Nexavar

There is no specific treatment for NEXAVAR overdose.

The highest dose of NEXAVAR studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals.

In cases of suspected overdose, NEXAVAR should be withheld and supportive care instituted.

Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Sorafenib is used to treat a type of kidney cancer called advanced renal cell carcinoma. It is also used to treat liver cancer.

Sorafenib may also be used for purposes not listed in this medication guide.

Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects.

Do not breast-feed while using this medication.

You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

Before you take sorafenib, tell your doctor if you have kidney or liver problems (other than cancer), a bleeding or blood clotting disorder, high blood pressure, heart disease, slow heartbeats, congestive heart failure, a personal or family history of Long QT syndrome, a history of stroke or heart attack, or any allergies.

There are many other drugs that can interact with sorafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking sorafenib.

You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

To make sure you can safely take sorafenib, tell your doctor if you have any of these other conditions:

• kidney or liver problems other than cancer;
• lung cancer, especially if you are receiving gemcitabine (Gemzar) and cisplatin (Platinol);
• a bleeding or blood clotting disorder such as hemophilia;
• high blood pressure (hypertension), heart disease, slow heartbeats, congestive heart failure, chest pain;
• a personal or family history of Long QT syndrome;
• a history of stroke or heart attack; or
• any allergies.

FDA pregnancy category D. Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects.

It is not known whether sorafenib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medication.

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 scheduled dose. Do not take extra medicine to make up the missed dose.

If you take too much Nexavar call your local Poison Control Center or seek emergency medical attention right away.

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 scheduled dose. Do not take extra medicine to make up the missed dose.

Antineoplastic agent; inhibitor of several serine/threonine and receptor tyrosine kinases.1 2 4 5 6 7 8 9 10 11 12 13 15 16 17

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sorafenib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sorafenib in the elderly. However, elderly patients are more likely to be sensitive and may require a lower dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levomethadyl
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Enzalutamide
• Erythromycin
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Foscarnet
• Fosphenytoin
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Ivabradine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lopinavir
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Moxifloxacin
• Nafarelin
• Neomycin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Phenytoin
• Pimavanserin
• Pitolisant
• Prednisolone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Salmeterol
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vinflunine
• Voriconazole
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Docetaxel
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Heart disease (eg, angina, chest pain) or
• Hepatitis or
• Hypertension (high blood pressure) or
• Stomach or bowel perforation (hole in the gut)—Use with caution. May make these conditions worse.

• Congestive heart failure or
• Electrolyte imbalance (eg, high or low calcium, magnesium, or potassium levels in the blood) or
• Heart rhythm problems (eg, QT prolongation, slow heartbeat)—Use with caution. May increase risk for more serious side effects.

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Swallow the tablet whole with water. Do not crush, break, or chew it.

Take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For kidney cancer:
    • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For liver cancer:
    • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For thyroid cancer:
    • Adults—400 milligrams (mg) two times per day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Very bad and sometimes deadly liver problems have happened with NexAVAR. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad and sometimes deadly bleeding problems have happened with this medicine. Talk with the doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Holes in the GI (gastrointestinal) tract may rarely happen.
• This medicine may cause high blood pressure.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have an ECG checked often. Talk with your doctor.
• This medicine may affect how wounds heal. If you need to have surgery, you may need to stop NexAVAR before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Use birth control that you can trust to prevent pregnancy while taking this medicine and for at least 2 weeks after stopping the drug.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 2 weeks after stopping NexAVAR. Use birth control that you can trust.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Hepatocellular Carcinoma

Nexavar® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

Renal Cell Carcinoma

Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

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.

Effect of Strong CYP3A4 Inducers on Sorafenib

Rifampin, a strong CYP3A4 inducer, administered at a dose of 600 mg once daily for 5 days with a single oral dose of Nexavar 400 mg in healthy volunteers resulted in a 37% decrease in the mean AUC of sorafenib [see Clinical Pharmacology (12.3)]. Avoid concomitant use of strong CYP3A4 inducers (such as, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John’s wort), when possible, because these drugs can decrease the systemic exposure to sorafenib.

Effect of Strong CYP3A4 Inhibitors on Sorafenib

Ketoconazole, a strong inhibitor of CYP3A4 and P-glycoprotein, administered at a dose of 400 mg once daily for 7 days did not alter the mean AUC of a single oral dose of Nexavar 50 mg in healthy volunteers.

Effect of Sorafenib on Other Drugs

Nexavar 400 mg twice daily for 28 days did not increase the systemic exposure of concomitantly administered midazolam (CYP3A4 substrate), dextromethorphan (CYP2D6 substrate), and omeprazole (CYP2C19 substrate) [see Clinical Pharmacology (12.3)].

Neomycin

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 (12.3)].

Drugs that Increase Gastric pH

The aqueous solubility of sorafenib is pH dependent, with higher pH resulting in lower solubility. However, omeprazole, a proton pump inhibitor, administered at a dose of 40 mg once daily for 5 days, did not result in a clinically meaningful change in sorafenib single dose exposure. No dose adjustment for Nexavar is necessary.

There is no specific treatment for Nexavar overdose.

The highest dose of Nexavar studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals.

In cases of suspected overdose, Nexavar should be withheld and supportive care instituted.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with sorafenib.

Sorafenib was clastogenic when tested in an in vitro mammalian cell assay (Chinese hamster ovary) in the presence of metabolic activation. Sorafenib was not mutagenic in the in vitro Ames bacterial cell assay or clastogenic in an in vivo mouse micronucleus assay. One intermediate in the manufacturing process, which is also present in the final drug substance (<0.15%), was positive for mutagenesis in an in vitro bacterial cell assay (Ames test) when tested independently.

No specific studies with sorafenib have been conducted in animals to evaluate the effect on fertility. However, results from the repeat-dose toxicity studies suggest there is a potential for sorafenib to impair reproductive function and fertility. Multiple adverse effects were observed in male and female reproductive organs, with the rat being more susceptible than mice or dogs. Typical changes in rats consisted of testicular atrophy or degeneration, degeneration of epididymis, prostate, and seminal vesicles, central necrosis of the corpora lutea and arrested follicular development. Sorafenib-related effects on the reproductive organs of rats were manifested at daily oral doses ≥ 5 mg/kg (30 mg/m2). This dose results in an exposure (AUC) that is approximately 0.5 times the AUC in patients at the recommended human dose. Dogs showed tubular degeneration in the testes at 30 mg/kg/day (600 mg/m2/day). This dose results in an exposure that is approximately 0.3 times the AUC at the recommended human dose. Oligospermia was observed in dogs at 60 mg/kg/day (1200 mg/m2/day) of sorafenib.

Adequate contraception should be used during therapy and for at least 2 weeks after completing therapy.

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.

  Bottles of 120 tablets NDC 50419-488-58

Storage

Store at 25° C (77°F); excursions permitted to 15–30° C (59–86° F) (see USP controlled room temperature). Store in a dry place.

Nexavar® (NEX-A-VAR)

(sorafenib)

tablets, oral

Read this Patient Information before you start taking Nexavar and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Nexavar?

Nexavar is an anticancer medicine used to treat a certain type of liver, kidney or thyroid cancer called:

• Hepatocellular carcinoma (HCC, a type of liver cancer), when it cannot be treated with surgery • Renal cell carcinoma (RCC, a type of kidney cancer) • Differentiated thyroid carcinoma (DTC, a type of thyroid cancer) that can no longer be treated with radioactive iodine and is progressing

Nexavar has not been studied in children.

Who should not take Nexavar?

Do not take Nexavar if you:

• are allergic to sorafenib or any of the other ingredients in Nexavar. See the end of this leaflet for a complete list of ingredients in Nexavar. • have a specific type of lung cancer (squamous cell) and receive carboplatin and paclitaxel.   What should I tell my doctor before taking Nexavar?

Before you take Nexavar, tell your doctor if you:

• have any allergies • have heart problems, including a problem called “congenital long QT syndrome” • have chest pain • have bleeding problems • have high blood pressure • plan to have any surgical procedures • have lung cancer or are being treated for lung cancer • have kidney problems in addition to kidney cancer • have liver problems in addition to liver cancer • are pregnant or plan to become pregnant. See “What are the possible side effects of Nexavar?” • are breast-feeding or plan to breast-feed. It is not known if Nexavar passes into your breast milk. You and your doctor should decide if you will take Nexavar or breast-feed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Nexavar and certain other medicines can interact with each other and cause serious side effects.

Especially tell your doctor if you are taking the following medicines:

• warfarin (Coumadin, Jantoven®) • neomycin • St. Johns Wort • dexamethasone • phenytoin (Fosphenytoin sodium, Dilantin, Phenytek) • carbamazepine (Carbatrol, Equetro, Tegretol, Teril, Epitol) • rifampin (Rifater, Rifamate, Rifadin, Rimactane) • rifabutin (Mycobutin) • phenobarbital

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. Do not take other medicines with Nexavar until you have talked with your doctor.

How should I take Nexavar?

• Take Nexavar exactly as prescribed by your doctor. • The usual dose of Nexavar is 2 tablets taken 2 times a day (for a total of 4 tablets each day). Your doctor may change your dose during treatment, stop treatment for some time or completely stop treatment with Nexavar if you have side effects. • 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. 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.

What are the possible side effects of Nexavar?

Nexavar may cause serious side effects, including:

• decreased blood flow to the heart and heart attack. Get emergency help right away and call your doctor if you get symptoms such as chest pain, shortness of breath, feel lightheaded or faint, nausea, vomiting, or sweat a lot. • bleeding problems. Bleeding is a common side effect of Nexavar that can be serious and sometimes lead to death. Tell your doctor if you have any bleeding while taking 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 while you are taking Nexavar. • a skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for some time. • serious skin and mouth reactions. Nexavar can cause serious skin reactions which can be life-threatening. Tell your doctor if you have any of the following symptoms: • skin rash • blistering and peeling of the skin • blistering and peeling on the inside of your mouth • an opening in the wall of your stomach or intestines (perforation of the bowel). Tell your doctor right away if you get high fever, nausea, vomiting or severe stomach (abdominal) pain. • possible wound healing problems. If you need to have a surgical procedure, tell your doctor that you are taking Nexavar. Nexavar may need to be stopped until your wound heals after some types of surgery. • changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your doctor 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 ECG. Tell your doctor right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast while taking Nexavar. • inflammation of your liver (drug-induced hepatitis). Nexavar may cause liver problems that may lead to liver failure and death. Your doctor may stop your treatment with Nexavar if you develop changes in certain liver function tests. Call your doctor right away if you develop any of the following symptoms:   • your skin or the white part of your eyes turns yellow (jaundice)   • dark “tea-colored” urine   • light-colored bowel movements (stools)   • worsening nausea • worsening vomiting   • abdominal pain • birth defects or death of an unborn baby. Women should not get pregnant during treatment with Nexavar and for at least 2 weeks after stopping treatment. Men and women should use effective birth control during treatment with Nexavar and for at least 2 weeks after stopping treatment. Talk with your doctor about effective birth control methods. Call your doctor right away if you become pregnant during treatment with Nexavar. • change in thyroid hormone levels. If you have differentiated thyroid cancer, you can have changes in your thyroid hormone levels when taking Nexavar. Your doctor may need to increase your dose of thyroid medicine while you are taking Nexavar. Your doctor should check your thyroid hormone levels every month during treatment with Nexavar.

The most common side effects of Nexavar include:

• diarrhea (frequent or loose bowel movements) • tiredness • infection • hair thinning or patchy hair loss • rash • weight loss • loss of appetite • nausea • stomach (abdominal) pain • low blood calcium levels in people with differentiated thyroid cancer

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Nexavar. Ask your doctor or pharmacist for more information.

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

How should I store Nexavar?

• Store Nexavar tablets at room temperature between 68° F to 77° F (20° C to 25° C). • Store Nexavar tablets in a dry place.   Keep Nexavar and all medicines out of the reach of children.

General information about Nexavar

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Nexavar for a condition for which it is not prescribed. Do not give Nexavar to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Nexavar. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Nexavar that is written for health professionals.

For more information, go to www.Nexavar.com, or call 1-866-639-2827.

What are the ingredients in Nexavar?

Active Ingredient: sorafenib tosylate

Inactive Ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate, polyethylene glycol, titanium dioxide and ferric oxide red.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.,
Whippany, NJ 07981

Manufactured in Germany

  © 2015 Bayer HealthCare Pharmaceuticals Inc. Printed in U.S.A.

Revised 7/2015

Nexavar 200 mg Bottle Label

Rx Only

NDC 50419-488-58

Nexavar®
(sorafenib) tablets

Each tablet contains
200 mg
sorafenib

120 Tablets

Nexavar  sorafenib tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50419-488 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SORAFENIB (SORAFENIB) SORAFENIB 200 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   CELLULOSE, MICROCRYSTALLINE   HYPROMELLOSES   SODIUM LAURYL SULFATE   MAGNESIUM STEARATE   POLYETHYLENE GLYCOLS   TITANIUM DIOXIDE   FERRIC OXIDE RED

Product Characteristics Color RED Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code 200 Contains

Packaging # Item Code Package Description 1 NDC:50419-488-58 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021923 12/20/2005

Labeler - Bayer HealthCare Pharmaceuticals Inc. (005436809)

Establishment
Name	Address	ID/FEI	Operations
Bayer Pharma AG		341081414	MANUFACTURE(50419-488)

Revised: 07/2015   Bayer HealthCare Pharmaceuticals Inc.

Sorafenib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.