Linparza hard capsules 50 mg. №448 vial

Description

Linparza composition
active substance: olaparib;
1 hard capsule contains 50 mg of olaparib;
Excipients: laurylmacrogol-32 glycerides, hypromellose, titanium dioxide (E 171), gelan gum (E 418), potassium acetate, shellac, iron oxide black (E 172).

Dosage form
Hard capsules.

Pharmacological properties
Olaparib is a potent inhibitor of human poly (ADP-ribose) polymerases (PARP-1, PARP-2 and PARP-3), which inhibits the growth of certain tumor cells in vitro and tumor growth in vivo when used alone or in combination with traditional drugs. chemotherapy.

Indication
Linparza should be used as monotherapy for the supportive treatment of adult patients with platinum-sensitive recurrent serous epithelial cancer of the ovaries, fallopian tubes, or primary peritoneal cancer of high malignancy with a mutation in the BRCA gene (in the germinal or for chemotherapy with the use of platinum drugs.

Contraindication
Hypersensitivity to the active substance or to any of the excipients. Breast-feeding during treatment and for 1 month after the last dose.

Children
The safety and efficacy of the drug in children and adolescents have not been studied.
No data available.

Use during pregnancy or breastfeeding
This drug is not recommended to be taken during these periods.

Method of application and dosage
Linparza therapy should be initiated and supervised by a physician experienced in the use of anticancer drugs.
Before starting Linpars therapy, it is important to make sure that the patient has a mutation (germline or tumor cells) in the breast cancer predisposition gene (BRCA). The status of the BRCA mutation should be determined in a laboratory with relevant experience using a validated method.
Genetic counseling of patients with BRCA mutations should be performed according to local norms and requirements.
Doses
The recommended dose of Linparza is 400 mg (8 capsules) twice a day, which corresponds to a total daily dose of 800 mg.
Linparza should be started no later than 8 weeks after the last dose of platinum-containing chemotherapy.
It is recommended to continue the drug until the progression of the underlying disease. There are no data on re-treatment with Linparza after further recurrence.
Important differences between the dosage of Linpars in capsules and tablets
Linparza in capsules (50 mg) should not be used instead of Linparza in tablets (100 mg and 150 mg) with dosage to the nearest milligram due to differences in dosage and bioavailability of each dosage form. Therefore, it is necessary to follow specific recommendations for the dosage of each dosage form.
Missed dose
If you miss a dose of Linparza, you should take the next usual dose at the scheduled time.

Overdose
Symptoms of overdose are not established and there is no special treatment in case of overdose with Linpars. In case of overdose, general supportive measures should be taken and symptomatic treatment of the patient should be initiated.

Side effects:

• Blood and lymphatic system disorders: anemia, neutropenia, leukopenia, thrombocytopenia;
• Immune system disorders: rash
• From the metabolism and nutrition: decreased appetite
• From the nervous system: dizziness, headache, dysgeusia;
• Respiratory, thoracic and mediastinal disorders: cough;
• From the gastrointestinal tract: diarrhea, dyspepsia, stomatitis, upper abdominal pain, vomiting, diarrhea, nausea;
• The results of laboratory tests: increased blood creatinine.

Expiration date
2 years.

Storage conditions
Store at a temperature of 2 to 8 ° C. Keep out of reach of children.
The drug can be stored for up to 3 months at a temperature below 30 ° C and must be disposed of after this period.