Product Information for the Patient

Jakavi 5mg Tablets

Jakavi 10mg Tablets

Jakavi 15mg Tablets

Jakavi 20mg Tablets

ruxolitinib

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section4.
• The information in this product information is for you or your child – although in the product informationonly refers to "you".

1.What is Jakavi and for what it is used

2.What you need to know before starting to take Jakavi

3.How to take Jakavi

4.Possible adverse effects

5.Storage of Jakavi

6.Contents of the package and additional information

Ruxolitinib is the active ingredient in Jakavi.

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 polycythemia vera who are resistant or intolerant to hydroxyurea.

Jakavi is also used to treat:

• children aged 28 days or older and adults with acute graft-versus-host disease (GVHD) and
• children aged 6 months or older and adults with chronic GVHD.

There are two forms of GVHD: an early form called acute GVHD, which usually develops shortly after transplantation and can affect the skin, liver, and gastrointestinal tract, and a later form called chronic GVHD, which develops later, usually within weeks to months after transplantation. With chronic GVHD, almost any organ can be affected.

How Jakavi works

One of the characteristics of myelofibrosis is the enlargement of the spleen. Myelofibrosis is a bone marrow alteration, in which the marrow is replaced by scar tissue. The altered marrow cannot produce a sufficient amount of normal blood cells, and as a result, the spleen increases significantly. By blocking the action of some enzymes (called Janus kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and alleviate symptoms such as fever, night sweats, bone pain, and weight loss in patients with myelofibrosis. Jakavi can help reduce the risk of severe blood or vascular complications.

Polycythemia vera is a bone marrow alteration, in which the marrow produces too many red blood cells. The blood becomes thicker as a result of the increase in red blood cells. Jakavi can alleviate symptoms, reduce the size of the spleen and the volume of red blood cells produced in patients with polycythemia vera, by selectively blocking some enzymes called Janus kinases (JAK1 and JAK2), and thus potentially reduce the risk of severe blood or vascular complications.

Graft-versus-host disease is a complication that occurs after a transplant, when specific cells (T cells) from the donor's graft (for example, from bone marrow) do not recognize the recipient's cells/ organs and attack them. Jakavi reduces the signs and symptoms of acute and chronic graft-versus-host disease by selectively blocking the enzymes called Janus kinases (JAK1 and JAK2), leading to an improvement in the disease and survival of the transplanted cells.

If you have any doubts about how Jakavi works or why you have been prescribed this medication, consult your doctor.

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

Do not take Jakavi

-if you are allergic to ruxolitinib or to any of the other components of this medication (including those listed in section6)

-if you are pregnant or breastfeeding (see section2 “Pregnancy, breastfeeding and contraceptives”)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Jakavi if:

• You have any infection. You may need 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 problems or have had liver problems, as your doctor may need a different dose of Jakavi
• You have had cancer, particularly skin cancer
• You have or have had heart problems
• You are over 65years old. Patients 65years old or older may have a higher risk of developing heart problems, including myocardial infarction, and some types of cancer
• You smoke or have smoked in the past

Inform your doctor or pharmacist during treatment with Jakavi if:

• You present fever, chills or other symptoms of infections
• You present chronic cough with blood-stained sputum, fever, night sweats and weight loss (these may be signs of tuberculosis)
• You present 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, decrease in strength or weakness on one side of your body, blurry vision and/or loss of vision. These may be signs of a severe brain infection and your doctor may recommend additional tests and follow-up
• You develop painful skin rash with blisters (these are signs of herpes)
• You have any change in your skin. This may require closer observation, as some types of cancer (not 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 sensitivity in the legs, redness or change in color in the legs or arms, which may be signs of blood clots in the veins

Children and adolescents

This medication is not indicated for use in children or adolescents under 18years old, with myelofibrosis or polycythemia 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 28days or older.

Other medications and Jakavi

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication. While taking Jakavi, do not start taking a new medication without consulting first with the doctor who prescribed Jakavi. This includes prescription medications, over-the-counter medications and herbal or alternative medicine.

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

The following medications may increase the risk of adverse effects with Jakavi:

• Some medications used to treat infections:
• • medications 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)
  • medications to treat viral infections, including HIV/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medications to treat hepatitis C (boceprevir, telaprevir)
• A medication to treat depression (nefazodone)
• Medications to treat high blood pressure and chest pain (mibefradil or diltiazem)
• A medication to treat stomach acid (cimetidine)
• A medication to treat heart disease (avasimibe)
• Medications used to treat seizures or attacks (phenytoin, carbamazepine or phenobarbital and other antiepileptic medications)
• Medications used to treat tuberculosis (rifabutin or rifampicin)
• A herbal medication used to treat depression (St. John's Wort (Hypericum perforatum))

Discuss with your doctor if you are unsure, if the above information applies to you.

Pregnancy, breastfeeding and contraceptives

Pregnancy

• If you are pregnant or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.
• Do not take Jakavi during pregnancy (see section2 “Do not take Jakavi”).

Breastfeeding

• Do not breastfeed while taking Jakavi (see section2 “Do not take Jakavi”). Consult your doctor.

Contraceptives

• It is not recommended to take Jakavi in women who may become pregnant and who do not use contraceptives. Discuss with your doctor about the most suitable contraceptives to avoid becoming pregnant while taking Jakavi.
• Discuss with your doctor if you become pregnant while taking Jakavi.

Driving and operating machinery

If you experience dizziness after taking Jakavi, do not drive or operate machinery.

Jakavi contains lactose and sodium

Jakavi contains lactose (milk sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Mielofibrosis

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

Policitemia vera

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

Chronic graft-versus-host disease

• Children 6 years and younger: The recommended initial dose in chronic graft-versus-host disease is 5mg twice a day in patients 6 to 12years old.
• Children 12 years and older and adults: The recommended initial dose in chronic graft-versus-host disease is 10mg twice a day for patients 12years or older.

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

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

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

You must continue taking Jakavi for the time 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 prescribed, contact your doctor or pharmacist immediately.

If you forget to take Jakavi

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

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

Like all medicines, Jakavi can cause side effects, although not everyone will experience them.

The majority of Jakavi side effects are mild to moderate and usually disappear within a few days to a few weeks of treatment.

Mielofibrosis and polycythemia vera

Some side effects can be serious

Seek immediate medical attention 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 intestines, such as black stools or stools with blood, or vomiting with blood
• unexpected bruises and/or bleeding, abnormal fatigue, difficulty breathing during exercise or at rest, unusual paleness, or frequent infections - possible symptoms of blood abnormalities
• painful rash on the skin with blisters - possible symptoms of herpes (herpes zoster)
• fever, chills, or other symptoms of infections

• low levels of red blood cells (anemia), low levels of white blood cells (neutropenia) or low levels of platelets (trombocytopenia)

Common (may affect up to 1 in 10 people)

• any sign of bleeding in the brain, such as sudden changes in level 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 (hypertriglyceridemia)
• 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 could also be the cause of dizziness or headaches
• constipation
• high levels of lipase in the blood

Common (may affect up to 1 in 10 patients)

• low levels of the three types of blood cells - red blood cells, white blood cells, and platelets (pancytopenia)
• flatulence (frequent gas)

Rare (may affect up to 1 in 100 patients)

-tuberculosis

-recurring hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, right upper abdominal pain, fever, and nausea or discomfort)

Transplant rejection

Some side effects can be serious

Seek immediate medical attention 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 associated with:
• muscle pain, skin redness, and/or difficulty breathing (cytomegalovirus infection)
• painful urination (urinary tract infection)
• rapid heart rate, confusion, and rapid breathing (sepsis, which is a disease associated with a widespread infection and inflammation)
• frequent infections, fever, chills, sore throat, or ulcers in the mouth
• 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 muscle enzyme (elevated creatine phosphokinase in blood)

• high levels of creatinine, an enzyme indicating that your kidneys are not functioning properly

• low counts of the three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)
• nausea
• fatigue, tiredness, paleness - possible symptoms of anemia caused by low red blood cell levels

Common (may affect up to 1 in 10 patients)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAnexo V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister after«CAD/EXP».

Do not store above 86°F.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medication that you no longer need. This will help protect the environment.

Composition of Jakavi

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

Appearance of the product and contents of the pack

Jakavi 5 mg tablets are round white to off-white tablets with the inscription "NVR" engraved on one face and "L5" engraved on the other face.

Jakavi 10 mg tablets are round white to off-white tablets with the inscription "NVR" engraved on one face and "L10" engraved on the other face.

Jakavi 15 mg tablets are oval white to off-white tablets with the inscription "NVR" engraved on one face and "L15" engraved on the other face.

Jakavi 20 mg tablets are elongated white to off-white tablets with the inscription "NVR" engraved on one face and "L20" engraved on the other face.

Jakavi tablets are presented 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

Responsible for manufacturing

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

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