40 mg thioguanine tablets
What Lanvis is and what it is used for
Lanvis tablets contain a medicine called thioguanine. It belongs to a group of medicines called cytotoxic medicines (also called chemotherapy ). Lanvis is used for certain blood problems and cancers of the blood. It works by reducing the number of new blood cells your body produces.
Lanvis is used for acute (fast-growing) leukemias, especially these:
- Acute myelogenous leukemia (also called acute myeloid leukemia or AML ) – a fast-growing disease that increases the number of abnormal white blood cells produced by bone marrow . This can cause infection and bleeding.
- Acute lymphoblastic leukemia (also called acute lymphocytic leukemia or ALL ) – a fast-growing disease that increases the number of immature white blood cells . These immature white blood cells cannot grow and function properly. They can therefore not fightyou infection , but they can cause bleeding.
Ask your doctor if you want to know more about these diseases.
What you need to know before taking Lanvis
Do not take Lanvis
if you are allergic to thioguanine or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding, see the section “Pregnancy, breast-feeding and fertility”.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Lanvis:
- if you have been taking this medicine for a long time. This can increase the risk of side effects , such as liver problems
- if you have a condition where your body produces too little of something called TPMT or “thiopurine methyltransferase”
- if you have “Lesch-Nyhan’s syndrome”. This is a rare, inherited condition caused by a deficiency of something called HPRT or ‘hypoxanthine- guanine phosphoribosyltransferase’.
If you are not sure if any of the above applies to you, contact your doctor, nurse, or pharmacist before taking Lanvis.
NUDT15 gene mutation
If you have a hereditary mutation in the NUDT15 gene (a gene that is involved in the breakdown of Lanvis in the body), then the risk is higher for you to get infection and hair loss and the doctor can in this case give you a lower dose.
Lanvis and the sun
While taking Lanvis, you may be sensitive to sunlight which may cause a rash or discoloration of the skin. Be sure to avoid too much sun, wear opaque clothing, and use sunscreen.
Other medicines and Lanvis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- olsalzine, balsalazide or mesalazine – used for a bowel problem called ulcerative colitis
- sulfasalazine – used for rheumatoid arthritis or ulcerative colitis
- drugs that can have a detrimental effect on bone marrow , such as other chemotherapy or radiation therapy. This can lead to bone marrow damage and dose one of Lanvis may need to be reduced.
Get vaccines while you are taking Lanvis
If you are about to be vaccinated, talk to your doctor or nurse before doing so. The reason is that some vaccines (such as polio, measles, mumps, and rubella) can give you an infection if you take them while taking Lanvis.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Reliable contraceptives must be used to avoid pregnancy while you or your partner are taking these tablets. This applies to both men and women. Thioguanine can damage your semen or eggs.
Breast-feeding should be discontinued during treatment with Lanvis.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Lanvis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Lanvis tablets.
How to take Lanvis
Lanvis should only be given to you by a specialist doctor who has experience in treating blood problems.
Always take this medicine exactly as your doctor has told you. You must take the tablets at the right time. The label on the package indicates how many tablets to take and how often to take them. If you are not sure, talk to your doctor, pharmacist, or nurse.
- Swallow the tablets whole with a glass of water.
- If you need to break the tablet into two parts, make sure you do not inhale any tablet powder. Wash your hands afterwards. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
- While you are taking Lanvis, your doctor will take blood samples at regular intervals. The reason is to check the number and type of blood cells and to ensure that your liver is functioning properly. Your doctor may sometimes change your dose as a result.
The dose of Lanvis that you are given is determined by your doctor based on:
- your body size (surface area)
- the result of the blood tests
- which disease is being treated.
The usual dose is between 60 and 200 mg / m 2 body surface area/day. If you have kidney or liver problems, you can get a lower dose of Lanvis.
If you forget to take Lanvis
If you forget to take a dose, contact your doctor. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of these side effects, talk to your healthcare provider immediately or consult a hospital. These side effects are very common (affects more than 1 in 10 people)
- signs of fever or infection (sore throat, sore mouth or difficulty urinating)
- unexpected bruising or bleeding, as this can mean that too few blood cells of a certain type are produced
- if you suddenly feel unwell (even if you do not have a fever)
- yellowing of the whites of the eyes or skin (jaundice), fatigue and nausea, followed by itching , dark urine and may include rash or fever (severe liver damage).
Talk to your doctor if you get any of the following side effects that may also occur with this medicine:
Very common (affects more than 1 in 10 people)
- decreased number of blood cells and platelets
- jaundice (skin and whites of the eyes turn yellow) and severe liver damage (symptoms are fatigue and nausea, followed by itching , dark urine and may include rash or fever) – with long-term use or high doses of Lanvis. This can also show up in your blood tests.
Common (affects less than 1 in 10 people)
- liver damage that can cause enlarged liver (a swelling under the chest) – with short-term use of Lanvis. This can also show up in your blood tests
- nausea or vomiting, diarrhea and cold sores
- increased concentration of uric acid in the blood (hyperuricemia), which can sometimes lead to impaired kidney function.
Uncommon ( affects less than 1 in 100 people)
- liver damage that can cause jaundice (skin and whites of the eyes turn yellow).
Rare (affects less than 1 in 1,000 people)
- a problem with the intestines called necrotizing colitis , which can cause severe stomach pain, vomiting, diarrhea and fever
- severe liver damage when Lanvis is used with other chemotherapeutic drugs, birth control pills and alcohol.
Unknown frequency
- Hypersensitivity to light.
How to store Lanvis
- Store the jar in the outer carton. Sensitive to light
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after “EXP” / “EXP”.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is thioguanine. Each tablet contains 40 mg of thioguanine.
The other ingredients are lactose monohydrate, potato starch, acacia, stearic acid, and magnesium stearate.
What the medicine looks like and contents of the pack
Lanvis tablets are white to off-white tablets, round, biconvex with a scoreline and embossed with T40 on the front, without a score and embossing on the back.
The medicine is supplied in a brown glass jar with a child-resistant lid containing 25 tablets.
Marketing Authorization Holder and Manufacturer
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
Excella GmbH & Co. KG
Nurnberger Strasse 12
90537 Moisture
Germany
Agent
Questions about medical information:
Tel: 0046 856642572