250 mg film-coated tablets
lapatinib
What Tyverb is and what it is used for
Tyverb is used to treat certain types of breast cancer (that overexpress HER2 ) that have spread beyond the original tumor or to other organs ( advanced or metastatic breast cancer). It can slow or stop the growth of cancer cells, or kill them.
Tyverb is prescribed to be taken in combination with another cancer medicine.
Tyverb is prescribed in combination with capecitabine for patients who have previously received treatment for advanced or metastatic breast cancer. The previous treatment of metastatic breast cancer must have included trastuzumab.
Tyverb is prescribed in combination with trastuzumab for patients who have hormone receptor-negative metastatic breast cancer and who have previously received other treatments for advanced or metastatic breast cancer.
Tyverb is prescribed in combination with an aromatase inhibitor for patients with hormone-sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones ) who are not currently scheduled to receive chemotherapy.
Information about these medicines can be found in separate leaflets. Ask your doctor for information about these other medicines.
What you need to know before taking Tyverb
Do not take Tyverb
- if you are allergic to lapatinib or any of the other ingredients of this medicine (listed in section 6).
Be especially careful with Tyverb
Your doctor will check that your heart is working normally before and during treatment with Tyverb.
Tell your doctor if you have any heart problems before you start taking Tyverb.
Before you start taking Tyverb, your doctor also needs to know:
- if you have lung disease
- if you have inflammation of the lung
- if you have any liver problems
- if you have any kidney problems
- if you have diarrhea (see section 4).
Your doctor will do tests to check that your liver is working normally before and during your treatment with Tyverb.
Tell your doctor if any of these apply to you.
Serious skin reactions
Serious skin reactions have been observed with Tyverb. Symptoms may include rashes, blisters, and peeling skin.
Tell your doctor as soon as possible if you get any of these symptoms.
Other medicines and Tyverb
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal remedies and other over-the-counter medicines that you bought.
Your doctor must know if you are taking or have recently taken any of the following medicines. Some medicines can affect how Tyverb works, or Tyverb can affect how other medicines work. These medicines include certain medicines in the following groups:
- St. John’s wort – a natural remedy for treating depression
- erythromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin, telithromycin – medicines to treat infection
- ciclosporin – a medicine used to suppress the immune system, for example after organ transplants
- ritonavir, saquinavir – medicines to treat HIV infection
- phenytoin , carbamazepine – anticonvulsant drugs
- cisapride – a medicine for certain indigestion
- pimozide – a medicine for certain mental illnesses
- quinidine, digoxin – medicines for certain heart problems
- repaglinide – a medicine used to treat diabetes
- verapamil – a medicine to treat high blood pressure or angina
- nefazodone – a medicine used to treat depression
- topotecan, paclitaxel, irinotecan, docetaxel – medicines for certain types of cancer
- rosuvastatin – a medicine for high cholesterol levels
- medicines that reduce the acidity of the stomach (for the treatment of stomach ulcers or indigestion ).
Tell your doctor if you are taking or have recently taken any of these.
Your doctor will review the medicines you are taking to make sure you are not taking anything that cannot be combined with Tyverb. Your doctor will then inform you of any options.
Tyverb with food and drink
Do not drink grapefruit juice while being treated with Tyverb. It can affect the function of the medicine.
Pregnancy and breastfeeding
The effect of Tyverb during pregnancy is not clear. You should not use Tyverb if you are pregnant unless your doctor specifically recommends this.
- Tell your doctor if you are pregnant or planning to become pregnant.
- Use a safe method of birth control so that you do not become pregnant while taking Tyverb and for at least 5 days after the last dose.
- Tell your doctor if you become pregnant during treatment with Tyverb.
It is not known whether Tyverb passes into breast milk. Do not breastfeed while taking Tyverb and for at least 5 days after the last dose.
- Tell your doctor if you are breastfeeding or plan to breastfeed.
Consult a doctor or pharmacist before taking Tyverb if you are not sure.
Driving ability and use of machinery
You are responsible for determining whether you are fit to drive a motor vehicle or perform work that requires increased attention. Due to the possible side effects of Tyverb, your ability to drive or operate machinery may be affected. These side effects are described in section 4 “Potential side effects”.
Tyverb contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Tyverb
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor determines the right dose of Tyverb depending on the type of breast cancer being treated.
If you have been prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day as a single dose.
If you have been prescribed Tyverb in combination with trastuzumab, the usual dose is 4 Tyverb tablets a day as a single dose.
If you have been prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day as a single dose.
Take the prescribed dose once every day for as long as your doctor tells you to.
Your doctor will explain how to dose your other cancer medicine and how to take it.
Taking the tablets
- Swallow the tablets whole with water, one at a time, at the same time each day.
- Take Tyverb either at least one hour before or at least one hour after a meal. Take Tyverb at the same time about a meal every day – for example, you can always take your tablet one hour before breakfast.
While taking Tyverb
- Depending on which side effects you experience, your doctor may decide that you should lower the dose or temporarily stop the treatment.
- Your doctor will also perform tests to check your heart and liver function before and during treatment with Tyverb.
If you have taken too much Tyverb
Contact a doctor or pharmacist immediately. If possible, show the packaging.
If you forget to take Tyverb
Do not take a double dose to make up for a missed dose. Just take the next dose as scheduled.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A severe allergic reaction is a rare side effect (may affect up to 1 in 1,000 people) and can develop quickly.
Symptoms may include:
- skin rash (including itchy and raised rash)
- unusual wheezing/wheezing or difficulty breathing
- swollen eyelids, lips, or tongue
- pain in muscles or joints
- collapse or temporary loss of consciousness
Tell your doctor immediately if you get any of these symptoms. Do not take any more tablets.
Very common side effects ( may affect more than 1 in 10 people):
- diarrhea (which can lead to dehydration and more serious complications)Tell your doctor immediately at the first sign of diarrhea (loose stools), as this must be treated immediately. Also, tell me immediately if your diarrhea gets worse. There is more advice on how to reduce the risk of diarrhea at the end of Section 4.
- rash, dry skin, itching. Tell your doctor if you get a rash. There is more advice on how to reduce the risk of skin rashes at the end of Section 4.
Other very common side effects:
- loss of appetite
- nausea
- vomiting
- fatigue, weakness
- indigestion
- constipation
- soreness/sores in the mouth
- stomach ache
- sleep difficulties
- back pain
- pain in hands and feet
- joint pain
- a skin reaction on the palms of the hands or soles of the feet (such as tingling, numbness, pain, swelling, or redness )
- cough, shortness of breath
- headache
- nosebleeds
- hot flashes
- unusual hair loss or thinning hair.
Tell your doctor if any of these side effects become severe or bothersome.
Common side effects ( may affect up to 1 in 10 people)
- an effect on how your heart works.
In most cases, this effect on your heart will not cause any symptoms. If you do experience symptoms linked to this side effect, these are likely to include irregular heartbeats and shortness of breath.
- liver problems which may cause itching, yellow discoloration of the eyes or skin (jaundice) or dark urine, or pain or discomfort in the upper right part of the stomach
- nail problems – such as a painful infection and swelling of the cuticles
- skin fissures (deep cracks in the skin or thin skin).
Tell your doctor if you get any of these symptoms.
Uncommon side effects ( may affect up to 1 in 100 people):
- treatment-induced pneumonia, which can cause shortness of breath or coughing. Tell your doctor immediately if you experience any of these symptoms.
Other less common side effects are:
- blood values that indicate liver damage (usually mild and transient).
Rare side effects ( may affect up to 1 in 1,000 people):
- severe allergic reactions (see the beginning of section 4).
The frequency of some side effects is not known (cannot be estimated from the available data):
- irregular heart rhythm (change in the electrical activity of the heart)
- serious skin reaction which may include: skin rash, reddening of the skin, blisters on the lips, eyes, or mouth, scaly skin, fever, or any combination of these
- pulmonary arterial hypertension (increased blood pressure in the lungs ‘ arteries (blood vessels)).
If you get any other side effect
Contact a doctor or pharmacist if you notice any side effects not mentioned above.
Reduce the risk of diarrhea and skin rashes
Tyverb can cause severe diarrhea
If you get diarrhea while taking Tyverb:
- drink plenty of fluids (8 to 10 glasses a day), e.g. water, sports drinks, or other clear liquids
- eat low-fat, high-protein foods instead of fatty or spicy foods
- eat cooked vegetables instead of raw vegetables and peel fruit before eating it
- avoid milk and milk products (including ice cream)
- avoid herbal supplements (some can cause diarrhea).
Tell your doctor if diarrhea persists.
Tyverb may cause a rash
Your doctor will check your skin before and during treatment.
Care for sensitive skin like this:
- wash with a detergent that does not contain soap
- use unscented, hypoallergenic beauty products
- use sunscreen (sun protection factor [SPF] 30 or higher).
Tell your doctor if you get a rash.
How Tyverb should be stored
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the blister or can and carton.
Store at a maximum of 30 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance in Tyverb is lapatinib. Each film-coated tablet contains lapatinib ditosylate monohydrate equivalent to 250 mg of lapatinib.
- Other ingredients are microcrystalline cellulose, povidone (K30), sodium starch glycolate (type A), magnesium stearate, hypromellose, titanium dioxide (E171), macrogol (400), polysorbate 80, yellow iron oxide (E172) and red iron oxide (E172).
Appearance and package sizes of the medicine
Tyverb film-coated tablets are oval, biconvex, yellow film-coated tablets, marked with “GS XJG” on one side.
Tyverb is supplied in blister packs or cans:
Blister packs
Each pack of Tyverb contains 70 or 84 tablets in aluminum foil blister cards, with 10 or 12 tablets in each. Each card is perforated along the center line and can be divided into two blister cards of 5 or 6 tablets each, depending on the pack size.
Tyverb is also available in a multipack of 140 tablets, consisting of 2 packs of 70 tablets each.
Cans
Tyverb is also supplied in plastic cans containing 70, 84, 105, or 140 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Glaxo Wellcome SA
Avenida de Extremadura 3
09400 Aranda de Duero
Burgos
Spain
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/BelgienNovartis Pharma NVTél/Tel: +32 2 246 16 11 | LithuaniaSIA Novartis Baltics Lietuvos filialasPhone: +370 5 269 16 50 |
| BulgariaNovartis Bulgaria EOODPhone: +359 2 489 98 28 | Luxembourg/LuxembourgNovartis Pharma NVTél/Tel: +32 2 246 16 11 |
| Czech RepublicNovartis s.r.oPhone: +420 225 775 111 | MagyarországNovartis Hungária Kft.Tel.: +36 1 457 65 00 |
| DenmarkNovartis Healthcare A/SPhone: +45 39 16 84 00 | MaltaNovartis Pharma Services Inc.Phone: +356 2122 2872 |
| DeutschlandNovartis Pharma GmbHPhone: +49 911 273 0 | The NetherlandsNovartis Pharma BVPhone: +31 88 04 52 555 |
| EstoniaSIA Novartis Baltics Eesti branch phone: +372 66 30 810 | NorwayNovartis Norway iPhone: +47 23 05 20 00 |
| GreeceNovartis (Greece) AEBEPhone: +30 210 281 17 12 | AustriaNovartis Pharma GmbHPhone: +43 1 86 6570 |
| SpainNovartis Farmacéutica, SAPhone: +34 93 306 42 00 | PolishNovartis Poland Sp. z o. iPhone: +48 22 375 4888 |
| FranceNovartis Pharma SASTel: +33 1 55 47 66 00 | PortugalNovartis Farma – Produtos Farmacêuticos, SAPhone: +351 21 000 8600 |
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| IrelandNovartis Ireland LimitedPhone: +353 1 260 12 55 | Slovenija Novartis Pharma Services Inc.Phone: +386 1 300 75 50 |
| IcelandVistor hf.Phone: +354 535 7000 | Slovenian RepublicNovartis Slovakia s.r.oPhone: +421 2 5542 5439 |
| ItalyNovartis Pharma SpAPhone: +39 02 96 54 1 | Finland/FinlandNovartis Finland OyTel: +358 (0)10 6133 200 |
| CyprusNovartis Pharma Services Inc.Phone: +357 22 690 690 | SwedenNovartis Sweden ABPhone: +46 8 732 32 00 |
| LatviaSIA Novartis BalticsPhone: +371 67 887 070 | United Kingdom (Northern Ireland)Novartis Ireland LimitedPhone: +44 1276 698370 |