Sorafenat Sorafenib

Brand Name: Sorafenat
Generic Name: Sorafenib Tosylate
Manufactured by: Natco Pharma Ltd.
Dose: 200 mg
Form: Tablets
Packing: One Bottle Pack of 120 Tablets

Description

Sorafenat 200 mg Tablets

Sorafenib (the name of the generic product – Sorafenat 200 mg from the Indian company Natco Pharma) is an anti-tumor agent of directional action. It is a low molecular weight multinucleate inhibitor. Provides a reduction in the proliferation of tumor cells in vitro. It has been shown that it suppresses both intracellular kinases (serine/threonine kinase c-CRAF, BRAF, and mutant BRAF), and receptor tyrosine kinases located on the cell surface. According to recent data, some of these kinases play a key role in the processes of angiogenesis and apoptosis. In clinical trials, it has been revealed that Sorafenib inhibits tumor growth in human renal and hepatocellular carcinoma. As a remedy for the treatment of renal cell carcinoma, Sorafenib was officially recognized: in the USA – in December 2005 (approved by the Food and Drug Administration, FDA), in the European Union – in July 2006. As a treatment for hepatocellular carcinoma (the most common type of liver cancer), Sorafenib was approved by the European Commission in October 2007 and approved by the FDA in November of the same year. In Russia, Sorafenib was registered for the treatment of patients with kidney cancer on May 31, 2007, and starting in 2012 it is included in the List of VED. In March 2014, the Ministry of Health of Russia recommended it also for therapy of locally advanced or metastatic differentiated thyroid cancer resistant to radioactive iodine. As a treatment for hepatocellular carcinoma (the most common type of liver cancer), Sorafenib was approved by the European Commission in October 2007 and approved by the FDA in November of the same year. In Russia, Sorafenib was registered for the treatment of patients with kidney cancer on May 31, 2007, and starting in 2012 it is included in the List of VED. In March 2014, the Ministry of Health of Russia recommended it also for therapy of locally advanced or metastatic differentiated thyroid cancer resistant to radioactive iodine. As a treatment for hepatocellular carcinoma (the most common type of liver cancer), Sorafenib was approved by the European Commission in October 2007 and approved by the FDA in November of the same year

Sorafenat Sorafenib instructions for use

Indications Sorafenat (Sorafenib): metastatic renal cell carcinoma; hepatocellular carcinoma; locally advanced or metastatic differentiated thyroid cancer resistant to radioactive iodine.

The recommended daily dose of Sorafenat is 800 mg (4 tablets). Take it in two doses (2 times 2 tablets) – either in the intervals between meals, or with it (while the fat content in food can be low or moderate, but not high); the tablets are swallowed with a glass of water. After taking the tablets, the maximum concentration of Sorafenib in the blood plasma is reached after about 3 hours; it is possible to take the drug both on an empty stomach and with food with a moderate fat content (if the fat content of food is high, the bioavailability of Sorafenib is reduced by about 30%). Equilibrium concentrations of Sorafenat in blood plasma are reached 7 days after the start of the drug. The connection with proteins is 99.5%.

The main contraindication in the use of Sorafenat 200 mg is an increased sensitivity to Sorafenib. The drug should not be used by pregnant women, because for the fetus the drug is potentially dangerous, having a teratogenic effect and embryotoxicity (in experiments on animals, the ability of Sorafenib to cause malformations). The effectiveness and safety of the drug for children and nursing mothers have not been established. Caution should be exercised when taking the drug with patients with hypertension, skin diseases, history of bleeding, unstable angina or myocardial infarction, and with therapy with irinotecan and docetaxel.

Below is a list (incomplete) of the main undesirable phenomena identified with the use of Sorafenat. Depending on their nature and degree of severity, the attending physician decides:

  • Continuation of treatment with this medication using standard or reduced dosage (and, if necessary, local symptomatic therapy);
  • About the suspension of taking the drug for 7 or more days;
  • Termination of therapy with Sorafenat.

Sorafenat Sorafenib 200mg Side Effects

From the skin: very often – skin rash, palmar-plantar erythrodysesthesia, erythematic, pruritus, alopecia; often – dry skin, skin peeling, acne, exfoliative dermatitis; infrequently – eczema, erythema multiforme, folliculitis;

On the part of the digestive system: very often – diarrhea, nausea, vomiting, abdominal pain; often – stomatitis, indigestion, constipation; infrequently – gastroesophageal reflux, gastritis, pancreatitis, cholecystitis, increased bilirubin level;

From the hemopoietic system: very often – lymphopenia; often – leukopenia, neutropenia, thrombocytopenia, anemia;

From the respiratory system: often – hoarseness; infrequently – rhinorrhea, pneumonia;

From the cardiovascular system: very often – bleeding, increased blood pressure; often – congestive heart failure, “tides” of blood to the face; infrequently hypertensive crisis, ischemia or myocardial infarction;

From the endocrine system: infrequently – hypothyroidism, hyperthyroidism;

From the side of the nervous system: often – peripheral sensory neuropathy, reversible encephalopathic syndrome;

Other: very often – increased fatigue, pain in the mouth, headaches; often – asthenia, flu-like syndrome.

Keep the drug in a dry place, protected from sun and inaccessible to children, at a temperature of 15 to 30 ° C. Date of manufacture and shelf life are indicated on the packaging.

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