Sorafenib

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Generic Name of Sorafenib - Learn More

Sorafenib

Sorafenib Precaution - What You Need to Know

Before starting Sorafenib, patients must consult their healthcare provider to ensure the drug is suitable for their individual condition and medical history. Several important precautions include:
- Cardiovascular Concerns: Sorafenib has been associated with hypertension and cardiac events, including myocardial infarction (heart attack). Blood pressure should be monitored regularly during treatment, and antihypertensive medications may be needed if hypertension occurs.
- Hepatic Impairment: Sorafenib is metabolized in the liver. Therefore, patients with pre-existing liver diseases or hepatic impairment (such as cirrhosis) should use the drug cautiously. Liver function should be monitored, and dose adjustments may be required.
- Hemorrhage: Sorafenib can increase the risk of bleeding, particularly in patients with existing coagulopathies or those undergoing anticoagulant therapy. Patients with a history of gastrointestinal bleeding or brain hemorrhage should be carefully monitored.
- Skin Reactions: Skin toxicity, including hand-foot syndrome (painful redness, swelling, and blisters on the palms of the hands and soles of the feet), is a common side effect. If severe, dose reduction may be necessary.
- QT Prolongation: Sorafenib has been linked to QT interval prolongation on the electrocardiogram, which can lead to arrhythmias. ECG monitoring is recommended, especially for patients with pre-existing heart conditions or those taking QT-prolonging drugs.

Sorafenib Indication - Uses and Benefits

Sorafenib is primarily indicated for the treatment of:
- Hepatocellular carcinoma (HCC): Sorafenib is used in patients with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be treated with surgery.
- Renal Cell Carcinoma (RCC): It is approved for the treatment of advanced renal cell carcinoma, a type of kidney cancer, in patients who have not responded to other therapies.
- Differentiated Thyroid Cancer: Sorafenib is used in the treatment of differentiated thyroid cancer that is refractory to iodine treatment and has metastasized.
- Other cancers: Sorafenib has shown efficacy in treating various other cancers, and ongoing studies are exploring its role in additional tumor types, such as gastrointestinal stromal tumors (GISTs) and cholangiocarcinoma.

Sorafenib Contraindications - Important Warnings

Sorafenib should not be used in the following situations:
- Hypersensitivity: If a patient has a known allergy to Sorafenib or any of its components, they should avoid its use.
- Severe Hepatic Impairment: Sorafenib should be avoided in patients with severe hepatic impairment (Child-Pugh class C), as the drug's metabolism is affected by liver function, increasing the risk of toxicity.
- Pregnancy and Lactation: Sorafenib is classified as pregnancy category D, indicating potential harm to the fetus. It should not be used during pregnancy unless the potential benefit justifies the potential risk. Sorafenib is also contraindicated during breastfeeding as it may pass into breast milk and harm the baby.
- Severe Renal Impairment: The safety and effectiveness of Sorafenib in patients with severe renal impairment have not been established. It is generally not recommended for use in such patients.

Sorafenib Side Effects - What to Expect

Common side effects of Sorafenib include:
- Fatigue: Many patients experience significant fatigue during treatment, which can affect daily activities.
- Diarrhea: A frequent side effect, which may lead to dehydration and electrolyte imbalances if not managed.
- Hand-foot syndrome: This is characterized by redness, pain, and peeling of the skin on the palms and soles. It is one of the most notable side effects and may require dose modification.
- Hypertension: Sorafenib can cause an increase in blood pressure, which may require management with antihypertensive medications.
- Rash and Skin Reactions: Skin rash, particularly on the face, arms, and legs, is common. Severe skin reactions can lead to dose reductions or discontinuation.
- Liver Toxicity: Although rare, Sorafenib can cause liver dysfunction and elevated liver enzymes, necessitating regular liver function tests.
- Bleeding: Sorafenib increases the risk of bleeding, including gastrointestinal bleeding, and must be closely monitored for signs of bleeding.

Severe side effects that require immediate medical attention include:
- Chest pain or signs of a heart attack.
- Severe bleeding (e.g., nosebleeds, blood in stools, or vomit).
- Severe skin reactions or blistering.
- Shortness of breath or swelling in the legs (possible signs of heart or lung complications).

Sorafenib Pregnancy Category ID - Safety Information

4

Sorafenib Mode of Action - How It Works

Sorafenib is a multi-kinase inhibitor that targets several proteins involved in cancer cell growth and angiogenesis (formation of new blood vessels). Its main actions include:
- Inhibition of tumor cell proliferation: Sorafenib blocks RAF kinase and VEGF receptor signaling, which play key roles in the proliferation of cancer cells and the formation of blood vessels that nourish tumors.
- Angiogenesis Inhibition: By inhibiting VEGF receptors and other kinases such as PDGF receptor, Sorafenib impairs the ability of tumors to form new blood vessels, thus starving the tumor of nutrients and oxygen, leading to tumor shrinkage or slowing its growth.
- Inducing tumor cell apoptosis: Sorafenib also induces apoptosis (programmed cell death) in cancer cells by inhibiting several proteins that help cancer cells survive and proliferate.
This action helps to slow the progression of cancers like liver, kidney, and thyroid cancer.

Sorafenib Drug Interactions - What to Avoid

Sorafenib has several known drug interactions that can alter its effectiveness or increase the risk of adverse effects:
- Cytochrome P450 Enzyme Interactions: Sorafenib is metabolized by the CYP3A4 enzyme, and drugs that inhibit or induce this enzyme can alter its levels. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase Sorafenib’s plasma concentration, leading to an increased risk of side effects. CYP3A4 inducers (e.g., rifampin, phenytoin) may decrease Sorafenib’s effectiveness.
- Anticoagulants: Sorafenib may increase the risk of bleeding when taken with anticoagulants (e.g., warfarin, dabigatran). Close monitoring of international normalized ratio (INR) is recommended for patients receiving anticoagulants.
- Other Anticancer Agents: Concomitant use with other chemotherapy agents may increase the risk of toxicity, particularly myelosuppression (reduction in blood cell production) and hepatic toxicity.
- Immunosuppressants: Immunosuppressive drugs like cyclosporine may alter the metabolism of Sorafenib, requiring dose adjustments.

Sorafenib Adult Dose - Recommended Dosage

The recommended starting dose of Sorafenib for adults is 400 mg taken orally twice daily (800 mg total per day).
- The dose may be adjusted based on the patient’s response and tolerance to the drug. If necessary, the dose can be reduced to 200 mg twice daily for patients experiencing side effects.
- The drug should be taken on an empty stomach, at least one hour before or two hours after a meal, to enhance absorption.
- Dose modifications are required in case of adverse effects, with a reduction in dose based on the severity of side effects or toxicity.

Sorafenib Child Dose - Dosage for Children

Sorafenib is not approved for use in children due to a lack of safety and efficacy data in pediatric populations. Its use in children has not been well studied, and therefore, the drug is not recommended for pediatric patients.

As always, it is crucial that patients consult their healthcare provider before beginning Sorafenib to determine if it is the right treatment based on individual health conditions and other medications they may be taking. Regular follow-ups are essential to monitor for potential side effects or complications during therapy.

Sorafenib Renal Dose - Dosage for Kidney Conditions

For patients with renal impairment, no dose adjustment is generally required for Sorafenib unless the impairment is severe.
- However, close monitoring is advised in patients with any degree of renal dysfunction.
- Sorafenib should not be used in patients with severe renal impairment (creatinine clearance <30 mL/min) due to a lack of safety data in this population.