Details for: LANVIS

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LANVIS® . Talk about any health conditions or problems you may have, including if you:

• are pregnant, or you are planning a pregnancy;
  Females who are pregnant or plan to become pregnant:
• LANVIS® may harm your unborn baby.
• Avoid becoming pregnant while you are taking LANVIS® .
• Use effective methods of birth control while you are taking LANVIS® . Talk to your healthcare professional about methods of birth control that may be right for you.
• If you do become pregnant while taking LANVIS® , stop using it and tell your healthcare professional right away.
• are breastfeeding or are planning to breastfeed. It is not known if LANVIS® passes into breast milk. You and your doctor should discuss whether you will take LANVIS® or breastfeed. You should not do both. Talk to your doctor about ways to feed your baby while you are taking LANVIS® .
• plan to father a child. Your partner should not become pregnant while you are using LANVIS® . You should use birth control to prevent pregnancy in your partner during your treatment. If your partner becomes pregnant while you are receiving LANVIS® , tell your healthcare professional right away.
• you have been vaccinated, or are planning to be vaccinated, with a live vaccine.
• Your body does not make enough of (you are deficient in) the enzyme called thiopurine methyltransferase (TPMT). If you do not have enough of this enzyme, you may get serious side effects if you use LANVIS® .
• you have kidney problems;
• you have liver problems;
• you have a mutation in your NUDT15 gene. If you have this mutation, you may be more likely to develop low levels of white cells in your blood. This may cause you to get infections. The mutation may also put you at a higher risk of losing your hair. Patients of Asian descent may be particularly at risk.
• You are going to be exposed to sunlight, sun lamps or tanning beds. Your treatment with LANVIS® may make you more sensitive to sun and ultraviolet (UV) light. Limit your exposure to the sun and to UV light while you are taking LANVIS® . Be sure to also wear protective clothing and use sunscreen with a high protection factor (spf).

Other warnings you should know about:
Intestinal necrosis and perforation can occur with LANVIS® use.

• Intestinal necrosis is a condition that occurs when there is low blood flow to the intestines.
• Intestinal perforation is when a hole forms in the wall of the intestine.
• These are serious and potentially life-threatening side effects of LANVIS® use. If you experience bloating or swelling in the abdomen, bloody stools, diarrhea severe abdominal pain and vomiting, call your healthcare professional right away. These may be signs that you are experiencing intestinal necrosis or a perforation.

Bone marrow suppression:
As LANVIS® use may cause low white blood cells, low red blood cells and low platelets, you may be at increased risk of infection, bleeding and bruising, be sure to:

• Wash your hands often.
• Keep your mouth and skin clean and healthy.
• Avoid people who are sick.
• Try not to bump into things or cut yourself.
• Blow your nose gently.
• Avoid getting constipated.
• Brush your teeth gently with a soft toothbrush.
• Avoid products containing aspirin or ibuprofen.
• Rest if you need to.
• Call your doctor if you have a fever or other flu-like symptoms or if you have any bleeding, bruising, fatigue, tiny red spots on the skin or weakness.

Risk for cancer and damage to DNA:
Thioguanine, the medicinal ingredient in LANVIS® , may cause cancer or damage to the genetic material in cells (DNA). Talk to your healthcare professional if you have questions about this.

Driving and operating machines:
Before you do tasks that require special attention, wait until you know how you respond to LANVIS® treatment.

Blood tests:
Your doctor will ask you to have blood tests done before you take LANVIS® for the first time. Some of these tests will be repeated every week and others will be repeated every month while you are taking LANVIS® . This is to check your blood cell counts and to monitor how well your liver is working.

Your doctor may also perform genetic testing before or during your treatment. These tests will determine if you have the NUDT15 gene mutation and if you are deficient in the enzyme, TPMT. The results of these tests will help your doctor to know if your response to LANVIS® may be affected by your genetics. Your doctor may change your dose of LANVIS® after these tests.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.