5 mg, 10 mg, 15 mg, 20 mg tablets
ruxolitinib

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 with symptoms related to myelofibrosis, a rare form of blood cancer.

Jakavi is also used to treat patients with polycythemia vera who are resistant to or intolerant to hydroxyurea.

How Jakavi works

Enlargement of the spleen is one of the hallmarks of myelofibrosis. Myelofibrosis is a disorder of the bone marrow, which means that the marrow is replaced by scar tissue. The abnormal bone marrow can no longer produce enough normal blood cells, which leads to a significant increase in the size of the spleen. By blocking the activity of certain enzymes (called Janus kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, skeletal pain, and weight loss in patients with myelofibrosis. Jakavi can help reduce the risk of serious blood or vascular complications.

Polycythaemia vera is a disease of the bone marrow, in which the bone marrow produces too many red blood cells. The blood becomes thicker due to 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 polycythemia vera, by selectively blocking enzymes called Janus kinases (JAK1 and JAK2), potentially reducing the risk of serious blood or vascular complications.

Ask your doctor if you are wondering how Jakavi works or why you have been prescribed it.

2. What you need to know before taking Jakavi

Do not use Jakavi

Follow your doctor’s instructions carefully. They may differ 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 breastfeeding.

If any of the above applies to you, tell your doctor who will then decide if you should start treatment with Jakavi.

Warnings and cautions

Talk to your doctor or pharmacist before taking Jakavi

  • if you have an infection . It may be necessary to treat your infection before you start taking Jakavi. It is important that you tell your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis . Your doctor may take samples to see if you have tuberculosis or other infections . It is important that you tell your doctor if you have ever had hepatitis B.
  • if you have kidney problems. Your doctor may need to give you another dose of Jakavi.
  • if you have or have had liver problems. Your doctor may need to give you another dose of Jakavi.
  • if you are taking other medicines (see section “Other medicines and Jakavi”).
  • if you have ever had tuberculosis .
  • if you have ever had skin cancer.

Tell your doctor or pharmacist during treatment with Jakavi:

  • if you get unexpected bruising and / or bleeding, abnormal fatigue, shortness of breath during exertion or at rest, abnormally pale skin or frequent infections (these are signs of blood clots).
  • if you get a fever, chills or other symptoms of infection you.
  • if you get a chronic cough with blood-stained cough, fever, night sweats and weight loss (these may be signs of tuberculosis ).
  • if you have any of the following symptoms or if someone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, speech difficulties, decreased strength or weakness in one side of the body, blurred and / or or loss of vision. This may be a sign of a serious brain infection and your doctor may suggest further examinations and follow-ups.
  • if you develop painful skin rash with blisters (this is a sign of shingles ).
  • if you notice skin changes. This may require further observation, as certain types of skin cancer (non- melanoma type) have been reported.

Blood tests

Before starting treatment with Jakavi, your doctor will examine your blood to determine the best starting dose for you. You will need to provide more blood samples during treatment so that your doctor can check the number of blood cells ( white blood cells, red blood cells, and platelets ) in your body, and assess how you respond to the treatment and whether Jakavi has an unwanted effect on the blood cells. Your doctor may need to change your dose or stop your treatment. Your doctor will carefully check if you have any signs or symptoms of infection before and during treatment with Jakavi. The doctor will also regularly check the level of lipid is (fat) in the blood.

To stop with Jakavi

When you stop taking Jakavi, the myelofibrosis symptoms may return. Your doctor may want the amount of Jakavi taken each day to be reduced gradually, before stopping completely.

Children and young people

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

Other medicines and Jakavi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must mention the following types of medicines that contain any of the mentioned active substances as your doctor may need to change your dose of Jakavi.

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

  • Some medicines used to treat your infection . These include medicines used to treat fungal infections (such as ketoconazole , itraconazole, posaconazole, fluconazole and voriconazole), medicines used to treat certain types of bacterial infections ( antibiotics such as clarithromycin, telithromycin, ciprofloxacin or erythromycin), including HIV infection / AIDS (such as amprenavir, atazanavir, indinavir, lopinavir / ritonavir, nelfinavir, ritonavir, saquvinavir), medicines for the treatment of hepatitis C (boceprevir, telaprevir).
  • Nefazodone, a medicine used to treat depression.
  • Mibefradil or diltiazem , medicines used to treat hypertension and chronic angina.
  • Cimetidine, a medicine used to treat heartburn.

The following may reduce the effect of Jakavi:

  • Avasimib, a medicine used to treat heart disease.
  • Phenytoin , carbamazepine or phenobarbital and other drugs for epilepsy that is used to stop seizures.
  • Rifabutin or rifampicin, a medicine used to treat tuberculosis (TB).
  • St. John’s wort ( Hypericum perforatum ), a (traditional) herbal medicine used to treat mild depression.

While taking Jakavi, never start taking a new medicine without first consulting the doctor who prescribed Jakavi. This includes prescription drugs, over-the-counter drugs, herbal remedies, and alternative medicines.

Pregnancy and breastfeeding

Do not take Jakavi during pregnancy. Talk to your doctor about the steps you should take to avoid getting pregnant during treatment with Jakavi.

Do not breastfeed while taking Jakavi. Tell your doctor if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you feel dizzy after taking Jakavi, do not drive or use machines.

Jakavi contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free. is next to “sodium-free”.

3. How to take Jakavi

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

Dose one of Jakavi depends on the patient’s blood cell values. Your doctor will measure the number of blood cells in your body and find the best dose for you, especially if you have liver or kidney problems.

  • The recommended starting dose for myelofibrosis is 5 mg twice daily, 10 mg twice daily, 15 mg twice daily or 20 mg twice daily, depending on the number of blood cells .
  • The recommended starting dose for polycythaemia vera is 10 mg twice daily.
  • The highest dose is 25 mg twice daily.

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

During treatment, your doctor may recommend a lower or higher dose for you if the results of the blood tests show that this is necessary, if you have problems with your liver or kidneys or if you also need treatment with other medicines.

If you are on dialysis, you should either take a single dose or two separate doses of Jakavi on your dialysis days, after one dialysis has been performed. Your doctor will tell you if you should take one or two doses and how many tablets to take for each dose.

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

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

Your doctor will regularly check your health to make sure the treatment is having the desired effect.

Ask your doctor or pharmacist if you are wondering how long to take Jakavi.

If you experience certain side effects (such as blood clots), your doctor may need to change the amount of Jakavi you should take or tell you to stop taking Jakavi for some time.

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, just take the next dose according to the treatment plan. Do not take a double dose to make up for a forgotten dose.

If you stop taking Jakavi

If you stop taking Jakavi, your myelofibrosis-related symptoms may return. Therefore, do not stop taking Jakavi without first discussing it with your doctor.

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

4. Possible side effects

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

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

Tell your doctor if you experience any of the following side effects. Some are very common (may affect more than 1 in 10 people), some are common (may affect up to 1 in 10 people):

  • signs of bleeding in the brain, such as sudden changes in levels of consciousness, persistent headache, numbness, tingling, weakness or paralysis (common)
  • signs of bleeding in the stomach or intestines, such as black or bloody stools or bloody vomiting (very common)
  • unexpected bruising and / or bleeding, abnormal fatigue, shortness of breath during exercise or at rest, unusually pale skin or frequent infections (possible symptoms of blood disease) (very common)
  • painful rash with blisters (possible symptoms of shingles ( herpes zoster )) (very common)
  • fever, chills or other symptoms of infection (very common)
  • low levels of red blood cells ( anemia ), low levels of white blood cells ( neutropenia ) or low levels of platelets ( thrombocytopenia ) (very common)

Other side effects include Jakavi

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

  • high cholesterol or fat in the blood ( hypertriglyceridemia )
  • deviating liver function values
  • dizziness
  • headache
  • urinary tract infection
  • weight gain
  • fever, cough, difficulty breathing or painful breathing, wheezing, chest pain when breathing (possible symptoms of pneumonia )
  • high blood pressure ( hypertension ), which can also be the cause of dizziness and headaches
  • constipation
  • high lipase level in the blood

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

  • decreased number of all three types of blood cells – red blood cells , white blood cells and platelets ( pancytopenia )
  • gas in the stomach ( flatulence )

Uncommon (may affect more than 1 in 100 people):

  • tuberculosis
  • recurrent hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown colored urine, right-sided abdominal pain, fever and feeling of nausea or vomiting)

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 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 to protect the environment.

6. Contents of the pack and other information

Content declaration

  • The active substance in 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, colloidal , anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate .

What the medicine looks like and contents of the pack

Jakavi 5 mg tablets are white to off-white, round tablets with “NVR” debossed on one side and “L5” debossed on the other side.

Jakavi 10 mg tablets are white to off-white, round tablets with “NVR” debossed on one side and “L10” debossed on the other side.

Jakavi 15 mg tablets are white to off-white, oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.

Jakavi 20 mg tablets are white to off-white, oblong tablets with “NVR” debossed on one side and “L20” debossed on the other side.

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

Not all 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 Pharmacéutica SA

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

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

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
.ΠροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070 United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370

Muhammad Nadeem

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