Rx Prescription information
TEMOBEL – BELMED
Trade name: Temobel - Belmed
International nonproprietary name: Temozolomide
Appearance: white hard gelatin capsules No. 1. Content of capsules – from white or almost white to light pink or light yellowish brown crystalline powder.
Composition: each capsule contains: active ingredients: temozolomide – 100 mg; excipients: stearic acid, tartaric acid, silica colloidal anhydrous, sodium starch glycolate type A, lactose anhydrous.
Composition of hard gelatin capsule: gelatin, glycerol, purified water, titanium dioxide, sodium lauryl sulfate.
Pharmaceutical form: capsules.
Pharmaceutical group: Antitumor alkylating agent.
Antitumor alkylating agent.
Multiform glioblastoma detected for the first time: administration in combination with beam therapy followed by adjuvant monotherapy. Malignant glioma (multiform glioblastoma or anaplastic astrocytoma) relapsed or progressing after the standard medical therapy. Disseminated metastazing melanoma (first-line drug product).
Dosage and mode administration
Oral, on an empty stomach. Adults and children older 3 years not exposed to chemotherapy – 200 mg/m2 once a day for 5 days within a 28-day cycle; those exposed to chemotherapy – 150 mg/m2 once a day; in the second cycle – 200 mg/m2 in case the neutrophil absolute number is not less than 1.5 ths./µl, the platelet number not less than 100 ths./µl. The minimal dose is 100 mg/m2. The treatment maximal duration is 2 years. Capsules should be swallowed in one piece washed down by a glass of water.
Nausea, vomiting, undue fatigability, constipations, headache, anorexia, diarrhea, skin eruption, fever, sleepiness, asthenia, abdominal pain, dizziness, body mass loss, malaise, dyspnea, dyspepsia, alopecia, shivering, dysgeusia, paresthesia; bone marrow haematopoeisis suppression (thrombocytopenia, neutropenia).
Hypersensitivity (including one to dacarbazine), evident myelosuppression, infancy and childhood (age up to 3 years – for managing relapsing or progressing malignant glioma and up to 18 tears – for managing multiform glioblastoma or malignant melanoma detected for the first time), pregnancy, lactation.
With caution: Renal or hepatic insufficiency, elderly age.
Administration in the period of pregnancy and lactation
Administration during pregnancy and lactation is contraindicated. Breast feeding should be stopped for the treatment period.
Symptoms: neutrocytopenia and thrombocytopenia.
Treatment: no specific antidote is available, symptomatic therapy is prescribed.
Interaction with other drug products
Valproic acid reduces the temozolomide clearance. Drug products suppressing the bone marrow haematopoeisis increase the risk of myelosuppression.
The dose prescribed should be ingested using the smallest possible number of capsules. Men and women should use efficient means of contraception during the treatment period and for 6 months after it has been completed. The following condition is mandatory for the treatment prescription: the neutrophil absolute number – not less than 1.5 ths./µl, platelets absolute number – not less than 100 ths./µl. A complete blood count determination is mandatory on day 21 after the first dose has been ingested followed by weekly assays until the neutrophil number exceeds 1.5 ths./µl and the platelets number – 100 ths./µl.
While being treated the patient should not drive and occupy with other potentially hazardous kind of activities needing more concentrated attention and quicker psychomotor reactions. Do not let the capsule filling (when the capsule is broken) get on the skin and mucous membranes. When it has got on the skin or mucous membrane, wash the same with a plenty of water.
Store in protected from moisture and light place at temperature below 25 °C.
Do not use after expiration of a shelf life.
6 capsules in a blister. 1 blister together with leaflet is placed in a cardboard pack.
Pharmacy purchasing terms
Republic of Belarus,
30, Fabritsius str.