Before taking Jakavi, tell your healthcare provider about any medical conditions, infections, allergies, or medications you are taking.
Jakavi is a prescription medication used to treat certain blood and bone marrow disorders, including myelofibrosis and polycythemia vera. It is also prescribed for certain forms of graft-versus-host disease (GVHD).
Jakavi belongs to a class of medications called Janus kinase (JAK) inhibitors. It works by blocking JAK1 and JAK2 enzymes, which help regulate blood cell production, inflammation, and immune system activity.
Although Jakavi can help control disease-related symptoms, it may also lower blood cell counts and weaken the body’s ability to fight infections.
Your healthcare provider will monitor your condition during treatment and may adjust your dosage based on your blood test results.
Liver Problems and Hepatotoxicity
Jakavi should be used with caution in people with liver disease or reduced liver function.
The liver helps process ruxolitinib after it enters the bloodstream. When liver function is impaired, the medication may remain in the body at higher levels, increasing the risk of side effects.
Jakavi may also cause elevated liver enzymes, which can be detected through blood tests.
Elevated liver enzymes can sometimes indicate irritation or damage to liver cells.
In some patients, significant liver problems may develop, particularly when other medical conditions or medications affect liver function.
Possible symptoms of liver problems include:
- Jaundice: Yellowing of the skin or whites of the eyes.
- Dark Urine: Urine that becomes darker than normal.
- Upper Abdominal Pain: Discomfort on the upper-right side of the abdomen.
- Persistent Nausea: Feeling sick to your stomach for an extended period.
- Loss of Appetite: Reduced interest in eating.
- Unusual Fatigue: Persistent tiredness or weakness.
- Pale Stools: Bowel movements that appear unusually light in colour.
Tell your healthcare provider if you have hepatitis, cirrhosis, or a history of abnormal liver function tests.
Your healthcare provider may recommend liver function tests before treatment and periodically afterward.
Patients with liver impairment may require a lower starting dosage or additional monitoring.
Contact your healthcare provider promptly if you develop yellowing of the skin, dark urine, or persistent abdominal pain.
Severe liver injury is not a common established effect of Jakavi, but serious liver complications may occur in some circumstances, including hepatitis B reactivation.
Hepatitis B Reactivation
Jakavi may increase the risk of reactivating certain viral infections, including hepatitis B.
Hepatitis B is a viral infection that affects the liver and may cause inflammation, liver damage, or long-term liver disease.
Some people recover from hepatitis B but continue to carry inactive viral material in their bodies.
When the immune system becomes weakened, the virus may become active again. This is called hepatitis B reactivation.
Because Jakavi affects immune system signalling, it may reduce the body’s ability to keep certain infections under control.
Hepatitis B reactivation can cause liver inflammation and, in severe cases, liver failure.
Possible symptoms include:
- Fatigue: Unusual tiredness or lack of energy.
- Jaundice: Yellowing of the skin or eyes.
- Dark Urine: Urine that appears brown or tea-coloured.
- Abdominal Discomfort: Pain or pressure in the upper-right abdomen.
- Nausea and Vomiting: Persistent stomach upset.
- Loss of Appetite: Reduced desire to eat.
Tell your healthcare provider if you have hepatitis B, have previously been treated for hepatitis B, or have been exposed to the virus.
Your healthcare provider may recommend hepatitis B testing before starting Jakavi.
If you have a history of hepatitis B, additional monitoring or antiviral treatment may be necessary.
Seek medical attention promptly if you develop symptoms of liver inflammation while taking Jakavi.
Do not stop or change your medication without consulting your healthcare provider.
Non-Melanoma Skin Cancer
People taking Jakavi may have an increased risk of developing certain types of non-melanoma skin cancer.
Non-melanoma skin cancer refers mainly to basal cell carcinoma and squamous cell carcinoma.
These cancers develop in skin cells and are often associated with long-term ultraviolet (UV) exposure.
Some patients treated with Jakavi have developed non-melanoma skin cancers, particularly those with a history of skin cancer or previous treatment with certain medications that affect the immune system.
Because Jakavi influences immune system activity, regular skin monitoring is important.
Possible warning signs include:
- A New Skin Growth: An unusual bump or raised area that was not previously present.
- A Sore That Does Not Heal: A wound that remains open or repeatedly returns.
- Changes in Existing Spots: A skin lesion that changes in size, colour, shape, or appearance.
- Scaly Patches: Rough, thickened, or persistent areas of skin.
- Unexplained Bleeding: A skin growth that bleeds without an obvious injury.
Your healthcare provider may recommend periodic skin examinations during Jakavi treatment.
You can also reduce UV exposure by using sunscreen, wearing protective clothing, and avoiding excessive direct sunlight.
Contact your healthcare provider if you notice new or changing skin lesions.
Early evaluation can help identify suspicious skin changes before they become more serious.
Cardiovascular Events and Blood Clots
Tell your healthcare provider if you have heart disease, a history of blood clots, or other cardiovascular risk factors before taking Jakavi.
Important cardiovascular conditions include heart attack, stroke, and venous thromboembolism.
Venous thromboembolism refers to blood clots that form in veins, including deep vein thrombosis (DVT) and pulmonary embolism (PE).
Certain JAK inhibitors have been associated with increased risks of serious cardiovascular events, blood clots, and some cancers.
Health Canada has identified these risks as important safety concerns for the JAK inhibitor class, including Jakavi.
However, the evidence of increased heart attack or stroke risk is stronger for certain other JAK inhibitors than for ruxolitinib specifically. The risks should not be assumed to be identical across all medications in this class.
Your underlying blood disorder may also increase your risk of blood clots, making cardiovascular monitoring especially important.
Tell your healthcare provider if you have:
- A history of heart attack or stroke.
- Previous deep vein thrombosis or pulmonary embolism.
- High blood pressure or high cholesterol.
- Diabetes.
- A history of smoking.
- Obesity or other cardiovascular risk factors.
- A family history of certain blood clotting disorders.
Possible symptoms of a blood clot or cardiovascular emergency include:
- Chest Pain: Sudden pressure, tightness, or discomfort in the chest.
- Shortness of Breath: Unexpected difficulty breathing.
- Leg Swelling: Swelling, warmth, or pain in one leg.
- Sudden Weakness: Weakness affecting one side of the body.
- Speech Problems: Sudden difficulty speaking or understanding words.
- Vision Changes: Sudden loss or blurring of vision.
Your healthcare provider will assess your cardiovascular history and determine whether additional monitoring is necessary.
Seek emergency medical attention if you experience symptoms of a heart attack, stroke, or pulmonary embolism.
Tuberculosis Reactivation
Jakavi may increase the risk of developing serious infections, including tuberculosis (TB).
Tuberculosis is a bacterial infection caused by Mycobacterium tuberculosis.
It most commonly affects the lungs but may also involve other organs.
Some people have latent tuberculosis, meaning the bacteria remain in the body without causing symptoms.
If the immune system becomes weakened, latent tuberculosis may become active.
Jakavi affects immune system signalling and may increase the risk of reactivating tuberculosis in susceptible individuals.
Possible symptoms of active tuberculosis include:
- Persistent Cough: A cough lasting several weeks.
- Fever: An elevated body temperature.
- Night Sweats: Excessive sweating during sleep.
- Unexplained Weight Loss: Losing weight without trying.
- Fatigue: Ongoing tiredness or weakness.
- Chest Pain: Discomfort when breathing or coughing.
- Coughing Up Blood: Blood appearing in mucus from the lungs.
Tell your healthcare provider if you have previously had tuberculosis, have been exposed to someone with active TB, or have lived in an area where tuberculosis is common.
Your healthcare provider may recommend tuberculosis screening before starting Jakavi.
If latent tuberculosis is detected, appropriate treatment may be recommended before or during Jakavi therapy.
Jakavi should not be started in people with an active serious infection until the condition is appropriately managed.
Contact your healthcare provider promptly if you develop a persistent cough, fever, or unexplained weight loss during treatment.
Herpes Zoster (Shingles)
Jakavi may increase the risk of herpes zoster infection, commonly called shingles.
Shingles is caused by reactivation of the varicella-zoster virus, the same virus responsible for chickenpox.
After a person recovers from chickenpox, the virus remains inactive in certain nerve cells.
The virus may reactivate later in life, particularly when immune system activity is reduced.
Because Jakavi affects immune signalling, some patients may become more susceptible to shingles.
Common symptoms include:
- Pain or Burning: Tingling, burning, or pain in a particular area of skin.
- Skin Rash: A red rash that often appears on one side of the body.
- Fluid-Filled Blisters: Small blisters that may become painful.
- Skin Sensitivity: Increased discomfort when the affected area is touched.
- Fever or Fatigue: General symptoms that may occur alongside the rash.
Shingles can sometimes cause complications, including persistent nerve pain called postherpetic neuralgia.
Tell your healthcare provider if you have previously experienced shingles or frequently develop viral infections.
Your healthcare provider may recommend vaccination before treatment when appropriate.
If you notice a painful blistering rash, contact your healthcare provider promptly.
Early antiviral treatment may reduce the severity and duration of shingles.
Pregnancy and Breastfeeding
Jakavi should not be used during pregnancy or breastfeeding.
Ruxolitinib affects signalling pathways involved in cell growth, blood cell production, and immune system activity.
There is insufficient information from human studies to establish the safety of Jakavi during pregnancy.
Animal studies have shown harmful effects on developing offspring, raising concerns about possible risks to an unborn baby.
Tell your healthcare provider if you are pregnant, planning to become pregnant, or think you may be pregnant before starting Jakavi.
People who can become pregnant should use effective contraception during treatment, following their healthcare provider’s recommendations.
If you become pregnant while taking Jakavi, contact your healthcare provider promptly to discuss your treatment.
It is not known whether ruxolitinib passes into human breast milk. However, animal studies have shown that the medication and its metabolites can enter milk.
Because serious effects on a breastfed infant cannot be ruled out, breastfeeding is not recommended during Jakavi treatment.
Pregnancy and breastfeeding are listed as contraindications in European and UK Jakavi prescribing information.
Drug Interactions
Jakavi may interact with medications that affect how ruxolitinib is processed in the body.
The liver breaks down ruxolitinib mainly through an enzyme called CYP3A4, with CYP2C9 also contributing to its metabolism.
Certain medications can slow or increase the activity of these enzymes, changing the amount of Jakavi in your bloodstream.
These interactions may increase the risk of side effects or reduce the effectiveness of treatment.
Important interactions include:
- Strong CYP3A4 Inhibitors: Medications such as ketoconazole, itraconazole, and clarithromycin may increase ruxolitinib concentrations.
- Fluconazole: This antifungal medication inhibits CYP3A4 and CYP2C9 and may require special dosage precautions.
- CYP3A4 Inducers: Medications such as rifampin, carbamazepine, and phenytoin may increase ruxolitinib metabolism and reduce medication exposure.
- Other Immunosuppressive Medications: Combining Jakavi with medications that suppress immune function may increase the risk of infections.
- Other Medications Affecting Blood Cell Production: Certain treatments may increase the risk of low blood cell counts when combined with Jakavi.
Tell your healthcare provider about all prescription medications, over-the-counter drugs, vitamins, and herbal supplements you take.
Your healthcare provider may adjust your Jakavi dosage or recommend additional blood tests when certain medications are prescribed.
Do not start, stop, or change any medication without medical advice.
Kidney Disease and Renal Impairment
Tell your healthcare provider if you have kidney disease or reduced kidney function before taking Jakavi.
The kidneys help eliminate certain metabolites of ruxolitinib from the body.
People with significant kidney impairment may have increased exposure to these metabolites, which can affect treatment safety.
Patients with severe renal impairment may require a lower starting dosage.
Jakavi can also be used in certain patients receiving hemodialysis, but specialized dosing instructions are necessary.
The prescribed dosage depends on the condition being treated, kidney function, platelet count, and dialysis schedule.
Your healthcare provider may recommend:
- Kidney function tests before treatment.
- Regular complete blood counts.
- Dosage adjustments based on kidney function.
- Additional monitoring for medication-related side effects.
Do not adjust your Jakavi dosage or dosing schedule yourself if you have kidney disease or receive dialysis.
Your healthcare provider will determine the appropriate regimen and monitor your response.
Stopping Jakavi and Withdrawal-Related Symptoms
Do not stop taking Jakavi suddenly without consulting your healthcare provider.
Jakavi helps control inflammatory signalling and disease-related symptoms in people with myelofibrosis and certain other conditions.
After treatment is interrupted or discontinued, symptoms of myelofibrosis may return, sometimes within approximately one week.
In some patients, symptoms may become more severe after treatment stops.
Possible symptoms include:
- Fever: An elevated body temperature.
- Night Sweats: Excessive sweating during sleep.
- Fatigue: Persistent weakness or reduced energy.
- Abdominal Discomfort: Pain or fullness related to spleen enlargement.
- Bone Pain: Aching or discomfort in the bones.
- Difficulty Breathing: Breathing problems that require urgent assessment.
Serious complications have occasionally been reported after Jakavi discontinuation, although the role of sudden withdrawal has not been fully established.
Your healthcare provider may recommend gradually reducing the dosage in certain situations.
However, tapering is not necessary or appropriate in every case, especially when treatment must be stopped urgently because of a serious complication.
Glucocorticoid Withdrawal
Glucocorticoids are medications such as prednisone and dexamethasone that reduce inflammation and suppress immune system activity.
Some patients taking Jakavi, particularly those being treated for GVHD, may also receive glucocorticoids.
Stopping glucocorticoids suddenly after prolonged treatment may cause withdrawal symptoms or adrenal insufficiency.
Possible symptoms include severe fatigue, weakness, nausea, dizziness, and low blood pressure.
Glucocorticoid withdrawal is different from the return of symptoms that may occur after stopping Jakavi.
Your healthcare provider will determine how each medication should be reduced or discontinued.
Do not stop Jakavi or prescribed glucocorticoids without medical guidance.
Vaccinations and Immunization
Talk to your healthcare provider before receiving vaccines while taking Jakavi.
Jakavi affects immune system activity, which may influence how your body responds to certain vaccines.
Some vaccines contain weakened forms of living viruses or bacteria. These are called live attenuated vaccines.
Because Jakavi can suppress immune responses, live vaccines may pose additional risks during treatment.
Examples include:
- Measles, Mumps, and Rubella (MMR) Vaccine: Protects against three viral infections.
- Varicella Vaccine: Protects against chickenpox.
- Live Intranasal Influenza Vaccine: A nasal spray containing weakened influenza viruses.
- Yellow Fever Vaccine: Protects against yellow fever and contains a live attenuated virus.
Live vaccines should generally be avoided during Jakavi treatment unless a specialist determines that they are appropriate.
Non-live vaccines, such as injectable influenza vaccines and recombinant shingles vaccines, may be recommended depending on your medical history.
However, some patients may have a reduced immune response to vaccination while receiving Jakavi.
Your healthcare provider may review your vaccination history before starting treatment and recommend appropriate immunizations.
Do not receive a live vaccine without first consulting your healthcare provider.
Low Blood Cell Counts
Jakavi may reduce the number of red blood cells, white blood cells, and platelets in the bloodstream.
This is one of the most important safety precautions associated with ruxolitinib treatment.
Red blood cells carry oxygen, white blood cells help fight infections, and platelets help the blood clot.
When these blood cell levels become too low, serious complications may develop.
Potential effects include:
- Anemia: A low red blood cell count that may cause fatigue, weakness, dizziness, or shortness of breath.
- Thrombocytopenia: A low platelet count that may increase bruising or bleeding.
- Neutropenia: A low neutrophil count that may increase susceptibility to certain infections.
Your healthcare provider will perform a complete blood count before starting Jakavi and regularly during treatment.
Depending on the results, your healthcare provider may reduce your dosage, temporarily interrupt treatment, or recommend additional care.
Contact your healthcare provider promptly if you experience unusual bruising, persistent bleeding, fever, or significant fatigue.
This monitoring is essential because low blood cell counts may develop even before noticeable symptoms appear.
When to Contact Your Healthcare Provider
Contact your healthcare provider if you experience unusual fatigue, frequent infections, new skin lesions, persistent abdominal discomfort, or unexpected changes in your health while taking Jakavi.
Tell your healthcare provider if you have liver disease, kidney problems, hepatitis B, tuberculosis, a history of blood clots, or other cardiovascular conditions.
Seek prompt medical attention if you develop fever, painful shingles blisters, persistent coughing, unexplained bruising, or signs of liver problems.
Seek emergency medical attention if you experience severe bleeding, sudden chest pain, difficulty breathing, symptoms of a stroke, or serious signs of infection.
Jakavi can help manage myelofibrosis, polycythemia vera, and certain forms of graft-versus-host disease, but regular medical monitoring is essential. Blood tests, infection screening, medication reviews, and appropriate dosage adjustments help reduce the risk of serious treatment-related complications.
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