Patient leaflet - Jakavi 5 mg/ml oral solution
1. What Jakavi is and what it is used for
Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat adults and children aged 2 years and older with acute or chronic graft-versus-host disease (GvHD). There are two forms of GvHD: an early form called acute GvHD that usually develops soon after the transplantation and can affect skin, liver and gastrointestinal tract, and a form called chronic GvHD, which develops later, usually weeks to months after the transplantation. Almost any organ can be affected by chronic GvHD. How Jakavi works
Graft-versus-host disease is a complication which occurs after transplantation when specific cells (T cells) in the donor’s graft (e.g. bone marrow) do not recognise the host cells/organs and attack them. By selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), Jakavi reduces signs and symptoms of the acute and the chronic forms of graft-versus-host disease leading to disease improvement and survival of the transplanted cells.
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take Jakavi
Follow all 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 breast-feeding (see section 2 “Pregnancy, breast-feeding and contraception”).
If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Jakavi. Warnings and precautions
Talk to your doctor or pharmacist before taking Jakavi if:
- you have any infections. It may be necessary to treat your infection before starting Jakavi.
you have ever had tuberculosis or if you 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 infections.
- you have ever had hepatitis B.
- you have kidney problems
- you have or have ever had liver problems because your doctor may need to prescribe a different dose of Jakavi.
- you have ever had cancer, in particular skin cancer.
- you have or have had heart problems.
you are 65 years of age or older. Patients aged 65 years and older may be at increased risk of heart problems, including heart attack, and some
types of cancer.
- you are a smoker or have smoked in the past.
Talk to your doctor or pharmacist during your treatment with Jakavi if:
- you experience fever, chills or other symptoms of infections.
- you experience chronic coughing with blood-tinged sputum, fever, night sweats and weight loss (these can be signs of tuberculosis).
you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking,
loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision. These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
- you develop painful skin rash with blisters (these are signs of shingles).
- you have any skin changes. This may require further observation, as certain types of skin cancer (non-melanoma) have been reported.
you experience sudden shortness of breath or difficulty breathing, chest pain or pain in upper back, swelling of the leg or arm, leg pain or
tenderness, or redness or discoloration in the leg or arm as these can be signs of blood clots in the veins.
Blood tests
Before you start treatment with Jakavi, your doctor will perform blood tests to determine the best starting dose for you. You will need to have further blood tests during treatment so that your doctor can monitor the amount of blood cells (white cells, red cells and platelets) in the body and assess how you are responding to the treatment and whether Jakavi is having an unwanted effect on these cells. Your doctor may need to adjust the dose or stop treatment. Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi. Your doctor will also regularly check the level of lipids (fat) in the blood.
Children and adolescents
For the treatment of graft-versus-host disease, Jakavi can be used in patients aged 2 years and older.
Other medicines and Jakavi
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you mention any of the following medicines containing any of the following active substances, as your doctor may need to adjust the Jakavi dose.
The following may increase the risk of side effects with Jakavi:
Some medicines used to treat infections. These include medicines used to treat fungal diseases (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), medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir).
Nefazodone, a medicine to treat depression.
- Mibefradil or diltiazem, medicines to treat hypertension and chronic angina pectoris.
- Cimetidine, a medicine to treat heartburn.
The following may reduce the effectiveness of Jakavi:
- Avasimibe, a medicine to treat heart disease.
- Phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits.
- Rifabutin or rifampicin, medicines used to treat tuberculosis (TB).
- St. John’s wort (Hypericum perforatum), a herbal product used to treat depression.
While you are taking Jakavi you should never start a new medicine without checking first with the doctor who prescribed Jakavi. This includes prescription medicines, non-prescription medicines and herbal or alternative medicines.
Pregnancy and breast-feeding
Do not take Jakavi during pregnancy. Talk to your doctor about how to take appropriate measures to avoid becoming pregnant during treatment with Jakavi.
Do not breast-feed while taking Jakavi. Tell your doctor if you are breast-feeding.
If you are pregnant or breast-feeding, 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 experience dizziness after taking Jakavi, do not drive, ride a bike/scooter, use machines, or take part in other activties that need alertness. Jakavi contains propylene glycol
This medicine contains 150 mg of propylene glycol in each ml of oral solution.
If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
Jakavi contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
May cause allergic reactions (possibly delayed).
3. How to take Jakavi
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For detailed instructions on how to use the oral solution for Jakavi, see “Instructions for use” at the end of this leaflet. Before you start treatment with Jakavi and during treatment, your doctor will do blood tests to find the best dose, to see how you are responding to the treatment and whether Jakavi is having an unwanted effect. Your doctor may need to adjust the dose or stop treatment. Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi.
You should take Jakavi twice daily at approximately the same time, either with or without food.
You should continue taking Jakavi for as long as your doctor tells you to.
Your doctor will regularly monitor your condition to make sure that the treatment is having the desired effect.
If you have questions about how long you should take Jakavi, talk to your doctor or pharmacist.
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 forgot to take Jakavi simply take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose. If you stop taking Jakavi
In graft-versus-host disease, a reduction in your dose or stopping your treatment with Jakavi is possible if you respond to treatment and the doctor will supervise this procedure. Therefore, you should not stop taking Jakavi or change the dose without discussing it with your doctor. If you have any further questions on 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 everybody gets them.
Most of the side effects of Jakavi are mild to moderate and will generally disappear after a few days to a few weeks of treatment. Some side effects could be serious
Seek medical help immediately prior to taking the next scheduled dose if you experience the following serious side effects:
Very common (may affect more than 1 in 10 people):
- fever, pain, redness, and/or difficulty breathing (possible symptoms of an infection with the cytomegalovirus (cytomegalovirus infection))
- fever, pain when urinating (possible symptoms of a urinary tract infection)
fast heart rate, fever, confusion and rapid breathing (possible symptoms of sepsis, which is a serious condition that occurs in response to an
infection that causes widespread inflammation)
tiredness, fatigue, pale skin (possible symptoms of anaemia which is caused by low level of red blood cells), frequent infections, fever, chills, sore
throat or mouth ulcers due to infections (possible symptoms of neutropenia which is caused by low level of white blood cells), spontaneous bleeding or bruising (possible symptoms of thrombocytopenia which is caused by low levels of platelets)
- low counts of all three types of blood cells - red blood cells, white blood cells, and platelets (pancytopenia)
Other side effects
Other possible side effects include the following listed below. If you experience these side effects talk to your doctor or pharmacist. Very common (may affect more than 1 in 10 people):
- high level of cholesterol (hypercholesterolaemia)
- headache
- high blood pressure (hypertension)
- feeling sick (nausea)
- abnormal liver function test results
increased blood level of enzyme from muscle potentially indicating muscle damage and/or muscle breakdown (increased blood creatine
phosphokinase)
increased blood level of creatinine, a substance normally eliminated by the kidneys into the urine, which may mean that your kidneys are not
functioning properly (increased blood creatinine)
Common (may affect up to 1 in 10 people):
- fever, pain, redness, and/or difficulty breathing (possible symptoms of infection with BK virus)
- weight gain
- constipation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the carton or bottle after “EXP”. Store in a refrigerator. Do not freeze.
After opening use within 60 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Jakavi contains
- The active substance of Jakavi is ruxolitinib.
- Each ml solution contains 5 mg ruxolitinib
The other ingredients are: propylene glycol (E 1520), citric acid anhydrous, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate
(E 216), sucralose (E 955), strawberry flavour, nitrogen, purified water
What Jakavi looks like and contents of the pack
Jakavi comes in the form of an oral solution. It is a clear, colourless to light yellow solution which may have some small colourless particles or a small amount of sediment in it.
Jakavi oral solution is available in 70 ml amber glass bottles with a white polypropylene child-resistant screw cap closure. Packs containing one bottle of 60 ml oral solution, two 1 ml oral syringes and one press-in bottle adapter. Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited
2nd Floor, WestWorks Building, White City Place
195 Wood Lane
W12 7FQ
United Kingdom
Manufacturer
Novartis Pharmaceuticals UK Limited
2nd Floor, The WestWorks Building, White City Place
195 Wood Lane,
London,
W12 7FQ
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom
Novartis Pharmaceuticals UK Ltd.
Tel: +44 1276 698370
This leaflet was last revised in April 2025.
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Instructions for use
Oral solution 5 mg/ml
Please read these “Instructions for Use” carefully before you start using Jakavi. Your healthcare provider should show you how to prepare and use Jakavi correctly. If you have any questions about using Jakavi talk to your healthcare provider.
Your Jakavi pack should contain:
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1 bottle containing Jakavi oral liquid
2 reuseable oral syringes (1 ml size with
0.1 ml graduations)
1 bottle adapter
Tip
Dose markings
Barrel Plunger
Black stopper
The healthcare provider must determine whether the patient can self-administer the medication or if assistance from a caregiver is
necessary.
- Do not use the Jakavi oral solution if packaging is damaged or expiry date has passed.
- Do not use the syringe if it is damaged or dose marking scale is faded.
- Always follow the proper syringe cleaning procedure.
- Do not use the syringe for more than one patient.
- If Jakavi oral solution gets in to the skin, immediately wash the area well with soap and water.
If Jakavi oral solution gets in the eyes, immediately rinse eyes with cool water.
IMPORTANT INFORMATION
Administration
Always wash and dry your hands before preparing and using a dose of Jakavi oral solution.
Push the plunger into the syringe as far as it will go to remove all the air inside.
Insert the tip of the syringe into the opening of the bottle adapter.
Push down to ensure the syringe is securely attached.
Carefully turn the bottle upside down and pull down on the plunger until the top of the black stopper lines up with the prescribed dose on the syringe barrel.
Note: Small air bubbles are ok. Check the bottle tamper evident seal is intact and check the expiry date on the bottle label.
Do not use Jakavi oral solution if the tamper evident seal is broken, or the expiry date has passed.
Shake the bottle before opening.
Remove the child-resistant cap by pushing down on the cap and turning it in the direction of the arrow (anti-clockwise).
Place the bottle on a flat surface and hold it firmly. With your other hand, insert the adapter into the bottle using your thumb or palm.
Important: Inserting the adapter may require a high force. Push hard until it is fully inserted. The adapter should be fully flush with the bottle, and you should not be able to see any ridges. 2
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Continue to hold the syringe in place and carefully turn the bottle back upright.
Remove the syringe from the bottle by gently pulling straight up.
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Do not remove the bottle adapter.
Place the child-resistant cap back on the bottle and turn it clockwise to close it.
Make sure the cap is securely attached onto the bottle.
Make sure the child is sitting upright or standing.
Place the end of the syringe inside the mouth with the tip touching inside of either cheek.
Slowly push the plunger all the way down to give the prescribed dose of Jakavi oral solution.
WARNING: Administering to the throat or pushing the plunger too fast may cause choking.
A drink can be given to the child after to ensure the dose of Jakavi oral solution is swallowed.
Check there is no Jakavi oral solution left in the syringe.
If there is any Jakavi oral solution left in the syringe, administer it.
Check again to be sure that the top of the black stopper is at your prescribed dose.
If not, repeat measuring steps again.
Leave the plunger and barrel on a dry surface to air dry before next use.
Always keep the syringe out of reach of children.
Remove the plunger from the barrel.
Rinse the glass, plunger and barrel under warm tap water.
Place the syringe into the glass with the warm water.
Pull up and then push down on the plunger to pull the water in and out of the syringe 4 to 5 times.
Fill a glass with warm water.
Note: keep your oral syringe separate from your other kitchen items.
Cleaning the syringe
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- Do not throw away any Jakavi oral solution via wastewater or household waste.
- Ask your healthcare provider how to safely throw away (dispose of) Jakavi oral solution that is out of date or no longer needed.
Ask your healthcare provider how to safely throw away (dispose of) old syringes.
Disposal
Please read the following important information only if you’re going to administer Jakavi oral solution via a feeding tube:
- Always talk to your healthcare provider before administering Jakavi oral solution via a feeding tube. Your healthcare provider should show you how to administer Jakavi oral solution via a feeding tube.
- Jakavi oral solution can be administered via a Nasogastric (NG) or Gastric (G) feeding tube of size French 4 (or greater) and not exceeding 125 cm in length.
You may need an ENFIT adapter (not included in pack) to connect the 1 ml syringe to the feeding tube.
Administration via Feeding Tube 1
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Storage
- Store your syringes in clean, dry place and at room temperature of below 25°C.
- Always keep the syringes out of sight and reach of children.
- Always use a new oral syringe for each new bottle of Jakavi oral solution.
- Store the bottle containing Jakavi oral solution in a refrigerator between 2°C and 8°C, upright with the cap tightly closed.
- Do not freeze the bottle.
- Always keep the bottle out of sight and reach of children.
Jakavi oral solution can be used for 60 days after it is opened. Do not use after 60 days.
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