Package leaflet: Information for the patient

Jakavi 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets

ruxolitinib
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
The information in this leaflet is intended for you or for the child, but the text will refer only to “you”.

Contents of this leaflet

What Jakavi is and what it is used for
What you need to know before taking Jakavi
How to take Jakavi
Possible side effects
How to store Jakavi
Contents of the pack and other information

1. What Jakavi is and what it is used for

Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat adult patients with an enlarged spleen or symptoms related to
myelofibrosis, a rare form of blood cancer.
Jakavi is also used to treat adult patients with polycythaemia vera who are resistant or intolerant to
hydroxyurea.
Jakavi is also used to treat:

children aged 28 days and older and adults with acute graft-versus-host disease (GvHD).
children aged 6 months and older and adults with chronic GvHD. There are two forms of GvHD: an early form called acute GvHD, which usually develops soon after transplantation and may affect the skin, liver, and gastrointestinal tract, and a later form called chronic GvHD, which develops later, usually weeks or months after transplantation. Almost any organ can be affected by chronic GvHD.

How Jakavi works
One of the features of myelofibrosis is an enlarged spleen. Myelofibrosis is a bone marrow disorder in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce a sufficient number of blood cells, and as a result the spleen becomes significantly enlarged. By blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi can reduce spleen size in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain, and weight loss in patients with myelofibrosis. Jakavi may help reduce the risk of serious blood or vascular complications.
Polycythaemia vera is a bone marrow disorder in which the marrow produces too many red blood cells. Blood becomes thicker as a result of the increased number of red blood cells. Jakavi can relieve symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), thereby potentially reducing the risk of serious blood or vascular complications.
Graft-versus-host disease is a complication that occurs after transplantation when certain cells (T cells) from the donor’s transplanted organ (e.g. bone marrow) fail to recognize the recipient’s cells/organs and attack them. By selectively blocking certain enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces the signs and symptoms of both acute and chronic forms of graft-versus-host disease, leading to improvement of the disease and survival of the transplanted cells.
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Jakavi

Follow all your doctor's instructions carefully. These instructions may differ from the general information contained in this leaflet.

Do not take Jakavi

if you are allergic to ruxolitinib or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Jakavi if:

you have infections. It may be necessary to treat the infection before starting treatment with Jakavi.
you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may carry out tests to check whether you have tuberculosis or other infections.
you have ever had hepatitis B.
you have kidney problems or have or have ever had liver problems, as your doctor may need to prescribe a different dose of Jakavi.
you have ever had cancer, particularly skin cancer.
you have or have had heart problems.
you are aged 65 years or older. Patients aged 65 years or older may have an increased risk of heart problems, including heart attack, and certain types of cancer.
you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during treatment with Jakavi if:

you develop fever, chills or other signs of infection.
you develop a chronic cough with blood-streaked sputum, fever, night sweats, or weight loss (these may be signs of tuberculosis).
you experience any of the following symptoms, or if someone close to you notices any of these symptoms: confusion or difficulty concentrating, loss of balance or difficulty walking, lack of coordination, difficulty speaking, loss of strength or weakness on one side of the body, blurred vision and/or loss of vision. These may be signs of a serious brain infection, and your doctor may recommend further tests and follow-up examinations.
you develop painful skin rashes with blisters (these are signs of shingles).
you notice changes in your skin. This may require further monitoring, as certain types of non-melanoma skin cancer have been reported.
you suddenly develop shortness of breath or difficulty breathing, chest pain or upper back pain, swelling of an arm or leg, pain or tenderness in the leg, or redness or discoloration in the arm or leg, as these may be signs of blood clots in the veins.

Children and adolescents

This medicine is not recommended 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 aged 28 days and 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, you must never start taking a new medicine without first consulting the doctor who prescribed Jakavi for you. This applies to prescription medicines, over-the-counter medicines, and herbal or alternative remedies.

It is particularly important that you inform your doctor about medicines containing the following active substances, as your doctor may need to adjust the dose of Jakavi:

Some medicines used to treat infections:
medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, fluconazole, and voriconazole)
antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
medicines to treat viral infections, including HIV/AIDS infection (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
medicines to treat hepatitis C (boceprevir, telaprevir).
A medicine used to treat depression (nefazodone).
Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness, or pain (chronic angina pectoris) (mibefradil or diltiazem).
A medicine to treat heartburn (cimetidine).
A medicine to treat heart disease (avasimibe).
Medicines used to prevent seizures or convulsions (phenytoin, carbamazepine, phenobarbital, and other antiepileptics).
Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
A herbal product used for the treatment of depression (St John’s wort (Hypericum perforatum)). Talk to your doctor if you are unsure whether any of the above applies to you.

Pregnancy, breastfeeding and contraception

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breastfeeding

Do not breastfeed while taking Jakavi (see section 2 “Do not take Jakavi”). Ask your doctor for advice.

Contraception

Taking Jakavi is not recommended for women who could become pregnant and who are not using contraceptive measures. Talk to your doctor about using appropriate contraception to avoid becoming pregnant during treatment with Jakavi.
Talk to your doctor if you become pregnant while taking Jakavi.

Driving and using machines

If you feel dizzy after taking Jakavi, do not drive or operate machinery.

Jakavi contains lactose and sodium

Jakavi contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Jakavi

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Before starting treatment with Jakavi and during treatment, your doctor will perform blood tests to determine the best dose, to assess how you are responding to treatment, and whether Jakavi is causing any unwanted effects. Your doctor may need to adjust the dose or stop treatment. Your doctor will carefully monitor you for any signs or symptoms of infection before starting and during treatment with Jakavi.

Myelofibrosis

Adults: The recommended starting dose in myelofibrosis is 5 to 20 mg twice daily. The maximum dose is 25 mg twice daily.

Polycythaemia vera

Adults: The recommended starting dose in polycythaemia vera is 10 mg twice daily. The maximum dose is 25 mg twice daily.

Acute and chronic graft-versus-host disease

Children aged 6 years and older but less than 12 years: the recommended starting dose is 5 mg twice daily.
Children aged 12 years and older and adults: the recommended starting dose is 10 mg twice daily.

An oral solution is available if you have difficulty swallowing whole tablets and for children under 6 years of age.
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 taking Jakavi for as long as your doctor tells you to.

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects of Jakavi are mild to moderate in severity and usually go away after a period of treatment ranging from a few days to a few weeks.

Myelofibrosis and Polycythaemia vera
Some side effects may be serious.
Contact your doctor immediately before taking your next scheduled dose if you experience any of the following serious side effects:

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

any signs of bleeding in the stomach or intestines, such as black or bloody stools, or vomiting blood
unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections – possible symptoms of blood disorders
painful skin rashes with blisters – possible symptoms of shingles (herpes zoster)
fever, chills, or other signs of infections
low levels of red blood cells (anaemia), low levels of white blood cells (neutropenia), or low levels of platelets (thrombocytopenia)

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

any signs of bleeding in the brain, such as sudden change in level of consciousness, persistent headache, numbness, tingling, weakness, or paralysis

Other side effects
Other possible side effects include those listed below. If you experience any of these side effects, contact your doctor or pharmacist.

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

high levels of cholesterol or fats in the blood (hypertriglyceridaemia)
abnormal liver function test results
dizziness
headache
urinary tract infections
weight gain
fever, cough, difficult or painful breathing, wheezing, chest pain when breathing – possible symptoms of pneumonia
high blood pressure (hypertension), which may also cause dizziness and headache
constipation
elevated levels of lipase in the blood

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

reduced number of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
frequent flatulence

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

tuberculosis
reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, stomach pain on the right side, fever, and feeling nauseous or unwell)

Graft-versus-host disease (GvHD)
Some side effects may be serious.
Contact your doctor immediately before taking your next scheduled dose if you experience any of the following serious side effects:

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

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

Other side effects

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

headache
high blood pressure (hypertension)
abnormal blood test results, including:
high levels of lipase and/or amylase
high levels of cholesterol
abnormal liver function
increased levels of an enzyme found in muscles (increased blood creatine phosphokinase)
increased creatinine levels, an enzyme that may indicate impaired kidney function
low levels of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
nausea, tiredness, fatigue, pale skin – possible symptoms of anaemia, a condition caused by low red blood cell levels

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

fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold symptoms, or difficulty breathing – possible symptoms of BK virus infection
weight gain
constipation (constipation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Jakavi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp./EXP".
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Jakavi contains

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

Description of the appearance of Jakavi and pack contents
Jakavi 5 mg tablets are round, white to almost white tablets marked with “NVR” on one side and “L5” on the other side.
Jakavi 10 mg tablets are round, white to almost white tablets marked with “NVR” on one side and “L10” on the other side.
Jakavi 15 mg tablets are oval, white to almost white tablets marked with “NVR” on one side and “L15” on the other side.
Jakavi 20 mg tablets are elongated, white to almost white tablets marked with “NVR” on one side and “L20” on the other side.
Jakavi tablets are supplied in blister packs containing 14 or 56 tablets, or multiple packs containing 168 tablets (3 packs of 56).
Not all pack sizes may be marketed in your country.

Marketing Authorization 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
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf.: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/ .

Patient information leaflet

Jakavi 5 mg/ml oral solution

ruxolitinib
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
The information in this leaflet applies to you or to the child, but the text will refer only to “you”.

Contents of this leaflet

What Jakavi is and what it is used for
What you need to know before taking Jakavi
How to take Jakavi
Possible side effects
How to store Jakavi
Contents of the pack and other information

1. What Jakavi is and what it is used for

Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat:

children aged 28 days and older and adults with acute graft-versus-host disease (GvHD)
children aged 6 months and older and adults with chronic GvHD. There are two forms of GvHD: an early form called acute GvHD, which typically develops soon after a transplant and may affect the skin, liver, and gastrointestinal tract; and a later form called chronic GvHD, which develops weeks or months after transplantation. Chronic GvHD can affect almost any organ.

How Jakavi works
Graft-versus-host disease is a complication that occurs after transplantation when specific cells (T cells) from the donor’s transplanted organ (e.g. bone marrow) do not recognize the recipient’s cells/organs and attack them. By selectively blocking certain enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces the signs and symptoms of both acute and chronic graft-versus-host disease, leading to improvement of the disease and survival of the transplanted cells.
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, please consult your doctor.

2. What you should know before taking Jakavi

Follow all your doctor's instructions carefully. These instructions may differ from the general
information contained in this leaflet.
Do not take Jakavi

if you are allergic to ruxolitinib or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Jakavi if:

you have infections. It may be necessary to treat the infection before starting treatment with Jakavi.
you have ever had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may carry out tests to check whether you have tuberculosis or other infections.
you have ever had hepatitis B.
you have kidney problems or have or have ever had liver problems, as your doctor may need to prescribe a different dose of Jakavi.
you have ever had cancer, particularly skin cancer.
you have or have had heart problems. Patients aged 65 years or older may have an increased risk of heart problems, including heart attack, and certain types of cancer.
you are a smoker or have smoked in the past.

Talk to your doctor or pharmacist during treatment with Jakavi if:

you develop fever, chills or other signs of infection.
you develop a chronic cough with blood-streaked sputum, fever, night sweats, or weight loss (these may be signs of tuberculosis).
you experience any of the following symptoms, or if anyone close to you notices that you have any of these symptoms: confusion or difficulty concentrating, loss of balance or difficulty walking, lack of coordination, difficulty speaking, loss of strength or weakness on one side of the body, blurred vision and/or loss of vision. These may be signs of a serious brain infection, and your doctor may recommend further tests and follow-up examinations.
you develop painful skin rashes with blisters (these are signs of shingles).
you notice changes in your skin. This may require further monitoring, as some types of non-melanoma skin cancer have been reported.
you suddenly develop shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of an arm or leg, pain or tenderness in the leg, or redness or discoloration in the arm or leg, as these may be signs of blood clots in the veins.

Other medicines and Jakavi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. You must never start taking a new medicine without first consulting the doctor who
prescribed Jakavi for you. This applies to prescription medicines, over-the-counter medicines,
and herbal or alternative remedies.
It is particularly important that you inform your doctor about medicines containing the following
active substances, as your doctor may need to adjust the dose of Jakavi.

Some medicines used to treat infections:
medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, fluconazole, and voriconazole)
antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
medicines to treat viral infections, including HIV/AIDS infection (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir)
medicines to treat hepatitis C (boceprevir, telaprevir).
A medicine used to treat depression (nefazodone).
Medicines to treat high blood pressure (hypertension) and chest tightness, heaviness, or pain (chronic angina pectoris) (mibefradil or diltiazem).
A medicine to treat heartburn (cimetidine).
A medicine to treat heart disease (avasimibe).
Medicines used to prevent seizures or convulsions (phenytoin, carbamazepine, or phenobarbital and other anti-epileptics).
Medicines used to treat tuberculosis (TB) (rifabutin or rifampicin).
A herbal product used to treat depression (St. John’s wort (Hypericum perforatum)). Please consult your doctor if you are unsure whether any of the above applies to you.

Pregnancy, breastfeeding and contraception
Pregnancy

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

Breastfeeding

Do not breastfeed while being treated with Jakavi (see section 2 “Do not take Jakavi”). Consult your doctor.

Contraception

Taking Jakavi is not recommended for women who could become pregnant and who are not using contraceptive measures. Talk to your doctor about using appropriate contraception to avoid becoming pregnant during treatment with Jakavi.
Consult your doctor if you become pregnant while taking Jakavi.

Driving and using machines
If you experience dizziness after taking Jakavi, do not drive, do not ride a bicycle/scooter, do not
operate machinery, or do not engage in any other activities requiring alertness.
Jakavi contains propylene glycol
This medicine contains 150 mg of propylene glycol per ml of oral solution.
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this
medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
Jakavi contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
May cause allergic reactions (including delayed reactions).

3. How to take Jakavi

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Before starting treatment with Jakavi and during treatment, your doctor will perform blood tests to determine the best dose, to assess how you are responding to treatment, and whether Jakavi is causing any unwanted effects. Your doctor may need to adjust the dose or stop treatment. Your doctor will carefully monitor you for any signs or symptoms of infection before starting and during treatment with Jakavi.
You should take Jakavi twice daily, approximately at the same time each day. Your doctor will tell you the correct dose for you. Always follow the instructions given by your doctor. Jakavi may be taken with or without food. You may drink water afterwards to ensure the entire dose of oral Jakavi solution is swallowed.
You should continue taking Jakavi for as long as your doctor tells you to.
For detailed instructions on how to use the oral solution, see “Instructions for use” at the end of this leaflet.
Jakavi tablets are available for patients over 6 years of age who can swallow tablets whole.
If you take more Jakavi than you should
If you accidentally take more Jakavi than prescribed by your doctor, contact your doctor or pharmacist immediately.
If you forget to take Jakavi
If you forget to take a dose of Jakavi, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most of the side effects of Jakavi are mild to moderate in severity and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some side effects may be serious
Contact your doctor immediately before taking your next scheduled dose if you experience any of the following serious side effects:
Very common (may affect more than 1 in 10 people):

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

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

headache
high blood pressure ( hypertension )
abnormal blood test results, including:
high levels of lipase and/or amylase
high cholesterol levels
abnormal liver function
increased levels of an enzyme present in muscles (increased blood creatine phosphokinase)
increased creatinine levels, an enzyme which may indicate that your kidneys are not functioning properly
low levels of all three types of blood cells: red blood cells, white blood cells, and platelets ( pancytopenia )
nausea
tiredness, fatigue, pale skin - possible symptoms of anaemia, a condition caused by low red blood cell levels

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

fever, muscle pain, pain or difficulty urinating, blurred vision, cough, cold symptoms or difficulty breathing - possible symptoms of BK virus infection
weight gain
constipation (stool retention)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. 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. How to store Jakavi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after "Exp.".
Do not store above 30°C.
After opening, use within 60 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Jakavi contains

The active substance in Jakavi is ruxolitinib.
Each ml of solution contains 5 mg of ruxolitinib.
The other components are: propylene glycol (E 1520) (see section 2), anhydrous citric acid, methyl parahydroxybenzoate (E 218) (see section 2), propyl parahydroxybenzoate (E 216) (see section 2), sucralose (E 955), strawberry flavour, purified water.

Description of the appearance of Jakavi and contents of the pack
Jakavi 5 mg/ml oral solution is a clear, colourless to pale yellow solution which may contain small colourless particles or a slight sediment.
Jakavi oral solution is available in amber glass bottles with a white polypropylene child-resistant screw cap.
Packs contain one 60 ml bottle of oral solution, two 1 ml oral administration syringes, and one press-in bottle adapter.

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 Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: