Jakavi (Ruxolitinib)

Follow your doctor’s instructions carefully. Do not take more JAKAVI than what your doctor told you.

How long to take JAKAVI:

You should continue taking JAKAVI for as long as your doctor tells you to. This is a long-term treatment. 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 to take JAKAVI, talk to your doctor or pharmacist.

Monitoring during your treatment with JAKAVI:

Before you start treatment with JAKAVI, your doctor will perform blood tests and other tests for your heart beat and your blood pressure to determine the starting dose for you.

You will have some blood tests during your treatment with JAKAVI to monitor the amount of blood cells in your body (white and red blood cells, platelets), and your kidney and liver functions. These tests are performed to see how you respond to the treatment, or to see if JAKAVI is having an unwanted effect. Your doctor may need to adjust the dose of JAKAVI or interrupt your treatment with JAKAVI. You will also have other tests during your treatment with JAKAVI to monitor the condition of your heart beat and blood pressure.

Overdose:

If you take more JAKAVI than you should or in case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

Do not use a double dose of JAKAVI to make up for a forgotten dose. If you forgot to take JAKAVI simply take your next dose at the scheduled time.

If you stop taking JAKAVI:

If you are taking JAKAVI to treat myelofibrosis and you interrupt your treatment, your myelofibrosis related symptoms may come back. Therefore, you should not stop taking JAKAVI while being treated for myelofibrosis without checking first with your doctor.

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

Side effects may include:

• High level of cholesterol (hypercholesterolemia) or fat (hypertriglyceridemia) in the blood
• Dizziness
• Headache
• Abnormal liver function test results
• Weight gain
• Frequently passing gas (flatulence), diarrhea, nausea
• Muscle spasms
• Ringing in the ears
• Back pain
• Numbness
• Anxiety
• Cough, pain in the mouth and/or throat
• Nose bleeds
• Constipation
• High blood pressure (hypertension) may also be the cause of dizziness and headache

If any of these affects you severely, tell your doctor or pharmacist.

BEFORE you use JAKAVI talk to your doctor or pharmacist if you:

• have any infections. It may be necessary to treat your infection before starting 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 had or has tuberculosis. Your doctor may test you to see if you have tuberculosis.
• have any kidney problems.
• have or have ever had liver problems.
• have any heart problems, including low heart rate, or if you ever have fainting spells.
• have intolerance to lactose (milk sugar). JAKAVI contains lactose.
• are pregnant or plan to become pregnant. JAKAVI is not recommended during pregnancy. You must use an effective method of birth control to avoid becoming pregnant while taking JAKAVI.
• are breast-feeding. JAKAVI may harm your baby.
• are a male patient. You must take appropriate precautions to avoid fathering a child during JAKAVI treatment.
• have ever had skin cancer.
• have ever had viral hepatitis B (a liver disease).

Children and adolescents (under 18 years old):

The safety of JAKAVI in patients younger than 18 years old have not been established.

During your treatment with JAKAVI:

Tell your doctor straight away:

• If you experience unexpected bruising and/or bleeding, unusual tiredness, shortness of breath with exercise or at rest, looking pale, or frequent infections (signs of blood disorders).
• If you experience fever, chills or other symptoms of infections or develop painful skin rash with blisters (signs of shingles).
• If you experience chronic cough with blood-tinged sputum, fever, night sweats, and weight loss (these are signs of tuberculosis).
• If 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 are signs of progressive multifocal leukoencephalopathy).
• If you notice any skin changes. This may require further observation, as certain types of skin cancer (non-melanoma) have been reported with the use of JAKAVI. You should minimize your exposure to sunlight and other sources of UV light, such as tanning beds, while taking JAKAVI.

As with most medicines, interactions with other drugs are possible. Tell your doctor or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

It is particularly important that you mention any of the following medicines:

• some medicines used to treat infections. These include medicines which treat fungal diseases (antifungals like fluconazole, ketoconazole, itraconazole, posaconazole and voriconazole, or medicines to treat types of bacterial infections (antibiotics like clarithromycin, or telithromycin), or medicines to treat viral infections, including HIV/AIDS (atazanavir, indinavir, nelfinavir, ritonavir, saquinavir).
• Any medications that you are taking that affect the heart or blood pressure, such as antiarrhythmics, digitalis glycosides, antihypertensives and cimetidine (a medicine to treat heartburn).

While you are taking JAKAVI you should never start a new medicine without checking first with the doctor who has prescribed you JAKAVI. This includes prescribed medicines, over the counter medicines and herbal or alternative medicines.