Avenium® Pro

The active ingredient of the drug Avenium® Pro is nintedanib, which belongs to the group of protein kinase inhibitors. Syntedanib blocks intracellular mechanisms that lead to excessive activation of the processes of active vascular growth (including the growth of blood vessels in tumors), as well as the formation of fibrous (scar) tissue in the lungs. Therefore, this drug is used to treat cancer – non-small cell lung cancer (NSCLC), as well as interstitial lung diseases, when there are signs of fibrosis.

Avenium® Pro is used in adults over the age of 18 for the treatment of:
• Locally advanced, metastatic, or recurrent non-small cell lung cancer (adenocarcinoma) after first-line chemotherapy in combination with docetaxel.
• Idiopathic pulmonary fibrosis (IPF) (idiopathic fibrotic alveolitis); to treat and slow the progression of the disease.
• Other chronic fibrosing interstitial lung diseases (ILS) with a progressive phenotype.
• Interstitial lung diseases in systemic scleroderma (SSC).

If you have taken Avenium® Pro more than you should have
Consult your doctor immediately.

Contact your doctor immediately if, during treatment with Avenium®, The following serious adverse reactions have occurred:
Very often, they may occur in more than 1 person out of 10:
• Liquid multiple stools (diarrhea) – can lead to loss of fluids and important salts (electrolytes, for example, sodium or potassium) in the body. At the first sign of diarrhea, drink plenty of fluids and consult your doctor immediately. Start the recommended antidiarrheal therapy as soon as possible after consulting your doctor.
Infrequently – may occur in no more than 1 person out of 100:
• There may be a feeling of compression, compression or pain in the chest, which may spread to the left arm, lower jaw, under the left shoulder blade; lack of air, dizziness - signs of an acute heart attack (myocardial infarction)
Other adverse reactions that may occur when taking Avenium® Pro:
In the treatment of locally advanced, metastatic, or recurrent NSCLC (adenocarcinoma) after first-line chemotherapy in combination with docetaxel
Very often, they may occur in more than 1 person out of 10:
• Joint pain, inflammation of the oral mucosa, abdominal pain, fever, weakness, neurological disorders, vomiting, nausea (neutropenia) with a possible risk of infectious complications such as fever, cough, difficulty or painful breathing, wheezing, chest pain when breathing (possible symptoms of pneumonia)
• Decreased appetite
• Electrolyte imbalance, including a decrease in blood potassium (hypokalemia)
• Pain, numbness and/or tingling in the fingers and toes (peripheral neuropathy)
• Bleeding
• Nausea
• Vomiting
• Abdominal pain
• Increased activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) in laboratory blood analysis
• Inflammation of the mucous membranes lining the digestive tract, including suppuration and ulcers in the oral cavity (mucositis, including stomatitis)
• Redness of the skin, which may be accompanied by itching, bumps, fluid discharge or blisters (rash)
• Hair loss (alopecia)
Often – may occur in no more than 1 person out of 10:
• Inflammation of tissues with the formation of a purulent cavity (abscess)
• Blood poisoning (sepsis)
• Decrease in the number of white blood cells accompanied by fever (febrile neutropenia) in laboratory blood analysis
• Decrease in the number of platelets (thrombocytopenia) in the laboratory blood test
• Extreme thirst, dizziness, fainting or loss of consciousness (dehydration)
Weight loss
• Headache
• Increased blood pressure
• Formation of blood clots in the veins, blockage of blood vessels by detached clots
blood (venous thromboembolism)
• Increased activity of gamma-glutamyltransferase (GGT) in laboratory blood analysis
• Increased bilirubin concentration in laboratory blood analysis
• Increased amount of protein in urine (proteinuria)
• Itching
Infrequently – may occur in no more than 1 person out of 100:
• Drug-induced liver damage
• Inflammation of the pancreas (pancreatitis)
• Rupture of the wall of the stomach or intestines (perforation of the gastrointestinal tract)
Unknown – it is impossible to estimate based on the available data:
• Decreased white blood cell count (leukopenia)
• Increased fatigue (asthenia)
• Shortness of breath, cough, rapid heartbeat, decreased blood pressure, cold and sticky sweat, loss of consciousness, pale skin, slight fever (arterial thromboembolism)
• Weakening of the wall or rupture of the wall of blood vessels (aneurysms and artery dissection)
• Inflammation of the large intestine (colitis)
• Decreased urine output, edema, general lethargy, nausea, decreased appetite (kidney failure)
• Pneumonia (a disease called interstitial lung disease)
• Shortness of breath
• General cerebral symptoms, for example, headaches, confusion (posterior reversible encephalopathy syndrome).
In the treatment of idiopathic pulmonary fibrosis
Very often, they may occur in more than 1 person out of 10:
• Nausea
• Abdominal pain
• Increased activity of liver enzymes in laboratory blood analysis
Often – may occur in no more than 1 person out of 10:
• Decreased appetite
• Weight loss
• Bleeding
• Vomiting
• Increased activity of AST, ALT, GGT in laboratory blood analysis
• Redness of the skin, which may be accompanied by itching, bumps, fluid discharge or blisters (rash)
• Headache
Infrequently – may occur in no more than 1 person out of 100:
• Loss of body fluids (dehydration)
• Increased blood pressure
a decrease in the number of platelets (thrombocytopenia) in the laboratory blood test
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the large intestine (colitis)
• Increased activity of alkaline phosphatase in laboratory blood analysis
• Increased bilirubin concentration in laboratory blood analysis
• Drug-induced liver damage
• Itching
• Hair loss (alopecia)
• Increased amount of protein in urine (proteinuria)
Unknown – it is impossible to estimate based on the available data:
• Weakening of the wall or rupture of the wall of blood vessels (aneurysms and artery dissection)
• Decreased urine output, edema, general lethargy, nausea, decreased appetite (kidney failure)
• General cerebral symptoms, for example, headaches, confusion (posterior reversible encephalopathy syndrome).

Do not take Avenium® Pro:
• if you are allergic to syntedanib or any other components of the drug
(listed in section 6 of the leaflet);
• If you are pregnant or breastfeeding.
In case of concomitant use with docetaxel, regarding contraindications for docetaxel, please refer to the relevant instructions for use of this drug.

Tell your doctor that you are taking, have recently taken, or may be taking any other medications.
In particular, the following drugs, when used in combination with Avenium® They can increase its level in the blood and, consequently, increase the risk of adverse reactions.:
• ketoconazole (a drug for the treatment of fungal infections);
• erythromycin (a drug for the treatment of bacterial infections);
• cyclosporine (a drug that affects the immune system).
The following drugs can reduce the effectiveness of Avenium® Pro:
• rifampicin (an antibiotic for the treatment of tuberculosis);
• carbamazepine, phenytoin (drugs for the treatment of seizures);
• preparations of St. John's wort (Hypericum perforatum) (herbal preparation for the treatment of depression).

The holder of the registration certificate
Russian Federation
PROMOMED RUS LLC
Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640-25-28
Email: reception@promomed.pro
Manufacturer
Russian Federation
JSC "Biochemist"
Address: 15A Vasenko str., Saransk, Republic of Mordovia, 430030
Reporting of adverse reactions
Russian Federation
 Federal Service for Healthcare Supervision
Address: 109012, Moscow, Slavyanskaya square, 4, building 1
Phone number: +7 800 550 99 03
Email: pharm@roszdravnadzor.gov.ru or npr@roszdravnadzor.gov.ru
Website: www.roszdravnadzor.gov.ru

Do not give the drug to children aged 0 to 18 years because the efficacy and safety of the drug in this age group have not been established.

Pregnancy
Syntedanib should not be used during pregnancy, so take a pregnancy test before starting treatment, as well as during therapy as needed.
Pregnancy should be avoided during therapy with this drug. If you can become pregnant, you should use reliable methods of contraception during therapy and for at least 3 months after taking the last dose of the drug. This is due to the possible risk to the unborn child.
The effectiveness of hormonal oral contraceptives may be adversely affected by vomiting and/or diarrhea or other conditions with possible malabsorption. Women using hormonal oral contraceptives should be advised to use alternative highly effective contraceptive measures.
If you become pregnant while taking this medication, inform your doctor immediately.
Breastfeeding
Breast-feeding should not be performed while taking Avenium® Pro due to the risk to the child.

There have been no studies on the effect of the drug on the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
While taking Avenium® Pro, care must be taken when driving vehicles or mechanisms.

Keep the drug out of the reach of the child so that the child cannot see it.
Do not take the drug after the expiration date (shelf life) indicated on the carton after "Good before".
The expiration date is the last day of the given month.
Store at a temperature not exceeding 25 ° C. Store in the original packaging (contour cell packaging in a pack/ sealed bag with contour cell packaging in a pack/ jar in a pack) to protect from light and moisture.
Do not dispose (pour) the drug into the sewer. Ask the pharmacy employee how to dispose (destroy) the drug that is no longer needed. These measures will help protect the environment.