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); 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, hemolytic uremic syndrome.
From the digestive system: very often - nausea, vomiting, diarrhea, stomatitis, mucositis, abdominal pain, constipation, loss of appetite; increased activity of alkaline phosphatase, activity of "liver" enzymes, bilirubin, lactate dehydrogenase; often - dyspepsia, gastroesophageal reflux, hiccough, gastrointestinal bleeding; infrequently - intestinal obstruction; rarely - colitis, including cases of pseudomembranous colitis.
From the nervous system: very often - peripheral sensory neuropathy,disorders of sensitivity, headache, asthenia; often - dizziness, meningism, depression, insomnia; infrequent - increased nervousness; rarely - dysarthria.
Neurotoxicity is a dose-limiting factor. 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 in the form of difficulty in performing accurate 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 are weakened or they completely stop. 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, acute neurosensory manifestations were noted, which usually occurred within a few hours after the administration of the drug and were most often provoked by exposure to cold.They were characterized by transient paresthesia, dysesthesia or, hypoesthesia, rarely (1-2%) - an acute syndrome of laryngeal dysaesthesia. 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 muscles, dysesthesia of the tongue, dysarthria and a feeling of pressure in the chest. Usually, these symptoms were quickly stopped both without the use of drug therapy, and with the administration of antihistamines and bronchodilators. Increasing the infusion time during subsequent cycles of oxaliplatin therapy can reduce the incidence of this syndrome.
From the side of 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 side of the cardiovascular system: often - chest pain, thrombophlebitis of deep veins, thromboembolism of pulmonary arteries, hypertension.
From the urinary system: often - hematuria, dysuria; very rarely - acute tubular necrosis, acute interstitial nephritis, acute renal failure.
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, changes from the nails.
From the sense organs: often - conjunctivitis, visual impairment; rarely - transient reduction in visual acuity, loss of vision, hearing loss, neuritis of the auditory nerve, deafness.
Allergic reactions: rarely (with monotherapy) or often (in combination with fluorouracil ± calcium folinate) can be observed bronchospasm, angioedema, arterial 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 injection site.
Laboratory indicators: very often - hypokalemia, hyponatremia, hyperglycemia; often - increasing the concentration of creatinine.
Other: very often - increased body temperature, increased fatigue, weight gain, taste disorders.