Fareston (Toremifene) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

Adverse drug reactions are principally due to the antiestrogenic hor-monal actions of FARESTON and typically occur at the beginning of treatment.

The incidences of the following eight clinical toxicities were prospectively assessed in the North American Study. The incidence reflects the toxicities that were considered by the investigator to be drug related or possibly drug related.

North American Study

FAR60 TAM20

n = 221 n = 215

        Hot Flashes 35% 30%

        Sweating 20% 17%

        Nausea 14% 15%

        Vaginal Discharge 13% 16%

        Dizziness 9% 7%

        Edema 5% 5%

        Vomiting 4% 2%

        Vaginal Bleeding 2% 4%

Approximately 1% of patients receiving FARESTON (n = 592) in the three controlled studies discontinued treatment as a result of adverse events (nausea and vomiting, fatigue, thrombophlebitis, depression, lethargy, anorexia, ischemic attack, arthritis, pulmonary embolism, and myocardial infarction).

Serious adverse events occurring in patients receiving FARESTON in the three major trials are listed in the table below.

* Most of the ocular abnormalities were observed in the North American Study in which on-study and biannual opthalmic examinations were performed. No cases of retinopathy were observed in any arm.

** Elevated defined as follows: North American Study: SGOT >100 IU/L; alkaline phosphatase >200 IU/L; bilirubin > 2 mg/dL. Eastern European and Nordic studies: SGOT, alkaline phosphatase, and bilirubin – WHO Grade 1 (1.25 times the upper limit of normal).

Adverse Events North American Eastern European Nordic

FAR60
n=221(%) TAM20
n=215(%) FAR60
n=157(%) TAM40
n=149(%) FAR60
n=214(%) TAM40
n=201(%)

Cardiac

Cardiac Failure 2 (1) 1 (<1) - 1 (<1) 2 (1) 3 (1.5)

Myocardial Infarction 2 (1) 3 (1.5) 1 (<1) 2 (1) - 1 (<1)

Arrhythmia - - - - 3 (1.5) 1 (<1)

Angina Pectoris - - 1 (<1) - 1 (<1) 2 (1)

Ocular*

Cataracts 22 (10) 16 (7.5) - - - 5 (3)

Dry Eyes 20 (9) 16 (7.5) - - - -

Abnormal Visual Fields 8 (4) 10 (5) - - - 1 (<1)

Corneal Keratopathy 4 (2) 2 (1) - - - -

Glaucoma 3 (1.5) 2 (1) 1 (<1) - - 1 (<1)

Abnormal Vision/Diplopia - - - - 3 (1.5) -

Thromboembolic

Pulmonary Embolism 4 (2) 2 (1) 1 (<1) - - 1 (<1)

Thrombophlebitis - 2 (1) 1 (<1) 1 (<1) 4 (2) 3 (1.5)

Thrombosis - 1 (<1) 1 (<1) - 3 (1.5) 4 (2)

CVA/TIA 1 (<1) - - 1 (<1) 4 (2) 4 (2)

Elevated Liver Tests**

SGOT 11 (5) 4 (2) 30 (19) 22 (15) 32 (15) 35 (17)

Alkaline Phosphatase 41 (19) 24 (11) 16 (10) 13 (9) 18 (8) 31 (15)

Bilirubin 3 (1.5) 4 (2) 2 (1) 1 (<1) 2 (1) 3 (1.5)

Hypercalcemia 6 (3) 6 (3) 1 (<1) - - -

Other adverse events of unclear causal relationship to FARESTON included leukopenia and thrombocytopenia, skin discoloration or dermatitis, constipation, dyspnea, paresis, tremor, vertigo, pruritis, anorexia, reversible corneal opacity (corneal verticulata), asthenia, alopecia, depression, jaundice, and rigors.

In the 200 and 240 mg FARESTON dose arms, the incidence of SGOT elevation and nausea was higher. Approximately 4% of patients were withdrawn for toxicity from the high-dose FARESTON treatment arms. Reasons for withdrawal included hypercalcemia, abnormal liver function tests, and one case each of toxic hepatitis, depression, dizziness, incoordination, ataxia, blurry vision, diffuse dermatitis, and a constellation of symptoms consisting of nausea, sweating, and tremor.

REPORTS OF SUSPECTED FARESTON SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Fareston. The information is not vetted and should not be considered as verified clinical evidence.

Possible Fareston side effects / adverse reactions in 83 year old female

Reported by a individual with unspecified qualification from Japan on 2011-10-07

Patient: 83 year old female

Reactions: White Blood Cell Count Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Fareston

Possible Fareston side effects / adverse reactions in 83 year old female

Reported by a individual with unspecified qualification from Japan on 2011-11-14

Patient: 83 year old female

Reactions: White Blood Cell Count Decreased, Diarrhoea

Adverse event resulted in: hospitalization

Suspect drug(s):
Fareston
    Dosage: 120 mg, oral
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-08-28
    End date: 2011-09-03

TS-1 (Tegafur)
    Dosage: 80 mg oral
    Administration route: Oral
    Indication: Breast Cancer
    Start date: 2011-08-28
    End date: 2011-09-03