Biovinate Adverse Reactions

Neoplasms benign, malignant and unspecified (inc cysts and polyps): Secondary acute malignancies, myeloid leukemia, myelodysplastic syndrome.
Infections and infestations: Infection.
Blood and lymphatic system disorders: Myelosuppression, thrombocytopenia, neutropenia, leukopenia, anemia, bone marrow failure, febrile neutropenia.
Immune system disorders: Hypersensitivity, anaphylactoid type reaction, bronchospasm, urticaria, facial edema, exfoliative dermatitis.
Metabolism and nutrition disorders: Dehydration, anorexia, hyponatremia, hypokalemia, hypocalcemia, hypomagnesemia.
Nervous system disorders: Peripheral neuropathy, paresthesia, decrease of osteotendinous reflexes, sensory disturbance, dysgeusia, cerebrovascular accident, perioral tingling.
Eye disorders: Visual disturbance (including rare cases of loss of vision).
Ear and labyrinth disorders: Hypoacusia, tinnitus, hearing loss.
Cardiac disorders: Cardiac failure, dyspnea, tachycardia, ischemic coronary artery disorders (myocardial infarction, cardiac arrest, angina, myocardial ischemia).
Vascular disorders: Hemorrhage, cardiovascular disorder, embolism, hypertension, hypotension, anaphylactic shock.
Respiratory, thoracic and mediastinal disorders: Respiratory disorder, interstitial lung disease, pulmonary fibrosis, hypoxia.
Gastrointestinal disorders: Vomiting, nausea, abdominal pain, diarrhea, constipation, stomatitis, cramps.
Skin and subcutaneous tissue disorders: Alopecia, skin disorder, rash, erythema, pruritus, erythematous rash.
Musculoskeletal and connective tissue disorders: Musculoskeletal disorder, chills, myalgia, arthralgia.
Renal and urinary disorders: Hemolytic-uremic syndrome, urogenital disorder, abnormal renal function, acute renal failure.
General disorders and administration site conditions: Mucous membrane disorder, asthenia, malaise, fever, mucositis, fatigue, pain, flu-like symptoms.
Investigations: Creatinine renal clearance decreased, blood urea increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, liver function test abnormal, blood sodium decreased, blood potassium decreased, blood calcium decreased, blood magnesium decreased, blood bilirubin increased, blood creatinine increased, blood uric acid increased.
Injury, poisoning and procedural complications: Ototoxicity, injection site necrosis, injection site reaction (burning, pain, reddening, swelling, urticaria) injection site extravasation, injection site erythema.