Bicalutamide, 150 mg, film-coated tablets, 28 pcs.
The pharmacological action of bicalutamide can cause the following side effects:
- very often (>10%) - gynecomastia (may persist even after cessation of therapy, especially if the drug is taken for a long time), tenderness of the mammary glands, flushing of the face, decreased libido, sexual dysfunction;
- often (>1%, but <10%) - diarrhea, nausea, transient increase in the activity of liver transaminases, cholestasis and jaundice (the described changes in liver function were rarely assessed as serious, were transient in nature, completely disappeared or decreased with continued therapy or after discontinuation drug), itching, asthenia; when using the drug in a daily dose of 150 mg - alopecia or hair regrowth, weight gain;
- rarely (>0.1%, but <1%) - hypersensitivity reactions, including angioedema and urticaria, interstitial pulmonary diseases; when using the drug in a daily dose of 150 mg - abdominal pain, depression, dyspepsia, hematuria;
- very rarely (>0.01%, but <0.1%) - vomiting, dry skin (when using the drug in a daily dose of 150 mg, dry skin is often observed), liver failure (a cause-and-effect relationship with taking bicalutamide has not been reliably established ).
With the simultaneous use of bicalutamide and GnRH analogues, the following side effects may also be observed with a frequency of >1% (a cause-and-effect relationship with the drug has not been established; some of the observed side effects occurred in elderly patients).
From the cardiovascular system:
heart failure, angina pectoris, conduction disturbances, including prolongation of the PR and QT intervals, rhythm disturbances, nonspecific changes on the ECG, increased blood pressure, myocardial infarction, fainting.
From the digestive system:
stomach bleeding, anorexia, dry mouth, dyspepsia, constipation, flatulence, periodontal abscess, stomach/intestinal cancer.
From the nervous system:
dizziness, headache, insomnia, anxiety, drowsiness, neuropathy.
From the respiratory system:
shortness of breath, chest pain, cough, pharyngitis, bronchitis, pneumonia, rhinitis, bronchospasm, nosebleeds.
From the urinary system:
nocturia, dysuria, urinary retention, edema, frequent urination, hydronephrosis, infections.
From the hematopoietic system:
anemia.
From the skin and its appendages:
alopecia, skin rash, excessive sweating, hirsutism, dry skin,
herpes zoster
, skin cancer.
From the musculoskeletal system:
myasthenia gravis, myalgia, cramps, arthritis, joint contractures, bone pain, leg cramps.
From the laboratory parameters:
hyperglycemia, increased alkaline phosphatase, hypercreatininemia, hypercholesterolemia, hyperbilirubinemia.
Other:
diabetes mellitus, polyuria, increase or decrease in body weight, pain in the abdomen, chest, pelvic area, sexual dysfunction, development of the tumor process, chills, dehydration, gout, cataracts.
Bicalutamide tablet p/pl/o 50 mg N30 (Atoll)
The frequency of adverse reactions listed below was determined according to the following criteria: very often (at least 1/10), often (more than 1/100, less than 1/10); uncommon (more than 1/1000, less than 1/100); rare (more than 1/10000, less than 1/1000); very rare (less than 1/10000), including isolated reports.
Immune system disorders:
Rarely - hypersensitivity reactions, including angioedema, urticaria, skin rash.
Endocrine system disorders:
Very often - gynecomastia (may persist even after cessation of therapy, especially if the drug is taken for a long time), tenderness of the mammary glands;
Often - decreased libido, erectile dysfunction, weight gain, hyperglycemia.
Nervous system disorders:
Often - asthenia, headache, dizziness, insomnia or drowsiness, anxiety, loss of appetite;
Rarely - depression, “flushes” of blood to the face.
Cardiac disorders:
Common: myocardial infarction (fatal cases have been reported)*, development or worsening of heart failure*, increased blood pressure.
Disorders of the respiratory system, chest and mediastinal organs:
Rarely - shortness of breath, chest pain, cough, pharyngitis, bronchitis, pneumonia, interstitial pulmonary diseases (including fatal ones), rhinitis.
Gastrointestinal disorders:
Often - nausea;
Rarely - abdominal pain, dyspepsia, constipation, diarrhea, vomiting, flatulence.
Disorders of the liver and biliary tract:
Rarely - transient increase in the activity of “liver” transaminases, jaundice;
Very rarely - liver failure (including fatal).
Disorders of the skin and subcutaneous tissues:
Often - alopecia, hirsutism or hair regrowth, dry skin, itching. Musculoskeletal and connective tissue disorders;
Often - myasthenia gravis, myalgia, convulsions, arthritis, joint contractures.
Renal and urinary tract disorders:
Uncommon: dysuria, polyuria, urinary retention, peripheral edema;
Rarely - hematuria.
General disorders and disorders at the injection site:
Often - fever, flu-like syndrome, chills, increased sweating, pain in the pelvic area, infections.
Blood and lymphatic system disorders:
Common: anemia.
*observed in the treatment of prostate cancer in combination with a GnRH analogue. The risk of development increased with simultaneous use of bicalutamide at a dose of 50 mg with a GnRH analogue. When bicalutamide 150 mg was used as monotherapy for the treatment of prostate cancer, an increase in incidence was not evident.
Bicalutamide Canon (50mg, 150mg)
WHO classification of the incidence of side effects: very often - > 1/10 prescriptions (> 10%) often - from > 1/100 to < 1/10 prescriptions (> 1% and <10%) uncommon - from > 1/1000 to <1/100 prescriptions (>0.1% and <1%) rare - >1/10000 to <1/1000 prescriptions (>0.01% and <0.1%) very rare - <1/10000 prescriptions (<0.01%) Classification unwanted adverse reactions in accordance with damage to organs and organ systems (medical dictionary for regulatory activities Med-DRA).
Immune system disorders: rarely - hypersensitivity reactions, including angioedema, urticaria, skin rash. Endocrine system disorders: very often - gynecomastia (may persist even after cessation of therapy, especially if the drug is taken for a long time), tenderness of the mammary glands; often - decreased libido, erectile dysfunction, weight loss or gain, hyperglycemia, diabetes mellitus. Nervous system disorders: often - asthenic syndrome, dizziness, insomnia or drowsiness, anxiety, loss of appetite, rarely - depression, flushing of the face. Cardiac disorders: often - angina pectoris, development or worsening of heart failure, increased blood pressure. Disorders of the respiratory system, chest and mediastinal organs: rarely - chest pain, cough, pharyngitis, bronchitis, pneumonia, interstitial pulmonary diseases (including fatal ones), rhinitis. Gastrointestinal disorders: often - nausea; rarely - abdominal pain, dyspepsia, constipation, diarrhea, vomiting, flatulence, gastric bleeding, dry oral mucosa. Disorders of the liver and biliary tract: rarely - transient increase in the activity of “liver” transaminases, cholestasis, jaundice; very rarely - liver failure (including fatal outcomes). Disorders of the skin and subcutaneous tissues: often - alopecia, hirsutism or hair regrowth, dry skin. Musculoskeletal and connective tissue disorders: often - myasthenia gravis, myalgia, convulsions, arthritis, joint contractures. Renal and urinary tract disorders: uncommon - dysuria, polyuria, urinary retention, peripheral edema; rarely - hematuria. General disorders and disorders at the injection site: often - fever, flu-like syndrome, chills, increased sweating, pain in the pelvic area. Laboratory and instrumental data: often: anemia.
BICALUTAMIDE
Side effects
Bicalutamide is generally well tolerated.
Only in rare cases is the use of bicalutamide discontinued due to side effects caused by the drug. According to WHO recommendations, the side effects that bicalutamide can cause are classified according to the frequency of their development as follows: very often - ≥ 10%, often - ≥ 1% and < 10%, infrequently - ≥ 0.1% and < 1%, rarely - ≥ 0.01% and < 0.1%, very rarely - < 0.01%, unknown (cannot be estimated based on available data). The following are side effects that occurred when using bicalutamide 150 mg once daily and when using bicalutamide 50 mg once daily with GnRH analogues:
Blood and lymphatic system disorders
often: anemia.
Immune system disorders
uncommon: hypersensitivity reactions (including angioedema and urticaria*).
Mental disorders
often: decreased sexual desire (libido), depression.
Nervous system disorders
very often: dizziness**;
often: drowsiness, headache*, paresthesia*, insomnia*, anxiety*.
Vascular disorders
very often: hot flashes**; often: arterial hypertension*.
Heart disorders
Common: myocardial infarction (fatal cases reported)*;
uncommon: heart failure.
Gastrointestinal disorders
very often: abdominal pain**, constipation**, nausea**, diarrhea*;
often: dyspepsia, flatulence, vomiting*.
Respiratory, thoracic and mediastinal disorders
very often: shortness of breath;
often: increased cough*, pharyngitis*, bronchitis*, pneumonia*, rhinitis*;
uncommon: interstitial lung disease (fatal cases reported) (post-marketing experience).
Disorders of the liver and biliary tract
often: transient changes in the liver (hepatotoxicity), incl. increased activity of “liver” transaminases, jaundice, increased activity of alkaline phosphatase* (the described changes in liver function were rarely assessed as serious, often were transient in nature, completely disappeared or decreased after discontinuation of the drug)
rarely: liver failure (a cause-and-effect relationship with taking bicalutamide has not been reliably established) (post-marketing experience).
Skin and subcutaneous tissue disorders
very common: rash***;
Common: alopecia, hirsutism/hair regrowth, dry skin, itching, increased sweating*.
Musculoskeletal and connective tissue disorders
often: bone pain*, myasthenia gravis*, arthralgia*, arthritis*, back pain*, pathological fractures*.
Renal and urinary tract disorders
very often: hematuria**, urge to urinate at night*;
Common: urinary tract infection*, frequent urination*, urinary retention*, urinary dysfunction*, urinary incontinence*.
Genital and breast disorders
very often: gynecomastia (may persist even after cessation of therapy, especially if the drug is taken for a long time) and tenderness of the mammary glands;
often: impotence/erectile dysfunction.
Endocrine system disorders
often: hyperglycemia*.
frequency unknown: decreased glucose tolerance (post-marketing experience)*.
Metabolic and nutritional disorders
very often: asthenia;
often: anorexia, weight gain, weight loss*.
General and administration site disorders
very often: chest pain**, peripheral edema**, pain*, pain in the pelvic area*, infections*;
often: influenza-like syndrome*.
* These side effects were observed only when taking bicalutamide (50 mg once daily) concomitantly with GnRH analogues.
** These side effects observed with bicalutamide 150 mg once daily were common, not very common.
***These side effects were observed when bicalutamide (50 mg once daily) was co-administered with GnRH analogues frequently, but not very often.
