Jakafi
- Generic Name: ruxolitinib
- Brand Name: Jakafi
- Drug Class: , DMARDs, JAK Inhibitors
Jakafi (Ruxolitinib) side effects drug center
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- bruising,
- dizziness,
- headache,
- urinary tract infections,
- weight gain,
- bloating,
- gas,
- low blood platelet levels (thrombocytopenia),
- anemia,
- fatigue,
- diarrhea,
- shortness of breath, and
- nausea.
- pale skin,
- lightheadedness,
- shortness of breath,
- rapid heart rate,
- trouble concentrating,
- easy bruising,
- unusual bleeding (nose, mouth, vagina, or rectum),
- purple or red pinpoint spots under your skin,
- fever,
- chills,
- body aches,
- flu symptoms,
- vomiting,
- sores in your mouth and throat,
- pain or burning when you urinate, or
- blisters or painful skin rash.
- blisters or painful skin rash;
- changes in the size, shape, or color of a mole or skin lesion;
- problems with speech, thought, vision, or muscle movement (these symptoms may start gradually and get worse quickly);
- nausea, vomiting, weakness, general ill feeling;
- pain or burning when you urinate;
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
- signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.
- low blood cell counts;
- fluid retention;
- diarrhea;
- dizziness; or
- headache.
- Thrombocytopenia, Anemia and Neutropenia [see WARNINGS AND PRECAUTIONS]
- Risk of Infection [see WARNINGS AND PRECAUTIONS]
- Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see WARNINGS AND PRECAUTIONS]
- Non-Melanoma Skin Cancer [see WARNINGS AND PRECAUTIONS]
- 25% of patients treated with Jakafi and 7% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 2% for Jakafi with 1% Grade 3 and no Grade 4 ALT elevations.
- 17% of patients treated with Jakafi and 6% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was <1% for Jakafi with no Grade 3 or 4 AST elevations.
- 17% of patients treated with Jakafi and <1% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was <1% for Jakafi with no Grade 3 or 4 cholesterol elevations.
What Is Jakafi?
Jakafi (ruxolitinib) is a kinase inhibitor used in the treatment of intermediate or high-risk types of myelofibrosis, a potentially life-threatening blood cancer
What Are Side Effects of Jakafi?
Common side effects of Jakafi include:
Some side effects of Jakafi may be similar to the symptoms of myelofibrosis. Tell your doctor if you have serious side effects of Jakafi including:
Dosage for Jakafi
The starting dose of Jakafi is 20 mg given orally twice daily for patients with a platelet count greater than 200 X 109/L, and 15 mg twice daily for patients with a platelet count between 100 X 109/L and 200 X 109/L. Jakafi is available in the following forms and strengths: 5, 10, 15, 20, and 25 mg tablets.
What Drugs, Substances, or Supplements Interact with Jakafi?
Jakafi may interact with conivaptan, imatinib, isoniazid, nefazodone, antibiotics, antifungal medications, heart or blood pressure medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use.
Jakafi During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant while using Jakafi; it is unknown if it will harm a fetus. It is unknown if Jakafi passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Jakafi is not recommended.
Additional Information
Our Jakafi Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may be similar to the symptoms of myelofibrosis. Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Jakafi (Ruxolitinib)
SIDE EFFECTS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
Clinical Trials Experience In Myelofibrosis
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with MF in two Phase 3 studies.
In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In patients starting treatment with 15 mg twice daily (pretreatment platelet counts of 100 to 200 X 109/L) and 20 mg twice daily (pretreatment platelet counts greater than 200 X 109/L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy.
In a double-blind, randomized, placebo-controlled study of Jakafi, among the 155 patients treated with Jakafi, the most frequent adverse reactions were thrombocytopenia and anemia [see Table 12]. Thrombocytopenia, anemia and neutropenia are dose-related effects. The three most frequent nonhematologic adverse reactions were bruising, dizziness and headache [see Table 11].
Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with Jakafi and 11% of patients treated with placebo.
Table 11 presents the most common nonhematologic adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment.
Table 11: Myelofibrosis: Nonhematologic Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment
| Adverse Reactions | Jakafi (N=155) | Placebo (N=151) | ||||
| All Gradesa (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
| Bruisingb | 23 | <1 | 0 | 15 | 0 | 0 |
| Dizzinessc | 18 | <1 | 0 | 7 | 0 | 0 |
| Headache | 15 | 0 | 0 | 5 | 0 | 0 |
| Urinary Tract Infectionsd | 9 | 0 | 0 | 5 | <1 | <1 |
| Weight Gaine | 7 | <1 | 0 | 1 | <1 | 0 |
| Flatulence | 5 | 0 | 0 | <1 | 0 | 0 |
| Herpes Zosterf | 2 | 0 | 0 | <1 | 0 | 0 |
| a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia | ||||||
Description Of Selected Adverse Reactions
Anemia
In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (<1%) discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy.
In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients.
Thrombocytopenia
In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 5% of patients receiving Jakafi and to 4% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in <1% of patients receiving Jakafi and <1% of patients receiving control regimens. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (17% versus 7%).
Neutropenia
In the two Phase 3 clinical studies, 1% of patients reduced or stopped Jakafi because of neutropenia.
Table 12 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.
Table 12: Myelofibrosis: Worst Hematology Laboratory Abnormalities in the Placebo-Controlled Studya
| Laboratory Parameter | Jakafi (N=155) | Placebo (N=151) | ||||
| All Gradesb (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
| Thrombocytopenia | 70 | 9 | 4 | 31 | 1 | 0 |
| Anemia | 96 | 34 | 11 | 87 | 16 | 3 |
| Neutropenia | 19 | 5 | 2 | 4 | <1 | 1 |
| a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 | ||||||
Additional Data From The Placebo-Controlled Study
Clinical Trial Experience In Polycythemia Vera
In a randomized, open-label, active-controlled study, 110 patients with PV resistant to or intolerant of hydroxyurea received Jakafi and 111 patients received best available therapy [see Clinical Studies]. The most frequent adverse reaction was anemia. Discontinuation for adverse events, regardless of causality, was observed in 4% of patients treated with Jakafi.
Table 13 presents the most frequent nonhematologic adverse reactions occurring up to Week 32.
Table 13: Polycythemia Vera: Nonhematologic Adverse Reactions Occurring in > 5% of Patients on Jakafi in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatment
| Adverse Reactions | Jakafi (N=110) | Best Available Therapy (N=111) | ||
| All Gradesa (%) | Grade 3-4 (%) | All Grades (%) | Grade 3-4 (%) | |
| Diarrhea | 15 | 0 | 7 | <1 |
| Dizzinessb | 15 | 0 | 13 | 0 |
| Dyspneac | 13 | 3 | 4 | 0 |
| Muscle Spasms | 12 | <1 | 5 | 0 |
| Constipation | 8 | 0 | 3 | 0 |
| Herpes Zosterd | 6 | <1 | 0 | 0 |
| Nausea | 6 | 0 | 4 | 0 |
| Weight Gaine | 6 | 0 | <1 | 0 |
| Urinary Tract Infectionsf | 6 | 0 | 3 | 0 |
| Hypertension | 5 | <1 | 3 | <1 |
| a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes dizziness and vertigo c includes dyspnea and dyspnea exertional d includes herpes zoster and post-herpetic neuralgia e includes weight increased andabnormal weight gain f includes urinary tract infectionand cystitis | ||||
Clinically relevant laboratory abnormalities are shown in Table 14.
Table 14: Polycythemia Vera: Selected Laboratory Abnormalities in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatmenta
| Laboratory Parameter | Jakafi (N=110) | Best Available Therapy (N=111) | ||||
| All Gradesb (%) | Grade 3 (%) | Grade 4 (%) | All Grades (%) | Grade 3 (%) | Grade 4 (%) | |
| Hematology | ||||||
| Anemia | 72 | <1 | <1 | 58 | 0 | 0 |
| Thrombocytopenia | 27 | 5 | <1 | 24 | 3 | <1 |
| Neutropenia | 3 | 0 | <1 | 10 | <1 | 0 |
| Chemistry | ||||||
| Hypercholesterolemia | 35 | 0 | 0 | 8 | 0 | 0 |
| Elevated ALT | 25 | <1 | 0 | 16 | 0 | 0 |
| Elevated AST | 23 | 0 | 0 | 23 | <1 | 0 |
| Hypertriglyceridemia | 15 | 0 | 0 | 13 | 0 | 0 |
| a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 | ||||||
Clinical Trial Experience In Acute Graft-Versus-Host Disease
In a single-arm, open-label study, 71 adults (ages 18-73 years) were treated with Jakafi for acute GVHD failing treatment with steroids with or without other immunosuppressive drugs [see Clinical Studies]. The median duration of treatment with Jakafi was 46 days (range, 4-382 days).
There were no fatal adverse reactions to Jakafi. An adverse reaction resulting in treatment discontinuation occurred in 31% of patients. The most common adverse reaction leading to treatment discontinuation was infection (10%). Table 15 shows the adverse reactions other than laboratory abnormalities.
Table 15: Acute Graft-Versus-Host Disease: Nonhematologic Adverse Reactions Occurring in ≥ 15% of Patients in the Open-Label, Single-Cohort Study
| Adverse Reactionsa | Jakafi (N=71) | |
| All Gradesb (%) | Grade 3-4 (%) | |
| Infections | 55 | 41 |
| Edema | 51 | 13 |
| Hemorrhage | 49 | 20 |
| Fatigue | 37 | 14 |
| Bacterial infections | 32 | 28 |
| Dyspnea | 32 | 7 |
| Viral infections | 31 | 14 |
| Thrombosis | 25 | 11 |
| Diarrhea | 24 | 7 |
| Rash | 23 | 3 |
| Headache | 21 | 4 |
| Hypertension | 20 | 13 |
| Dizziness | 16 | 0 |
| a Selected laboratory abnormalities are listed in Table 16 below b National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 | ||
Selected laboratory abnormalities during treatment with Jakafi are shown in Table 16.
Table 16: Acute Graft-Versus-Host Disease: Selected Laboratory Abnormalities Worsening from Baseline in the Open-Label, Single Cohort Study
| Laboratory Parameter | Jakafi (N=71) | |
| Worst grade during treatment | ||
| All Gradesa (%) | Grade 3-4 (%) | |
| Hematology | ||
| Anemia | 75 | 45 |
| Thrombocytopenia | 75 | 61 |
| Neutropenia | 58 | 40 |
| Chemistry | ||
| Elevated ALT | 48 | 8 |
| Elevated AST | 48 | 6 |
| Hypertriglyceridemia | 11 | 1 |
| a National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 | ||
Read the entire FDA prescribing information for Jakafi (Ruxolitinib)
© Jakafi Patient Information is supplied by Cerner Multum, Inc. and Jakafi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.