Jakavi: Uses, Side Effects and Dosage

What is JAKAVI used for?

JAKAVI is used to:

• treat adults with an enlarged spleen (splenomegaly) and/or its associated symptoms. These patients will have myelofibrosis (MF), which is a rare form of blood cancer.
• control the haematocrit (the amount of red blood cells in the blood) in adults with polycythemia vera (PV). PV is a disorder of the bone marrow. These patients will not be able to use other medicines to control their hematocrit or these medicines no longer work for them.

• treat adults and children 12 years of age and older with graft-versus-host disease (GVHD), which can happen after a blood or bone marrow transplant. These patients will have acute or chronic GVHD

  • acute GVHD can happen soon after a transplant. These patients will have already received steroids for their GVHD, but these did not work well enough.
  • chronic GVHD can happen weeks to months after a transplant. These patients will have received other medicines for their GVHD but these did not work well enough.

How does JAKAVI work?

JAKAVI blocks the action of certain enzymes in the body called Janus Associated Kinases (JAK1 and JAK2).

Serious Warnings and Precautions

• Serious infections have been reported in patients treated with JAKAVI. Some cases were life-threatening or led to death.

• Your doctor should carefully assess and monitor you for the risk of developing any serious infections while you are taking JAKAVI.

  • In MF, this can help to reduce the size of the spleen size and/or other symptoms.
  • In PV, this can help to lower the hematocrit.

In GVHD, this helps to reduce the signs and symptoms of GVHD. It can also lead to improvement of the disease and survival of the transplanted cells.

What are the ingredients in JAKAVI?

Medicinal ingredient: Ruxolitinib phosphate

Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate (Type A).

JAKAVI comes in the following dosage forms:

Tablets; 5 mg, 10 mg, 15 mg and 20 mg ruxolitinib (as ruxolitinib phosphate)

Do not use JAKAVI if:

• you are allergic to ruxolitinib, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
• you have or have had a disease called progressive multifocal leukoencephalopathy (PML). PML is a rare brain infection.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAKAVI. Talk about any health conditions or problems you may have, including if you:

• have any type of infections. It may be necessary to treat your infection before starting JAKAVI.
• 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, including Hepatitis B.
• have any heart problems, including low heart rate, or if you ever have fainting spells.
• have intolerance to lactose (milk sugar). JAKAVI contains lactose.
• have ever had skin cancer or any other type of cancer.
• are a current or past smoker.

Other warnings you should know about:

• Skin cancers including basal cell, squamous cell and Merkel cell carcinoma have been reported in patients taking JAKAVI. While taking JAKAVI, limit your exposure to sunlight and other sources of UV light like tanning beds. Your doctor will examine your skin regularly.
• Low blood cell counts including thrombocytopenia (low platelets), anemia (low hemoglobin) and low white blood cells are possible while taking JAKAVI. If this happens, your dose of JAKAVI may need to be stopped temporarily or reduced. It is possible that you may need a blood transfusion.
• Treatment with JAKAVI can cause Progressive Multifocal Leukoencephalopathy (PML). This is rare infection of the brain can lead to severe disability and, possibly, death. Your healthcare professional will monitor you for signs of PML. Be sure to tell them if you experience 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. If you have PML, your treatment with JAKAVI may need to be stopped and you may need to see a specialist.
• Eye infections related to JAKAVI can cause visual problems, such as loss of sight. Your doctor should monitor you for eye infections while you are taking JAKAVI.

• Major heart and blood vessels problems have been reported with a similar drug. This similar drug is used to treat a type of arthritis (joint pain, swelling and stiffness) which JAKAVI is not used for. You may be at a higher risk of heart and blood vessel problems, including heart failure, heart attack and stroke if you:

  • are 65 years of age or older,
  • are a smoker or were a smoker in the past, or
  • have any heart problems.

• Lymphoma (cancer of the lymphatic system) and other cancers have been reported with a similar drug. This similar drug is used to treat a type of arthritis (joint pain, swelling and stiffness) which JAKAVI is not used for. You may be at an even greater risk of cancer if you:

  • are 65 years of age or older,
  • are a smoker or were a smoker in the past, or
  • had other cancers before.

Pregnancy and breastfeeding – female patients:

• If you are pregnant, think you are pregnant or plan to become pregnant, there are specific risks you should discuss with your healthcare professional.
• You should not take JAKAVI if you are pregnant. It may harm your unborn baby.
• If you are able to become pregnant, use an effective method of birth control to avoid becoming pregnant while taking JAKAVI.
• It is not known if JAKAVI passes into breastmilk. JAKAVI could harm your nursing baby. You should not breastfeed during your treatment with JAKAVI and for 2 weeks after your last dose.

Pregnancy – male patients: It is not known if JAKAVI will pass into your semen. Because of this you must take appropriate precautions to avoid fathering a child during your treatment.

Tests and check-ups:

• You will need blood tests before starting JAKAVI. These tests will help your doctor determine your starting dose. These blood tests will be repeated regularly during your treatment. They will show how your treatment with JAKAVI is affecting your blood (white and red blood cells, platelets), liver and kidneys and will measure the amount of fats in your blood.
• You will have regular visits with your healthcare professional before and during your treatment. At these visits, your healthcare professional will check your heart rate and blood pressure. You will also need to have electrocardiograms done. Your healthcare professional will also check you for any signs or symptoms of infection.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

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.

The following may interact with JAKAVI:

• medicines used to treat fungal, bacterial and viral (including HIV and AIDS) infections, including: fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole, erythromycin, rifampin, clarithromycin, telithromycin, atazanavir, indinavir, nelfinavir, ritonavir, and saquinavir.
• medicines that affect the heart or blood pressure, such as digitalis glycosides, cimetidine (a medicine to treat heartburn) and medicines for an abnormal heartbeat.
• medicines to treat dementia such as rivastigmine and donepezil
• medicines to treat multiple sclerosis such as fingolimod and siponimod

How to take JAKAVI:

• Take JAKAVI exactly as directed by your doctor. Do not take more JAKAVI than your doctor has told you.

• Take JAKAVI twice per day, at about the same times each day.

  • If you require hemodialysis: take one dose of JAKAVI after each hemodialysis session. Your doctor will tell you how much to take.

• Take with or without food. Swallow tablets whole with a glass of water. Do NOT cut, break, dissolve or chew the tablet.

• 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 working for you.

Usual dose: Your doctor will tell you exactly how much JAKAVI to take. It will depend on:

• your blood counts,
• whether you have kidney or liver problems or tuberculosis and
• what other medications you are taking.

The usual starting doses are:

• Patients with MF: 5 mg to 20 mg by mouth twice daily
• Patients with PV: 5 mg to 10 mg by mouth twice daily
• Patients with acute GVHD: 5 mg by mouth twice daily
• Patients with chronic GVHD: 10 mg by mouth twice daily

You may receive a lower starting dose if you have kidney or liver problems or are taking certain other medicines. As well, your health care professional may change your dose, interrupt or stop your treatment. This may happen if you experience certain side effects or if you are not responding to treatment. If you have MF or PV, your healthcare professional may increase your dose to improve your response. For MF and PV, the highest dose you might receive is 25 mg per day. For acute and chronic GVHD, the highest dose you might receive is 20 mg per day.

Do not stop taking JAKAVI or change your dose without first checking with your doctor. If you are taking JAKAVI to treat MF and you stop your treatment, your symptoms may come back.

If you are taking JAKAVI for GVHD and you respond to treatment, you may be able to stop your treatment. This will be done slowly over several months. Your doctor will supervise this procedure.

Overdose:

Missed Dose:

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

What are possible side effects from using JAKAVI?

These are not all the possible side effects you may have when taking JAKAVI. If you experience any side effects not listed here, tell your healthcare professional.

• Dizziness
• Bruising
• Headache
• Weight gain
• Frequently passing gas
• Diarrhea
• Nausea
• Constipation
• Muscle spasms
• Ringing in the ears
• Back pain
• Numbness
• Anxiety
• Cough, pain in the mouth and/or throat
• Nose bleeds
• High blood pressure may also be the cause of dizziness and headache
• BK virus infection (fever, pain, redness, and/or difficulty breathing)
• Fever

JAKAVI can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment. The results of these tests will tell how JAKAVI is affecting your blood, muscles, kidneys and liver.

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

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Do not take JAKAVI after the expiry date shown on the box.
• Store between 15-25^oC.
• Store in the original package.
• Keep out of the reach and sight of children.

If you have any unused JAKAVI, dispose of it according to the local rules and requirements.

If you want more information about JAKAVI:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.novartis.ca, or by calling 1-800-363-8883.

Last Revised Apr 28, 2023

^PrJAKAVI^® (ruxolitinib) is a registered trademark.