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Faslodex

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Faslodex

Faslodex

Faslodex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Faslodex (fulvestrant) Injection is used to treat some hormone-related breast cancer. Faslodex is also used in postmenopausal women whose breast cancer has progressed after treatment with other anti-estrogen medication. It is an estrogen receptor antagonist. Common side effects include pain/swelling/redness at the injection site, nausea, vomiting, loss of appetite, constipation, diarrhea, upset stomach, dizziness, tiredness, weakness, headache, body aches/pains, flushing and sweating (hot flushes/hot flashes), or trouble sleeping.

The recommended dose of Faslodex is 500 mg to be administered intramuscularly into the buttocks slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter. Faslodex may interact with a blood thinner such as warfarin. Other drugs may interact with Faslodex. Tell your doctor all prescription and over-the-counter medications and supplements you use. Faslodex is used mainly in women after menopause. This medication should not be used during pregnancy. It may cause miscarriage, or harm to a fetus. Women of childbearing age should use non-hormonal birth control during treatment. Consult your doctor. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.

Our Faslodex (fulvestrant) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Faslodex in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache, back pain;
  • nausea, vomiting, stomach pain;
  • constipation, diarrhea;
  • sore throat, cough;
  • weakness;
  • warmth, redness, or tingly feeling under your skin;
  • loss of appetite;
  • swelling in your hands or feet;
  • unusual vaginal bleeding;
  • hot flashes; or
  • mild pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Faslodex (Fulvestrant) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Faslodex Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/swelling/redness at the injection site, nausea, vomiting, loss of appetite, constipation, diarrhea, upset stomach, dizziness, tiredness, weakness, headache, body aches/pains, flushing and sweating (hot flushes/hot flashes), or trouble sleeping may occur. Changes in diet such as eating several small meals or limiting physical activity may help lessen the chance of nausea and vomiting. If any of these effects continue or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: burning/painful/frequent urination, numbness/tingling/swelling of the hands or feet, pain/redness/swelling of the arms or legs, bone/pelvis/hip pain, signs of infection (e.g., fever, persistent sore throat), persistent cough, persistent vaginal bleeding, mental/mood changes (e.g., anxiety, depression), chest pain, trouble breathing.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Faslodex (Fulvestrant)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Faslodex FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Faslodex (Fulvestrant) »

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Faslodex - User Reviews

Faslodex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Faslodex sorted by most helpful. Patient Discussions FAQs

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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