• About IXEMPRA
• How IXEMPRA May Help
  • IXEMPRA Used Alone
  • IXEMPRA Used
    With Xeloda
• How IXEMPRA Is
  Thought to Work
• How IXEMPRA Is Given
• Possible Side Effects
  of IXEMPRA
  • Serious Side Effects
    of IXEMPRA
  • Common Side Effects
    of IXEMPRA
• Tips for Coping
  With Certain Side Effects
• IXEMPRA Reimbursement

Tiredness/fatigue

Feeling tired is a common side effect with IXEMPRA. Even with plenty of rest, you can still feel tired.

In one clinical trial, 60% of women who received IXEMPRA and Xeloda and 29% of women who received Xeloda alone had fatigue

In another clinical trial, 56% of women who received IXEMPRA alone had fatigue

Loss of appetite

IXEMPRA may affect your appetite. You may not feel like eating for different reasons, such as a changed sense of taste or smell, nausea, pain, or depression.

Loss of appetite:

In one clinical trial, 34% of women who received IXEMPRA and Xeloda and 15% of women who received Xeloda alone had a loss of appetite

In another clinical trial, 19% of women who received IXEMPRA alone had a loss of appetite

Change in taste:

In one clinical trial, 12% of women who received IXEMPRA and Xeloda and 4% of women who received Xeloda alone had a change in taste

In another clinical trial, 6% of women who received IXEMPRA alone had a change in taste

Problems with your toenails and fingernails

With IXEMPRA, nails may turn dark or yellow or get brittle and cracked. Nails sometimes can fall off.

In one clinical trial, 24% of women who received IXEMPRA and Xeloda and 10% of women who received Xeloda alone had problems with nails

In another clinical trial, 9% of women who received IXEMPRA alone had problems with nails

Hair loss

IXEMPRA may damage the cells that cause hair growth. Hair loss can occur anywhere on your body.

In one clinical trial, 31% of women who received IXEMPRA and Xeloda and 3% of women who received Xeloda alone had hair loss

In another clinical trial, 48% of women who received IXEMPRA alone had hair loss

Fever

Call your healthcare provider right away if your temperature is 100.5°F or higher. This may be a sign of an infection. If you get a fever or infection when your white blood cell count is very low, you can become seriously ill and die. You may need treatment in the hospital with antibiotic medicines. Your healthcare provider will monitor your white blood cell count often with blood tests.

In one clinical trial, 10% of women who received IXEMPRA and Xeloda and 4% of women who received Xeloda alone had fever

In another clinical trial, 8% of women who received IXEMPRA alone had fever

Decreased red blood cell count (anemia)

With fewer red blood cells, your body may not get enough oxygen. This can make you tired. You may also have shortness of breath and feel dizzy. These are common symptoms of anemia. They also may be symptoms of a serious side effect. If you have any of these symptoms, call your healthcare provider right away.

In one clinical trial, 10% of women who received IXEMPRA and Xeloda and 5% of women who received Xeloda alone had anemia

In another clinical trial, 8% of women who received IXEMPRA alone had anemia

Joint and muscle pain

With IXEMPRA, you may feel pain in your body. The pain may be mild or severe, dull or sharp, constant or brief. You may also feel weak and tired.

In one clinical trial, 39% of women who received IXEMPRA and Xeloda and 5% of women who received Xeloda alone had joint and muscle pain

In another clinical trial, 49% of women who received IXEMPRA alone had joint and muscle pain

Headache

IXEMPRA may cause headache.

In one clinical trial, 8% of women who received IXEMPRA and Xeloda and 3% of women who received Xeloda alone had headache

In another clinical trial, 11% of women who received IXEMPRA alone had headache

Decreased platelet count (thrombocytopenia)

Platelets help your blood clot when you bleed. When you don’t have enough platelets, you may get nosebleeds, a rash of tiny red dots, or purple bruises when you bump into things.

In one clinical trial, 8% of women who received IXEMPRA and Xeloda and 4% of women who received Xeloda alone had decreased platelet count

In another clinical trial, 7% of women who received IXEMPRA alone had decreased platelet count

Nausea and vomiting

Nausea and vomiting can occur with IXEMPRA. These side effects can occur during or right after treatment, or days later.

Nausea

In one clinical trial, 53% of women who received IXEMPRA and Xeloda and 40% of women who received Xeloda alone had nausea

In another clinical trial, 42% of women who received IXEMPRA alone had nausea

Vomiting

In one clinical trial, 39% of women who received IXEMPRA and Xeloda and 24% of women who received Xeloda alone had vomiting

In another clinical trial, 29% of women who received IXEMPRA alone had vomiting

Diarrhea

Diarrhea may happen when IXEMPRA harms the healthy cells that line the intestines.

In one clinical trial, 44% of women who received IXEMPRA and Xeloda and 39% of women who received Xeloda alone had diarrhea

In another clinical trial, 22% of women who received IXEMPRA alone had diarrhea

Constipation

IXEMPRA may cause constipation. You may have gas, cramping, or a bloated and nauseated feeling.

In one clinical trial, 22% of women who received IXEMPRA and Xeloda and 6% of women who received Xeloda alone had constipation

In another clinical trial, 16% of women who received IXEMPRA alone had constipation

Abdominal pain

IXEMPRA may cause abdominal pain.

In one clinical trial, 24% of women who received IXEMPRA and Xeloda and 14% of women who received Xeloda alone had abdominal pain

In another clinical trial, 13% of women who received IXEMPRA alone had abdominal pain

Sores on the lips, in the mouth, and in the throat

Damage to the fast-growing cells lining the lips, the mouth, and the throat may cause you to have open red sores and greater sensitivity to heat and cold.

In one clinical trial, 31% of women who received IXEMPRA and Xeloda and 20% of women who received Xeloda alone had sores on the lips, in the mouth, and in the throat

In another clinical trial, 29% of women who received IXEMPRA alone had sores on the lips, in the mouth, and in the throat

Tender, red palms of the hands and soles of the feet (hand-foot syndrome)

The palms of your hands and the soles of your feet may look sunburned and may be painfully sensitive. In severe cases, the skin may blister and become dry and peel. There may also be numbness and tingling.

In one clinical trial, 64% of women who received IXEMPRA and Xeloda and 63% of women who received Xeloda alone had hand-foot syndrome

In another clinical trial, 8% of women who received IXEMPRA alone had hand-foot syndrome

Please see the Patient Information and the patient section in the Full US Prescribing Information, including boxed WARNING regarding liver disease.