Sorafenib in Pakistan is available under the brand name Nexavar. Bayer's Pharmaceuticals market it. Sorafenib (Nexavar) is indicated for treating liver and renal cancers.
Nexavar 200 mg Tablets are specifically prescribed for treating liver cancer that cannot be surgically removed. In addition, it is also indicated for treating renal cell carcinoma (cancer of the kidneys) that is too advanced.
Sorafenib is also approved for treating differentiated thyroid cancer that is resistant or refractory to radioiodine therapy and despite treatment, it is progressive or recurrent or has spread to distant parts of the body.
Sometimes, as off-label medicine, it is also used to treat angiosarcoma and GIST (gastrointestinal stromal tumors).
What is the usual dose of Sorafenib?
The usual dose of Sorafenib for all the above-mentioned cancers is 400 mg two times a day. Since 200 mg tablets of Sorafenib in Pakistan have to be taken as two tablets two times a day.
It is best to take Sorafenib 200 mg tablets on an empty stomach. It should be taken one hour before or two hours after a meal.
What is the dose of Sorafenib in patients with kidney and liver impairment?
In mild to moderate liver and kidney impairment, no adjustment is required in the dose. However, in severe kidney and liver disease, the following dosing schedule should be followed:
Sorafenib Dose in severe kidney dysfunction:
- CrCl of 20 to 40 ml/minute: Reduce the dose by half i.e. 200 mg one tablet two times a day.
- Patients who are on dialysis: Sorafenib 200 mg tablet once daily
Sorafenib Dose in severe liver dysfunction:
- There are no specific dose adjustments mentioned in severe liver disease, however, in patients with a bilirubin level of 1.5 to 3 mg/dl, the dose is reduced by half i.e. 200 mg one tablet two times a day.
- In DCLD and albumin of less than 2.5 gm/L, the dose is reduced to 200 mg once daily
In patients who develop Sorafenib-induced liver injury, treatment should be permanently discontinued if the patient has any of the following features:
- Hepatic encephalopathy
- INR of more than 1.5
- ALT is thrice the ULN
- Bilirubin is twice the ULN
- an increase in Alkaline phosphatase in the absence of any bony pathology
What are the side effects of Sorafenib 200 mg Tablets?
Sorafenib should not be used by people who are allergic to it and those who are being treated for squamous cell carcinoma of the lungs, especially in addition to carboplatin and paclitaxel.
Cardiac Side effects:
Sorafenib use may be associated with angina, an increased incidence of cardiovascular events, and myocardial infarction. Patients should be monitored for new-onset cardiovascular symptoms.
It may also cause hypertension, heart failure, and flushing. Hypertension has been reported during the first six weeks of starting the treatment. In addition, Sorafenib may also prolong the QT interval and causes cardiac rhythm abnormalities like ventricular tachycardia.
Blood-related side effects:
Bleeding diathesis is a common side effect. Patients should be monitored for bleeding tendencies and marrow suppression which can manifest as anemia, low platelet counts, leukopenia, thrombocytopenia, and lymphopenia.
Skin-related side effects:
Skin rashes and Steven-Jhonson syndrome as well as TEN (toxic epidermal necrolysis) have been reported with its use. Other less common skin-related side effects include exfoliative dermatitis, redness, skin dryness, and had-foot-skin reactions.
GI side effects:
Gastrointestinal side effects may include dyspepsia, GERD, mucositis, heartburn, altered taste, abdominal pain, and in severe cases, GI perforation may occur.
Patients should be monitored for new-onset symptoms of severe abdominal pain that might suggest intestinal perforation.
Thyroid abnormalities:
Sorafenib may alter thyroid functions. It is associated with an increase in the TSH levels. Periodic monitoring of thyroid functions is required.
Wound healing and infections:
Sorafenib (Nexavar) use is associated with delayed wound healing and frequent infection. The manufacturer recommends discontinuing it before a major surgical procedure and when the patient acquires a serious or life-threatening infection.
Sorafenib 200 mg tablets in Pakistan:
Sorafenib is available as 200 mg tablets in Pakistan.
