about the product
Film-coated tablets
Specifications
use
Recommended dose
The recommended starting dose is 5 mg 2 times a day with an interval of approximately 12 hours between doses. Your doctor may increase or decrease the dose of the drug, depending on how you tolerate treatment with this drug.
If the dose of axitinib is well tolerated, 7 mg 2 times a day, your doctor may increase the dose to a maximum of 10 mg 2 times a day.
In the event that you have impaired liver function, your doctor may reduce the dose of the drug. Your doctor may also adjust the dose of axitinib depending on which medications you are taking at the same time as axitinib.
Route and (or) method of administration
Axitinib-Promomed should be taken orally, swallowing the tablet whole, with a glass of water, regardless of food intake.
Duration of therapy
Therapy should be continued until a positive effect of treatment is observed or until severe toxicity develops, which cannot be controlled by the appointment of additional therapy or by dose adjustment of axitinib.
Help
Package leaflet
The drug Axitinib-Promomed is used to treat advanced kidney cancer (advanced renal cell carcinoma) in adults over the age of 18 in the event that another drug is no longer effective in preventing the progression of the disease.
If there is no improvement or you feel worse, you should consult a doctor.
Symptoms of overdose
One case of azacitidine overdose has been reported during a clinical trial.
The patient had loose, multiple stools (diarrhea), nausea and vomiting after a single intravenous injection of the drug at a dose of 290 mg / m 2, which exceeded the recommended initial dose by almost 4 times.
Treatment
In case of overdose, the doctor will monitor the concentration of the relevant blood cells and prescribe, if necessary, supportive treatment.
Like all medications, Axitinib-Promomed can cause undesirable reactions, but they do not occur in everyone.
Description of adverse reactions. Some adverse reactions can be serious. Contact your doctor immediately if you experience any of the following serious adverse reactions.:
• Heart failure. If you feel severe fatigue, your stomach will increase in volume, there will be swelling on your legs, shortness of breath, or the veins in your neck will begin to swell, inform your doctor about this.
• The formation of blood clots in veins and arteries (types of blood vessels), including those manifested in the form of stroke, heart attack, thromboembolism or thrombosis. Seek immediate emergency help and contact your doctor if you experience the following symptoms: chest pain or pressure sensations radiating to your arms, back, neck, or jaw, shortness of breath, numbness or weakness in one half of your body, speech disorders, headache, visual disturbances, or dizziness.
• Bleeding. Immediately notify your doctor if you develop serious bleeding or any of the following symptoms during treatment with Axitinib Promomed: black tar-like stools, coughing up blood or sputum with blood, or a change in your mental state.
• Perforation (an open hole in the wall) of the stomach or intestines or the formation of a fistula (a channel of pathological origin connecting one natural body cavity with another cavity or body surface). Notify your doctor if you experience severe abdominal pain.
• Marked increase in blood pressure (hypertensive crisis).
• Notify your doctor if your blood pressure rises significantly, if you have a severe headache or severe chest pain.
Reversible cerebral edema (reversible posterior leukoencephalopathy syndrome). Seek immediate emergency help and contact your doctor if you experience the following symptoms: headache, confusion, seizures, or vision changes with or without high blood pressure.
Do not take the drug Axitinib-Promomed: • if you are allergic to axitinib or any of the other components of the drug listed in section 6 of the leaflet.
Tell your doctor that you are taking, have recently taken, or are about to take any other medications.
Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Axitinib-Promomed, and possibly adjust the doses of medications you are taking, change the dose of Axitinib-Promomed, or switch you to another medication.
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 St., 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 temperatures below 30 °C. Store in the original packaging (pack).
Do not give AZACITIDINE-PROMOMED to children aged 0 to 17 years due to the risk of inefficiency and possible insecurity.
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