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Nexavar

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Nexavar

Nexavar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nexavar (sorafenib) is used to treat a type of kidney cancer called advanced renal cell carcinoma. It is also used to treat liver cancer. It is a cancer (chemotherapeutic) medication. Common side effects include acne, dry skin, nausea, diarrhea, patchy hair loss/thinning, loss of appetite, dry mouth, hoarseness, or tiredness.

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). Nexavar may interact with warfarin, dexamethasone, rifampin, St. John's wort, seizure medication, or other cancer medications. Tell your doctor all medications and supplements you use. Nexavar is not recommended for use during pregnancy. It may harm a fetus. Men and women must use birth control during treatment and for at least 2 weeks after stopping this drug. Consult your doctor. 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.

Our Nexavar (sorafenib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nexavar in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sorafenib and call your doctor at once if you have a serious side effect such as:

  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;
  • mouth sores;
  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • dry cough, wheezing;
  • swelling, rapid weight gain, feeling short of breath (even with mild exertion);
  • sudden numbness or weakness, especially on one side of the body;
  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • sudden weight loss, increased appetite, trouble sleeping, increased bowel movements, feeling hot, feeling nervous or anxious, swelling in your neck (goiter);
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, confusion, uneven heartbeats, seizure); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • tired feeling;
  • vomiting, diarrhea, mild stomach pain;
  • mild itching or rash; or
  • thinning hair.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nexavar (Sorafenib) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nexavar Overview - Patient Information: Side Effects

SIDE EFFECTS: Acne, dry skin, nausea, diarrhea, patchy hair loss/thinning, loss of appetite, dry mouth, hoarseness, or tiredness may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you notice skin problems (such as rash, blisters, redness, swelling, pain), especially on the palms of your hands or the soles of your feet. Your doctor may prescribe medication for your skin or change your treatment plan.

Tell your doctor right away if you have any serious side effects, including: bone/muscle pain, depression, easy bruising or bleeding, headache, tongue/mouth sores or pain, numbness/tingling of the hands/feet, shortness of breath, swollen hands/ankles/feet, signs of liver problems (such as stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, severe abdominal/stomach pain, bloody vomit, coughing up blood, bloody stools, difficulty speaking, loss of balance, sudden vision changes, seizures, mental/mood changes (e.g., confusion), severe dizziness, fainting, fast/irregular heartbeat.

This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nexavar (Sorafenib)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nexavar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described in sections 6.1 and 6.2 reflect exposure to NEXAVAR in 748 patients who participated in placebo controlled studies in hepatocellular carcinoma (N=297) or advanced renal cell carcinoma (N=451).

The most common adverse reactions ( ≥ 20%), which were considered to be related to NEXAVAR, in patients with HCC or RCC are fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia, nausea and abdominal pain.

Adverse Reactions in HCC Study

Table 2 shows the percentage of patients with HCC experiencing adverse reactions that were reported in at least 10% of patients and at a higher rate in the NEXAVAR arm than the placebo arm. CTCAE Grade 3 adverse reactions were reported in 39% of patients receiving NEXAVAR compared to 24% of patients receiving placebo. CTCAE Grade 4 adverse reactions were reported in 6% of patients receiving NEXAVAR compared to 8% of patients receiving placebo.

Table 2: Adverse Reactions Reported in at Least 10% of Patients and at a Higher Rate in NEXAVAR Arm than the Placebo Arm - HCC Study

Adverse Reaction NCI- CTCAE v3 Category/Term NEXAVAR N=297 Placebo N=302
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
Any Adverse Reaction 98 39 6 96 24 8
Constitutional symptoms
Fatigue 46 9 1 45 12 2
Weight loss 30 2 0 10 1 0
Dermatology/skin
Rash/desquamation 19 1 0 14 0 0
Pruritus 14 < 1 0 11 < 1 0
Hand-foot skin reaction 21 8 0 3 < 1 0
Dry skin 10 0 0 6 0 0
Alopecia 14 0 0 2 0 0
Gastrointestinal
Diarrhea 55 10 < 1 25 2 0
Anorexia 29 3 0 18 3 < 1
Nausea 24 1 0 20 3 0
Vomiting 15 2 0 11 2 0
Constipation 14 0 0 10 0 0
Hepatobiliary/pancreas
Liver dysfunction 11 2 1 8 2 1
Pain
Pain, abdomen 31 9 0 26 5 1

Hypertension was reported in 9% of patients treated with NEXAVAR and 4% of those treated with placebo. CTCAE Grade 3 hypertension was reported in 4% of NEXAVAR-treated patients and 1% of placebo-treated patients. No patients were reported with CTCAE Grade 4 reactions in either treatment group.

Hemorrhage/bleeding was reported in 18% of those receiving NEXAVAR and 20% of placebo-treated patients. The rates of CTCAE Grade 3 and 4 bleeding were also higher in the placebo-treated group (CTCAE Grade 3 - 3% NEXAVAR and 5% placebo and CTCAE Grade 4 - 2% NEXAVAR and 4% placebo). Bleeding from esophageal varices was reported in 2.4% in NEXAVAR-treated patients and 4% of placebo-treated patients.

Renal failure was reported in < 1% of patients treated with NEXAVAR and 3% of placebo-treated patients.

The rate of adverse reactions (including those associated with progressive disease) resulting in permanent discontinuation was similar in both the NEXAVAR and placebo-treated groups (32% of NEXAVAR-treated patients and 35% of placebo-treated patients).

Laboratory Abnormalities

The following laboratory abnormalities were observed in patients with HCC:

Hypophosphatemia was a common laboratory finding, observed in 35% of NEXAVAR-treated patients compared to 11% of placebo-treated patients; CTCAE Grade 3 hypophosphatemia (1-2 mg/dL) occurred in 11% of NEXAVAR-treated patients and 2% of patients in the placebo-treated group; there was 1 case of CTCAE Grade 4 hypophosphatemia ( < 1 mg/dL) reported in the placebo-treated group. The etiology of hypophosphatemia associated with NEXAVAR is not known.

Elevated lipase was observed in 40% of patients treated with NEXAVAR compared to 37% of patients in the placebo-treated group. CTCAE Grade 3 or 4 lipase elevations occurred in 9% of patients in each group. Elevated amylase was observed in 34% of patients treated with NEXAVAR compared to 29% of patients in the placebo-treated group. CTCAE Grade 3 or 4 amylase elevations were reported in 2% of patients in each group. Many of the lipase and amylase elevations were transient, and in the majority of cases NEXAVAR treatment was not interrupted. Clinical pancreatitis was reported in 1 of 297 NEXAVAR-treated patients (CTCAE Grade 2).

Elevations in liver function tests were comparable between the 2 arms of the study. Hypoalbuminemia was observed in 59% of NEXAVAR-treated patients and 47% of placebo-treated patients; no CTCAE Grade 3 or 4 hypoalbuminemia was observed in either group.

INR elevations were observed in 42% of NEXAVAR-treated patients and 34% of placebo-treated patients; CTCAE Grade 3 INR elevations were reported in 4% of NEXAVAR-treated patients and 2% of placebo-treated patients; there was no CTCAE Grade 4 INR elevation in either group.

Lymphopenia was observed in 47% of NEXAVAR-treated patients and 42% of placebo-treated patients.

Thrombocytopenia was observed in 46% of NEXAVAR-treated patients and 41% of placebo-treated patients; CTCAE Grade 3 or 4 thrombocytopenia was reported in 4% of NEXAVAR-treated patients and less than 1% of placebo-treated patients.

Hypocalcemia was reported in 27% of NEXAVAR-treated patients and 15% of placebo-treated patients. CTCAE Grade 3 hypocalcemia (6-7 mg /dL) occurred in 2% of NEXAVAR-treated patients and 1% of placebo-treated patients. CTCAE Grade 4 hypocalcemia ( < 6 mg/dL) occurred in 0.4% of NEXAVAR-treated patients and in no placebo-treated patients.

Hypokalemia was reported in 9.4% of NEXAVAR- treated patients compared to 5.9% of placebo-treated patients. Most reports of hypokalemia were low grade (CTCAE Grade 1). CTCAE Grade 3 hypokalemia occurred in 0.3% of NEXAVAR-treated patients and 0.7% of placebo-treated patients. There were no reports of Grade 4 hypokalemia.

Adverse Reactions in RCC Study 1

Table 3 shows the percentage of patients with RCC experiencing adverse reactions that were reported in at least 10% of patients and at a higher rate in the NEXAVAR arm than the placebo arm. CTCAE Grade 3 adverse reactions were reported in 31% of patients receiving NEXAVAR compared to 22% of patients receiving placebo. CTCAE Grade 4 adverse reactions were reported in 7% of patients receiving NEXAVAR compared to 6% of patients receiving placebo.

Table 3: Adverse Reactions Reported in at Least 10% of Patients and at a Higher Rate in NEXAVAR Arm than the Placebo Arm - RCC Study 1

Adverse Reactions NCI- CTCAE v3 Category/Term NEXAVAR
N=451
Placebo
N=451
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
Any Adverse Reactions 95 31 7 86 22 6
Cardiovascular, General
  Hypertension 17 3 < 1 2 < 1 0
Constitutional symptoms
  Fatigue 37 5 <1 28 3 <1
  Weight loss 10 <1 0 6 0 0
Dermatology/skin
  Rash/desquamation 40 <1 0 16 <1 0
  Hand-foot skin reaction        30 6 0 7 0 0
  Alopecia 27 <1 0 3 0 0
  Pruritus 19 <1 0 6 0 0
  Dry skin 11 0 0 4 0 0
Gastrointestinal symptoms
  Diarrhea 43 2 0 13 <1 0
  Nausea 23 <1 0 19 <1 0
  Anorexia 16 <1 0 13 1 0
  Vomiting 16 <1 0 12 1 0
  Constipation 15 <1 0 11 <1 0
Hemorrhage/bleeding
  Hemorrhage - all sites 15 2 0 8 1 <1
Neurology
  Neuropathy-sensory 13 <1 0 6 <1 0
Pain
  Pain, abdomen 11 2 0 9 2 0
  Pain, joint 10 2 0 6 <1 0
  Pain, headache 10 <1 0 6 <1 0
Pulmonary
  Dyspnea 14 3 <1 12 2 <1

The rate of adverse reactions (including those associated with progressive disease) resulting in permanent discontinuation was similar in both the NEXAVAR and placebo-treated groups (10% of NEXAVAR-treated patients and 8% of placebo-treated patients).

Laboratory Abnormalities

The following laboratory abnormalities were observed in patients with RCC in Study 1:

Hypophosphatemia was a common laboratory finding, observed in 45% of NEXAVAR-treated patients compared to 11% of placebo-treated patients. CTCAE Grade 3 hypophosphatemia (1-2 mg/dL) occurred in 13% of NEXAVAR-treated patients and 3% of patients in the placebo-treated group. There were no cases of CTCAE Grade 4 hypophosphatemia ( < 1 mg/dL) reported in either NEXAVAR or placebo-treated patients. The etiology of hypophosphatemia associated with NEXAVAR is not known.

Elevated lipase was observed in 41% of patients treated with NEXAVAR compared to 30% of patients in the placebo-treated group. CTCAE Grade 3 or 4 lipase elevations occurred in 12% of patients in the NEXAVAR-treated group compared to 7% of patients in the placebo-treated group. Elevated amylase was observed in 30% of patients treated with NEXAVAR compared to 23% of patients in the placebo-treated group. CTCAE Grade 3 or 4 amylase elevations were reported in 1% of patients in the NEXAVAR-treated group compared to 3% of patients in the placebo-treated group. Many of the lipase and amylase elevations were transient, and in the majority of cases NEXAVAR treatment was not interrupted. Clinical pancreatitis was reported in 3 of 451 NEXAVAR-treated patients (one CTCAE Grade 2 and two Grade 4) and 1 of 451 patients (CTCAE Grade 2) in the placebo-treated group.

Lymphopenia was observed in 23% of NEXAVAR-treated patients and 13% of placebo-treated patients. CTCAE Grade 3 or 4 lymphopenia was reported in 13% of NEXAVAR-treated patients and 7% of placebo-treated patients. Neutropenia was observed in 18% of NEXAVAR-treated patients and 10% of placebo-treated patients. CTCAE Grade 3 or 4 neutropenia was reported in 5% of NEXAVAR-treated patients and 2% of placebo-treated patients.

Anemia was observed in 44% of NEXAVAR-treated patients and 49% of placebo-treated patients. CTCAE Grade 3 or 4 anemia was reported in 2% of NEXAVAR-treated patients and 4% of placebo-treated patients.

Thrombocytopenia was observed in 12% of NEXAVAR-treated patients and 5% of placebo-treated patients. CTCAE Grade 3 or 4 thrombocytopenia was reported in 1% of NEXAVAR-treated patients and in no placebo-treated patients.

Hypocalcemia was reported in 12% of NEXAVAR-treated patients and 8% of placebo-treated patients. CTCAE Grade 3 hypocalcemia (6-7 mg/dL) occurred in 1% of NEXAVAR-treated patients and 0.2% of placebo-treated patients, and CTCAE Grade 4 hypocalcemia ( < 6 mg/dL) occurred in 1% of NEXAVAR-treated patients and 0.5% of placebo-treated patients.

Hypokalemia was reported in 5.4% of NEXAVAR-treated patients compared to 0.7% of placebo-treated patients. Most reports of hypokalemia were low grade (CTCAE Grade 1). CTCAE Grade 3 hypokalemia occurred in 1.3% of NEXAVAR-treated patients and 0.2% of placebo-treated patients. There were no reports of Grade 4 hypokalemia.

Additional Data from Multiple Clinical Trials

The following additional drug-related adverse reactions and laboratory abnormalities were reported from clinical trials of NEXAVAR (very common 10% or greater, common 1 to less than 10%, uncommon 0.1% to less than 1%):

Cardiovascular: Common: congestive heart failure*†, myocardial ischemia and/or infarction Uncommon: hypertensive crisis* Rare: QT prolongation*

Dermatologic: Very common: erythema Common: exfoliative dermatitis, acne, flushing Uncommon: folliculitis, eczema, erythema multiforme, keratoacanthomas/squamous cell cancer of the skin

Digestive: Very common: increased lipase, increased amylase Common: mucositis, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia Uncommon: pancreatitis, gastrointestinal reflux, gastritis, gastrointestinal perforations*, cholecystitis, cholangitis

Note that elevations in lipase are very common (41%, see below); a diagnosis of pancreatitis should not be made solely on the basis of abnormal laboratory values

General Disorders: Very common: hemorrhage (including gastrointestinal* & respiratory tract* and uncommon cases of cerebral hemorrhage*), asthenia, pain (including mouth, bone, and tumor pain) Common: decreased appetite, influenza-like illness, pyrexia Uncommon: infection

Hematologic: Very common: leukopenia, lymphopenia Common: anemia, neutropenia, thrombocytopenia Uncommon: INR abnormal

Hypersensitivity: Uncommon: hypersensitivity reactions (including skin reactions and urticaria)

Metabolic and Nutritional: Very common: hypophosphatemia Common: transient increases in transaminases, hypocalcemia, hypokalemia Uncommon: dehydration, hyponatremia, transient increases in alkaline phosphatase, increased bilirubin (including jaundice), hypothyroidism, hyperthyroidism

Musculoskeletal: Common: arthralgia, myalgia

Nervous System and Psychiatric: Common: depression Uncommon: tinnitus, reversible posterior leukoencephalopathy*

Renal and Genitourinary: Common: renal failure, proteinuria Rare: Nephrotic syndrome

Reproductive: Common: erectile dysfunction Uncommon: gynecomastia

Respiratory: Common: hoarseness Uncommon: rhinorrhea, interstitial lung disease-like events (includes reports of pneumonitis, radiation pneumonitis, acute respiratory distress, interstitial pneumonia, pulmonitis and lung inflammation)

In addition, the following medically significant adverse reactions were uncommon during clinical trials of NEXAVAR: transient ischemic attack, arrhythmia, thromboembolism. For these adverse reactions, the causal relationship to NEXAVAR has not been established.

*adverse reactions may have a life-threatening or fatal outcome.
†reported in 1.9% of patients treated with sorafenib (N= 2276).

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of NEXAVAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN)

Hepatobiliary disorders: Drug-induced hepatitis, including reports of hepatic failure and death

Hypersensitivity: Angioedema, anaphylactic reaction

Musculoskeletal: Rhabdomyolysis, osteonecrosis of the jaw

Respiratory: Interstitial lung disease-like events (which may have a life-threatening or fatal outcome)

Read the entire FDA prescribing information for Nexavar (Sorafenib) »

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Nexavar - User Reviews

Nexavar User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nexavar sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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