The following undesirable phenomena noted when taking Temodal® are distributed according to the frequency of occurrence according to the following classification: very often (> 10% of cases), often (> 1% to <10%), infrequently (> 0,1 % to <1%), rarely (from> 0.01% to <0.1%) and very rarely (0.01%).
The newly discovered multiform glioblastoma (adult patients) Combined phase of treatment (with radiotherapy)
On the part of mechanisms of resistance to infections
Often: oral cavity, herpes simplex, pharyngitis, wound infection, other infection.
On the part of the blood and lymphatic system
Often: leukopenia, lymphopenia, neutropenia, thrombocytopenia.
Infrequently: anemia, febrile neutropenia.
From the side of the cardiovascular system Often: edema, including legs, hemorrhage.
Infrequently: a feeling of heartbeat, an increase in blood pressure, a hemorrhage into the brain.
On the part of the respiratory system Often: cough, shortness of breath.
Infrequently: pneumonia, upper respiratory tract infection, nasal congestion.
From the endocrine system Infrequently: Istsnko-Cushing syndrome.
From the skin and subcutaneous fat, breast Often: alopecia, rash.
Often: dermatitis, dry skin, erythema, skin itching, face swelling.
Infrequently: photosensitivity reaction, pigmentation disorder, exfoliation.
From the nervous system Often: headache.
Often: anxiety, emotional lability, insomnia, dizziness, aphasia, balance disorder, impaired concentration, confusion and decreased consciousness, convulsions, memory impairment, neuropathy, paresthesia, drowsiness, speech disorder, tremor.
Infrequently: agitation, anagia, behavioral disorders, depression, hallucinations, impaired perception, extrapyramidal disorders, dysphasia, ataxia, gait disorders, hemiparesis, hyperesthesia, gypsus, neurological disorders (unspecified),epileptic status, peripheral neuropathies, parosmia. thirst. From the side of the musculoskeletal system Often: arthralgia, muscle weakness.
Infrequently: pain in the back, musculoskeletal pain, myalgia, myopathy.
From the side of the organ of vision Often: blurred vision.
Infrequently: pain in the eyes, hemianopsia, visual impairment, decreased visual acuity, and limited vision.
From the genitourinary system
Often: frequent urination, urinary incontinence.
Infrequently: impotence.
With the hearing organs and the weight of the tybular system Often: worsening of hearing.
Infrequently: pain in the ears, hyperacia, ringing in the ears, otitis media.
From the digestive system Often: anorexia, constipation, nausea, vomiting.
Often: increased activity of alanine aminotransferase, hyperglycemia, weight loss, abdominal pain, diarrhea, dyspepsia, dysphagia, stomatitis, impaired taste. Infrequently: hypocalysis, increased alkaline phosphatase activity, weight gain, discoloration of the tongue, increased activity of gamma-glutamyltransferase, aspartate aminotransferase, liver enzymes.
From the body as a whole
Often: increased fatigue.
Often: fever, pain syndrome, radiation damage, allergic reaction. Infrequently: "hot flushes" to the body, asthenia, worsening of the condition, chills.
Adjuvant phase of treatment
On the part of mechanisms of resistance to infections
Often: Candidiasis of the oral mucosa, another infection.
Infrequently: herpes simplex, herpes zoster, influenza-like syndrome.
On the part of the blood and lymphatic system
Often: anemia, febrile neutropenia, leukopenia, thrombocytopenia. Infrequently: lymphocyte, petechiae.
From the side of the eslechno-soyleous system
Often: edema of the legs, hemorrhage, deep vein thrombosis.
Infrequently: edema, including peripheral, pulmonary embolism.
On the part of the respiratory system Often: cough, shortness of breath.
Infrequently: pneumonia, upper respiratory tract infection, sinusitis, bronchitis.
From the endocrine system Infrequently: syndrome Itenko-Cushing.
From the skin and the skin of the skin-fat, breast Often: alopecia, rash.
Often: dryness, itching of the skin.
Infrequently: erythema, impaired pigmentation, excessive sweating, pain in the breast, swelling of the face.
From the nervous system Often: headache, convulsions.
Often: anxiety, depression, emotional lability, insomnia,
dizziness, aphasia, imbalance, impaired concentration, confusion, dysphasia, speech disorder, hemiparesis, memory impairment, neurological disorders (unspecified), neuropathy, peripheral neuropathy, paresthesia, drowsiness, tremor.
Infrequently: hallucinations, ataxia, impaired coordination, amnesia, gait disorders, hemiplegia, hyperesthesia, impaired sensory organs.
From the side of the musculoskeletal system
Often: arthralgia, musculoskeletal pain, myalgia, muscle weakness.
Infrequently: back pain, myopathy.
From the side of the organ of vision
Often: blurred vision, diplopia, limitation of visual fields.
Infrequently: pain in the eyes, dry eyes, decreased visual acuity.
From the genitourinary system Often: urinary incontinence.
Infrequently: dysuria, amenorrhea, menorrhagia, vaginal bleeding, vaginitis.
From the side of the hearing and vestibular system Often: hearing impairment, ringing in the ears. Infrequently: deafness, pain in the ears, vertigo. |
From the digestive system Often: anorexia, constipation, nausea, vomiting.
Often: increased activity of alanine aminotraferase, weight loss, diarrhea, dyspepsia, dysphagia, stomatitis, dry mouth, perversion of taste.
Infrequently: hyperglycemia, weight gain, bloating, fecal incontinence, hemorrhoids, gastroenteritis, dental diseases, gastrointestinal disturbances.
From the body as a whole
Often: increased fatigue.
Often: fever, pain syndrome, radiation damage, allergic reaction.
Infrequently: asthenia, worsening of the condition, chills.
Laboratory indicators
Myelosuppression (neutropenia and thrombocytopenia) is a dose-limiting side effect. Among patients in both groups (combined and adjuvant therapy), neutrophil changes, including neutropenia, were detected 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)
On the part of the hematopoiesis system
Often: thrombocytopenia, neutropenia, lymphopenia.
Often: pancytopenia, leukopenia, anemia.In the treatment of patients with glioma and metastatic melanoma, cases of thrombocytopenia and neutropenia of grade 3 or 4 in 19% and 17%, respectively, in glioma, and in 20% and 22% in melanoma, respectively. Hospitalization of the patient and / or withdrawal of the drug Temodal ® It was required in 8% and 4% of cases, respectively, for glioma and 3% and 1.3% for melanoma. Bone marrow depression developed usually during the first few cycles of treatment, with a maximum between 21 and 28 days, the recovery occurred, usually within 1-2 weeks. No evidence of cumulative myelosuppression was noted.
From the side of the digestive system Often: nausea, vomiting, constipation, anorexia.
Often: diarrhea, abdominal pain, dyspepsia, taste perversion. The most frequent were nausea and vomiting. In most cases, these events were 1-2 (from mild to moderate) severity and were treated independently or were easily controlled with standard antiemetic therapy. The frequency of severe nausea and vomiting is 4%. From the nervous system Often: headache.
Often: drowsiness, dizziness, paresthesia, asthenia, pain syndrome.
From the skin and subcutaneous fat Often: rash, itching, alopecia, petechiae.
Rarely: urticaria, exanthema, erythroderma.
Other
Often: increased fatigue.
Often: weight loss, shortness of breath, fever, chills, general malaise.
Rarely: opportunistic infections, including pancytopenia.
Rarely: angioedema.
Post-registration research data
During post-registration studies, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, and allergic reactions, including anaphylaxis, were very rare.
There have been reports of hepatotoxicity, including increased activity of liver enzymes, hyperbilirubinemia, cholestasis and hepatitis. Very rarely there were violations of the liver, including cases with a fatal outcome.
Opportunistic infections were rare, including pneumonia caused by Pneumocystis carinii, and cases of reactivation of cptomoglgovirus and hepatitis B. Very rarely reported cases of interstitial pneumonitis and pneumonitis, as well as pulmonary fibrosis. Also very rarely was the development of myelodysplastic syndrome (MDS) andsecondary malignant processes, including leukemia; very rarely met the development of prolonged pancytopenia. Perhaps the development of aplastic anemia, which in a few cases led to a legal outcome. There have also been cases of development of diabetes mellitus.