how long is the course of nexavar

Precautions

Peak blood levels of Nexavar are reached 3 hours after dosing. The drug reaches steady state within 7 days of the first dose. The half-life of Nexavar is between 25 and 48 hours. High-fat meals decrease the overall bioavailability of the drug by 29%, which causes less exposure. This is why it’s recommended to take Nexavar in the fasted state.

How long does Nexavar stay in your system?

The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

How much Nexavar can you take in a day?

What is NEXAVAR? a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing It is not known if NEXAVAR is safe and effective in children.

What is Nexavar?

Temporary interruption of NEXAVAR is recommended in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of NEXAVAR following major surgical intervention.

When should Nexavar be stopped after surgery?

When should I stop taking Nexavar?

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, sudden/severe back pain or headache, weakness on one side of the body, sudden ...

How long do you take sorafenib?

Results: 188 advanced HCC patients received > 4 weeks of sorafenib. Median treatment duration was 5.4 months and median overall survival (mOS) 10 months (95% confidence interval 15–27).

How long can you live with sorafenib?

Median overall survival was 26.1 months with overall 6- and 12-month survival rates of 92.1 and 85%, respectively. Median time to radiological progression was 8 months. The progression-free rate was 64.3%. Fatigue, skin disorders and diarrhea were the most frequent grade 3-4 side effects.

Does Nexavar cure cancer?

NEXAVAR will not cure your cancer, but it has been shown to slow or temporarily stop the growth or spread of certain cancer cells. This is called stable disease.

What happens when you stop taking sorafenib?

Our results showed that the side effects of sorafenib, such as HFSR, diarrhea and hypertension, resolved after the discontinuation of sorafenib. Weight loss and alopecia also improved gradually.

How long does it take for Nexavar to work?

for at least half of the people taking Nexavar, their cancer didn't progress for at least 10.8 months after starting treatment. for at least half of the people taking a placebo, their cancer didn't progress for at least 5.8 months after starting treatment.

What is the success rate of sorafenib?

The median survival time (MST) for all patients was 11.0 months. The survival rate was significantly higher in the HAIC/sorafenib group than HAIC alone group (MST 22.2 vs 8.7 months, P = 0.017). From administration sorafenib, the disease control rate was 51.8% with MST of 10.4 months.

How effective is Nexavar?

The patients administered with Nexavar showed a 41% reduction in the risk of progression or death when compared to placebo-treated patients. The median PFS was 10.8 months in patients treated with Nexavar, compared to 5.8 months in patients receiving placebo.

Can sorafenib shrink tumors?

These findings are supported by previous works. Not only that, MRI scans showed rapid shrinkage of the tumor size during early sorafenib treatment (39.8% in week 5 and by 96.9% in week 15), which indicated that rapid tumor shrinking on the imaging may be another indicator of the therapeutic effects of sorafenib.

Can last stage liver cancer be cured?

Unfortunately when liver cancer is advanced, treatment won't be able to cure it. It aims to control the cancer, relieve symptoms and give you a good quality of life.

How much does Nexavar cost per month?

Nexavar, used in kidney, liver and thyroid cancers, carries a list price of about $18,670 per month.

Is Nexavar a chemotherapy?

What Is Nexavar? Nexavar (sorafenib) is a cancer (chemotherapeutic) medication used to treat a type of kidney cancer called advanced renal cell carcinoma. Nexavar is also used to treat liver cancer.

Before Taking This Medicine

You should not use Nexavar if you are allergic to sorafenib, or if you have squamous cell lung cancer and you are being treated with carboplatin (P...

How Should I Take Nexavar?

Nexavar is usually taken 2 times per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts...

What Happens If I Miss A Dose?

Take the missed dose as soon as you remember, but at least 2 hours since your last meal. Skip the missed dose if it is almost time for your next sc...

What Other Drugs Will Affect Nexavar?

Tell your doctor about all other cancer medicines you use, especially cisplatin, cyclophosphamide, docetaxel, doxorubicin, fluorouracil, gemcitabin...

How much Nexavar should I take daily?

The recommended dosage of Nexavar is 400 mg orally twice daily without food ( at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or until unacceptable toxicity.

What is Nexavar used for?

Differentiated Thyroid Carcinoma. Nexavar is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

What are the side effects of Nexavar?

The most common adverse reactions (≥20%), which were considered to be related to Nexavar, in patients with HCC, RCC or DTC are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.

Does Nexavar harm a fetus?

Based on its mechanism of action and findings in animals, Nexavar may cause fetal harm when administered to a pregnant woman .Sorafenib caused embryo-fetal toxicities in animals at maternal exposures that were significantly lower than the human exposures at the recommended dose of 400 mg twice daily. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Nexavar. Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment and for 3 months following the last dose of Nexavar [see Use in Specific Populations (8.1, 8.3 )].

Can Nexavar be used for lung cancer?

Nexavar in combination with gemcitabine/cisplatin is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of Nexavar has not been established in patients with non-small cell lung cancer.

Is sorafenib a dose adjustment?

No dose adjustment is necessary for patients with mild, moderate or severe renal impairment who are not on dialysis.The pharmacokinetics of sorafenib have not been studied in patients who are on dialysis [see Clinical Pharmacology ( 12.3 )].

Does Nexavar cause rash?

Hand-foot skin reaction and rash represent the most common adverse reactions attributed to Nexavar. Rash and hand-foot skin reaction are usually Grade 1 and 2 and generally appear during the first six weeks of treatment with Nexavar. Permanent discontinuation of therapy due to hand-foot skin reaction occurred in 4 (1.3%) of 297 Nexavar-treated patients with HCC, 3 (0.7%) of 451 Nexavar-treated patients with RCC, and 11 (5.3%) of 207 Nexavar-treated patients with DTC.

What is Nexavar used for?

Nexavar is used to treat liver cancer, thyroid cancer, or kidney cancer. It is not known if Nexavar is safe and effective in children.

What are the side effects of Nexavar?

To make sure Nexavar is safe for you, tell your doctor if you have: 1 heart problems, chest pain, or a heart attack; 2 long QT syndrome (in you or a family member); 3 high blood pressure; 4 an electrolyte imbalance (such as abnormal levels of calcium, magnesium, or potassium in your blood); 5 bleeding problems; or 6 surgery.

How long after Nexavar can you breastfeed?

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Can you take Nexavar if you are allergic to sorafenib?

You should not use Nexavar if you are allergic to sorafenib, or if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel. To make sure Nexavar is safe for you, tell your doctor if you have: heart problems, chest pain, or a heart attack;

Can Nexavar cause heart problems?

You should not use Nexavar if you have squamous cell lung cancer and you are being treated with carboplatin and paclitaxel. Nexavar can cause heart problems. Get emergency medical help if you have: chest pain, fast heartbeats, trouble breathing, or swelling around your midsection or in your lower legs.

Does Nexavar cause hives?

Nexavar side effects. Get emergency medical help if you have signs of an allergic reaction to Nexavar ( hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Precautions

Before starting Nexavar treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).

Self-Care Tips

Prevention of hand-foot syndrome. Modification of normal activities of daily living to reduce friction and heat exposure to hands and feet, for about a week after treatment. (for more information see - Managing side effects: hand foot syndrome)

Monitoring and Testing

You will be checked regularly by your health care professional while you are taking Nexavar, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Nexavar Works

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that divide rapidly.

How much Nexavar should I take a day?

For advanced renal cell carcinoma (RCC), a type of kidney cancer, the typical Nexavar dosage is 400 mg twice a day. You should take two tablets that are 200 mg each, twice per day.

How long does it take for a hand to react to Nexavar?

Hand-foot skin reactions usually happen within the first 6 weeks of treatment. In clinical trials: 21% to 69% of people taking Nexavar developed hand-foot skin reactions. This reaction was much more common in people taking Nexavar for differentiated thyroid cancer (DTC) than for other conditions.

How much Nexavar should I take for thyroid cancer?

To treat differentiated thyroid carcinoma (DTC), a type of thyroid cancer, the usual Nexavar dosage is 400 mg twice a day. You’ll take two tablets that are 200 mg each.

What is the active ingredient in Nexavar?

The active drug ingredient in Nexavar is sorafenib. The active drug in Lenvima is lenvatinib. Both sorafenib and lenvatinib are targeted therapies that belong to a class of medications known as kinase inhibitors. Targeted therapies work by interfering with certain proteins that help cancer cells to grow and spread.

What is Nexavar used for?

Nexavar is a brand-name prescription medication that’s used to treat certain types of liver, kidney, and thyroid cancer in adults. Nexavar is FDA-approved to treat: Hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer. Nexavar is used in people with HCC whose tumor can’t be surgically removed.

How many people have a rash from taking Nexavar?

19% to 40% of people taking Nexavar for any of the approved uses developed a rash. Up to 5% of people taking Nexavar developed a rash that was considered serious. 7% to 16% of people taking a placebo (a treatment with no active drug) had a rash. Less than 1% of those taking a placebo had a serious rash.

What is the FDA's approval for Nexavar?

The Food and Drug Administration (FDA) approves prescription drugs such as Nexavar to treat certain conditions. Nexavar may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

How long after nexavar is used?

Use effective birth control (contraception) during your treatment with NEXAVAR and for 6 months after the last dose of NEXAVAR. For males with female partners who are able to become pregnant: Use effective birth control (contraception) during your treatment with NEXAVAR and for 3 months after the last dose of NEXAVAR.

How to know if Nexavar is working?

Your healthcare provider will do blood tests to check your liver function regularly during your treatment with NEXAVAR. Tell your healthcare provider right away if you develop any of the following symptoms: yellowing of your skin or the whites of your eyes. dark “tea-colored” urine.

What does Nexavar test for?

Your healthcare provider may do tests during your treatment with NEXAVAR to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an electrocardiogram ( ECG). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly ...

How often should I check my blood pressure for Nexavar?

high blood pressure. High blood pressure is a common side effect of NEXAVAR and can be serious. Your blood pressure should be checked every week during the first 6 weeks of starting NEXAVAR. Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with NEXAVAR.

When should I stop Nexavar?

You should stop taking NEXAVAR at least 10 days before planned surgery. Your healthcare provider should tell you when you may start taking NEXAVAR again after surgery. changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening.

Can Nexavar harm a baby?

are pregnant or plan to become pregnant. NEXAVAR may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with NEXAVAR. For females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with NEXAVAR.

Is Nexavar safe for children?

a type of kidney cancer called renal cell carcinoma (RCC) a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing. It is not known if NEXAVAR is safe and effective in children. See More.

How long after eating can you take Nexavar?

Take NEXAVAR without food (at least 1 hour before or 2 hours after a meal). If you miss a dose of NEXAVAR, skip the missed dose, and take your next dose at your regular time.

What are the side effects of Nexavar?

Hand-foot skin reaction and rash represent the most common adverse reactions attributed to NEXAVAR. Rash and hand-foot skin reaction are usually CTCAE Grade 1 and 2 and generally appear during the first six weeks of treatment with NEXAVAR. Management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of NEXAVAR, or in severe or persistent cases, permanent discontinuation of NEXAVAR [see DOSAGE AND ADMINISTRATION ]. Permanent discontinuation of therapy due to hand-foot skin reaction occurred in 4 (1.3%) of 297 NEXAVAR-treated patients with HCC, 3 (0.7%) of 451 NEXAVAR-treated patients with RCC, and 11 (5.3%) of 207 NEXAVAR-treated patients with DTC.

What is Nexavar 200 mg?

NEXAVAR tablets are supplied as round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side, each containing sorafenib tosylate equivalent to 200 mg of sorafenib.

How long does it take for neomycin to decrease AUC?

Neomycin administered as an oral dose of 1 g three times daily for 5 days decreased the mean AUC of sorafenib by 54% in healthy volunteers administered a single oral dose of NEXAVAR 400 mg. The effects of other antibiotics on the pharmacokinetics of sorafenib have not been studied [see CLINICAL PHARMACOLOGY ].

How long does it take for sorafenib to reach peak plasma levels?

Following oral administration, sorafenib reached peak plasma levels in approximately 3 hours. With a moderate-fat meal (30% fat; 700 calories), bioavailability was similar to that in the fasted state. With a high-fat meal (50% fat; 900 calories), bioavailability was reduced by 29% compared to that in the fasted state.

Can Nexavar cause rash?

skin problems. A condition called hand-foot skin reactions and skin rash are common with Nexavar treatment and can be severe. Nexavar may also cause severe skin and mouth reactions that can be life-threatening. Tell your healthcare provider if you have any of the following symptoms: skin rash. skin redness.

Can Nexavar cause irregular heartbeats?

QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider may do tests during your treatment with Nexavar to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an electrocardiogram ( ECG ).

How much Nexavar should I take daily?

Recommended Dosage. The recommended dosage of NEXAVAR is 400 mg orally twice daily without food ( at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or until unacceptable toxicity.

How far apart should I take 400 mg?

400 mg orally in the morning and 200 mg orally in the evening about 12 hours apart. OR. 200 mg orally in the morning and 400 mg orally in the evening about 12 hours apart. Second Dose Reduction. 200 mg orally once daily.

How long after nexavar is used?

Use effective birth control (contraception) during your treatment with NEXAVAR and for 6 months after the last dose of NEXAVAR. For males with female partners who are able to become pregnant: Use effective birth control (contraception) during your treatment with NEXAVAR and for 3 months after the last dose of NEXAVAR.

How many times a day should I take Nexavar?

Take NEXAVAR exactly as your healthcare provider tells you to take it. The recommended daily dose of NEXAVAR is 2 tablets taken 2 times a day (for a total of 4 tablets each day). Your healthcare professional may change your dose during treatment or stop treatment for some time if you have side effects.

How often should I check my blood pressure for Nexavar?

high blood pressure. High blood pressure is a common side effect of NEXAVAR and can be serious. Your blood pressure should be checked every week during the first 6 weeks of starting NEXAVAR. Your blood pressure should be checked regularly and any high blood pressure should be treated during treatment with NEXAVAR.

How long before surgery should I stop Nexavar?

have bleeding problems. have high blood pressure. plan to have surgery or have had a recent surgery. You should stop taking NEXAVAR at least 2 weeks before planned surgery. are pregnant or plan to become pregnant.

What to do if you miss Nexavar?

If you miss a dose of NEXAVAR, skip the missed dose, and take your next dose at your regular time. Do not double your dose of NEXAVAR. If you take too much NEXAVAR, call your doctor or go to the nearest hospital emergency room right away.

When should I stop Nexavar?

You should stop taking NEXAVAR at least 10 days before planned surgery. Your healthcare provider should tell you when you may start taking NEXAVAR again after surgery. changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening.

Can Nexavar be used for thyroid cancer?

NEXAVAR has been studied in patients with liver cancer that cannot be treated with surgery, in patients with advanced kidney cancer, and in patients with differentiated thyroid carcinoma (DTC, a type of thyroid cancer) that can no longer be treated with radioactive iodine. Only you and your healthcare provider can decide if treatment is right ...

Indications and Usage For Nexavar

Dosage and Administration

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

• Recommended Dosage
  The recommended dosage of Nexavar is 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or until unacceptable toxicity.
• Dosage Modifications for Adverse Reactions
  The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3. 1 1. Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0). 2 1. If no recovery after 30 day interrup…

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Drug Interactions

Use in Specific Populations

Overdosage

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