ruxolitinib

Trade Name:

Jakavi®

Appearance:

tablet

in various strengths and shapes

Monograph Name:

ruxolitinib

Monograph Body:

Drug Monograph

A - Drug Name

ruxolitinib

COMMON TRADE NAME(S): Jakavi®

B - Mechanism of Action and Pharmacokinetics

Ruxolitinib is a Janus kinase (JAK) inhibitor, with selectivity for JAK1 and JAK2 which mediate the signaling of cytokines and growth factors for hematopoiesis and immune function. In myelofibrosis and polycythemia vera, JAK1/2 activity is dysregulated. Ruxolitinib interrupts JAK-STAT signaling and inhibits cell proliferation.

Absorption

Rapidly absorbed; dose proportional pharmacokinetics

Bioavailability

95% or greater, no significant effects with food administration

Peak plasma levels

1 hour

Distribution

Rapidly and widely distributed

PPB

97%, mostly to albumin

Cross blood brain barrier?

Metabolism

Metabolized mainly in the liver by CYP3A4, and to a lesser extent by CYP2C9

Active metabolites

Yes

Elimination

Urine

74% (< 1% unchanged)

Feces

22% (< 1% unchanged)

Half-life

3 hours for ruxolitinib alone

5.8 hours for ruxolitinib + metabolites

C - Indications and Status

Health Canada Approvals:

Myelofibrosis (MF)
Polycythemia vera (PV)
Graft-versus-host disease (GVHD)

Refer to the product monograph for a full list and details of approved indications.

D - Adverse Effects

Emetogenic Potential:

Minimal – No routine prophylaxis; PRN recommended

The following side effect information is based on two pivotal phase II studies (COMFORT I and II) and one phase II supporting study involving myelofibrosis (MF) patients. Side effect information specific to polycythemia vera (PV) patients is derived from a pivotal phase III study (RESPONSE) and a supporting phase II study. This table also includes severe or life-threatening adverse effects from other sources.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Angina (4%-MF)	E D
	Bradycardia (3%- MF, 7%-PV)	E
	Endocarditis infective (rare)	E D
	Hypertension (5%-PV)	E D
	Palpitations (5%) (MF)	E
	PR interval prolonged (12%)	E D
	Venous thromboembolism (rare)	E
Gastrointestinal	Constipation (8%-PV)	E D
	Diarrhea (15%-PV)	E D
	Nausea (6%-PV)	E D
	Weight gain (11%-MF, 5%-PV)	E D
General	Fever (15%) (MF)	E
Hematological	Myelosuppression ± infection, bleeding (82%-MF, 44%-PV) (may be severe, includes viral reactivation, opportunistic/atypical infections such as tuberculosis)	E
	Other - Withdrawal/rebound syndrome (MF)	E
Hepatobiliary	↑ LFTs (28%) (MF)	E
Metabolic / Endocrine	Hyperlipidemia (17%-MF, 30%-PV)	E
Musculoskeletal	Musculoskeletal pain (Muscle spasms, back pain) (12%-PV)	E D
Neoplastic	Secondary malignancy (Non-melanoma skin cancers)	E D
Nervous System	Dizziness (19%-MF; 12%-PV)	E
	Headache (16%) (MF)	E
	Leukoencephalopathy (PML) (rare)	E
	Other -Tinnitis (6%-PV)	E D
Respiratory	Cough, dyspnea (10%-PV)	E D

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for ruxolitinib include myelosuppression ± infection, bleeding, hyperlipidemia, ↑ LFTs, dizziness, headache, diarrhea, musculoskeletal pain, weight gain and cough.

Major adverse cardiovascular events (MACE), arterial/venous thrombosis, and/or malignancy, including fatal outcomes, have been reported with the JAK inhibitor tofacitinib. Consider the benefits and risks prior to initiating, or continuing, therapy of JAK inhibitors, especially in patients > 65 years, who are current or past smokers, or with other cardiovascular, thrombosis or malignancy risk factors.

Bradycardia and PR interval prolongation have been reported in the phase 3 clinical trials. Significant QTc increases were observed with ruxolitinib in a phase 3 clinical trial when compared with best available therapy, but no difference was demonstrated in another clinical trial which compared ruxolitinib to placebo.

Venous thromboembolism (VTE), including fatal cases, has been reported with the use of JAK inhibitors. Based on case reports, there is a possible link between ruxolitinib and VTE; however, patients also had blood disorders that may increase the risk of VTE.

Lipid abnormalities, including increases in total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides have been reported. Patients should be monitored and treated according to guidelines.

Increases in systolic pressure by 20 mmHg or more from baseline were reported in some trials but are of unclear significance.

Dose-related myelosuppression can occur, including anemia, neutropenia and thrombocytopenia. Median time of onset of myelosuppression is 6 - 12 weeks as observed in the phase 3 trials. Patients with low platelet counts at baseline (< 200 x 10⁹/L) are at higher risk of experiencing thrombocytopenia during treatment.

Bleeding events reported in the phase 3 clinical trials include intracranial, gastrointestinal, bruising, epistaxis, post-procedural hemorrhage and hematuria (and may be severe).

Herpes zoster infections have been reported in phase 3 clinical trials. Prompt treatment is required when signs and symptoms of this infection present. PML (JC virus) has been reported and may be life-threatening. Ruxolitinib should be held if PML is suspected and discontinued if it is confirmed.

Hepatitis B viral load increases have been reported in patients with chronic HBV infections taking ruxolitinib. These patients should be treated and monitored according to clinical guidelines.

Tuberculosis has been reported, including fatal cases, with patients receiving ruxolitinib.

Visual disorders, including loss of vision, secondary to eye infection is a risk with ruxolitinib. Other severe infections have also been reported, including fungal, as well as sepsis and endocarditis

Withdrawal effects may occur following interruption or discontinuation of ruxolitinib in patients with myelofibrosis, which may include symptoms of myelofibrosis returning, or septic shock-like symptoms within 1 week. Gradual tapering of ruxolitinib should be considered; however, the benefit of this practice is unproven.

Non-Melanoma Skin Cancers (NMSC’s), including basal cell, squamous cell, and Merkel cell carcinoma have been reported in patients treated with ruxolitinib, although a causal relationship has not been established. Most of the patients had previous extended hydroxyurea use or pre-malignant skin lesions. Patients are advised to minimize risk factors, such as UV exposure, and periodically examine skin (especially those who have other skin cancer risk factors).

E - Dosing

Refer to protocol by which patient is being treated.

Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.

Perform tuberculosis skin test and/or Interferon-gamma release assay before treatment initiation. Caution with interpreting results in severely immunocompromised patients due to possible false negatives.

Starting dose is based on indication, platelet and neutrophil counts, and degree of hepatic or renal impairment.

Treatment should not be started until neutrophils are ≥ 1 x 10⁹/L and platelets ≥ 50 x 10⁹/L.

Refer to product monograph for GVHD dosing information.

Refer to Interactions section for dosing recommendations when co-administered with CYP3A4 inhibitors.

Other supportive care:

Patients should minimize exposure to risk factors for skin cancer such as exposure to sunlight.

Adults:

Starting Dose

ANC ( x10⁹/L)	Platelet Count ( x10⁹/L)	Starting Dose Myelofibrosis	Starting Dose Polycythemia vera
> 1	> 200	20 mg PO twice daily	10 mg PO twice daily
> 1	100 - 200	15 mg PO twice daily	10 mg PO twice daily
> 1	75 - 99	10 mg PO twice daily	5 mg PO twice daily
> 1	50 - 74	5 mg PO twice daily	5 mg PO twice daily
≤ 1	< 50	Do not use	Do not use

Titration of Dose

If response to treatment is inadequate (for MF or PV), escalation may proceed as detailed below. The maximum dose is 25 mg PO BID.

The starting dose should not be increased during the first 4 weeks of treatment (for patients with MF) and 8 weeks of treatment (for PV).

Discontinue after 6 months if no improvement in symptoms or spleen size (MF) or after 16 months if no clinical benefit (PV).

ANC		Platelets (x 10⁹/L)	At 4 weeks (MF), or 8 weeks (PV)	Every 2 weeks (or more) thereafter
>0.75	AND	> 125 (and nadir >100)	↑ by 5mg bid	↑ by 5mg bid, if blood counts criteria are met.
≤0.75	OR	≤ 125 (or nadir < 100 )	Do not escalate.	Do not escalate.

Dosage with Toxicity:

MF or PV:

Toxicity (x 10⁹/L)	Action
Hb < 80 g/L (PV pts only)	Hold; when Hb recovers, may restart at 5 mg PO twice daily and titrate gradually.
Hb < 120 g/L (PV pts only)	Consider dose reduction, especially if Hb < 100 g/L.
Platelets < 50 or ANC < 0.5	Hold; when platelet and ANC counts above these levels, may restart at 5 mg PO twice daily and titrate gradually.
Platelets 50 to < 125 (MF pts only)	Refer to Dose Modification for Thrombocytopenia table below to minimize holds. May titrate gradually if appropriate.
PML, active tuberculosis, severe infection	Hold and investigate; discontinue if confirmed.
Bleeding requiring intervention (regardless of platelet count)	Hold until event is resolved; consider restart at previous dose if cause of bleeding controlled. If the underlying cause persists, consider restart at a lower dose.

Dose Modification for Thrombocytopenia (MF)

	Dose at Time of Platelet Decline
Platelet count	25 mg BID	20 mg BID	15 mg BID	10 mg BID	5 mg BID
	New dose	New dose	New dose	New dose	New dose
100 to < 125	20 mg BID	15 mg BID	No change	No change	No change
75 to < 100	10 mg BID	10 mg BID	10 mg BID	No change	No change
50 to < 75	5 mg BID	5 mg BID	5 mg BID	5 mg BID	No change

Dosage with Hepatic Impairment:

Avoid use in patients with hepatic impairment and platelets < 100 x 10⁹/L.

Hepatic impairment	Ruxolitinib Dose (MF or PV)
None	No adjustment required.
Any degree	Start at 50% of usual dose*. Monitor carefully and adjust as appropriate.

*round up to the nearest dosage strength, if necessary.

Dosage with Renal Impairment:

Avoid use in patients with moderate to severe renal impairment if platelets < 100 x 10⁹/L.

Hemodialysis is not expected to enhance the elimination of ruxolitinib.

Renal Impairment	Ruxolitinib Dose (MF or PV)
Mild	No adjustment required.
Moderate (CrCl 30-50 mL/min)	Start at 50% of usual dose*. Monitor closely for toxicity. Avoid if platelets < 100 x 10⁹/L.
Severe (CrCl < 30 mL/min)
Patients on hemodialysis	Single dose given only after each dialysis session based on platelet count. MF: 15 mg for platelets 100-200 x 10⁹/L; 20mg for platelets > 200 x 10⁹/L PV: 10 mg

*round up to the nearest dosage strength, if necessary

Dosage in the elderly:

No dosage adjustments required. No overall differences in safety or effectiveness were observed between patients > 65 years of age and younger patients with MF or PV.

Dosage based on gender:

Female MF patients may be at a higher risk of anemia than male patients. Ruxolitinib clearance in women with MF was lower compared to men, however, no specific dose adjustment has been recommended.

Children:

Safety and effectiveness of ruxolitinib in pediatric patients with MF or PV have not been established.

F - Administration Guidelines

Administer with or without food with a glass of water.
The tablets should be swallowed whole; do not cut, break, dissolve, crush or chew the tablets.
Avoid grapefruit, starfruit, Seville oranges, their juices or products during treatment.
If a dose is missed, skip this dose and take the next dose as scheduled. Do not double the dose to make up for the missed one.

Store at room temperature (15-25°C).

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to this drug or any of its components
Patients who have/had progressive multifocal leukoencephalopathy (PML)

Other Warnings/Precautions:

Major adverse cardiovascular events (MACE), arterial/venous thrombosis, and/or malignancy, including fatal outcomes, have been reported with the JAK inhibitor tofacitinib. Consider the benefits and risks prior to initiating, or continuing, therapy of JAK inhibitors, especially in patients > 65 years, who are current or past smokers, or with other cardiovascular, thrombosis or malignancy risk factors.
Ruxolitinib can cause bradycardia and prolongation of PR interval; use with caution in patients on drugs with similar effects or with history of cardiovascular disease including bradycardia, syncope or arrhythmia, sick sinus syndrome, sinoatrial block, atrioventricular (AV) block, ischemic heart disease, or congestive heart failure.
Serious bacterial, mycobacterial, fungal, and viral infections including viral reactivation and opportunistic infections (in some cases fatal) have been reported. Do not administer ruxolitinib in patients with active tuberculosis or active serious infections.
Contains lactose and should not be used in patients with hereditary lactase/glucose or galactose disorders.

Other Drug Properties:

Carcinogenicity: Unknown

Pregnancy and Lactation:

Embryotoxicity: Documented in animals
Fetotoxicity: Documented in animals
Mutagenicity: No
Clastogenicity: No
Teratogenicity: Unknown
Crosses placental barrier: Yes
Pregnancy:
Ruxolitinib is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners during treatment, and for at least 6 months after the last dose (general recommendation).
Excretion into breast milk: Documented in animals
Breastfeeding:
Breastfeeding is not recommended during treatment and for 2 weeks after the last dose.
Fertility effects: Probable

H - Interactions

Concurrent use of hematopoietic growth factors or cytoreductive agents and ruxolitinib has not been studied.

Monitor more frequently for cytopenias (e.g., twice a week) when starting a strong CYP3A4 inhibitor or combined moderate CYP2C9 and CYP3A4 inhibitors. Avoid concomitant use if platelet < 100.

Refer to product monograph for management in GVHD.

AGENT	EFFECT	MECHANISM	MANAGEMENT
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)	↑ ruxolitinib concentration and/or toxicity (↑ 91% in AUC)	↓ metabolism of ruxolitinib	For MF and PV, ↓ ruxolitinib by 50% with concomitant use of strong CYP3A4 inhibitors. Monitor for cytopenias. Avoid concomitant use if platelet < 100.
Moderate CYP3A4 inhibitors (e.g., erythromycin, ciprofloxacin, fruit or juice from grapefruit, Seville oranges or starfruit)	↑ ruxolitinib concentration and/or toxicity (↑ 27% in AUC)	↓ metabolism of ruxolitinib	Monitor for cytopenias.
Combined moderate CYP2C9 and CYP3A4 inhibitors (e.g., fluconazole)	↑ ruxolitinib concentration and/or toxicity (↑ 232% in AUC)	↓ metabolism of ruxolitinib	↓ ruxolitinib by 50%; avoid fluconazole doses > 200 mg daily. Monitor for cytopenias. Avoid concomitant use if platelet < 100.
Drugs that decrease heart rate and/or prolong the PR interval (ie. antiarrhythmics, beta blockers, digitalis glycosides, cholinesterase inhibitors, HIV protease inhibitors, non-dihydropyridine calcium channel blockers)	↑ risk of bradycardia and/or ↑ PR interval	Additive	Avoid if possible.

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
CBC	Baseline, every 2 - 4 weeks until doses are stabilized, and then as clinically indicated. Monitor more frequently for cytopenias (e.g., twice a week) when starting a strong CYP3A4 inhibitor or combined moderate CYP2C9 and CYP3A4 inhibitors.
Liver and renal function tests	Baseline and as clinically indicated
Lipids (total cholesterol, LDL, triglycerides)	Prior to starting, 4 weeks after starting, then as clinically indicated
Pulse rate and blood pressure	Baseline and as clinically indicated
ECG	Baseline and as clinically indicated
Clinical toxicity assessment for cardiovascular effects, infections (including ocular), bleeding, thrombosis, skin effects (including malignancies) and withdrawal syndrome (if applicable)	At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

ruxolitinib - For patients with intermediate to high risk symptomatic myelofibrosis, or patients with symptomatic splenomegaly, according to specific criteria
ruxolitinib - For the treatment of patients with polycythemia vera according to criteria.

K - References

Harrison C, Kiladjian J, Kathrin Al-Ali H, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med 2012;366-787-98.

Health Professional Risk Communication. Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis (Including Fatal Events) and Malignancy. Health Canada. November 2022.

Prescribing information: Jakafi® (ruxolitinib). Incyte Corporation (US), September 2021.

Product monograph: Jakavi® (ruxolitinib). Novartis Pharmaceuticals Canada Incorporated, June 8, 2022.

Summary Safety Review - Xeljanz and Xeljanz XR (tofacitinib), and Jakavi (ruxolitinib) - Janus Kinase (JAK) inhibitors - Health Canada. June 2020.

Tefferi A and Pardanani A. Serious adverse events during ruxolitinib treatment discontinuation in patients with myelofibrosis. Mayo Clinic Proceedings 2011;86(12):1188-91.

Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012;366:799-807.

March 2025 Updated Pregnancy/Lactation section

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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Info Sheet Name:

ruxolitinib (patient)

Info Sheet Introduction:

For treating certain types of blood cancers (such as myelofibrosis or polycythemia vera) or symptoms related these cancers

Info Sheet Date: Thursday, July 6, 2023 Info Sheet body:

Medication Information Sheet

ruxolitinib (RUX-oh-LI-ti-nib)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Jakavi®

Appearance:

tablet

in various strengths and shapes

What is this medication for?

For treating certain types of blood cancers (such as myelofibrosis or polycythemia vera) or symptoms related these cancers

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), especially if you have / had:

heart problems (such as low heart rate or abnormal heart rhythms),
serious infections,
kidney, liver problems, or
any allergies.

Ruxolitinib tablets contain a small amount of lactose. If you cannot have lactose, talk to your health care team.

Remember to:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this medication may affect your sexual health.
How this medication may affect your ability to have a baby, if this applies to you.

This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until at least 6 months after your last dose (general recommendation). Talk to your health care team about which birth control options are best for you.
Do not breastfeed while on this medication and until 2 weeks after your last dose.

How is this medication given?

This medication is usually taken twice a day by mouth. Talk to your health care team about how and when to take your medication.
Take tablets with a glass of water, with or without food.
Do not crush, chew, or split the tablets.
You may need a mix of tablets of different strengths to get the right dose. Make sure you look at your tablets closely so that you take the right dose.
Do not eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while taking this drug. They may increase the amount of drug in your blood and increase side effects.
If you vomit (throw up) after taking your medication, talk to your health care team about what to do.
If you forget to take a dose of your medication, skip this dose and take the next dose as scheduled. Do not take extra (double up) to make up for the missed dose. Follow the instructions given to you or talk to your health care team if you are unsure about what to do.
Your health care team will monitor your blood cell counts regularly to decide what the right dose is for you. They may ask you to stop taking this medication temporarily when your blood counts are too low.
Make sure you understand your health care team’s instructions and follow them carefully. Do not stop your medication unless you have been told to do so by your health care team.
If you take too much of your oral anticancer medication by accident, or if you think a child or a pet may have swallowed your medication, you must call the Ontario Poison Control Center right away at: 1-800-268-9017.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?
- This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment not work as well or cause severe side effects.
- Tell your health care team about all of your:
  - prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
  - natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
- Check with your health care team before starting or stopping any of them.
What should I do if I feel unwell, have pain, a headache or a fever?
- Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).
  - Fever can be a sign of infection that may need treatment right away.
  - If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).
- You have a fever if your temperature taken in your mouth (oral temperature) is:
  - 38.3°C (100.9°F) or higher at any time
    
    OR
  - 38.0°C (100.4°F) or higher for at least one hour.
If you do have a fever:
- Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
- Ask your health care team for the Fever pamphlet for more information.
If you do not have a fever but have mild symptoms such as headache or mild pain:
- Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
- Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
- Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

What to DO while on this medication:

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
DO tell your health care team about any serious infections that you have now or have had in the past.
DO talk to your health care team about your risk of getting other cancers after this treatment.

What NOT to DO while on this medication:

DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.
DO NOT eat or drink grapefruit, starfruit, Seville oranges or their juices (or products that contain these) while taking this drug. They may increase the amount of drug in your blood and increase side effects.

How should I safely store this medication?

Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.
How to safely touch oral anti-cancer medications

If you are a patient:
- Wash your hands before and after touching your oral anti-cancer medication.
- Swallow each pill whole. Do not crush or chew your pills.
If you are a caregiver:
- Wear nitrile or latex gloves when touching tablets, capsules or liquids.
- Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the oral anti-cancer medication.
- Throw out your gloves after each use. Do not re-use gloves.
- Do not touch oral anti-cancer medications if you are pregnant or breastfeeding.
What to do if oral anti-cancer medication gets on your skin or in your eyes

If medication gets on your skin:
- Wash your skin with a lot of soap and water.
- If your skin gets red or irritated, talk to your health care team.
If medication gets in your eyes:
- Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.

What are the side effects of this medication?

The following table lists side effects that you may have when taking ruxolitinib. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.

Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on ruxolitinib.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
Low neutrophils (white blood cells) in the blood (neutropenia) (May be severe) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen). Do not eat or drink anything hot or cold right before taking your temperature. You have a fever if your temperature taken in your mouth (oral temperature) is: 38.3°C (100.9°F) or higher at any time OR 38.0°C (100.4°F) or higher for at least one hour. What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.	If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.
Low platelets in the blood (May be severe) When your platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding red or pink coloured urine (pee) What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend a blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.	Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe (very heavy), you MUST get emergency help right away.
Anemia (low red blood cells) (May be severe) What to look for? You may feel more tired or weaker than normal. Pale skin and cold hands and feet. You may feel short of breath, dizzy or lightheaded. This may occur in days to weeks after your treatment starts. What to do? If your health care team has told you that you have anemia (low red blood cells): Rest often and eat well. Light exercise, such as walking may help. You may need medication or a blood transfusion. If it is very bad, your doctor may need to make changes to your treatment regimen.	Talk to your health care team if it does not improve or if it is severe

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Liver problems Your health care team may check your liver function with a blood test. The liver changes do not usually cause any symptoms. What to look for? Rarely, you may develop yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. This may be severe. What to do? If you have any symptoms of liver problems, get emergency medical help right away.	Get emergency medical help right away
Higher than normal cholesterol or fat levels in the blood What to look for? High cholesterol or fat levels usually do not cause any symptoms. Since your treatment may cause high cholesterol, your health care team may do regular blood tests to check your cholesterol levels. What to do? Your health care team may give you medication to treat high cholesterol or fat levels. If you already take medication for high cholesterol or fat levels, your health care team may change the amount or type of medication you take.	Talk to your health care team if it does not improve or if it is severe

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Dizziness What to look for? You may feel light-headed and like you might faint (pass out). What to do? Lay down right away so you do not fall. Slowly get up and start moving once you feel better. Do not drive a motor vehicle or use machinery if you feel dizzy.	Talk to your health care team if it does not improve or if it is severe
Headache; Mild joint, muscle pain or cramps What to look for? Mild headache. New pain in your muscles or joints, muscle cramps, or feeling achy. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Diarrhea What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day)
Weight gain What to look for? You may notice your clothes fit tighter. You may gain weight even though you have not changed the way you eat or exercise. What to do? Try to eat a healthy and well balanced diet. Eat small meals throughout the day. Ask your health care team to see a dietician to help you control your weight if this bothers you. If you notice you are gaining weight, talk to your health care team to find out what may be causing this and what to do.	Talk to your health care team if it does not improve or if it is severe
Cough and feeling short of breath What to look for? You may have a cough and feel short of breath. Symptoms that commonly occur with a cough are: Wheezing or a whistling breathing Runny nose Sore throat Heartburn Weight loss Fever and chills Rarely this may be severe with chest pain, trouble breathing or coughing up blood. What to do? Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?". If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away. If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.	Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away.

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

Irregular heartbeat, chest pain, or fainting
Swelling in legs, ankles or belly
Pain, swelling and hardening of a vein in your arm or leg
Unusual skin changes (skin sores that do not heal; new growths)
Difficulty thinking, speaking or walking
Confusion, loss of balance, weakness on one side of your body
Blurry and/or loss of vision

Who do I contact if I have questions or need help?

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

Other Notes:

____________________________________________________________________________

February 2023 Updated/Revised info sheet

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

ruxolitinib patient.pdf Info Sheet (French):

ruxolitinib pour le patient.pdf Monograph:

ruxolitinib.pdf Funding Program: Exceptional Access Program Funding Instance:

ruxolitinib - For patients with intermediate to high risk symptomatic myelofibrosis, or patients with symptomatic splenomegaly, according to specific criteria
ruxolitinib - For the treatment of patients with polycythemia vera according to criteria.

Phonetic Spelling:

RUX-oh-LI-ti-nib

Cancer Type: Hematologic Myeloproliferative Neoplasms (MPNs) Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Wednesday, March 5, 2025 Universal Date: 2025-03-05 00:00:00 AddThis: Title URL: ruxolitinib Drug Display Status: Active Revision Summary:
Drug Monograph: Updated Pregnancy/Lactation section