The incidence of adverse reactions listed below is described in accordance with the following gradation: very often (> 1/10), often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), including individual messages.
On the part of the hematopoiesis system: very often - anemia, leukopenia, neutropenia, thrombocytopenia, lymphopenia; often - febrile neutropenia (including grade 3-4), sepsis against neutropenia; rarely - hemolytic anemia, immune thrombocytopenia.
On the part of the digestive system: very often - nausea, vomiting, diarrhea, stomatitis, mucositis, pain in the stomach, constipation, loss of appetite; often - dyspepsia, gastroesophageal reflux, hiccough; infrequently - intestinal obstruction; rarely - colitis, including cases of pseudomembranous colitis.
From the central and peripheral nervous system: very often - peripheral neurosensory neuropathy, sensitivity disorders, headache, asthenia; often - dizziness, meningism, depression, insomnia; infrequent - increased nervousness; rarely - dysarthria.
Neurotoxicity is a dose-limiting side effect. Often the symptoms of sensory neuropathy are provoked by cold.The duration of these symptoms, which are usually docked in the interval between courses, increases depending on the total dose of oxaliplatin. Functional disorders, which are expressed by the difficulty of performing precise movements, are possible consequences of sensory damage. The risk of functional disorders for a total dose of about 850 mg / m2 (10 cycles) is about 10%, reaching 20% in the case of a total dose of 1020 mg / m2 (12 cycles). In most cases, neurologic symptoms improve or completely disappear after discontinuation of treatment. However, in 3% of patients 3 years after the end of treatment, either stable localized paresthesias of moderate intensity (2.3%) or paresthesia, affecting functional activity (0.5%) were observed. On the background of treatment with oxaliplatin, there were acute neurosensory manifestations, which usually occurred within a few hours after the administration of the drug and were most often provoked by cold. They were characterized by transient paresthesia, dyss- stesia or hypostasis, rarely (1-2%) with acute laryngeal-pharyngeal dysesthesia syndrome. The latter manifested itself as a subjective feeling of dysphagia and dyspnea without objective signs of respiratory distress syndrome (cyanosis or hypoxia),or spasm of the larynx or bronchospasm (without stridor or wheezing). Also observed were such phenomena as spasm of the jaw, dysesthesia of the tongue, dysarthria and a feeling of pressure in the chest. Usually, these symptoms quickly stopped as without the use of drug therapy, and with the introduction of antihistamine and bronchodilators. Increasing the infusion time during subsequent cycles of oxaliplatin therapy can reduce the incidence of this syndrome.
From the musculoskeletal system: very often - back pain; often - arthralgia, pain in the bones.
On the part of the respiratory system: very often - cough, shortness of breath; often - rhinitis, infections of the upper respiratory tract; rarely - pulmonary fibrosis.
From the cardiovascular system: often - chest pain, thrombophlebitis of deep veins, thromboembolism of pulmonary arteries.
From the urinary system: often - hematuria, dysuria.
From the skin and skin appendages: very often - alopecia, skin rashes; often - peeling of the skin of the palms and feet, erythematous rashes, excessive sweating, violations from the nails.
On the part of the organs of sight and hearing: often - conjunctivitis, visual impairment; seldom - transitorous, reduced visual acuity, loss of visual fields, decreased hearing, neuritis of the auditory nerve.
Allergic reactions: rarely (with monotherapy) or often (in combination with 5-fluorouracil +/- calcium folinate) can have bronchospasm, angioedema, hypotension and anaphylactic shock.
Often there have been cases of allergic manifestations, such as a rash (especially hives), conjunctivitis or rhinitis.
Local Reactions: with extravasation of the drug - pain and inflammatory reactions at the site of administration.
From the laboratory indicators: very often - an increase in the level of alkaline phosphatase, the activity of "liver" enzymes, bilirubin, lactate dehydrogenase, hypokalemia, violation of sodium and glucose in the blood serum; often - increasing the level of creatinine.
Other: very often - increased body temperature, increased fatigue, weight gain, taste disorders.