CABOZANTINIB-PROMMED blocks the action of proteins called tyrosine kinase receptors (RTKs), which are involved in cell growth and the development of new blood vessels that supply them. These proteins can be present in large quantities in cancer cells, and by blocking their action, the drug CABOZANTINIB-PROMOMED can slow down the rate of tumor growth and help stop the blood supply needed by the tumor.

The drug CABOZANTINIB-PROMOMED is intended for the treatment of adults in
at the age of 18.
Renal cell carcinoma
CABOZANTINIB-PROMOMED is intended as monotherapy (treatment with a single drug containing cabozantinib) for the treatment of advanced renal cell carcinoma:
− in adults with an intermediate or poor prognosis who have not previously received therapy; − in adults after previous therapy with antiangiogenic drugs (VEGF-targeted therapy is a method of treatment for cancer).
CABOZANTINIB-PROMOMED in combination with nivolumab is intended as the first line of treatment for advanced renal cell carcinoma in adult patients.
Liver cell carcinoma
The drug CABOZANTINIB-PROMOMED is intended as monotherapy for the treatment of liver cell carcinoma in adults, after previous therapy with sorafenib.
Differentiated thyroid cancer
CABOZANTINIB-PROMOMED is indicated for use in adults as monotherapy for the treatment of locally advanced or metastatic differentiated thyroid cancer, resistant or unsuitable for radioiodine therapy (RT), with disease progression during or after
previous systemic therapy.

If you have taken more of CABOZANTINIB PROMOMED than you are prescribed, talk to your doctor or visit the hospital, taking the pills and this leaflet with you.

Like all medications, CABOZANTINIB-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
If you experience any adverse reactions, your doctor may advise you to take CABOZANTINIB-PROMOMED at a lower dose. Your doctor may also prescribe other medications to control your adverse reactions.
Inform your doctor immediately if you find the following undesirable reactions — you may need urgent medical attention.:
• Severe or uncontrolled bleeding with symptoms such as vomiting blood, black stools, bloody urine, headache, hemoptysis (may occur very often, in more than 1 person out of 10); • Symptoms including abdominal pain, nausea (feeling sick), vomiting, constipation, or fever. These may be signs of perforation of the gastrointestinal tract - a hole that forms in the stomach or intestines and can be life—threatening (it can occur frequently, in no more than 1 person out of 10); • Swelling, pain in the hands and feet, or shortness of breath (thrombosis) (may occur frequently, in no more than 1 person out of 10); • A wound that does not heal (may occur frequently, in no more than 1 person out of 10); * Feeling drowsy, confused, or unconscious. This may be due to liver problems (hepatic encephalopathy) (may occur frequently, in no more than 1 person out of 10); • Pain in the mouth, teeth and/or jaw, swelling or ulcers in the mouth, numbness or a feeling of heaviness in the jaw or loosening of the tooth. These may be signs of damage to the bone tissue of the jaw (osteonecrosis) (which may occur infrequently, in no more than 1 person out of 100); Seizures, headaches, confusion, or difficulty concentrating. These may be signs of a condition called posterior reversible encephalopathy syndrome (PRES) (frequency of occurrence unknown).

For more information about all possible adverse reactions and the frequency of their occurrence, see the leaflet

Do not take the drug CABOZANTINIB-PROMOMED:

• − if you are allergic to cabozantinib or any other components of the drug (listed in section 6 of the leaflet).

Tell your doctor that you are taking, have recently taken, or may start taking any other medications.
This is due to the fact that the drug CABOZANTINIB-PROMOMED may affect the effect of some other drugs. In addition, some medications may affect the effect of CABOZANTINIB-PROMOMED. This may mean that your doctor needs to change the dose you are taking. You should tell your doctor about every medication, especially if you are taking:
– medications for the treatment of fungal infections, such as ketoconazole and posaconazole; – medicines used to treat bacterial infections (antibiotics), such as erythromycin, clarithromycin and rifampicin; – allergy medications such as fexofenadine;
– medications for the treatment of angina pectoris (chest pain due to insufficient blood supply to the heart muscle), such as ranolazine; – medications used to treat epilepsy or epileptic seizures, such as phenytoin, carbamazepine and phenobarbital; – herbal preparations containing St. John's wort (Hypericum perforatum), sometimes used to treat depression or related conditions such as anxiety; – medicines used to thin blood, such as warfarin and dabigatran etexilate;
– medicines for the treatment of high blood pressure or other heart diseases, such as aliskiren, ambrisentan, digoxin, talinolol and tolvaptan;
– medications for diabetes, such as saxagliptin and sitagliptin; – medicines used to treat gout, such as colchicine;
– drugs used to treat HIV or AIDS, such as ritonavir, maraviroc. "

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
An 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

Keep the drug out of the reach of the child so that the child cannot see it. Do not use the drug after the expiration date indicated on the contour cell packaging, the label of the jar, or the cardboard pack after "Good before". The expiration date is the last day of the given month. Store at temperatures below 25 ° C. Store in the original packaging (pack).

Do not give the drug to children and adolescents under the age of 18, as the safety and efficacy of CABOZANTINIB-PROMOMED in children and adolescents under the age of 18 have not been established.