CABOMETYX Differentiated Thyroid Cancer black female patient portrayal

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BE Informed

Learn about Differentiated Thyroid Cancer (DTC)

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What is Differentiated Thyroid Cancer?

Differentiated thyroid cancer is a disease in which cancer cells develop in the thyroid. These cells often form a mass of tissue known as a tumor.

Some types of thyroid cancer – such as papillary, follicular and Hürthle thyroid cancers – are known as differentiated thyroid cancers.

This means the cancer cells can look and behave like normal thyroid cells. The tumors tend to grow very slowly. Differentiated thyroid cancer makes more than 90% of all thyroid cancers.


What are the stages of Differentiated Thyroid Cancer?

Like many cancers, thyroid cancer can progress or worsen. These phases of progression are called stages. Healthcare professionals assign stages to cancer to evaluate how severe the cancer is and how best to treat it. Thyroid cancer is staged from I to IV and these stages are defined as follows:

Stage I

In people under 55 years old: the tumor is in the thyroid. The cancer may or may not have spread to lymph nodes. The cancer has not spread to other parts of the body

In people 55 years or older: the tumor is in the thyroid only and is between 2 cm and 4 cm. It has not spread

Stage II

In people under 55 years old: the cancer has spread beyond the thyroid and neck to other areas of the body

In people aged 55 or older: the tumor in the thyroid is no larger than 4 cm. It has spread to nearby lymph nodes

Stage III

People 55 years old or younger are only considered Stages I or II

In people aged 55 or older: The tumor is any size and has grown beyond the thyroid into nearby tissues of the neck. The cancer may or may not have spread to lymph nodes. It has not spread to other parts of the body

Stage IV

In people aged 55 or older: The tumor is any size. The cancer has spread to other parts of the body, such as distant lymph nodes, internal organs, and bones


What are the treatment options?

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Surgery

Surgery is the most common treatment for people with differentiated thyroid cancer that has not spread. The type of surgery depends on the size and stage of the cancer. It may involve:

  • Removing the section where the thyroid cancer is found
  • Removing all or most of the thyroid, and possibly, the lymph nodes near the cancer

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Radiation Therapy

Radiation therapy uses high-energy x-rays to kill cancer cells or stop them from growing. It may be used after surgery to kill any remaining thyroid cancer cells.


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Radioactive Iodine Therapy

Radioactive iodine therapy (RAI) is sometimes used to treat differentiated thyroid cancer. It collects in thyroid cancer cells that have spread to other places in the body. It can destroy them without harming other tissue.


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Chemotherapy

Chemotherapy involves giving drugs by mouth or through a tube or needle, directly into the bloodstream. It kills cancer cells or stops them from dividing. It can reach cancer cells throughout the body.


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Thyroid Hormone Therapy

Thyroid hormone therapy removes hormones or blocks their actions to stop cancer cells from growing.


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Targeted Therapy

Targeted therapy is a category of treatment including drugs that target specific features of cancer cells that help them grow. They may also affect normal cells, causing side effects. Tyrosine kinase inhibitors (TKI) are one type of targeted therapy used to treat thyroid cancer.

  • TKIs block proteins known to send signals that tell cancer cells to grow. Without these signals, the tumor may stop growing or shrink.

CABOMETYX is a type of therapy called a tyrosine kinase inhibitor. You may hear your doctor refer to it as a TKI.

Learn More About

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How CABOMETYX may help you

CABOMETYX is proven to help certain people with differentiated thyroid cancer.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What are the possible side effects of CABOMETYX?

CABOMETYX may cause serious side effects, including:

Bleeding (hemorrhage). CABOMETYX can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including:

  • Coughing up blood or blood clots
  • Vomiting blood or if your vomit looks like coffee grounds
  • Red or black (looks like tar) stools
  • Menstrual bleeding that is heavier than normal
  • Any unusual or heavy bleeding

A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomach area (abdomen) that is severe or that does not go away.

Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you get:

  • Swelling or pain in your arms or legs
  • Shortness of breath
  • Feel lightheaded or faint
  • Sweating more than usual
  • Numbness or weakness of your face, arm, or leg, especially on one side of your body
  • Sudden confusion, trouble speaking or understanding
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking
  • Dizziness, loss of balance or coordination
  • A sudden severe headache

High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and regularly during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.

Diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.

A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.

Protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet. Your healthcare provider will check you for this problem during treatment with CABOMETYX.

Severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth before you start and during treatment with CABOMETYX. Tell your dentist that you are taking CABOMETYX. It is important for you to practice good mouth care during treatment with CABOMETYX. Tell your healthcare provider right away if you develop any symptoms of jaw problems, including: jaw pain, toothache, or sores on your gums.

Wound healing problems. Wound healing problems have happened in people who take CABOMETYX. Tell your healthcare provider if you plan to have any surgery before or during treatment with CABOMETYX.

  • You should stop taking CABOMETYX at least 3 weeks before planned surgery.
  • Your healthcare provider should tell you when you may start taking CABOMETYX again after surgery.

Reversible posterior leukoencephalopathy syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.

Change in thyroid function. CABOMETYX can cause changes in your thyroid function, including changes to thyroid hormone levels in your blood. Your healthcare provider will do blood tests to check your thyroid function before and during treatment with CABOMETYX.

Decreased calcium level in your blood (hypocalcemia). CABOMETYX can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:

  • Muscle stiffness or muscle spasms
  • Numbness or tingling in your fingers, toes, or around your mouth
  • Seizures
  • Sudden weight gain
  • Swelling of your arms, hands, legs, and ankles

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects.

The most common side effects of CABOMETYX include:

  • Tiredness
  • Decreased appetite
  • Nausea and vomiting
  • Weight loss
  • Constipation

CABOMETYX may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of CABOMETYX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you:

  • Have had a liver problem other than liver cancer.
  • Have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
  • Have an open or healing wound.
  • Have high blood pressure.
  • Have a low calcium level in your blood (hypocalcemia).
  • Plan to have any surgery, dental procedure, or have had a recent surgery. You should stop treatment with CABOMETYX at least 3 weeks before planned surgery.
  • Are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby.
    • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with CABOMETYX.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after your final dose of CABOMETYX.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • Are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other, causing side effects.

What should I avoid while taking CABOMETYX?

Avoid drinking grapefruit juice, eating grapefruit, or taking supplements that contain grapefruit or St. John’s wort during treatment with CABOMETYX.

Please see the Patient Information in the accompanying full Prescribing Information.

INDICATION

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat:

  • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
    • has progressed after treatment with a VEGFR-targeted treatment, and
    • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.

  • Adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC) that has spread (locally advanced or metastatic), and,
    • has progressed after treatment with a VEGFR-targeted treatment, and
    • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment.