Umbralisib (oral route)

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 1 month after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 month after the last dose. If you think you have become pregnant, tell your doctor right away.

Some men who use this medicine have become infertile (unable to have children). Talk yo your doctor before using this medicine if you plan to have children.

This medicine may cause serious infections. Check with your doctor right away if you have chest pain, fever or chills, confusion, cough or hoarseness, dizziness, fainting, fast heartbeat, lightheadedness, lower back or side pain, painful or difficult urination, sneezing, sore throat, tightness in the chest, or trouble breathing.

Umbralisib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause severe diarrhea or non-infectious colitis. Check with your doctor right away if you have fever, pain, stomach cramps, tenderness, or watery or bloody diarrhea.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious skin reactions (eg, exfoliative dermatitis). Check with your doctor right away if you have cracks in the skin, flushing, redness of the skin, loss of heat from the body, rash, red, swollen skin, scaly skin, or unusually warm skin.