Faslodex Side Effects

Generic Name: fulvestrant

Please note - some side effects for Faslodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Faslodex - for the Consumer

Faslodex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Faslodex:

Abnormal skin sensations; anxiety; back, bone, joint, or pelvic pain; constipation; diarrhea; dizziness; headache; hot flushes; increased cough; loss of appetite; nausea; pain, swelling, or redness at the injection site; sleeplessness; sore throat; stomach pain; sweating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Faslodex:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fever or chills; frequent or painful urination; mental or mood changes; pain, redness, or tenderness in the legs; persistent sore throat; persistent vaginal bleeding; severe tiredness or weakness; shortness of breath; swelling of the hands or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Faslodex Side Effects - for the Professional

Faslodex

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 Reaction*	Faslodex 250 mg N=423 (%)	Anastrozole 1 mg N=423 (%)
* A patient may have more than one adverse Reaction. † All patients on Faslodex received injections, but only those anastrozole patients who were in the North American Study 2 received placebo injections.
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 Pain†	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

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.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included nausea (26%), vomiting (13%), constipation (12.5%), diarrhea (12.3%), abdominal pain (11.8%), and anorexia (9%).

Hematologic

Hematologic side effects have included anemia (4.5%).

Cardiovascular

Cardiovascular side effects have included vasodilation (17.7%), and peripheral edema (9%).

Musculoskeletal

Musculoskeletal side effects have included bone pain (15.8%), and arthritis (2.8%).

Nervous system

Nervous system side effects have included dizziness (6.9%), insomnia (6.9%), paresthesia (6.4%), depression (5.7%), and anxiety (5%).

Respiratory

Respiratory side effects have included pharyngitis (16.1%), dyspnea (14.9%), and cough increased (10.4%).

Genitourinary

Genitourinary side effects have included urinary tract infection (6.1%).

Dermatologic

Dermatologic side effects have included rash (7.3%).

Endocrine

Endocrine side effects have included sweating (5%).

General

General side effects have included asthenia (22.7%), pain (18.9%), headache (15.4%), back pain (14.4%), pain at injection site (10.9%), pelvic pain (9.9%), chest pain (7.1%), flu syndrome (7.1%), fever (6.4%), and accidental injury (4.5%).

Hypersensitivity

Hypersensitivity side effects including angioedema and urticaria have been reported.

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