Gefitinib, being a selective tyrosine kinase inhibitor of epidermal growth factor receptors, the expression of which is observed in many solid tumors, inhibits tumor growth, metastasis and angiogenesis, as well as accelerates apoptosis of tumor cells.

Locally advanced or metastatic non-small cell lung cancer with activating mutations of the tyrosine kinase domain of the epidermal growth factor receptor.

Possible symptoms include an increase in the frequency and severity of certain dose–dependent adverse reactions, mainly diarrhea and skin rash.

The most common adverse reactions observed in more than 20% of cases were: diarrhea, skin and acne, itching, and dry skin.
Usually, adverse reactions occur within the first month of using the drug and are usually reversible. Approximately 10% of patients had serious adverse reactions (grade 3-4 severity according to general toxicity criteria).
(For more information about all possible adverse reactions, see the leaflet)

− Hypersensitivity to gefitinib or other components of the drug.
− Pregnancy and breastfeeding.
− Childhood and adolescence (safety and efficacy in this group of patients have not been evaluated).

     The combined use of gefitinib and rifampicin (a powerful inducer of the CYP3A4 isoenzyme) leads to a decrease in the average values of the area under the pharmacokinetic curve "concentration-time" (AUC) for gefitinib by 83%.      Concomitant use of gefitinib and itraconazole (an inhibitor of the CYP3A4 isoenzyme) leads to an 80% increase in the AUC of gefitinib, which may be clinically significant, since adverse events depend on the dose and concentration.
     The simultaneous use of gefitinib and drugs that contribute to a significant (≥ 5) and prolonged increase in the pH of gastric contents led to a decrease in AUC for gefitinib by 47%.
The combined use of gefitinib and vinorelbine may enhance the neutropenic effect of vinorelbine. Drugs that induce the activity of the CYP3A4 isoenzyme can increase metabolism and reduce the concentration of gefitinib in blood plasma. Thus, the simultaneous use of gefitinib with drugs that induce the CYP3A4 isoenzyme, such as phenytoin, carbamazepine, barbiturates, and preparations based on St. John's wort, may reduce the effectiveness of gefitinib.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., 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

Store at a temperature not exceeding 25 ° C. Store in the original packaging (pack) to protect from light. Keep out of reach of children.

3 years. Do not use after the expiration date.

The drug Gefitinib-Promomed is contraindicated for use during pregnancy and lactation.