Warnings and Precautions of Sorafenib

 

Sorafenib is introduced to treat liver cancer (hepatocellular carcinoma), kidney cancer (advanced renal cell carcinoma), and thyroid cancer (differentiated thyroid carcinoma). The sorafenib a multikinase inhibitor may also be known as a so-called multikinase inhibitor. It acts by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancerous cells growing.

Sorafenib comes in the form of tablets you can take at home. Take sorafenib twice daily. Take the sorafenib tablets with a glass of water at a persistent time each day. The sorafenib tablets should be taken without food or with a low-fat meal. In case you are going to have a high-fat meal, take sorafenib tablets at least one hour prior to or two hours after your meal.

 

WARNINGS AND PRECAUTIONS:

Pregnancy and Lactation: Females should not become pregnant while on sorafenib therapy. Females of childbearing age must be apprised of the potential hazard to the fetus, which includes teratogenicity, and embryotoxicity. Sorafenib therapy should not be used during pregnancy. Also, breastfeeding should be discontinued during Sorafenib therapy.

 

Dermatological Toxicities: Hand-foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse medicine reactions with Sorafenib. The rash and hand-foot skin reactions (Grade 1 & 2) generally appear during the initial six weeks of therapy with Sorafenib. As noted in one clinical study, the incidence of hand-foot skin reaction may be greater in the Asian group. The management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption or dose modification of Sorafenib, or in severe or persistent cases, permanent discontinuation of Sorafenib.

 

Hypertension: An increased incidence of hypertension was observed in patients treated with Sorafenib. Hypertension was noted mild to moderate at the beginning of the therapy and was amenable in order to manage with the standard antihypertensive therapy. Blood pressure should be monitored regularly and treated, in case needed, in accordance with standard medical practice. In cases of severe or persistent hypertension, or hypertensive crisis despite apt antihypertensive therapy, permanent interruption of sorafenib therapy should be considered.

 

Aneurysms and artery dissections: The VEGF pathway inhibitors used in patients either with or without hypertension can promote the development of aneurysms or artery dissections. Prior to starting Sorafenib therapy, this risk should be precisely considered in all those patients who are with hypertension or a history of aneurysm.

 

Haemorrhage: An increase in the risk of bleeding may occur following the use of Sorafenib. The incidence of serious bleeding events is uncommon. If any bleeding event necessitates medical intervention, it is recommended that permanent discontinuation of therapy with Sorafenib should be considered. Because of the risk of bleeding, bronchial, tracheal, and oesophageal infiltration needs to be treated with localised therapy before administration of Sorafenib in patients with DTC-Differentiated Thyroid Carcinoma.

 

Warfarin: The infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been observed in certain patients taking warfarin while on Sorafenib therapy. Patients concomitantly with warfarin should be monitored regularly for changes in prothrombin time, INR, and for clinical bleeding episodes.

 

Wound Healing Complications: No formal studies of the effect of concomitantly on wound healing have been conducted. In all those patients who are undergoing any major surgical procedures, temporary interruption of Sorafenib tablets therapy is required just for precautionary reasons. There is limited clinical experience regarding the timing of reinitiation of therapy after major surgical intervention. Thus, the intent to resume Sorafenib therapy after any major surgical intervention should be based on behalf of the clinical judgment of adequate wound healing.

 

Gastrointestinal Perforation: Gastrointestinal perforation has appeared as an uncommon event and has been reported in less than one percent of patients taking treatment with Sorafenib. In certain cases, this was not linked with an apparent intra-abdominal tumour. The sorafenib therapy should be discontinued if gastrointestinal perforation develops.

 

Hepatic Impairment: Experience in Child-Pugh B hepatic impairment is limited. No data is available on patients with Child-Pugh C (severe) hepatic impairment. Since sorafenib medication is mainly eliminated through the hepatic route, exposure could be increased in patients with severe hepatic impairment.

 

Drug-induced Hepatitis: Drug-induced hepatitis has been noted in post-marketing experience. Sorafenib should be interrupted if drug-induced hepatitis is suspected.

Hypocalcaemia: When using Sorafenib in patients with differentiated thyroid carcinoma, precise monitoring of blood calcium level is required. As per clinical trials, hypocalcaemia was observed more frequently and more severely in patients with DTC, especially with a known history of hypoparathyroidism, in comparison to patients with renal cell or hepatocellular carcinoma.

TSH Suppression in Differentiated Thyroid Carcinoma (DTC): In the Differentiated Thyroid Carcinoma clinical trials, increases in TSH levels above 0.5mU/L were noted in patients treated with Sorafenib. When using Sorafenib in differentiated thyroid carcinoma patients, precise monitoring of TSH levels is needed.