Lanvis: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is LANVIS used for?

• LANVIS is used to treat acute leukemia. This is a cancer of the blood and bone marrow.
• LANVIS will not be given to you as treatment to help prevent your cancer from coming back after it had disappeared. It will also not be given as a long-term treatment.

How does LANVIS work?

LANVIS works by reducing the number of new blood cells your body makes.

What are the ingredients in LANVIS?

Medicinal ingredients: thioguanine

Non-medicinal ingredients: gum acacia, lactose, magnesium stearate, potato starch and stearic acid

LANVIS comes in the following dosage forms:

Tablets, 40 mg

Do not use LANVIS if:

• your disease has previously stopped responding to LANVIS or to treatment with another drug called mercaptopurine.
• you are allergic to thioguanine or any of the other ingredients in this medicine, including any non-medicinal ingredient or component of the container.

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:

• have been vaccinated, or are planning to be vaccinated, with a live vaccine.
• are deficient in (your body does not make enough of) 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.
• have kidney problems.
• have liver problems.
• 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.
• 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:

• LANVIS may cause:

  • Intestinal necrosis and perforation.

    • 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 healthcare professional 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.

    • Increased risk of infections. Taking LANVIS together with other treatments that weakens your immune system (immunosuppressive or chemotherapeutic agents) could put you at a greater risk of developing viral, fungal and bacterial infections. Your symptoms and complications can be more severe than patients who are not taking these medicines.

      Talk to your healthcare professional right away if you notice any signs of infection. They may need to give you medicine to treat your infection.

• Female patients

  Pregnancy and birth control

  • If you are pregnant, or planning on becoming pregnant during treatment with LANVIS, there are specific risks you should discuss with your healthcare professional.
  • 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.

Breastfeeding

• Do NOT breastfeed during treatment with LANVIS. It is not known if LANVIS passes into breast milk.
• You and your healthcare professional should discuss whether you will take LANVIS or breastfeed. You should not do both. Talk to your healthcare professional about ways to feed your baby while you are taking LANVIS.
• Male patients
• Do NOT father a child during treatment with LANVIS. 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.

• Driving and using machines:

  Before you do tasks that require special attention, wait until you know how you respond to LANVIS treatment.

• Check-ups and testing:

  You will have regular visits with your healthcare professional before and during treatment with LANVIS. They will do:

• Blood tests to check your blood cell counts and monitor how well your liver is working. This will be 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.
• 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 healthcare professional to know if your response to LANVIS may be affected by your genetics. Your healthcare professional 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.

The following may also interact with LANVIS:

• Busulfan. This is a medicine used to treat a type of cancer.

How to take LANVIS:

• Take this medicine exactly as your healthcare professional has told you to.
• Take it once per day by mouth.
• Check with your healthcare professional if you are not sure how to take it.
• Your healthcare professional will tell you how much LANVIS to take and when to take it.

Usual dose:

The amount of LANVIS you will take will depend on your weight and how you respond to treatment.

• The usual starting dose is 2 mg/kg of body weight.
• If, after one month of treatment, your condition has not improved, your dose may be increased to 3 mg/kg of body weight.
• Your healthcare professional may interrupt or stop your treatment, or reduce your dose of LANVIS. This will depend on how you are feeling or if your disease has gotten worse.

Overdose:

Missed Dose:

• If you miss a dose of LANVIS, take it as soon as possible.
• If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule as prescribed by your healthcare professional.
• Never take two doses at the same time to make up for a missed dose.
• If you miss two doses of LANVIS, contact your healthcare professional.

What are possible side effects from using LANVIS?

These are not all the possible side effects you may feel when taking LANVIS. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• loss of appetite
• increased sensitivity to sun exposure

LANVIS may cause abnormal blood test results. Your healthcare professional may perform blood tests before you take LANVIS and while you are taking it. Your healthcare professional will interpret the results.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store LANVIS in a dry place between 15° and 25°C. Protect it from light.
• LANVIS is cytotoxic. Be careful not to contaminate your hands or inhale the drug when you are handling LANVIS.
• Return unused tablets to your healthcare professional. Be cautious when you are packaging your leftover LANVIS for transportation.
• Keep out of reach and sight of children.

If you want more information about LANVIS:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the Aspen Pharmacare Canada Inc. website (www.aspenpharma.ca), or by calling 1-844-330-1213.

Last Revised: December 14, 2023

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