Sorafenib

By Medically reviewed by hellodoktor

Generic Name: Sorafenib Brand Name(s): Generics only. No brands available.

Uses

What is Sorafenib used for?

Sorafenib is used to treat kidney, liver, and thyroid cancer. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

How should I take Sorafenib?

Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually twice a day.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

How do I store Sorafenib?

Sorafenib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Sorafenib in the bathroom or the freezer. There may be different brands of Sorafenib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Sorafenib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Sorafenib?

Before taking sorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart disease (such as heart attack, coronary artery disease), high blood pressure, liver disease.

Sorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sorafenib safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sorafenib. Sorafenib may harm an unborn baby. Males and females using this drug should ask about reliable forms of birth control during treatment and for 2 weeks after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Sorafenib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sorafenib. Sorafenib is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Sorafenib?

Weight loss, nausea/vomiting, diarrhea, loss of appetite, changes in taste, dry skin, mouth sores, hair loss, voice changes, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome. Tell your doctor right away if you experience swelling, pain, redness, blisters, or tingling/burning of the hands/feet. Depending on how severe your hand-foot syndrome is, your doctor may give you an additional medication to reduce the symptoms, or may stop or delay your sorafenib treatment.

This medication can affect how your thyroid works. Tell your doctor right away if you have signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, or unusual tiredness) or signs of an overactive thyroid (such as mental/mood changes, heat intolerance, unusual weight loss).

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn’t stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), numb/tingling skin, muscle spasms, signs of infection (such as sore throat that doesn’t go away, fever).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, fast/irregular heartbeat, severe dizziness, fainting, vomit that looks like coffee grounds, black/bloody stools.

Sorafenib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Sorafenib?

Other medications can affect the removal of sorafenib from your body, which may affect how sorafenib works. Examples include rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Sorafenib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Sorafenib?

Sorafenib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sorafenib?

Sorafenib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Sorafenib.

What is the dose of Sorafenib for an adult?

Usual Adult Dose for Renal Cell Carcinoma

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Usual Adult Dose for Thyroid Cancer

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Usual Adult Dose for Hepatocellular Carcinoma

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Child-Pugh A and B hepatic impairment: No adjustment recommended.

Dose Adjustments

Temporary interruption is recommended in patients undergoing major surgical procedures

Temporary interruption or permanent discontinuation may be required for the following:

Cardiac ischemia or infarction; hemorrhage requiring medical intervention; severe or persistent hypertension despite adequate anti-hypertensive therapy; gastrointestinal perforation; QTc prolongation; severe drug-induced liver injury

Dose modifications for Hepatocellular Carcinoma (HCC) and Renal Cell Carcinoma (RCC):

First Dose Reduction: 400 mg once daily

Second Dose Reduction: 400 mg every other day

The suggested dose modifications for skin toxicity for patients with HCC or RCC are as follows:

Skin Toxicity Grade 1 – Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema, or discomfort of the hands or feet which does not disrupt the patients normal activities.

Suggested Dose Modification For Any Occurrence:

-Continue treatment with sorafenib and consider topical therapy for symptomatic relief.

Skin Toxicity Grade 2 – Painful erythema and swelling of the hands or feet and/or discomfort affecting the patients normal activities.

Suggested Dose Modification For The First Occurrence:

-Continue treatment with sorafenib and consider topical therapy for symptomatic relief.

Suggested Dose Modification For The Second or Third Occurrence Or If There Is No Improvement Within Seven Days:

-Interrupt treatment until toxicity resolves to Grade 0 to 1.

-When resuming treatment, decrease the dose of sorafenib by one dose level (to 400 mg once daily or 400 mg once every other day).

Suggested Dose Modification For The Fourth Occurrence:

-Discontinue treatment with sorafenib.

Skin Toxicity Grade 3 – Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living.

Suggested Dose Modification For The First Or Second Occurrence:

-Interrupt treatment until toxicity resolves to Grade 0 to 1.

-When resuming treatment, decrease the dose of sorafenib by one dose level (to 400 mg once daily or 400 mg once every other day).

Suggested Dose Modification For The Third Occurrence:

-Discontinue treatment with sorafenib.

Dose modifications for Differentiated Thyroid Carcinoma (DTC):

First Dose Reduction: 600 mg total daily dose (400 mg and 200 mg 12 hours apart)

Second Dose Reduction: 200 mg twice daily

Third Dose Reduction: 200 mg once daily.

The suggested dose modifications for skin toxicity in patients with DTC are as follows:

Skin Toxicity Grade 1:

Suggested Dose Modification For Any Occurrence:

-Continue treatment with sorafenib.

Skin Toxicity Grade 2:

Suggested Dose Modification For The First Occurrence:

-Decrease sorafenib dose to 600 mg daily. If no improvement within 7 days, see below.

Suggested Dose Modification For The Second or Third Occurrence Or If There Is No Improvement Within Seven Days:

-Interrupt treatment until toxicity resolves to Grade 1.

-When resuming treatment, decrease the dose according to dose modification guidelines.

Suggested Dose Modification For The Fourth Occurrence:

-Discontinue treatment with sorafenib.

Skin Toxicity Grade 3:

Suggested Dose Modification For The First Occurrence:

-Interrupt treatment until toxicity resolves to Grade 1.

-When resuming treatment, decrease the dose of sorafenib by one dose level.

Suggested Dose Modification For The Second Occurrence:

-Interrupt treatment until toxicity resolves to Grade 1.

-When resuming treatment, decrease the dose of sorafenib by one dose level.

Suggested Dose Modification For The Third Occurrence:

-Discontinue sorafenib permanently.

What is the dose of Sorafenib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Sorafenib available?

Sorafenib is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sorafenib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 26, 2018 | Last Modified: September 12, 2019

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