What Are the Side Effects of JEVTANA?

Serious side effects

JEVTANA^® can cause serious side effects.
Serious side effects of JEVTANA include low white blood cell counts (neutropenia) that could lead to serious or life-threatening infections. Severe allergic reactions (hypersensitivity), GI symptoms (nausea, severe vomiting and diarrhea) that could lead to death, and kidney failure are other serious side effects of JEVTANA.

Other common side effects of JEVTANA.
JEVTANA can cause other side effects including:

• Low white blood cell count
• Low red blood cell count (anemia). Symptoms of anemia include shortness of breath and tiredness
• Low blood platelet count. Tell your doctor if you have any unusual bruising or bleeding
• Tiredness
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Weakness
• Blood in the urine
• Back pain
• Decreased appetite
• Fever
• Shortness of breath
• Stomach (abdominal) pain
• Change in your sense of taste
• Cough
• Joint pain
• Hair loss
• Numbness, tingling, burning or decreased sensation in your hands or feet

This Web page discusses some of the signs of JEVTANA's potential side effects. You may be able to address some of these conditions with the help of your doctor. But you should always talk to your doctors and nurses about whatever side effects you're experiencing.

Learn about addressing certain side effects

Low white blood cell count, or neutropenia

What is neutropenia?
Your blood is made up of different kinds of cells. Some of these cells, called white blood cells, protect your body from infection, or a disease caused by germs entering the body and growing there.

JEVTANA may cause a temporary drop in the number of white blood cells. When your body doesn't have enough of an important type of white blood cell called neutrophil, you are said to have neutropenia. This can lead to being more susceptible to infections, which can be fatal, especially if you are over the age of 65. Your doctor or nurse will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA. If you do not have enough neutrophils your doctor may change your dose, the frequency of infusions or stop JEVTANA until your doctor determines you have enough white blood cells. Although some people receiving JEVTANA may not have an infection even if they have a low white blood cell count, the risk of infection (including severe infections) is increased.

Signs of infection.
Fever, or having an above-average body temperature, is often an early sign of infection. To detect infection as early as possible, your doctor will recommend that you take your temperature frequently, especially after treatment
with JEVTANA.

Fever is often accompanied by chills or sweats. If you have a fever, tell your doctor or nurse immediately. If you have a fever, do not take any medications—even aspirin, acetaminophen, or ibuprofen products—without first talking with your doctor or nurse.

Besides fever, signs of infection can include redness, swelling, rash, chills, cough, earache, headache, a stiff neck, bloody urine, painful urination, or sinus pain. If you experience any of these symptoms, speak with your doctor
or nurse right away.

What is febrile neutropenia?
When you have a low white blood cell count and then develop a fever from an infection, you are said to have febrile neutropenia. This can be dangerous and life-threatening. You should contact your doctor immediately when fever arises while taking JEVTANA.

Find out about ways to address neutropenia

Other serious side effects of JEVTANA

Diarrhea is another serious side effect of JEVTANA.
Diarrhea is a condition in which you have more bowel movements than normal, and they are loose, soft, or watery. Diarrhea can make some people feel dizzy, cause cramps, raise the body’s temperature, and make the rectal area sore. It can also cause severe loss of body fluids or body salts (dehydration), which can lead to serious and possibly life-threatening consequences if not properly addressed. Be sure to report significant vomiting or diarrhea, decreased urinary output, fever, and hematuria (blood in urine) to your oncologist. Tell your doctor if your symptoms get worse or do not get better. You may need to go to the hospital for treatment.

Find out about ways to cope with diarrhea

Severe allergic reactions can happen with JEVTANA.
Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your doctor should prescribe medicines before each infusion to help prevent severe allergic reactions.

Symptoms of severe allergic reactions may include rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, and swelling of face. Tell your doctor right away if you have any of these symptoms. Your doctor will stop your JEVTANA treatment right away and treat your allergic reaction.

Kidney failure is another serious side effect of JEVTANA.
This may happen because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your doctor will check you for this problem and treat you if needed. Tell your doctor if you develop:

• Swelling of your face or body
• A decrease in the amount of urine that your body makes each day

If you have a history of kidney problems you should discuss them with your doctor before starting treatment with JEVTANA.

Common side effects

Everyone reacts to medication differently. Men taking JEVTANA may experience some of these side effects or many of them. Common side effects of JEVTANA include:

• Low red blood cell count, or anemia. JEVTANA can cause a drop in the number of red blood cells. These cells carry oxygen to different parts of the body. Your doctor will routinely check your red blood cell count and may recommend treatment if it is too low. A low red blood cell count can lead to shortness of breath
  and fatigue
• Low blood platelets, or thrombocytopenia. JEVTANA can cause a drop in the number of blood platelets. Low blood platelets can lead to excessive bleeding, because the blood cannot clot properly. Your doctor may recommend treatment
• Gastrointestinal problems. In addition to diarrhea, constipation can occur and nausea and vomiting are also common in patients receiving JEVTANA. Some patients also experience abdominal pain. Tell your doctor or nurse right away if you experience any of these side effects. There are medicines that doctors may administer to address some of these side effects, including vomiting
• Fatigue. A number of patients receiving JEVTANA feel very tired following their treatments. If you feel tired or weak, plan ahead to allow yourself extra rest before your next treatment. For example, if you work, you may want to schedule your treatment for Friday, to give you the weekend to take it easy before you go back on Monday. For the same reason, you may want to plan your treatments around any special events or holidays
• Bladder problems. Men taking JEVTANA may see blood in their urine. Talk to your doctor if this happens to you
• Muscle or joint pain. You may feel pain in your muscles or joints or pain in a specific region, such as back pain. This pain may be mild or severe, and may last a few minutes, or it may be constant. Tell your doctor or nurse if this happens. They may suggest ways to make you more comfortable
• Loss of appetite (anorexia).
• Nervous system problems/odd sensations. Some patients taking JEVTANA feel numbness, tingling, burning, or decreased sensation in their hands and feet (neuropathy). If you experience any of these, tell your doctor or nurse right away. Some patients may also develop weakness in their hands and feet. Generally, these problems go away within a few weeks or months after your treatments are completed
• Fever (pyrexia). Some patients on JEVTANA may experience abnormally high body temperature. Inform someone on your healthcare team if this happens to you
• Breathing problems. Some patients receiving JEVTANA may experience coughing and shortness of breath. Tell your doctor if you have trouble breathing
• Changes in taste (dysguesia). Some men on JEVTANA may experience altered taste sensation
• Hair loss. Many men taking JEVTANA lose the hair on their bodies. Hair loss begins after the first few treatments and varies from patient to patient. After the treatment cycle has been completed, hair generally grows back

There may be other side effects you experience while taking JEVTANA. For more information about side effects and other aspects of JEVTANA, please see the full Prescribing Information.

This information does not replace talking to your doctor. Tell your doctor if you have any side effect that bothers you or that does not go away.

Find out about ways to help address certain side effects