JAKAVI 20 mg TABLETS

2. What you need to know before you take Jakavi

Follow carefully all instructions given to you by your doctor or pharmacist. These may be different from the general information contained in this leaflet.

Do not take Jakavi

• if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breast-feeding (see section 2 “Pregnancy, breast-feeding and fertility”)

Warnings and precautions

Tell your doctor or pharmacist before you start taking Jakavi if:

• you have any infection. It may be necessary to treat the infection before starting treatment with Jakavi
• you have had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis or any other infection
• you have had hepatitis B
• you have kidney or liver problems, as your doctor may need to adjust your dose of Jakavi
• you have had cancer, particularly skin cancer
• you have had heart problems
• you are over 65 years old. Patients over 65 years old may have a higher risk of heart problems, including heart attack, and some types of cancer
• you smoke or have smoked in the past

Tell your doctor or pharmacist during treatment with Jakavi if:

• you develop fever, chills, or other symptoms of infection
• you develop a chronic cough with bloody sputum, fever, night sweats, and weight loss (these may be signs of tuberculosis)
• you develop any of the following symptoms or if someone close to you notices that you have any of these symptoms: confusion or difficulty reasoning, loss of balance or difficulty walking, lack of coordination (clumsiness), difficulty speaking, decreased strength or weakness on one side of your body, blurred vision and/or loss of vision. These may be signs of a serious brain infection and your doctor may recommend additional tests and follow-up)
• you develop a painful skin rash with blisters (these are signs of herpes)
• you have any changes in your skin. This may require closer monitoring, as some types of cancer (non-melanoma) have been reported
• you experience sudden shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling in the legs or arms, pain or tenderness in the legs, redness or discoloration of the legs or arms, may be signs of blood clots in the veins

Children and adolescents

This medicine is not intended for use in children or adolescents under 18 years of age with myelofibrosis or polycythaemia vera, as it has not been studied in this age group.

For the treatment of graft-versus-host disease, Jakavi may be used in patients 28 days of age or older.

Other medicines and Jakavi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. While taking Jakavi, do not start taking a new medicine without first talking to the doctor who prescribed Jakavi. This includes prescription medicines, non-prescription medicines, and herbal or alternative medicines.

It is particularly important that you mention medicines that contain any of the following active substances, as your doctor may need to adjust your dose of Jakavi.

The following medicines may increase the risk of side effects with Jakavi:

• Some medicines used to treat infections:
• • medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole, and voriconazole)
  • antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
  • medicines used to treat viral infections, including HIV/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines used to treat hepatitis C (boceprevir, telaprevir)
• a medicine used to treat depression (nefazodone)
• medicines used to treat high blood pressure (hypertension) and chest pressure or heaviness (angina pectoris) (mibefradil or diltiazem)
• a medicine used to treat stomach acid (cimetidine)
• a medicine used to treat heart disease (avasimibe)
• medicines used to treat seizures or fits (phenytoin, carbamazepine, or phenobarbital and other antiepileptics)
• medicines used to treat tuberculosis (rifabutin or rifampicin)
• a herbal product used to treat depression (St. John's Wort (Hypericum perforatum))

Check with your doctor if you are not sure if the above applies to you.

Pregnancy, breast-feeding, and fertility

Pregnancy

• If you are pregnant or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breast-feeding

• Do not breast-feed while being treated with Jakavi (see section 2 “Do not take Jakavi”). Consult your doctor.

Fertility

• Jakavi is not recommended for women who may become pregnant and are not using contraception. Discuss with your doctor the most suitable contraception to avoid becoming pregnant while being treated with Jakavi.
• Inform your doctor if you become pregnant while taking Jakavi.

Driving and using machines

If you experience dizziness after taking Jakavi, do not drive or use machines.

Jakavi contains lactose and sodium

Jakavi contains lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Jakavi

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Before starting treatment with Jakavi and during treatment, your doctor will ask you to have blood tests to determine the best dose, to see how you respond to treatment, and if Jakavi is having any side effects. Your doctor may need to adjust the dose or interrupt treatment. Before starting your treatment and during treatment with Jakavi, your doctor will check that you do not have signs or symptoms of infection.

Myelofibrosis

• Adults: The recommended starting dose in myelofibrosis is 5 mg to 20 mg twice a day. The maximum dose is 25 mg twice a day in adults.

Polycythaemia vera

• Adults: The recommended starting dose in polycythaemia vera is 10 mg twice a day. The maximum dose is 25 mg twice a day in adults.

Graft-versus-host disease

• Children from 6 to less than 12 years: The recommended starting dose in graft-versus-host disease is 5 mg twice a day in patients from 6 to 12 years
• Children from 12 years and older and adults: The recommended starting dose in graft-versus-host disease is 10 mg twice a day for patients 12 years or older.

If you have problems swallowing the whole tablets and for children under 6 years, there is an oral solution. Ask your doctor or pharmacist.

You should take Jakavi every day at the same time, with or without food.

Your doctor will always tell you exactly how many Jakavi tablets to take.

You should continue to take Jakavi for as long as your doctor tells you. This is a long-term treatment.

If you take more Jakavi than you should

If you accidentally take more Jakavi than your doctor has prescribed, contact your doctor or pharmacist immediately.

If you forget to take Jakavi

If you miss a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you have any other questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Most side effects of Jakavi are mild to moderate and usually disappear after a few days to a few weeks of treatment.

Myelofibrosis and polycythaemia vera

Some side effects can be serious

Seek medical attention immediately before taking the next dose if you notice any of the following serious side effects:

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

• any sign of bleeding in the stomach or intestine, such as black stools or blood in your stools, or vomiting blood
• unexpected bruising and/or bleeding, unusual tiredness, difficulty breathing when exercising or at rest, pale skin, or frequent infections - possible symptoms of blood disorders
• painful rash with blisters - possible symptoms of herpes (herpes zoster)
• fever, chills, or other symptoms of infection

• low red blood cell count (anaemia), low white blood cell count (neutropenia), or low platelet count (thrombocytopenia)

Common (may affect up to 1 in 10 people)

• any sign of bleeding in the brain, such as sudden changes in levels of consciousness, persistent headache, numbness, tingling, weakness, or paralysis

Other side effects with Jakavi

Other possible side effects are listed below. If you experience these side effects, talk to your doctor or pharmacist.

Very common (may affect more than 1 in 10 patients):

• high levels of cholesterol or fat in the blood (hypertriglyceridaemia)
• abnormal liver function test results
• dizziness
• headache
• urinary tract infections
• weight gain
• fever, cough, difficulty or pain when breathing, wheezing, chest pain when breathing - possible symptoms of pneumonia
• high blood pressure (hypertension), which may also cause dizziness or headaches
• constipation
• high levels of lipase in the blood

Common (may affect up to 1 in 10 patients):

• low levels of all three types of blood cells - red blood cells, white blood cells, and platelets (pancytopenia)
• passing gas frequently (flatulence)

Uncommon (may affect up to 1 in 100 patients):

• tuberculosis
• recurrent hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, pain in the upper right side of the abdomen, fever, and feeling sick or nauseous)

Graft-versus-host disease

Some side effects can be serious

Seek medical attention immediately before taking the next dose if you notice any of the following serious side effects:

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

• signs of infection with fever, including:
• • muscle pain, skin redness, and/or difficulty breathing (cytomegalovirus infection)
  • pain when urinating (urinary tract infection)
  • rapid heartbeat, confusion, and rapid breathing (sepsis, which is a disease associated with infection and widespread inflammation)
• frequent infections, fever, chills, sore throat, or mouth ulcers
• spontaneous bleeding or bruising - possible symptoms of thrombocytopenia caused by low platelet levels

Other side effects

Very common (may affect more than 1 in 10 patients):

• headache
• high blood pressure (hypertension)
• abnormal blood test results:
• • high levels of lipase and/or amylase
  • high levels of cholesterol
  • abnormal liver function

• high levels of the muscle enzyme creatine phosphokinase in the blood

• high levels of creatinine, an enzyme that indicates that your kidneys are not working properly

• low levels of all three types of blood cells - red blood cells, white blood cells, and platelets (pancytopenia)
• feeling sick (nausea)
• fatigue, tiredness, paleness - possible symptoms of anaemia caused by low red blood cell levels

Common (may affect up to 1 in 10 patients):

• fever, muscle pain, or pain or difficulty when urinating, blurred vision, cough, cold, or difficulty breathing - possible symptoms of BK virus infection
• weight gain
• constipation

Reporting of side effects

If you experience 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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Jakavi

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 carton or blister after “EXP”.

Do not store above 30°C.

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 protect the environment.

6. Container contents and additional information

Jakavi composition

• The active substance of Jakavi is ruxolitinib.
• Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
• Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
• Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
• Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, sodium starch glycolate (see section 2), povidone, hydroxypropylcellulose, lactose monohydrate (see section 2).

Product appearance and container contents

Jakavi 5 mg tablets are round, white to off-white tablets with «NVR» engraved on one side and «L5» engraved on the other side.

Jakavi 10 mg tablets are round, white to off-white tablets with «NVR» engraved on one side and «L10» engraved on the other side.

Jakavi 15 mg tablets are oval, white to off-white tablets with «NVR» engraved on one side and «L15» engraved on the other side.

Jakavi 20 mg tablets are elongated, white to off-white tablets with «NVR» engraved on one side and «L20» engraved on the other side.

Jakavi tablets are available in blister packs containing 14 or 56 tablets or multiple packs containing 168 tablets (3 packs of 56).

Only some pack sizes may be marketed in your country.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharmaceutical Manufacturing LLC

Verovškova ulica 57

1000 Ljubljana

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu