Lonsurf - Trifluridine / Tipiracil uses, dose and side effects

Trifluridine stops the growth of cancer cells.
Tipiracil prevents the breakdown of trifluridine in the body and helps trifluridine to work for a long time.

Lonsurf is used to treat adults with cancer of the colon or rectum, so-called colorectal cancer, and stomach cancer (including cancer of the connection between the esophagus and stomach).

It is used when the cancer has spread to other parts of the body ( metastasize ).
It is used when other treatment has not had an effect or when other treatment is not suitable for you.

What you need to know before using Lonsurf

Do not use 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 before taking Lonsurf.

Warnings and cautions

Talk to your doctor or pharmacist before taking Lonsurf

if you have kidney problems
if you have liver problems

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

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

reduced number of a certain type of white blood cell ( neutropenia ) that is important to protect the body against bacterial or fungal infections. As a result of neutropenia , fever (febrile neutropenia ) and infection in the blood ( septic shock ) may occur .
decreased number of red blood cells ( anemia )
decreased number of platelets ( thrombocytopenia ) which are important for stopping bleeding and which cause the blood to clot in case of damage to the blood vessels
problems in the gastrointestinal tract.

Samples and examinations

Your doctor will take blood samples before each Lonsurf treatment cycle. You start a new treatment cycle every four weeks. The tests are necessary because Lonsurf can sometimes affect the blood cells.

Children and young people

This medicine is not intended for the treatment of children and adolescents under 18 years of age, as it may not work or be safe for these patients.

Other drugs and Lonsurf

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. This is because Lonsurf may affect the effectiveness of certain other medicines. Some other medicines may also affect the effect of Lonsurf.

In particular, tell your doctor or pharmacist if you are taking medicines to treat HIV, such as zidovudine. This is because zidovudine may have a worse effect when used concomitantly with Lonsurf. Talk to your doctor to find out if you need to switch to another HIV medicine.

Talk to your doctor or pharmacist before taking Lonsurf if the above applies to you (or if you are unsure).

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 or pharmacist for advice before taking this medicine. Lonsurf can harm the fetus.

If you become pregnant, you and your doctor must determine if the benefits of Lonsurf outweigh the risk of harm to your baby.

You should not breastfeed during treatment with Lonsurf as it is unknown if Lonsurf passes into breast milk.

Preventive method

You must not become pregnant during treatment with this medicine, as it may cause birth defects.

You and your partner should use effective contraception during treatment with this medicine. You should also continue to do so for 6 months after stopping treatment. If you or your partner become pregnant during this period, consult a doctor or pharmacist immediately.

Driving and using machines

It is unknown whether Lonsurf affects the ability to drive or use machines. Do not drive or use tools or machines if you experience symptoms that may affect your ability to concentrate and react.

Lonsurf contains lactose

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

How to use Lonsurf

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

Your doctor will determine the appropriate dose for you based on your weight and height and any kidney problems.
Lonsurf is available in two strengths. Your doctor may prescribe both strengths to help you achieve your prescribed dose .
Your doctor will tell you how many tablets to take at a time.
You should take a dose twice a day.

When using Lonsurf

You should take Lonsurf for 10 days during the first 2 weeks and then take a break of 2 weeks. These 4 weeks are called a treatment cycle. The specific dosing schedule is as follows:

Week 1
take dose 2 times daily for 5 days
then make a break of 2 days – no medicine
Week 2
take dose 2 times daily for 5 days
then make a break of 2 days – no medicine
Week 3
no medicine
Week 4
no medicine

Then you start a new treatment cycle of 4 weeks according to the schedule above

How to take the medicine

Take the medicine by mouth.
Swallow the tablets whole with a glass of water.
Take the tablets within 1 hour after breakfast and supper.
Wash hands after handling the medicine

If you use more Lonsurf than you should

If you take more Lonsurf than you should, contact a doctor immediately or go to a hospital. Take the medicine pack with you.

If you forget to use Lonsurf

If you miss a dose , contact your doctor 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 product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur when using this medicine:

Serious side effects are

Immediately tell the doctor if you notice any of the following serious adverse reactions are (many of the side effects were seen in laboratory tests, such as the side effect is affecting blood cells):

decrease in white blood cells ( very common ), febrile neutropenia ( common ) and septic shock ( uncommon ). Symptoms include chills, fever, sweating or other signs of bacterial or fungal infection (see section 2).
anemia ( very common ). Symptoms include a feeling of shortness of breath, fatigue or paleness (see section 2).
vomiting ( very common ) and diarrhea ( very common ), which in severe or prolonged cases can lead to dehydration.
severe stomach and intestinal problems: abdominal pain ( common ), abdominal fluid ( uncommon ), colitis ( uncommon ), acute pancreatitis ( uncommon ), intestinal obstruction ( uncommon ) and incomplete intestinal obstruction ( uncommon ). Symptoms include severe abdominal or abdominal pain which may be associated with vomiting, blocked or partially blocked bowel, fever or abdominal swelling.
reduction in platelet count ( very common ). Symptoms include unusual bruising or bleeding (see section 2).
pulmonary embolism ( uncommon ): blood clot in the lungs. Symptoms include shortness of breath and pain in the chest or legs.
interstitial lung disease has been reported in patients receiving this drug. Symptoms include difficulty breathing, shortness of breath with cough or fever.

Some of these serious side effects can lead to death.

Other side effects are

Tell your doctor if you notice any of the following side effects. Many of the side effects are seen in laboratory tests, e.g. the side effects that affect the blood cells. Your doctor will check your test results to see if you have any of these side effects.

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

decreased appetite
severe fatigue (fatigue)
nausea
decreased number of white blood cells called leukocytes , which can increase the risk of infection

Common: may affect up to 1 in 10 users:

fever
hair loss
weight loss
taste changes
constipation
general malaise
low level of albumin in the blood
increased levels of bilirubin in the blood, which can cause yellowing of the skin or eyes
decreased number of white blood cells called lymphocytes , which may increase the risk of infection
swelling of the hands, legs or feet
redness , swelling, pain in palms and soles of the feet (hand-foot syndrome)
feeling of numbness or tingling and tingling in the hands or feet
pain or discomfort in the mouth
swelling of the mucous membranes inside the nose, mouth, throat, eyes, vagina, lungs or intestines
increased content of liver enzymes
protein is in the urine
rash, itchy or dry skin
feeling of shortness of breath, infections of the respiratory tract, lungs or breasts

Uncommon: may affect up to 1 in 100 people:

low or high blood pressure
blood clot e.g. in the brain or bones
blood test results that indicate problems with blood clotting so that you bleed more easily
more noticeable heartbeat, chest pain
abnormal increase or decrease in heart rate
changes in the heart curve ( electrocardiogram – ECG )
increased white blood cell count
increased number of white blood cells called monocytes you
increased level of lactate dehydrogenase in the blood
low levels of phosphate , sodium , potassium or calcium in the blood
decreased number of white blood cells called granulocytes or monocytes , which may increase the risk of infection
high blood sugar ( hyperglycaemia ), increased levels of salt, urea , creatinine and potassium in the blood
blood test results indicating inflammation (increase in C-reactive protein )
ear pain
rotating sensation ( vertigo )
dizziness, headache
runny nose or nosebleeds, sinus problems
sore throat, hoarse voice, voice problems
red and itchy eyes, eye infection , watery eyes
dry eyes
visual disturbances such as blurred vision, double vision, visual impairment, cataracts
dehydration
bloating, gas problems, indigestion
pain or inflammation in the upper or lower part of the gastrointestinal tract
inflammation , swelling or bleeding in the intestine
inflammation and infection of the intestine
inflammation or increased amount of acid in the stomach or esophagus, regurgitation
pain in the tongue, polyps in the mouth, cold sores, nausea
bad breath, caries , problems with teeth or gums, bleeding gums, gingivitis
reddening of the skin
swelling or pain in joints or big toes
pain or discomfort in arms or legs
pain, including cancer pain
skeletal pain, muscle aches, muscle weakness or – spasms , pain in tendons, nerves or ligaments
feeling cold
shingles (pain and rash with blisters over nerve pathways due to nerve inflammation caused by herpes zoster virus )
liver disease
inflammation or infection of the bile ducts, increase of the diameter of the bile ducts
kidney failure
virus infection
cough, sinus infection , throat infection
inflammation or infection of the bladder
changes in urine test results, blood in the urine
urination difficulties ( urinary retention ), loss of bladder control ( incontinence )
athlete’s foot , yeast infections
accumulation of fluid in the lungs
changes in the menstrual cycle
anxiety
fainting ( syncope )
burning sensation, unpleasant increase or loss of sensation and other non-serious neurological disorders
protruding itchy rash, reddening of the skin, blisters, skin flaking, hives , acne
excessive sweating, photosensitivity, nail diseases
difficulty sleeping or falling asleep
low level of total protein in the blood

How to store Lonsurf

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 outer carton or blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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

Lonsurf 15 mg / 6.14 mg film-coated tablets

The active substances are trifluridine and tipiracil. One film-coated tablet contains 15 mg trifluridine and 6.14 mg tipiracil.
Other ingredients are:
- Tablet core: lactose monohydrate , pregelatinised starch (maize) and stearic acid (see section 2 “Lonsurf contains lactose”).
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171) and magnesium stearate.
- Ink: shellac, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine aluminum lacquer (E132), carnauba wax and talc.

Lonsurf 20 mg / 8.19 mg film-coated tablets

The active substances are trifluridine and tipiracil. One film-coated tablet contains 20 mg trifluridine and 8.19 mg tipiracil.
Other ingredients are:
- Tablet core: lactose monohydrate , pregelatinised starch (maize) and stearic acid (see section 2 “Lonsurf contains lactose”).
- Film coating: hypromellose, macrogol (8000), titanium dioxide (E171), red iron oxide (E172) and magnesium stearate.
- Ink: shellac, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), indigo carmine aluminum lacquer (E132), carnauba wax and talc.

What the medicine looks like and contents of the pack

Lonsurf 15 mg / 6.14 mg is a white, biconvex, round, film-coated tablet, marked with “15” on one side and “102” and “15 mg” on the other with gray ink.
Lonsurf 20 mg / 8.19 mg is a pale red, biconvex, round, film-coated tablet, marked with “20” on one side and “102” and “20 mg” on the other with gray ink.

Each pack contains 20 film-coated tablets (2 blisters of 10 tablets) or 40 film-coated tablets (4 blisters of 10 tablets) or 60 film-coated tablets (6 blisters of 10 tablets). Each blister foil contains a desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Servier Laborierires Servier

50 rue Carnot

92284 Suresnes Cedex

France

Manufacturer

The Laboratories Servier Industrie

905, route de Saran

45520 Gidy