Jakavi 5 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Jakavi 5 mg/ml oral solution ruxolitinib

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

• Keep this leaflet, as 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, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child, even though the leaflet refers only to "you".

Leaflet contents

1. What Jakavi is and what it is used for
2. What you need to know before taking Jakavi
3. How to take Jakavi
4. Possible side effects
5. How to store Jakavi
6. 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 also used to treat:

• children 28 days of age or older and adults with acute graft-versus-host disease (GVHD) and
• children 6 months of age 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 may affect the skin, liver, and gastrointestinal tract, and another form called chronic GVHD, which develops later, typically weeks to months after transplantation. With chronic GVHD, almost any organ may be affected.

How Jakavi works

Graft-versus-host disease is a complication that occurs after transplantation, when specific cells (T cells) from the donor graft (e.g., derived from bone marrow) fail to recognize the recipient's cells/organs and attack them. Jakavi reduces the signs and symptoms of both acute and chronic forms of graft-versus-host disease by selectively inhibiting enzymes known as Janus-associated kinases (JAK1 and JAK2), leading to improvement in the disease and survival of the transplanted cells.

If you have any questions about how Jakavi works or why you have been prescribed this medicine, please consult your doctor.

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

Carefully follow all instructions given to you by your doctor. These 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

Consult your doctor or pharmacist before starting to take 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 check whether you have tuberculosis or any other infection
• you have had hepatitis B
• you have kidney problems or have or have had liver problems, as your doctor may need to adjust your Jakavi dose
• you have or have had cancer, particularly skin cancer
• you have or have had heart problems
• you are over 65 years of age. Patients aged 65 years or older may have an increased risk of heart problems, including myocardial infarction, and certain types of cancer
• you smoke or have smoked in the past

Inform your doctor or pharmacist during treatment with Jakavi if:

• you develop fever, chills, or other symptoms of infections
• you develop chronic cough with blood-stained 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 thinking, 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 monitoring
• you develop a painful skin rash with blisters (these are signs of herpes)
• you notice any changes in your skin. This may require further evaluation, as some types of non-melanoma skin cancer have been reported
• you suddenly experience shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in your arms or legs, pain or tenderness in your legs, redness or discoloration in your arms or legs—these may be signs of blood clots in the veins

Other medicines and Jakavi

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

It is particularly important to mention medicines containing any of the following active substances, as your doctor may need to adjust your Jakavi dose:

• Some medicines used to treat infections:

• medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole, or 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 used to treat high blood pressure (hypertension) and chest tightness, heaviness, or pain (chronic angina pectoris) (mibefradil or diltiazem)

• a medicine used to treat stomach acidity (cimetidine)

• a medicine used to treat heart disease (avasimibe)

• medicines used for 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))

Discuss with your doctor if you are unsure whether any of the above applies to you.

Pregnancy, breastfeeding and contraception

Pregnancy

• If you are pregnant or think you may be pregnant, or if you 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”).

Breastfeeding

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

Consult your doctor.

Contraception

• Jakavi is not recommended for women who could become pregnant and who are not using contraception. Discuss with your doctor the most appropriate contraceptive methods to prevent pregnancy while being treated with Jakavi.
• Inform your doctor if you become pregnant while taking Jakavi.

Driving and use of machines

If you experience dizziness after taking Jakavi, you should not drive, ride a bicycle/motorcycle, operate machinery, or engage in any activity requiring alertness.

Jakavi contains propylene glycol

This medicine contains 150 mg of propylene glycol in each ml of oral solution.

If the child is under 5 years of age, consult your doctor or pharmacist, particularly if other medicines containing propylene glycol or alcohol have been administered.

Jakavi contains methyl and propyl p-hydroxybenzoates

These may cause allergic reactions (possibly delayed).

3. How to take Jakavi

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment with Jakavi and during your treatment, your doctor will perform a blood test to determine the best starting dose for you, to monitor your response to treatment, and to check whether Jakavi is causing any unwanted effects. Your doctor may need to adjust the dose or interrupt treatment. Before starting and during treatment with Jakavi, your doctor will check that you do not have signs or symptoms of infection.

You should take Jakavi twice daily, approximately at the same time each day. Your doctor will tell you what your dose should be. Always follow the instructions given by your doctor. Jakavi may be taken with or without food. You may drink some water afterwards to ensure you have swallowed the full dose.

You should continue taking Jakavi for as long as your doctor instructs you to.

For 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 are able to swallow whole tablets.

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

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

4. Possible adverse effects

Like all medicines, Jakavi may cause adverse effects, although not everyone gets them.

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

Some adverse effects may be serious

Seek immediate medical attention before taking your next dose if you experience any of the following serious adverse 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)

• pain when urinating (urinary tract infection)

• rapid heartbeat, confusion and rapid breathing (sepsis, a condition 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 adverse effects

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

• headache

• high blood pressure (hypertension)

• abnormal blood test results:

• high levels of lipase and/or amylase

• high cholesterol levels

• abnormal liver function

• increased blood levels of muscle enzyme (elevated blood creatine phosphokinase)

• elevated creatinine levels, an enzyme indicating impaired kidney function

• low counts of all three blood cell types: red blood cells, white blood cells and platelets (pancytopenia)

• discomfort (nausea)

• tiredness, fatigue, paleness – possible symptoms of anaemia due to low red blood cell levels

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting adverse 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 stated on the carton or bottle after «EXP».

Do not store above 30 °C.

Once opened, use within 60 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This helps protect the environment.

6. Contents of the pack and other information

Composition of Jakavi

• 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 p-hydroxybenzoate (E 218) (see section 2), propyl p-hydroxybenzoate (E 216) (see section 2), sucralose (E 955), strawberry flavour, purified water.

Appearance of the product and contents of the pack

Jakavi 5 mg/ml oral solution is a clear, colourless to pale yellow solution, which may contain a few small colourless particles or a small amount of sediment.

Jakavi oral solution is available in amber glass bottles with a white polypropylene screw cap, child-resistant.

The pack contains one bottle with 60 ml of oral solution, two 1 ml oral syringes, and a press-in bottle adapter.

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 Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

For more information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

Instructions for use

Jakavi 5 mg/ml oral solution

Read these "Instructions for use" carefully before you start taking Jakavi. Your healthcare professional should show you how to correctly measure and administer a dose of Jakavi. If you have any questions about using Jakavi, speak with your healthcare professional.