about the product

Concentrate
Transparent oily liquid from colorless to light yellow or brownish yellow in color.
Solvent
Transparent, colorless liquid.

Specifications

Name
Kabazitaxel-Promomed
Dosage form
CONCENTRATE FOR PREPARATION OF INFUSION SOLUTION
Nosological classification
Antitumor drugs
INN
KABAZITAXEL
Dosages
40 mg/ml
ATC code
L01CD04
Active substance
kabazitaxel
Pharmacotherapeutic group
Cancer drugs

use

Always use Kabazitaxel-Promomed in full accordance with the recommendations of your doctor. If in doubt, consult your doctor. The use of Kabazitaxel-Promomed should be carried out only in specialized oncological departments under the supervision of a doctor with special training in the use of antitumor chemotherapy. The department must have the necessary facilities and medications to provide assistance in case of allergic reactions during treatment, such as lowering blood pressure and bronchospasm.
Before administering Kabazitaxel-Promomed, you will receive premedication medications to reduce the risk and severity of possible allergic reactions to the drug.
Premedication will include:

  • antihistamines (dexchloropheniramine 5 mg or diphenhydramine 25 mg or a similar drug in the same doses);
  • glucocorticosteroids (dexamethasone 8 mg or the same doses of another glucocorticoid);
  • H2-histamine receptor blockers (ranitidine or a similar drug in the same doses).
You will also be advised to use preventive antiemetics orally or, if necessary, intravenously.
Recommended dose The doctor will determine the dose for you individually, depending on the diagnosis and severity of the disease. The dose depends on the body surface area, which is calculated based on your height and body weight. The dose also depends on the results of your blood tests and whether you have had any adverse reactions to cabazitaxel before.
The recommended dose of Kabazitaxel-Promomed is 25 mg/m2 of body surface area. The drug is administered intravenously for 1 hour. Treatment cycles are repeated every 3 weeks in combination with oral administration of prednisone 10 mg daily during the entire period of treatment with the drug.
The way and method of administration You will receive the drug with an intravenous infusion lasting 1 hour.

Help

Package leaflet

Kabazitaxel is an antitumor agent. It has a broad spectrum of action against late-stage human tumors. Kabazitaxel slows down the process of cancer cell division, which slows down the growth of the tumor.

Kabazitaxel-Promomed is used only in adult men over the age of 18 with the following disease: metastatic castration-resistant prostate cancer in patients who previously received chemotherapy with docetaxel (in combination with prednisone).

Possible overdose symptoms
Deterioration of the severity of adverse reactions, such as symptoms of suppression of the hematopoietic function of the bone marrow, which is manifested by insufficient formation of blood cells (neutrophils, platelets, leukocytes, erythrocytes), and disorders of the gastrointestinal tract, such as diarrhea (diarrhea), vomiting, nausea.

Discontinue the use of Kabazitaxel-Promomed and seek immediate medical attention if one of the following symptoms occurs serious adverse reactions:
Very common (may occur in more than 1 person out of 10):
• fever (fever), signs of neutropenia, including neutropenic infection.
Often (may occur in no more than 1 person out of 10):
• sudden, within a few hours, and sometimes even several tens of minutes, an increase in body temperature above 38 ° C (signs of febrile neutropenia); • an increase or decrease in body temperature – above 38 ° C and below 36 ° C, a decrease in blood pressure below the operating value, an increase in pulse rate, an increase in the frequency of respiratory movements (shortness of breath), a decrease in the amount of urine excreted, general weakness, exhaustion, impaired consciousness or behavior (signs of sepsis, including neutropenic, septic shock);
• hypersensitivity reactions: the appearance of red itchy spots, blisters all over the body (generalized rash/erythema), shortness of breath, lack of air, cough (bronchospasm), pallor of the skin, increased sweating, palpitations, fainting, nausea or vomiting (decreased systolic blood pressure); • loss of large amounts of fluid (dehydration). May occur with severe or prolonged diarrhea, fever, or vomiting; • decrease or increase in urine output per day (signs of acute renal failure);
• an attack of very sharp pain in the lower back, which occurs due to difficulty in the outflow of urine from the kidney to the bladder (signs of renal colic).
Frequency unknown (it is impossible to estimate based on available data):
• fever, tenderness in the lower abdomen, diarrhea, possibly with an admixture of blood, bloating, nausea, vomiting (neutropenic enterocolitis); • sudden abdominal pain, retention of stools and gases, vomiting (intestinal obstruction, intestinal obstruction); • severe or persistent abdominal pain. It can occur if there is an opening in the stomach,
esophagus or intestines (perforation of the gastrointestinal tract) or gastrointestinal bleeding. This can lead to death.

Do not use the drug Kabazitaxel-Promomed:

  • if you are allergic to cabazitaxel or other taxanes, or any other components of the drug listed in section 6 of the leaflet;
  • if the number of neutrophils in your blood tests is less than 1,500/mm3;
  • if you have severe liver failure (in blood tests, total serum bilirubin is more than 3 times the upper limit of normal);
  • simultaneously with the yellow fever vaccine, as well as with other live attenuated vaccines

Avoid concomitant use of strong inhibitors of CYP3A isoenzymes (e.g. ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) and inducers of CYP3A isoenzymes (e.g. phenytoin, carbamazepine, rifampicin, rifabutin, rifapentin, phenobarbital) with the drug Kabazitaxel-Promomed. Be sure to tell your doctor if you need to use these medications during treatment.
Use caution when using Kabazitaxel-Prommed and moderate inhibitors of CYP3A isoenzymes (for example, amiodarone, aprepitant, ciprofloxacin, crizotinib, tofizopam, verapamil, diltiazem, erythromycin, fluconazole, miconazole, cyclosporine, imatinib, valerian).
Do not take St. John's wort preparations during treatment with Kabazitaxel-Promomed, as they are also inducers of the CYP3A4 isoenzyme.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Store at a temperature not exceeding 25 ° C. Do not store in the refrigerator. If the finished solution is not used immediately after preparation, the user is responsible for the time and conditions of storage of the solution after dilution. It should usually not be stored for more than 24 hours at a temperature of 2-8 ° C, provided that the dilution was carried out under controlled and validated aseptic conditions.

If your partner is planning a pregnancy, consult your doctor before using the drug.