Name of the medicinal product:
Bicamide
Composition
Active substance: Bicalutamide
Excipients: Lactose monohydrate, Povidone K-25, Sodium starch glycollate, Magnesium
stearate, Hypromellose, Titanium dioxide, Propylene glycol.
Pharmaceutical form
Film coated tablets.
Content in active substance
Each tablet contains 50mg or 150mg of Bicalutamide.
Description Packaging
Box that contains 2 blisters of 14 tablets each.
Pharmacotherapeutic group
Hormone andagonists and related agents (Anti-androgens).
Indications
Bicamide is a non-steroidal anti-androgen. It is indicated for the treatment of metastatic
carcinoma of prostate.
Contraindications
Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the
drug or any of the contents of the tablet. There is no indication for women and should not be
used by women who are pregnant or become pregnant or nursing mothers.
Special warnings and precautions for use
General
Bicamide should be used with caution in patients with moderate-to-severe hepatic impairment.
Bicalutamide is extensively metabolized by the liver. Limited data in subjects with severe
hepatic impairment suggest that excretion of Bicalutamide may be delayed and could lead to
further accumulation. Rare cases of death or hospitalization due to severe liver injury have been
reported in association with bicalutamide. Hepatotoxicity in these reports generally occurred
within the first three to four months of treatment. Periodic liver function tests should be
considered for hepatic-impairment patients on long-term therapy.
In clinical trials with bicalutamide as a single agent for prostate cancer, gynecomastia and
breast pain have been reported in up to 38% and 39% of patients, respectively.
Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring
the patient's response.
Safety and effectiveness of Bicalutamide in pediatric patients have not been established.
Pregnancy and lactation
Bicalutamide is not indicated for use in women. Bicalutamide should not be used by women
who are or become pregnant. If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the potential hazard to the
fetus. Bicalutamide may cause fetal harm when administered to pregnant women. It is not
known whether this drug is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when Bicalutamide is administered to a nursing
mother.
Effect on the ability to drive and use machines
During treatment with bicalutamide, no affect on drive ability and machinery use has been
observed.
Incompatibilities
None reported.
Drug interaction with other medicinal products and other forms of interaction
In vitro studies have shown Bicalutamide can displace coumarin anticoagulants, such as
warfarin, from their protein-binding sites. It is recommended that if Bicalutamide is started in
patients already receiving coumarin anticoagulants, prothrombin times should be closely
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monitored and adjustment of the anticoagulant dose may be necessary.
Dosage and administration
The recommended dose of bicalutamide for adults, including the elderly, is 1 tablet once daily.
The recommended dose for bicalutamide therapy in combination with a luteinizing hormone-
releasing hormone (LHRH) analogue is one 50 mg tablet once daily with or without food. No
dosage adjustment is necessary for patients with renal impairment and with mild to moderate
hepatic impairment, although increased accumulation of the drug may be observed in patients
with moderate to severe hepatic impairment.
Overdosage
There is no specific antidote; treatment of an overdose should be symptomatic. In the
management of an overdose with bicalutamide, vomiting may be induced if the patient is alert. It
should be remembered that, in this patient population, multiple drugs have been taken. Dialysis
is not likely to be helpful since Bicalutamide is highly protein bound and is extensively
metabolized. General supportive care, including frequent monitoring of vital signs and close
observation of the patient, is indicated.
Undesirable effects
In patients with advanced prostate cancer treated with Bicalutamide in combination with an
LHRH analogue, the most frequent adverse experience was hot flashes (53%).
Body as whole: incidence 5%: pain, back pain, asthenia, pelvic pain, infection, abdominal
pain, chest pain, headache, flu syndrome, 5% incidence 2%: neoplasm, neck pain, fever,
chilis, sepsis, hernia, cyst.
Cardiovascular: incidence 5%: hot flashes, hypertension, 5% incidence 2%: angina
pectoris, congestive heart failure, myocardial infarct, heart arrest, coronary artery disorder,
syncope.
Digestive: incidence 5%: constipation, nausea, diarrhea, increased liver enzyme test (AST,
ALT or both), dyspepsia, flatulence, anorexia, vomiting, 5% incidence 2%: melena, rectal
hemorrhage, dry mouth, dysphagia, gastrointestinal disorders, periodontal disease,
gastrointestinal carcinoma.
Hemic and lymphatic: incidence 5%: Anemia.
Metabolic and nutritional: incidence 5%: peripheral edema, weight loss, hyperglycemia,
alkaline phosphatase increased, weight gain, 5% incidence 2%: edema, BUN increased,
creatinine increased, dehydration, gout, hypercholesteremia.
Musculosketal: incidence 5%: bone pain, myasthenia, arthritis, pathological fracture, 5%
incidence 2%: myalgia, leg cramps.
Nervous system: incidence 5%: dizziness, paresthesia, insomnia, anxiety, depression, 5%
incidence 2%: hypertonia, confusion, somnolence, libido decreased, neuropathy,
nervousness.
Respiratory system: incidence 5%: dyspnea, cough increased, pharyngitis, bronchitis,
pneumonia, rhinitis, 5% incidence 2%: lung disorder, asthma, epistaxis, sinusitis.
Skin and appendages: incidence 5%: rash, sweating, 5% incidence 2%: dry skin, alopecia,
pruritus, herpes zoster, skin carcinoma, skin disorder.
Urogenital: incidence 5%: nocturia, hematuria, urinary tract infection, gynecomastia,
impotence, breast pain, urinary frequency, urinary retention, urination impaired, urinary
incontinence, 5% incidence 2%: dysuria, urinary urgency, hydronephrosis, urinary track
disorder.
Rare cases of interstitial pneumonitis and pulmonary fibrosis have been reported.
Missed dose
Not applicable
Self life
36 months
Storage
Store at temperature 25oC.
Date of last revision of the text : 01-02-2008