In the combined phase of treatment (with radiotherapy)
Most of the adverse events are due to radiation therapy and are not associated with taking the drug.
Infectious and parasitic diseases
Often: candidiasis of the oral cavity. herpes simplex, pharyngitis, wound infection, other infection.
Violations from the blood and lymphatic system Often: leukopenia, lymphopenia, neutropenia, thrombocytopenia.
Infrequently: anemia, febrile neutropenia.
On the part of the endocrine system Infrequently: cushingoid.
From the side of metabolism and nutrition Very often: anorexia.
Often: hyperglycemia, weight loss.
Infrequently: hypokalemia, increased alkaline phosphatase activity, weight gain.
From the side of the psyche
Often: anxiety, emotional lability, insomnia.
Infrequently: agitation, apathy, behavioral disorders, depression, hallucinations.
From the side of the nervous system Very often: headache.
Often: convulsions, confusion, snotty, aphasia, imbalance, dizziness, confusion, memory impairment, impaired concentration, neuropathy, paresthesia, speech disorder, tremor.
Infrequently: epileptic status, extrapyramidal disorders, hemiparesis, ataxia,impaired perception, dysphasia, gait disorders, hyperesthesia, gnepesthesia, neurological disorders (unspecified), peripheral neuropathy.
From the side of the eye Often: blurred vision.
Infrequently: hemianopia, decreased visual acuity, visual impairment, limitation of visual fields, pain in the eyes.
From the side of the hearing organ and labyrinthine disorders Often: worsening of hearing.
Infrequently: otitis media, ringing in the ears, hyperacusis, pain in the ears.
From the heart
Infrequently: a feeling of palpitations.
From the side of the vessels
Often: hemorrhage, swelling, incl. swelling of the feet.
Infrequently: cerebral hemorrhage, increased blood pressure.
From the respiratory system, chest and mediastinal organs Often: shortness of breath, cough.
Infrequently: pneumonia, upper respiratory tract infection, nasal congestion.
From the gastrointestinal tract Very often: constipation, nausea, vomiting.
Often: stomatitis, diarrhea, abdominal pain, indigestion, dysphagia.
From the skin and subcutaneous tissues Very often: rash, alopecia.
Often: dermatitis, dry skin, erythema, skin itching.
Infrequently: exfoliation, photosensitization reactions, pigmentation disorders.
From the musculoskeletal and connective tissue Often: muscle weakness, arthralgia.
Infrequently: Myopathy, back pain, musculoskeletal pain, myalgia.
From the side of the kidneys and urinary tract Often: frequent urination, urinary incontinence.
From the genital and breast (breast) infrequent infrequently: impotence.
General disorders and disorders at the injection site Very often: increased fatigue.
Often: allergic reaction, fever, radiation damage, edema of the face, pain syndrome, perversion of taste.
Infrequently: asthenia, flushing, hot flushes, deterioration, chills, change in the language of color, distortion of the sense of smell, thirst.
Laboratory and instrumental data
Often: increased activity of alanine aminotransferase (ALT).
Infrequently: increased activity of liver enzymes, gamma-glutamyltransferase, aspartate aminotransferase
(ACT). In the adjuvant phase of treatment Infectious and parasitic diseases
Often: Candidiasis of the oral mucosa, another infection.
Infrequently: herpes simple, herpes zoster, green-like symptoms.
Violations of the blood and lymphatic system
Often: febrile neutropenia, thrombocytopenia, anemia, and leukopenia.
Infrequently: lymphopenia, petechiae.
From the endocrine system Not often: kunshigoid.
From the side of metabolism and nutrition Very often: anorexia.
Often: decrease in body weight.
Infrequently: hyperglycemia, weight gain.
From the side of the psyche
Often: anxiety, depression, emotional lability, insomnia.
Infrequently: hallucinations, amnesia.
From the side of the nervous system Very often: convulsions, headache.
Often: hemiparesis, aphasia, imbalance, drowsiness, depression, dizziness, memory impairment, concentration disorder, dysphasia, unsettled neurological disorders, neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor.
Infrequently: hemiplegia, ataxia, decreased coordination, gait disturbance, hyperesthesia, sensory disturbances.
From the side of the organ of vision
Often: limitation of fields of vision, blurred vision, diplopia.
Infrequently: decreased visual acuity, pain in the eyes, dry eyes.
From the side of the hearing organ and labyrinthine disorders Often: hearing impairment, ringing in the ears.
Infrequently: г a lohot, a vertex, a pain in ears.
From the side of the vessels
Often: hemorrhage, deep vein thrombosis, edema of the legs.
Infrequently: pulmonary embolism, edema, peripheral edema.
From the respiratory system, chest and mediastinum organs Often: shortness of breath, cough.
Infrequently: pneumonia, sinusitis, upper respiratory tract infection, bronchitis.
From the side .gastrointestinal tract Very often: constipation, nausea, vomiting.
Often: stomatitis, diarrhea, dyspepsia, dysphagia, dryness of the oral mucosa. Infrequently: bloating, incontinence of the cap, gastrointestinal upset (unspecified), gastroenteritis, hemorrhoids.
From the side of the rut and subcutaneous tissue Very often: rash, alopecia.
Often: dry skin, itchy skin.
Infrequently: erythema, impaired pigmentation, increased sweating.
From the musculoskeletal and connective tissue
Often: muscular weakness, arthralgia, musculoskeletal pain, myalgia.
Infrequently: myopathy, back pain.
From the nights and urinary tract Often: urinary incontinence.
Infrequently: dysuria.
From the genitals and (thoracic) gland
Infrequently: vaginal bleeding, menorrhagia, amenorrhea, vaginitis, pain in the mammary glands.
General disorders and disorders at the injection site Very often: increased fatigue.
Often: allergic reaction, fever, radiation damage, pain syndrome, perversion of taste.
Infrequently: asthenia, edema of the face, pain, deterioration, chills, dental disorders, perversion of taste.
Laboratory and instrumental data
Often: increased activity of alanine aminotransferase.
Laboratory indicators
Myelosuppression (neutropenia and thrombocytopenia) is a dozolimitating undesirable phenomenon. Among patients in both groups (combined and adjuvant therapy), neutrophil changes, including neutropenia, were noted in 8% of cases, and platelet counts, including thrombocytopenia, in 14% of cases.
Progressive or recurrent malignant glioma (adults and children over 3 years old) or malignant melanoma (adults)
The following undesirable phenomena noted when taking Temodal® are distributed according to the frequency of occurrence according to the following classification: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (<1/1000), very rarely (<1/10000).
Infectious and parasitic diseases
Rarely: infections caused by conditionally pathogenic flora, including pneumocystis pneumonia.
On the part of the hematopoiesis system
Often: neutropenia or lymphopenia (3-4 degrees), thrombocytopenia (3-4 degrees).
Infrequently: pancytopenia, anemia (3-4 degrees), and leukopenia. In patients with glioma and metastatic melanoma, thrombocytopenia and grade 3 or 4 neutropenia were noted in 19% and 17%, respectively, in glioma and 20% and 22%, respectively, in melanoma. Patient hospitalization and / or removal of Temodal® was required in 8% and 4% of cases, respectively, for glioma and 3% and 1.3% for melanoma. Oppression of the bone marrow developed usually during the first few cycles of treatment, with a maximum between 21 and 28 days; recovery occurred, usually within 1-2 weeks. No evidence of cumulative myelosuppression was noted. Thrombocytopenia can increase the risk of bleeding, and neutropenia or leukopenia can increase the risk of infection.
From the side of metabolism and nutrition Very often: anorexia.
Often: decrease in body weight.
From the side of the nervous system Very often: headache.
Often: drowsiness, dizziness, paresthesia.
From the respiratory system, chest and mediastinal organs Often: dyspnea.
On the part of the digestive system Very often: nausea, vomiting, constipation.
Frequent: diarrhea, abdominal pain, indigestion. The most frequent were nausea and vomiting. In most cases, the phenomena were 1-2 (from mild to moderate) severity and passed independently or were easily controlled by standard antiemetic therapy. The frequency of severe nausea and vomiting is 4%.
From the skin and subcutaneous fat Often: rash, itching. alopecia.
Rarely: multiform erythema, erythroderma. hives, exanthema.
General disorders and disorders at the injection site Very often: increased fatigue.
Often: fever, asthenia, chills, malaise, pain, perversion of taste.
Rarely: allergic reactions. including anaphylactic shock.
angioedema.
Temodal ® in the form of a lyophilizate for the preparation of a solution for infusion provides equivalent doses and the effect of both temozolomide. gak and its active metabolite MTIC (monomethyltriazanoimidazole carboxamide),similar to those with Temodal ® in the form of capsules. The following undesirable phenomena, probably associated with the use of the drug Temodal ® lyophilizate for solution for infusion, reported in two studies (n = 35) and are not represented in studies with the drug receiving Temodal ® form of capsules: in the place of infusion - pain, irritation, itching. sensation of heat, edema, erythema, as well as hematomas. Post-registration data
In the post-registration period, very rarely reported cases of muliform erythema, toxic epidermal pecrolis. Stevens-Johnson syndrome and allergic reactions, including anaphylaxis. Also, reports of cases of geo-availability were received. including increased activity of liver enzymes, hyperbilirubinemia. cholestasis and hepatitis. Very rarely with Temodal ® hepatic insufficiency was noted, including fatal cases (see section "Special instructions"),
In rare cases, opportunistic infections have been reported, including pneumonia caused by Pneumocystis carinii, and cases of reactivation of cytomegalovirus and hepatitis B. Very rarely reported cases of interstitial pneumonitis / nimeimmitis and pulmonary fibrosis. Also very rarely observed mnolodysilatic syndrome, metastatic malignant neoplasms, including myeloleukemia. There have been reports of prolonged pancytopenia, which could result in aplastic anemia, which in some cases led to death. There have also been cases of development of non-acharian diabetes.