Description
Latin name
PROSTATILEN
Release form
Intramuscular injection solution
Packaging
1 syringe
Contraindications
hypersensitivity to fulvestrant or any other component of the
preparation severe liver dysfunction
pregnancy and lactation period
childhood (up to 18 years).
Caution: impaired renal and hepatic function.
Use during pregnancy and lactation
Contraindicated.
Special instructions
Treatment with Faslodex should only be carried out under the supervision of a physician with experience in the use of antitumor drugs.
Caution is advised when using Faslodex in patients with mild or moderate hepatic impairment. Caution is advised when using Faslodex in patients with severe impaired renal function (creatinine clearance <30 ml / min). Given the use of the drug, caution is advised when using Faslodex in patients with a tendency to bleed, thrombocytopenia, or in patients taking anticoagulants. Thromboembolism in women with advanced breast cancer is common. This should be taken into account when prescribing Faslodex to patients at risk of thromboembolism. The effects of prolonged use of fulvestrant on bone tissue have not been established. Given the mechanism of action of fulvestrant, the potential risk of osteoporosis cannot be ruled out. Faslodex should not be mixed with other drugs. The influence of Faslodeks on the ability to drive a car and other mechanisms is negligible. Patients with symptoms of asthenia should be careful when driving or using other mechanisms. Composition 1 filled syringe contains: Active substance: 250 m fulvestrant in 5 ml solution (50 mg / ml) Excipients: ethyl alcohol 96% 100 mg / ml benzyl alcohol 100 mg / ml, benzyl benzoate 150 mg / ml, castor oil to 5 ml. Dosage and administration of intramuscularly, by slow injection. Adult female patients (including advanced age). The recommended dose is 250 mg once a month. Children and adolescents. There are no data on safety and effectiveness in children and adolescents. Patients with impaired renal function. In cases of mild or moderate impaired renal function (creatinine clearance> 30 ml / min), dose adjustment is not required. Safety and efficacy of the drug in patients with severe renal impairment (creatinine clearance <30 ml / min) have not been established. Patients with impaired liver function Use of Faslodex in patients with mild or moderate impaired liver function requires caution. Safety and effectiveness of the drug in patients with impaired liver function have not been established. Side effects From the digestive system: very often – nausea often – vomiting, diarrhea, anorexia. From the CCC: very often – a feeling of heat (hot flashes) often – thromboembolism. From the skin and skin appendages: often a rash. Local reactions: very often – reactions at the injection site. From the genitourinary system: often – urinary tract infections. Other: very often asthenia, increased activity of liver enzymes (ALT, AST, ALP) often headaches, hypersensitivity reactions (edema, urticaria). Drug Interactions According to the results of a study of the clinical interaction with midazolam, fulvestrant does not inhibit the activity of CYP 3A4. In vitro data indicate that fulvestrant does not affect the activity of CYP 1A2, 2C9, 2C19 and 2D6. Possible inhibition of CYP 2A6, 2C8, and 2E1 activity has not been evaluated. In a study of clinical interaction with rifampicin (an inducer of CYP 3A4) and ketoconazole (an inhibitor of CYP 3A4), no clinically significant changes in fulvestrant clearance were detected. Therefore, when prescribing a fulvestrant in combination with inducers or CYP 3A4 inhibitors, dose adjustment is not required. Overdose There are no known cases of overdose in humans. In animal studies, only effects directly or indirectly associated with anti-estrogenic activity were observed at high doses of fulvestrant. Treatment: symptomatic therapy. Storage conditions At 2-8 ° C, in a dark place out of the reach of children. Shelf life 4 years. Active ingredient Fulvestrant Prescription dosage form injection Possible product names Fazlodex 250 mg / 5 ml No. 1 syringe + needle Fazlodex 250mg 5ml syringe appl No. 1 Fazlodex 250mg / 5ml shpr No. 1 FAZLODEX RVED FOR FOR. 250MG / 5ML SYRINGE 5ML No. 1 Fazlodeks solution for in / mouse. enter 250 mg / 5 ml 5 ml syringe 2 pcs. AstraZeneca, Britain
