection Site Pain 42 (11.6) 34 (9.1)
  Headache 28 (7.8) 25 (6.7)
  Back Pain 27 (7.5) 40 (10.7)
  Fatigue 27 (7.5) 24 (6.4)
  Pain in Extremity 25 (6.9) 26 (7.0)
  Asthenia 21 (5.8) 23 (6.1)
Vascular System
  Hot Flash 24 (6.6) 22 (5.9)
Digestive System
  Nausea 35 (9.7) 51 (13.6)
  Vomiting 22 (6.1) 21 (5.6)
  Anorexia 22 (6.1) 14 (3.7)
  Constipation 18 (5.0) 13 (3.5)
Musculoskeletal System
  Bone Pain 34 (9.4) 28 (7.5)
  Arthralgia 29 (8.0) 29 (7.8)
  Musculoskeletal Pain 20 (5.5) 12 (3.2)
Respiratory System
  Cough 19 (5.3) 20 (5.3)
  Dyspnea 16 (4.4) 19 (5.1)

In the pooled safety population (N=1127) from clinical trials comparing FASLODEX 500 mg to FASLODEX 250 mg, post-baseline increases of ≥ 1 CTC grade in either AST, ALT, or alkaline phosphatase were observed in > 15% of patients receiving FASLODEX. Grade 3-4 increases were observed in 1-2% of patients. The incidence and severity of increased hepatic enzymes (ALT, AST, ALP) did not differ between the 250 mg and the 500 mg FASLODEX arms.

Comparison of FASLODEX 250 mg and Anastrozole 1 mg in Combined Trials (Studies 2 and 3)

The most commonly reported adverse reactions in the FASLODEX and anastrozole treatment groups, regardless of the investigator's assessment of causality, were gastrointestinal symptoms (including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back pain, vasodilatation (hot flashes), and pharyngitis.

Injection site reactions with mild transient pain and inflammation were seen with FASLODEX and occurred in 7% of patients (1% of treatments) given the single 5 mL injection (predominantly European Trial Study 3) and in 27% of patients (4.6% of treatments) given the 2 x 2.5 mL injections (North American Trial Study 2).

Table 2 lists adverse reactions reported with an incidence of 5% or greater, regardless of assessed causality, from the two controlled clinical trials comparing the administration of FASLODEX 250 mg intramuscularly once a month with anastrozole 1 mg orally once a day.

Table 2: Combined Data from Studies 2 and 3, Adverse Reactions ≥ 5%

Body System and Adverse Reactiona FASLODEX 250 mg
N=423
(%)
Anastrozole
N=423
(%)
Body as a Whole 68.3 67.6
 Asthenia 22.7 27.0
  Pain 18.9 20.3
  Headache 15.4 16.8
  Back Pain 14.4 13.2
  Abdominal Pain 11.8 11.6
  Injection Site Painb 10.9 6.6
  Pelvic Pain 9.9 9.0
  Chest Pain 7.1 5.0
  Flu Syndrome 7.1 6.4
  Fever 6.4 6.4
  Accidental Injury 4.5 5.7
Cardiovascular System 30.3 27.9
  Vasodilatation 17.7 17.3
Digestive System 51.5 48.0
  Nausea 26.0 25.3
  Vomiting 13.0 11.8
  Constipation 12.5 10.6
  Diarrhea 12.3 12.8
  Anorexia 9.0 10.9
Hemic and Lymphatic Systems 13.7 13.5
  Anemia 4.5 5.0
Metabolic and Nutritional Disorders 18.2 17.7
  Peripheral Edema 9.0 10.2
Musculoskeletal System 25.5 27.9
  Bone Pain 15.8 13.7
  Arthritis 2.8 6.1
Nervous System 34.3 33.8
  Dizziness 6.9 6.6
  Insomnia 6.9 8.5
  Paresthesia 6.4 7.6
  Depression 5.7 6.9
  Anxiety 5.0 3.8
Respiratory System 38.5 33.6
  Pharyngitis 16.1 11.6
  Dyspnea 14.9 12.3
  Cough Increased 10.4 10.4
Skin and Appendages 22.2 23.4
  Rash 7.3 8.0
  Sweating 5.0 5.2
Urogenital System 18.2 14.9
  Urinary Tract Infection 6.1 3.5
aA patient may have more than one adverse reaction.
bAll patients on FASLODEX received injections, but only those anastrozole patients who were in the North American Study 2 received placebo injections.

Post-Marketing Experience

For FASLODEX 250 mg, other adverse reactions reported as drug-related and seen infrequently ( < 1%) include thromboembolic phenomena, myalgia, vertigo, leukopenia, and hypersensitivity reactions including angioedema and urticaria.

Vaginal bleeding has been reported infrequently ( < 1%), mainly in patients during the first 6 weeks after changing from existing hormonal therapy to treatment with FASLODEX. If bleeding persists, further evaluation should be considered.

Elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently ( < 1%).

Read the Faslodex (fulvestrant) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

There are no known drug-drug interactions. Although, fulvestrant is metabolized by CYP 3A4 in vitro, drug interactions studies with ketoconazole or rifampin did not alter fulvestrant pharmacokinetics. Dose adjustment is not needed in patients co-prescribed CYP3A4 inhibitors or inducers [see CLINICAL PHARMACOLOGY].

Read the Faslodex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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