English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Cabometyx (cabozantinib s-malate) – Package leaflet - L01XE26

Updated on site: 05-Oct-2017

Package leaflet: Information for the patient

CABOMETYX 20 mg film-coated tablets CABOMETYX 40 mg film-coated tablets CABOMETYX 60 mg film-coated tablets cabozantinib

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What CABOMETYX is and what it is used for

2.What you need to know before you take CABOMETYX

3.How to take CABOMETYX

4.Possible side effects

5.How to store CABOMETYX

6.Contents of the pack and other information

1.What CABOMETYX is and what it is used for

What CABOMETYX is

CABOMETYX is a cancer medicine that contains the active substance cabozantinib. It is used to treat advanced stages of a type of kidney cancer called renal cell carcinoma, in adults who have already had previous treatment.

How CABOMETYX works

CABOMETYX blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. These proteins can be present in high amounts in cancer cells, and by blocking their action CABOMETYX can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs.

2. What you need to know before you take CABOMETYX

Do not take CABOMETYX

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

Warnings and precautions

Talk to your doctor or pharmacist before taking CABOMETYX if you:

-have high blood pressure

-have diarrhoea

-have a recent history of significant bleeding

-have had surgery within the last month (or if surgical procedures are planned), including dental surgery

-

-have inflammatory bowel disease (for example, Crohn’s disease or ulcerative colitis, diverticulitis, or appendicitis)

-have a recent history of blood clot in the leg, stroke, or heart attack

-have liver or kidney disease.

Tell your doctor if any of these affect you. You may need treatment for them, or your doctor may decide to change your dose of CABOMETYX, or stop treatment altogether. See also section 4 “Possible side effects”.

Children and adolescents

CABOMETYX is not recommended for children or adolescents. The effects of CABOMETYX in people younger than 18 years old are not known.

Other medicines and CABOMETYX

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because CABOMETYX can affect the way some other medicines work. Also, some medicines can affect the way CABOMETYX works. This could mean that your doctor needs to change the dose(s) that you take. You should tell your doctor about every medicines, but in particular if taking:

-Medicines that treat fungal infections, such as itraconazole, ketoconazole, and posaconazole

-Medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin, and rifampicin

-Allergy medicines such as fexofenadine and ranolazine

-Medicines used to treat epilepsy or fits such as phenytoin, carbamazepine, and phenobarbital

-Herbal preparations containing St. John’s Wort (Hypericum perforatum), sometimes used for treating depression or depression-related conditions such as anxiety

-Medicines used to thin the blood, such as warfarin

-Medicines to treat high blood pressure or other heart conditions, such as aliskiren, ambrisentan, dabigatran etexilate, digoxin, talinolol, and tolvaptan

-Medicines for diabetes, such as saxagliptin and sitagliptin

-Medicines used to treat gout, such as colchicine

-Medicines used to treat HIV or AIDS, such as efavirenz, ritonavir, maraviroc and emtricitabine

-Medicines used to prevent transplant rejection (ciclosporin) and ciclosporin-based regimens in rheumatoid arthritis and psoriasis

Oral contraceptives

If you take CABOMETYX whilst using oral contraceptives, the oral contraceptives may be ineffective. You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking CABOMETYX and for at least 4 months after treatment has finished.

Taking CABOMETYX with food

You should not take CABOMETYX with food. You should not eat anything for at least 2 hours before taking CABOMETYX and for 1 hour after taking the medicine. Avoid consuming grapefruit-containing products for as long as you are using this medicine, as they may increase the levels of CABOMETYX in your blood.

Pregnancy, breast-feeding and fertility

Avoid becoming pregnant while being treated with CABOMETYX. If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished. Talk to your doctor about which methods of contraception are appropriate while you are taking CABOMETYX (see also under Other medicines and CABOMETYX, above).

Tell your doctor if you or your partner become pregnant or plan to become pregnant while you are being treated with CABOMETYX.

Talk to your doctor BEFORE taking CABOMETYX if you or your partner are considering or planning to have a baby after your treatment has finished. There is a possibility your fertility could be affected by treatment with CABOMETYX.

Women taking CABOMETYX should not breast-feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.

Driving and using machines

Use caution when driving or using machines. Keep in mind that treatment with CABOMETYX may make you feel tired or weak and can affect your ability to drive or use machines.

CABOMETYX contains lactose

CABOMETYX contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3.How to take CABOMETYX

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

You should continue to take this medicine until your doctor decides to stop your treatment. If you get serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned. Your doctor will tell you if you need your dose adjusted.

CABOMETYX should be taken once a day. The usual dose is 60 mg, however your doctor will decide on the right dose for you.

CABOMETYX should not be taken with food. You should not eat anything for at least 2 hours before taking CABOMETYX and for 1 hour after taking the medicine. Swallow the tablet with a full glass of water. Do not crush the tablets.

If you take more CABOMETYX than you should

If you have taken more CABOMETYX than you have been instructed to, talk to a doctor or go to the hospital with the tablets and this leaflet straight away.

If you forget to take CABOMETYX

-If there are still 12 hours or more before your next dose is due, then take the missed dose as soon as you remember. Take the next dose at the normal time.

-If your next dose is due in less than 12 hours, then do not take the dose that you have missed. Take your next dose at the normal time.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get side effects, your doctor may tell you to take CABOMETYX at a lower dose. Your doctor may also prescribe other medicines to help control your side effects.

Tell your doctor straight away if you notice any of the following side effects – you may need urgent medical treatment:

Symptoms including pain in the abdomen (belly), nausea (feeling sick), vomiting, constipation, or fever. These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.

Severe or uncontrollable bleeding with symptoms such as: vomiting blood, black stolls, bloody urine, headache, coughing up of blood.

Swelling, pain in your hands and feet, or shortness of breath.

A wound that does not heal.

Fits, headaches, confusion, or finding it difficult to concentrate. These may be signs of a condition called reversible posterior leukoencephalopathy syndrome (RPLS). RPLS is uncommon (it affects less than 1 in 100 people).

Other side effects include:

Very common side effects (may affect more than 1 in 10 people)

Stomach upset, including diarrhoea, nausea, vomiting, constipation, indigestion, and abdominal pain

Blisters, pain of the hands or soles of the feet, rash or redness of the skin, dry skin

Decreased appetite, weight loss, altered sense of taste

Fatigue, weakness, headache, dizziness

Hypertension (increase in blood pressure)

Anaemia (low levels of red blood cells)

Redness, swelling or pain in the mouth or throat, difficulty in speaking, hoarseness, cough

Changes in blood tests used to monitor general health and function of your organs (including the liver), low levels of electrolytes (like magnesium, calcium, sodium, or potassium)

Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)

Pain in arms, legs and joints, muscle spasms

Shortness of breath

Protein in urine (seen in tests)

Reduced thyroid activity; symptoms can include: tiredness, weight gain, constipation, feeling cold and dry skin

Common side effects (may affect up to 1 in 10 people)

Abscess (collection of pus, with swelling and inflammation)

Dehydration (lack of fluids)

Ringing in ears

Blood clots in the lungs

Pain in the upper part of the abdomen

Gastro-oesophageal reflux disease (bringing up stomach acid)

Haemorrhoids (piles)

Alopecia (hair loss and thinning)

Swelling in your legs, feet, arms and hands

Uncommon side effects (may affect 1 in 100 people)

Fits

A painful tear or abnormal connection of the tissue in your anus

Inflammation of the pancreas

Decrease in bile flow from the liver

Bone damage in the jaw

Reporting of side effects

If you get any side effects, talk to your doctor 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 listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5.How to store CABOMETYX

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 blister, bottle label and carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CABOMETYX contains

The active substance is cabozantinib (S)-malate.

CABOMETYX 20 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 20 mg of cabozantinib.

CABOMETYX 40 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 40 mg of cabozantinib.

CABOMETYX 60 mg film-coated tablets: Each tablet contains cabozantinib (S)-malate equivalent to 60 mg of cabozantinib.

The other ingredients are:

-Tablet contents: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide anhydrous, magnesium stearate. (see section 2 for lactose content)

-Film coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172)

What CABOMETYX looks like and contents of the pack

CABOMETYX 20 mg film-coated tablets are yellow, round with no score, and identified with “XL” on one side and “20” on the other side.

CABOMETYX 40 mg film-coated tablets are yellow, triangle shaped with no score, and identified with

“XL” on one side and “40” on the other side.

CABOMETYX 60 mg film-coated tablets are yellow, oval shaped with no score, and identified with “XL” on one side and “60” on the other side.

CABOMETYX tablets are available in packs containing either 4 blisters with 7 tablets each (28 total), or one plastic bottle with 30 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt France

Manufacturer

Patheon France

40 Boulevard de Champaret

38300 Bourgoin Jallieu, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien, Luxembourg/Luxemburg

Italia

Ipsen NV Guldensporenpark 87

Ipsen SpA

B-9820 Merelbeke

Via del Bosco Rinnovato n. 6

België /Belgique/Belgien

Milanofiori Nord Palazzo U7

Tél/Tel: + 32 - 9 - 243 96 00

20090 Assago (Mi)

 

Tel: + 39 - 02 - 39 22 41

България, România

Latvija

Ipsen Pharma

Ipsen Pharma representative office

Str. Grigore Alexandrescu nr. 59,

clădirea HQ Victoriei, Sector 1,

Riga

010626, Bucureşti

LV 1046

Tel: + 40 (021) 231 27 20

Tel: +371 67622233

Česká republika

Lietuva

Ipsen Pharma, o.s. Evropská 136/810 CZ-160 00

Ipsen Pharma SAS Lietuvos filialas

Praha 6

Jonavos g. 43a, LT-44131 Kaunas

Tel: + 420 242 481 821

Tel. + 370 37 337854

Danmark, Norge, Suomi/Finland, Sverige, Ísland

Magyarország

Institut Produits Synthèse (IPSEN) AB

Ipsen Pharma SAS Magyarországi Kereskedelmi

Kista Science Tower

Képviselet

Färögatan 33

Árbóc utca 6.

SE- 164 51 Kista

H- 1133 Budapest

Sverige/Ruotsi/Svíþjóð

Tel.: +36-1-555-5930

Tlf/Puh/Tel/Sími: +46 8 451 60 00

 

Deutschland, Österreich

Nederland

Ipsen Pharma GmbH

Ipsen Farmaceutica B.V.

Willy-Brandt-Str. 3

Taurusavenue 33b

D-76275 Ettlingen

2132 LS Hoofddorp

Tel.: +49 7243 184-80

Tel: + 31 (0) 23 554 1600

 

Eesti

Polska

ESTOBIIN OÜ

Ipsen Poland Sp. z o.o. Al. Jana Pawła II 29

00-867 Warszawa

EE-11913 Tallinn

Tel.: + 48 (0) 22 653 68 00

Tel: +372 51 55 810

 

Ελλάδα, Κύπρος, Malta

Portugal

Ipsen EΠΕ

Ipsen Portugal - Produtos Farmacêuticos S.A.

Αγ. Δημητρίοσ 63 Άλιμος

Alameda Fernão Lopes, n° 16-11°

GR-17456 Αθήνα Ελλάδα

Miraflores P-1495 - 190 Algés

Τηλ: + 30 - 210 - 984 3324

Portugal

 

Tel: + 351 - 21 - 412 3550

España

Slovenská republika

Ipsen Pharma, S.A.

Liek s.r.o.

Torre Realia, Plaza de Europa, 41-43

Hviezdoslavova 19

08908 L‟Hospitalet de Llobregat

SK-90301 Senec

Barcelona

Slovenská republika

Tel: + 34 - 936 - 858 100

Tel: + 421 253 412 018

France, Hrvatska, Slovenija

United Kingdom

Ipsen Pharma

Ipsen Ltd.

65 quai Georges Gorse

190 Bath Road

92100 Boulogne-Billancourt

Slough, Berkshire SL1 3XE

France

United Kingdom

Tél: + 33 1 58 33 50 00

Tel: + 44 (0)1753 - 62 77 00

Ireland

 

Ipsen Pharmaceuticals Ltd.

 

Blanchardstown Industrial Park

 

Blanchardstown

 

IRL-Dublin 15

 

Tel: +353-1-809-8256

 

This leaflet was last revised in

 

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

ANNEX IV

CONCLUSIONS ON THE REQUEST FOR ONE-YEAR DATA EXCLUSIVITY PRESENTED BY

THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

one-year marketing protection

The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed