Lonsurf is a type of cancer chemotherapy which belongs to the group of medicines called "cytostatic antimetabolite medicines".

Lonsurf contains two different active substances: trifluridine and tipiracil.

·     Trifluridine stops the growth of cancer cells. 

·     Tipiracil stops the trifluridine from being broken down by the body, helping trifluridine to work longer.

Lonsurf is used to treat adults with colon or rectal cancer - sometimes called ‘colorectal’ cancer and stomach cancer (including cancer of the junction between the oesophagus and the stomach).

·     It is used when the cancer has spread to other parts of the body (metastases).

·     It is used when other treatments have not worked - or when other treatments are not suitable for you.

Lonsurf may be given in combination with bevacizumab. It is important that you also read the package leaflet of bevacizumab. If you have any questions about this medicine, ask your doctor. 

Do not take Lonsurf

·     if you are allergic to trifluridine or tipiracil or any of the other ingredients of this medicine (listed in section 6).

Do not take Lonsurf if the above applies to you. If you are not sure, talk to your doctor or health care provider before taking Lonsurf.

b.  Take special care with Lonsurf

Warnings and precautions

Talk to your doctor, health care provider or pharmacist before taking Lonsurf if:

·     you have kidney problems

·     you have liver problems

If you are not sure, talk to your doctor, health care provider or pharmacist before taking Lonsurf.

Treatment may lead to the following side effects (see section 4):

·        a reduced number of certain types of white blood cells (neutropenia) which are important for protecting the body against bacterial or fungal infections. As a consequence of neutropenia, fever (febrile neutropenia) and blood infection (septic shock) may occur

·       a reduced number of red blood cells (anaemia)

·       a reduced number of platelets in the blood (thrombocytopenia) which are important to stop bleeding and work by clumping and clotting blood vessel injuries

·       gastrointestinal problems.

Tests and checks

Your doctor or health care provider will do blood tests before each cycle of Lonsurf. You start a new cycle every 4 weeks. The tests are needed because Lonsurf can sometimes affect your blood cells.

Children and adolescents

This medicine is not indicated for use in children and adolescents below the age of 18 years. This is because it may not work or be safe.

c.   Taking other medicines, herbal or dietary supplements

Tell your doctor, health care provider or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Lonsurf can affect the way some other medicines work. Also some other medicines can affect the way Lonsurf works.

In particular tell your doctor, health care provider or pharmacist if you are taking medicines used for treatment of HIV, such as zidovudine. This is because zidovudine may not work as well if you are taking Lonsurf. Talk to your doctor or health care provider about whether to switch to a different HIV medicine.

If the above applies to you (or you are not sure), talk to your doctor, health care provider or pharmacist before taking Lonsurf.

d.   Pregnancy, breast-feeding and contraception

If you are pregnant or breast-feeding or if you think you might be pregnant or are planning to have a baby, ask your doctor, health care provider or pharmacist for advice before taking this medicine. Lonsurf may harm your unborn baby.

Pregnancy

If you become pregnant, you and your doctor or health care provider will have to decide if the benefits of Lonsurf are greater than the risk of harm to the baby.

Breast-feeding

Do not breast-feed if you are taking Lonsurf as it is not known whether Lonsurf passes into the mother’s milk.

Contraception

You must not become pregnant while taking this medicine. This is because it may harm your unborn baby.

You and your partner should use effective methods of contraception while taking this medicine. You should also do this for 6 months after you stop taking the medicine. If you or your partner becomes pregnant during this time, you must talk to your doctor, health care provider or pharmacist straight away.

Fertility 

Lonsurf may affect your ability to have a baby. Talk to your doctor for advice before using it. 

e.   Driving and using machines

It is not known whether Lonsurf changes your ability to drive or use machines. Do not drive or use any tools or machines if you experience symptoms that affect your ability to concentrate and react.

f. Important information about some of the ingredients of Lonsurf

Lonsurf contains lactose

If you have been told by your doctor or health care provider that you have an intolerance to some sugars, contact your doctor or health care provider before taking this medicine.

Always take this medicine exactly as your doctor, health care provider or pharmacist has told you. Check with your doctor, health care provider or pharmacist if you are not sure.

How much to take

·       Your doctor or health care provider will decide the right dose for you - the dose depends on your weight and height and if you have kidney problems.

·      Lonsurf comes in two strengths. Your doctor may prescribe both strengths for your prescribed dose.

·       Your doctor or health care provider will tell you how many tablets to take each time.

·       You will take a dose 2 times a day.

When to take Lonsurf

You will take Lonsurf for 10 days during the first 2 weeks, and then have 2 weeks off. This 4-week period is called a ‘cycle.’ The specific dosing schedule is as follows:

·       Week 1

-               take the dose 2 times a day for 5 days

-               then have 2 days off - no medicine

·       Week 2

-               take the dose 2 times a day for 5 days

-               then have 2 days off - no medicine

·       Week 3

-               No medicine

·       Week 4

-               No medicine

You will then start again with another cycle of 4 weeks following the above pattern.

How to take

·       LONSURF should be prescribed by physicians experienced in the administration of anticancer therapy.

·       LONSURF is a cytotoxic drug. Need caution when handling LONSURF to minimize risk of exposure.

·       Personal not taking LONSURF should not be exposed to it.

• Take this medicine by mouth.
• Tablets should be swallowed as a whole with a glass of water.
• The tablets should not be broken or crushed.

·       Take within 1 hour after your morning and evening meals.

·       Wash your hands after handling this medicine.

a. If you take more Lonsurf than you should

If you take more Lonsurf than you should, talk to a doctor or health care provider or go to a hospital straight away. Take your pack(s) of medicine with you.

b. If you forget to take Lonsurf

·     If you forget a dose, talk to your doctor, health care provider or pharmacist.

·     Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, health care provider or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine when it is taken alone or in combination with bevacizumab:

Serious side effects

Tell your doctor or health care provider immediately if you notice any of the following serious side effects (many of the side effects are shown in laboratory tests - for example those affecting your blood cells):

·       Neutropenia (very common), febrile neutropenia (common) and septic shock (rareuncommon). The signs include chills, fever, sweating or other sign of bacterial or fungal infection (see section 2).

·       Anaemia (very common). The signs include feeling short of breath, tiredness or looking pale (see section 2).

·       Vomiting (very common) and diarrhoea (very common), which may lead to a dehydration if severe or persistent.

·       Severe gastrointestinal problems: abdominal pain (common), ascites (rareuncommon), colitis (rareuncommon), acute pancreatitis (uncommon), ileus (uncommon) and subileus (uncommon). The signs include intense stomach or abdominal pain that can be associated with vomiting, blocked or partly blocked bowel, fever or swelling of the abdomen.

·       Thrombocytopenia (very common). The signs include unusual bruising or bleeding (see section 2).

·       Pulmonary embolism (uncommon): blood clots in lungs. The signs include shortness of breath and pain in the chest or in the legs.

·       Interstitial lung disease has been reported in patients receiving the medicine. The signs include difficulty in breathing, shortness of breath, with cough or fever.

Some of these serious side effects may lead to death.

Other side effects

Tell your doctor or health care provider if you notice any of the following side effects. Many of the side effects are shown in laboratory tests - for example those affecting your blood cells. Your doctor or health care provider will be looking out for these side effects in your test results.

Very common: may affect more than 1 in 10 people:

·       decreased appetite

·       feeling very tired (fatigue)

·       feeling sick (nausea)

·       reduced white blood cells called leucocytes - can increase your risk for infection

·       swelling of mucous membranes in mouth 

Common: may affect up to 1 in 10 people:

·       fever

·       hair loss

·       weight loss

·       changes in taste

·       constipation

·       feeling generally out of sorts (malaise)

·       low levels of albumin in the blood

·       increased bilirubin in your blood - can cause yellowing of skin or eyes

·       reduced number of white blood cells called lymphocytes - can increase your risk for infection

·       swelling in your hands or legs or feet

·         redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)

·         feeling of numbness or pins and needles in hands or feet

·       mouth pain or problems

·       swelling of mucous membranes - this could be inside the nose, mouth, throat, eyes, vagina, lungs or gut

·       increased liver enzymes

·       protein in your urine

·       rash, itchy or dry skin

·       feeling short of breath, airway or lungs, chest infections

·       viral infection 

·       pain in your joints 

·       feeling dizzy, headache  

·       high blood pressure 

·       mouth ulcers 

·       muscle pain 

Uncommon: may affect up to 1 in 100 people

·       low or high blood pressure

·         blood clots, e.g. in the brain or legs

·       blood test results indicating problems with clotting making you bleed more easily

·       more noticeable heart-beat, chest pain

·       abnormal increase or decrease in heart rate

·       changes in your heart trace (ECG - electrocardiogram)

·       increased white blood cells

·       increased number of white blood cells called monocytes

·       increased lactate dehydrogenase level in your blood

·       low levels of phosphates, sodium, potassium  or calcium in your blood

·       reduced white blood cells called granulocytes or monocytes - can increase your risk for infection

·       high blood sugar (hyperglycaemia), increased salt, urea, creatinine and potassium in your blood

·       blood test result indicating inflammation (C-Reactive Protein increased)

·         ear pain

·       feeling of spinning (vertigo)

·       feeling dizzy, headache

·       runny or bloody nose, sinus problems

·       sore throat, hoarse voice, problems with your voice

·       redness, itching of the eye, eye infections, watery eyes

·         dry eyes

·         vision troubles as blurred vision, double vision, decreased vision, cataracts

·       dehydration

·       bloating, passing gas, indigestion

·       pain or inflammation in upper or lower part of digestive tract

·       inflammation, swelling or bleeding in your bowel

·         inflammation and infection in your gut

·       inflammation or increased acid in your stomach or gullet, reflux

·       painful tongue, polyps inside your mouth, mouth ulcers, retching

·       bad breath, tooth decay, tooth or gum problems, bleeding gums, gum infections

·       skin flushing

·         swelling or pain in your joints or big toes

·       pain or discomfort in your arms or legs

·       pain, including pain from the cancer 

·       bone pain, muscle pain, muscle weakness or spasms, pain in tendons, nerves or ligaments

·       feeling of being cold

·       shingles (pain and vesicular rash on skin over nerve tracts affected by nerve inflammation from herpes zoster virus)

·       liver disorder

·       inflammation or infection of bile ducts, increase in the diameter of the bile duct

·       kidney failure

·         viral infections

·       cough, infection of the sinuses, throat infections

·       inflammation or infection in your bladder

·       changes in urine test, blood in urine

·       problems passing water (urine retention), loss of bladder control (incontinence)

·         athlete’s foot - fungal infection of feet, yeast infections

·         accumulation of fluid in the lungs

·       changes in the menstrual cycle

·       anxiety

·         fainting (syncope)

·       burning sensation, unpleasant, increased or loss of sense of touch and other non-severe neurological troubles

·       raised itchy rash, red skin, blisters, skin sloughing off, hives, acne

·       sweating more than normal, sensitivity to light, nail problems

·       problem with sleeping or falling asleep

·       low level of total protein in the blood feeling of numbness or pins and needles in hands or feet

·       redness, swelling, pain on the palms of your hands and soles of your feet (hand-foot syndrome)

Rare: may affect up to 1 in 1 000 people 

·                inflammation and infection in your gut 

·                athlete’s foot - fungal infection of feet, yeast infections 

·                reduced white blood cells called granulocytes - can increase your risk for infection 

·                swelling or pain in your big toes 

·                swelling in your joints 

·                increased salt in your blood 

·                burning sensation, unpleasant, increased or loss of sense of touch 

·                fainting (syncope) 

·                vision troubles as blurred vision, double vision, decreased vision, cataracts 

·                dry eyes 

·                ear pain 

·                inflammation in upper part of digestive tract 

·                pain in upper or lower part of digestive tract 

·                accumulation of fluid in the lungs 

·                bad breath, gum problems, bleeding gums 

·                polyps inside your mouth 

·                inflammation or bleeding in your bowel  

·                increase in the diameter of the bile duct 

·                raised red skin, blisters, skin sloughing off 

·                sensitivity to light 

·                inflammation in your bladder  

·                changes in urine test 

·                blood clots, e.g. in the brain or legs 

·                changes in your heart trace (ECG - electrocardiogram) 

·                low level of total protein in the blood 

Reporting of side effects

If you experience any side effects, talk to your doctor, health care provider or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. • LONSURF is a cytotoxic drug; need caution when handling to minimize risk of exposure. • The tablets should not be divided, broken or crushed. • Transport and store medicine in the original container or blister. • For medication administration, use gloves and wash hands thoroughly before and after. If gloves are not worn, tip tablets and from their container/blister pack directly into a disposable medicine cup. • People who are not taking patient should not be exposed to it. • Caution should be observed in handling broken or crushed tablets Avoid direct contact of the LONSURF with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water, rinse eyes thoroughly with sterile water, or plain water if sterile water is unavailable. • Pregnant should avoid exposure to LONSURF tablets. • Family members use gloves when handling laundry or cleaning within or around toilets. • Close the lid before flushing the toilet and flush twice after each use by patient, for 48 hours after receiving chemotherapy. If available, use separate bathroom from family members. • Conduct double washing of linens and wash them separately from other family laundry. • If your doctor tells you to stop taking the meditation, or expired. Do not throw away via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use, or return it to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. • These measures will help protect environment. • Only keep the medicine if your doctor tells you to.
Do not use this medicine after the expiry date which is stated on the outer carton or blister tray after “EXP.” The expiry date refers to the last day of that month.
Storage conditions: store below 30°C. Store in the original carton.