20 mg, 40 mg and 60 mg film-coated tablets 
kabozantinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What CABOMETYX is and what it is used for 
2. What you need to know before you use CABOMETYX 
3. How to take CABOMETYX 
4. Possible side effects 
5. How to store CABOMETYX 6. Contents of the pack 
and other ingredients 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 kidney cancer
  • liver cancer in adults who have previously been treated with a specific anticancer medicine (sorafenib).

How CABOMETYX works

CABOMETYX blocks the effect of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply the cells. These proteins can be found in large amounts in cancer cells. By blocking their effect, CABOMETYX can slow down the growth rate of the tumor and help cut off the blood supply that the cancer cells need.

2. What you need to know before using 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 cautions

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

  • have high blood pressure
  • have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall
  • have diarrhea
  • recently had a major hemorrhage
  • have had surgery within the last month (or if any surgery is planned), including dental surgery
  • have inflammatory bowel disease (eg Crohn’s disease or ulcerative colitis , diverticulitis, or appendicitis)
  • recently had a blood clot in the leg, stroke, or heart attack
  • have any liver or kidney disease.

Tell your doctor if any of the above apply to you. You may need to be treated for it, or your doctor may change your dose of CABOMETYX, or stop your treatment altogether. See also section 4 “ Possible side effects”.

Also, tell your dentist that you are taking CABOMETYX. It is important that you take care of your oral hygiene during treatment with CABOMETYX.

Children and young people

CABOMETYX is not recommended for children and adolescents. The effects of CABOMETYX on persons under 18 years of age are unknown.

Other medicines and CABOMETYX

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is important because CABOMETYX may affect the way some other medicines work. In addition, some medicines may affect the way CABOMETYX works. This may mean that your doctor needs to change the dose (s) you are taking. You should inform your doctor about all the medicines you use, but it is especially important if you use:

  • Medicines for fungal infections, e.g. itraconazole, ketoconazole and posaconazole
  • Drugs against bacterial infections ( antibiotics ), e.g. erythromycin, clarithromycin, and rifampicin
  • Allergy drugs, e.g. fexofenadine
  • Medicines for angina pectoris (chest pain due to insufficient blood flow to the heart), e.g. ranolazine
  • Medicines for epilepsy or seizures, e.g. phenytoin, carbamazepine, and phenobarbital
  • (Traditional) herbal medicines containing St. John’s wort (Hypericum perforatum), which are sometimes used to treat depression or depression-related conditions, e.g. anxiety
  • Drugs that make the blood thinner, e.g. warfarin and dabigatran etexilate
  • Medicines for high blood pressure or other heart diseases, e.g. aliskiren, ambrisentan, digoxin, thalinolol, and tolvaptan
  • Drugs for diabetes, e.g. saxagliptin and sitagliptin
  • Medicines for gout, e.g. kolkicin
  • Medicines for HIV or AIDS , e.g. efavirenz, ritonavir, maraviroc and emtricitabine
  • Medicines to prevent graft rejection (cyclosporine) and cyclosporine-based treatments for rheumatoid arthritis ( rheumatoid arthritis ) and psoriasis

Birth control pills

If you take CABOMETYX while you are taking the contraceptive pill , the contraceptive pill may have no effect. Therefore, you should also use a barrier contraceptive (eg condom or diaphragm ) while taking CABOMETYX and for at least 4 months after stopping treatment.

CABOMETYX with food

Do not take CABOMETYX with food. You should not eat anything for at least 2 hours before taking CABOMETYX and 1 hour after taking the medicine. Avoid eating or drinking products that contain grapefruit while you are taking this medicine, as they may increase the amount of CABOMETYX in your blood.

Pregnancy, breastfeeding, and fertility

Avoid getting pregnant while you are being treated with CABOMETYX. If you or your partner may become pregnant, you must use appropriate contraception during treatment and for at least 4 months after the end of treatment. Ask your doctor which contraceptive methods are suitable while you are taking CABOMETYX (see also 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 you take CABOMETYX if you or your partner are considering or planning to have children after your treatment has ended. There is a risk that your fertility may be affected by treatment with CABOMETYX.

Women taking CABOMETYX should not breast-feed during treatment and not for at least 4 months after stopping treatment, as cabozantinib and/or its degradation products ( metabolites ) may be excreted in human milk and harm your baby.

Driving and using machines

Be careful when driving or using machines. Keep in mind that treatment with CABOMETYX may make you feel tired or weak and may 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, contact your doctor before taking this medicine.

How to take CABOMETYX

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

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

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

CABOMETYX should not be taken with food. You should not eat anything for at least 2 hours before taking CABOMETYX and 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 were told to, talk to a doctor or go straight to the hospital and take the tablets and this leaflet with you.

If you forget to take CABOMETYX

  • If it is still 12 hours or more until it is time for the next dose, take the missed dose as soon as you remember. Take the next dose at the usual time.
  • If it is less than 12 hours until it is time for the next dose, do not take the missed dose. Take the next dose at the usual 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 a lower dose of CABOMETYX. Your doctor may also prescribe other medicines to help keep the side effects under control.

Contact your doctor immediately if you notice any of the following side effects- you may need urgent medical attention:

  • Symptoms such as abdominal pain, nausea, vomiting, constipation, or fever. They may be signs of gastrointestinal perforation, ie. a hole that forms in the stomach or intestines and can be life-threatening.
  • Severe or uncontrollable bleeding with symptoms such as bloody vomiting, black stools, blood in the urine, headache, bloody cough.
  • Swelling, pain in hands and feet, or shortness of breath.
  • A wound that does not heal.
  • Seizures, headaches, confusion, or difficulty concentrating. They may be signs of a condition called posterior reversible encephalopathy syndrome (PRES). PRES is rare (affects less than 1 user in 1,000).
  • Feeling drowsy, confused, or losing consciousness. This may be due to liver problems.
  • Pain in the mouth, teeth and/or jaw, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw or tooth loss. This may be a sign of bone damage in the jaw ( osteonecrosis ).

Other side effects are:

Very common side effect is (can occur in more than 1 in 10) 

  • Stomach upset, including diarrhea, nausea, vomiting, constipation, indigestion, abdominal pain
  • Blisters, pain in the hands or soles of the feet, rash or redness of the skin
  • Decreased appetite, weight loss, altered taste experience
  • Fatigue, weakness, headache, dizziness
  • High blood pressure
  • Anemia (low red blood cell count )
  • Low platelet count
  • Redness, swelling or pain in the mouth and throat, difficulty speaking, hoarseness, cough
  • Changes in blood test results used to control general health and organ function (including liver and kidneys), low levels of electrolytes (such as magnesium or potassium )
  • Shortness of breath
  • Decreased activity of the thyroid gland with symptoms such as fatigue, weight gain, constipation, chills, and dry skin
  • Swelling of legs and arms
  • Pain in arms, hands, legs, or feet
  • Low levels of albumin in the blood

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

  • An abscess (accumulation of var, with swelling and inflammation )
  • Dehydration
  • Difficulty swallowing
  • Ringing in the ears ( tinnitus )
  • Blood clots in blood vessels and lungs
  • Low levels of white blood cells
  • Increase or decrease in blood sugar levels
  • Decreased level of calcium, sodium, and phosphate in the blood
  • Increased level of potassium in the blood
  • Increased levels of bilirubin in the blood (which may cause jaundice/yellowing of the skin or eyes)
  • Increased level of amylase in the blood
  • Increased level of lipase in the blood
  • Increased levels of cholesterol or triglyceride are in the blood
  • Numbness, tingling, burning sensation, or pain in arms and legs
  • A painful crack or abnormal channel in the body tissue you
  • Gastroesophageal reflux disease (leakage of acidic stomach contents into the esophagus)
  • Hemorrhoids
  • Dry mouth and pain in the mouth
  • Feeling drowsy, confused, or losing consciousness due to liver problems
  • Dry skin, severe itchy skin, acne
  • Thickening of the outer layer of skin
  • Alopecia (hair loss and thinning hair), change in hair color
  • Joint pain, muscle spasms
  • Protein in the urine (detected by the test)
  • A burning or stinging sensation in the tongue

Less common side effects are (may affect 1 in 100)

  • Cramps
  • Inflammation of the pancreas
  • Decreased flow of bile from the liver
  • Injury to the jawbone
  • Wound complications

Has been reported (occurs in an unknown number of users)

  • Stroke
  • Myocardial infarction
  • An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 can label and carton 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.

6. Contents of the packaging and other information

Content declaration

The active substance is kabozantinib ( S ) -malate.

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

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

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

Other ingredients are:

  • Tablet contents: microcrystalline cellulose, anhydrous lactose, hydroxypropyl cellulose, croscarmellose sodium, anhydrous colloidal silicon dioxide, magnesium stearate. (See section 2 for lactose content).
  • Film coating: hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

CABOMETYX 20 mg film-coated tablets are yellow, round without a notch, marked with “XL” on one side and “20” on the other.

CABOMETYX 40 mg film-coated tablets are yellow, triangular in shape without a notch, marked with “XL” on one side and “40” on the other.

CABOMETYX 60 mg film-coated tablets are yellow, oval without a notch, marked with “XL” on one side and “60” on the other.

CABOMETYX tablets are supplied in packs of 30 plastic tablets.

The jar contains three desiccant containers with silica gel. Store the desiccant containers in the jar and do not swallow them.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

France

Manufacturer

Patheon France

40 Boulevard de Champaret

38300 Bourgoin Jallieu

France

Or

Tjoapack Netherlands BV

New Donk 9

4879 AC Etten-Leur

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Denmark, Norway, Finland / Finland, Iceland

Institute of Synthesis Products (IPSEN) AB

Kista Science Tower

Färögatan 33

SE-164 51 Kista

Sverige / Ruotsi / Sverige

Phone / Puh / Tel / Phone: +46 8 451 60 00

Muhammad Nadeem

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