On-screen – Text
Angela Fleischman, MD, PhD
Physician Scientist
Southern California
Dr Fleischman has been compensated by GSK for participation in this program.
Audio – Dr Angela Fleischman
Hello. I'm Angela Fleischman. I'm an associate professor at an academic institution in Southern California. My clinical and research focus is on myeloproliferative neoplasms. And I have been seeing myeloproliferative neoplasm patients, including myelofibrosis patients, for the past 10 years at my university.
On-screen – Text
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
INDICATION
OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
IMPORTANT SAFETY INFORMATION
Risk of Infections
- Serious (including fatal) infections (e.g., bacterial and viral, including COVID-19) occurred in 13% of patients treated with OJJAARA. Infections regardless of grade occurred in 38% of patients. Delay starting therapy until active infections have resolved. Monitor patients for signs and symptoms of infection and initiate appropriate treatment promptly.
Please see additional Important Safety Information at the end of this video and click the link for the accompanying full Prescribing Information.
Audio – Voiceover Artist
INDICATION
OJJAARA (momelotinib) is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
IMPORTANT SAFETY INFORMATION
Risk of Infections
- Serious (including fatal) infections (for example, bacterial and viral, including COVID-19) occurred in 13% of patients treated with OJJAARA. Infections regardless of grade occurred in 38% of patients. Delay starting therapy until active infections have resolved. Monitor patients for signs and symptoms of infection and initiate appropriate treatment promptly.
Please see additional Important Safety Information at the end of this video and click the link for the accompanying full Prescribing Information.
On-screen – Text
What were the results of the MOMENTUM trial?
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
On-screen – Dr Angela Fleischman
Audio – Dr Angela Fleischman
OJJAARA was studied in JAK inhibitor-experienced patients with myelofibrosis, who were symptomatic and anemic in the MOMENTUM trial.
Because many myelofibrosis patients have been treated with a JAK inhibitor and are also anemic, that's why I think that the patients included in the MOMENTUM trial are specifically relevant to patients that are seen in my practice, as well as in community practice.
On-screen – Text
MOMENTUM Study Design in JAKi-Experienced Patients
MOMENTUM: Head-to-head trial evaluating OJJAARA vs danazol1,2
JAKi-Experienced Patients With MF Who Were Symptomatic and Anemic (N=195)*
JAKi-Experienced
Symptomatic (TSS >10) and anemic (Hb <10 g/dL)* with baseline splenomegaly†
Minimum platelet count of 25 x 109/L
Day 1
Double-Blind Treatment
Week 24
Open-Label Extended Treatment
Week 48
Patients
N=195
2:1 randomization
JAKi taper/washout >21 days‡
200 mg daily + placebo
OJJAARA
danazol
300 mg 2x daily + placebo
Primary Endpoint
OJJAARA
200 mg daily
All patients were eligible to receive OJJAARA after Week 24.
MOMENTUM was a double-blind, randomized, active-controlled Phase 3 trial in 195 symptomatic and anemic patients with primary MF, post-PV MF, or post-ET MF who had been previously treated with an approved JAK inhibitor therapy.
Hb=hemoglobin; JAKi=Janus kinase inhibitor; MF=myelofibrosis; MFSAF=Myelofibrosis Symptom Assessment Form; RBC=red blood cells; TSS=total symptom score.
*JAKi-experienced, defined as previously treated with an approved JAKi for >90 days or >28 days if therapy was complicated by >4 units of RBC transfused in 8 weeks, or Grade 3 or 4 adverse events of thrombocytopenia, anemia, or hematoma. Symptomatic and anemic, defined as an MFSAF v4.0 TSS of >10 at screening, and Hb <10 g/dL, respectively.2
†Baseline splenomegaly, defined as a palpable spleen of >5 cm below the left costal margin or volume of >450 cm3 on imaging.2
‡Patients receiving JAKi therapy at screening tapered therapy over more than 1 week, then completed at least 2 weeks of no treatment, starting at least 7 days before baseline assessments.2
References: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
2. Verstovsek S, et al; MOMENTUM Study Investigators. Lancet. 2023;401(10373):269-280.
Audio – Dr Angela Fleischman
MOMENTUM was a double-blind, randomized, active-controlled, Phase 3 trial that evaluated the safety and efficacy of OJJAARA versus danazol in 195 symptomatic and anemic patients with primary MF, post-PV MF, or post-ET MF who had previously received an approved JAK inhibitor therapy.
Symptomatic and anemic were defined as an MFSAF version 4.0 total symptom score of greater than or equal to 10 at screening and a hemoglobin of less than 10 grams per deciliter, respectively.
Patients receiving a JAK inhibitor at screening tapered therapy over more than one week, then completed at least two weeks of no treatment, starting at least seven days before baseline assessments.
Patients were treated with OJJAARA 200 milligrams once daily or danazol 300 milligrams twice daily for 24 weeks, then were eligible to switch to open-label treatment with OJJAARA in an extended-treatment phase.
On-screen – Dr Angela Fleischman + text
MOMENTUM Study Design in JAKi-Experienced Patients
Baseline patient characteristics1
Characteristic
Overall Population (N=195)
Median age, years (range)
71 (38 to 86)
>65 years of age
79%
Male, Female
63%, 37%
White, Asian, Black, Hispanic or Latino
81%, 9%, 2%, 6%
Primary MF, Post-PV, Post-ET
64%, 19%, 17%
Intermediate-1 risk, Intermediate-2 risk, High-risk*
5%, 57%, 35%
*As defined by the Dynamic International Prognostic Scoring System (DIPSS) for MF.1
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
The baseline characteristics are shown on the screen. Some of the baseline characteristics in the MOMENTUM trial were:
The median age was 71 years, with an age range of 38 to 86 years.
64 percent of patients had primary myelofibrosis and 36 percent had secondary myelofibrosis.
Five percent of patients had intermediate-1 risk, 57 percent had intermediate-2 risk, and 35 percent had high-risk disease.
On-screen – Dr Angela Fleischman + text
MOMENTUM Study Design in JAKi-Experienced Patients
Baseline patient characteristics (cont’d)1
8 g/dL median Hb count
96 x 109/L (range 24 x 109/L to 733 x 109/L) median platelet count
Characteristic
Overall Population (N=195)
Received RBC transfusions within 8 weeks prior to treatment
79% (Median of 4 RBC units; IQR: 1-6)
Median Hb, g/dL
8
Median platelet count x 109/L (range)
96 (24 to 733)
Median palpable spleen length
11 cm below the left costal margin
Median central spleen volume, MRI or CT, cm3 (range)
2105 (609 to 9717)
Mean TSS, MFSAF v4.0
28 in OJJAARA treatment arm, 26 in danazol treatment arm
Transfusion independent (TI)*
13% in OJJAARA treatment arm, 15% in danazol treatment arm
CT=computed tomography; Hb=hemoglobin; IQR=interquartile range; MRI=magnetic resonance imaging.
*TI at baseline, defined as no RBC transfusions in the 12 weeks before the first dose and Hb >8 g/dL.1
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
79 percent of patients received red blood cell transfusions within the eight weeks prior to enrollment.
The baseline median hemoglobin was eight grams per deciliter. And the median platelet count was 96,000.
Median palpable spleen length for patients in the study was 11 centimeters below the left costal margin. Median spleen volume, as measured by MRI or CT, for patients in this study was 2,105 centimeters cubed.
On-screen – Table
MOMENTUM Study Design in JAKi-Experienced Patients
Baseline patient characteristics1
8 g/dL median Hb count
96 x 109/L (range 24 x 109/L to 733 x 109/L) median platelet count
Characteristic
Overall Population (N=195)
Median age, years (range)
71 (38 to 86)
>65 years of age
79%
Male, Female
63%, 37%
White, Asian, Black, Hispanic or Latino
81%, 9%, 2%, 6%
Primary MF, Post-PV, Post-ET
64%, 19%, 17%
Intermediate-1 risk, Intermediate-2 risk, High-risk*
5%, 57%, 35%
Received RBC transfusions within 8 weeks prior to treatment
79% (Median of 4 RBC units; IQR: 1-6)
Median Hb, g/dL
8
Median platelet count x 109/L (range)
96 (24 to 733)
Median palpable spleen length
11 cm below the left costal margin
Median central spleen volume, MRI or CT, cm3 (range)
2105 (609 to 9717)
Mean TSS, MFSAF v4.0
28 in OJJAARA treatment arm, 26 in danazol treatment arm
Transfusion independent (TI)†
13% in OJJAARA treatment arm, 15% in danazol treatment arm
CT=computed tomography; Hb=hemoglobin; IQR=interquartile range; MRI=magnetic resonance imaging.
*As defined by the Dynamic International Prognostic Scoring System (DIPSS) for MF.1
†TI at baseline, defined as no RBC transfusions in the 12 weeks before the first dose and Hb >8 g/dL.1
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Voiceover Artist
Mean TSS, based on the MFSAF v4.0, was 28 in the OJJAARA treatment arm and 26 in the danazol treatment arm.
13% of patients in the OJJAARA treatment arm and 15% in the danazol treatment arm were transfusion independent.
On-screen – Dr Angela Fleischman + text
TSS in JAKi-Experienced Patients
Achievement of >50% TSS reduction was almost 3x greater with OJJAARA vs danazol1
Primary Endpoint: Rate of TSS Reduction of >50% From Baseline at Week 24
Percent of Patients
Superiority Δ*=16% [95% CI: 6, 26], P<0.01
25%
9%
~3x greater % achievement of >50% TSS reduction
OJJAARA (n=32/130)
danazol (n=6/65)
Symptoms were measured using the MFSAF v4.0 diary. The MFSAF v4.0 patient diary, completed throughout the randomized treatment period, captured the core symptoms of MF:
- Fatigue, night sweats, itching, abdominal discomfort, pain under ribs on left side, feeling of fullness after beginning to eat, and bone pain
- For each item, symptom scores, ranging from 0 (absent) to 10 (worst imaginable) were added to create a daily TSS (maximum score of 70)
CI=confidence interval; MFSAF=myelofibrosis symptom assessment form.
*Analysis stratified by baseline MFSAF v4.0 TSS (<22 vs >22).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
The primary endpoint was rate of total symptom score, or TSS, reduction of 50 percent or more from baseline at Week 24.
OJJAARA was statistically superior to danazol for TSS reduction.
Achievement of TSS reduction was almost three times greater with OJJAARA, 25 percent, versus danazol, nine percent.
Symptoms were measured using the MFSAF version 4.0 diary.
On-screen – Table
Select secondary endpoints
Transfusion independence rate at Week 24, tested for noninferiority*
Spleen volume reduction of 35 percent or more from baseline at Week 24, tested for superiority†
Rate of no transfusions during the 24-week treatment period, tested for superiority‡
CT=computed tomography; Hb=hemoglobin; MRI=magnetic resonance imaging; SVR=spleen volume reduction; TI=transfusion independence.
*TI rate at Week 24 was defined as the proportion of patients with no transfusion or Hb <8 g/dL between Weeks 12 and 24.
†SVR rate at Week 24 was defined as the proportion of patients who had a ≥35% reduction in spleen volume from baseline. Spleen volume was measured by MRI or CT.
‡Rate of no transfusions at Week 24 was defined as the proportion of patients with no transfusions during the 24-week treatment period.
Audio – Dr Angela Fleischman
Select secondary endpoints
On-screen – Dr Angela Fleischman + text
Rate of TI in JAKi-Experienced Patients
TI rate with OJJAARA was statistically noninferior to danazol1
Secondary Endpoint: Rate of TI at Week 241,2
(No Transfusion or Hb <8 g/dL Between Weeks 12 and 24)
Percent of Patients
(Noninferiority Δ*,†=14% [95% CI: 2, 25], P=0.023)
13%
15%
30%
20%
Baseline
OJJAARA (n=17/130)
danazol (n=10/65)
Week 24
OJJAARA (n=39/130)
danazol (n=13/65)
Baseline data provided as contextual information.
CI=confidence interval; TI=transfusion independence.
*Analysis stratified by baseline RBC or whole blood units transfused in the 8-week period before randomization (0, 1-4, >5 units).
†Noninferiority difference between OJJAARA response rate and 80% of danazol response rate.
References: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023. 2. Verstovsek S, et al; MOMENTUM Study Investigators. Lancet. 2023;401(10373):269-280.
Audio – Dr Angela Fleischman
Transfusion independence rate at Week 24 was defined as the proportion of patients with no transfusion or hemoglobin less than eight grams per deciliter between Weeks 12 and 24.
Thirty percent of patients achieved transfusion independence with OJJAARA and 20 percent with danazol at Week 24.
Transfusion independence rate with OJJAARA was statistically noninferior to danazol.
On-screen – Table
No Transfusions in JAKi-Experienced Patients
Achievement of no transfusions was about 2x greater with OJJAARA vs danazol1
Secondary Endpoint: Rate of No Transfusions*,†
(During the 24-Week Treatment Period)
Percent of Patients
(Superiority Δ‡=17% [95% CI: 8, 26], P=0.001)
35%
17%
~2x greater % achievement of no transfusions
OJJAARA (n=46/130)
danazol (n=11/65)
CI=confidence interval.
*Least squares means and difference are reported.
†Eight patients treated with OJJAARA and 3 patients treated with danazol had no transfusion, but discontinued treatment prior to Week 24.
‡Analysis stratified by baseline red blood cell or whole blood units transfused in the 8-week period before randomization (0, 1-4, >5 units).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Achievement of no transfusions during the 24-week period was about two times greater with OJJAARA versus danazol.
On-screen – Dr Angela Fleischman + text
SVR in JAKi-Experienced Patients
SVR was almost 7x greater with OJJAARA vs danazol1
Secondary Endpoint: Rate of SVR was >35% From Baseline at Week 241
Percent of Patients
(Superiority Δ*=18% [95% CI: 10, 27], P=0.001)
22%
3%
OJJAARA (n=29/130)
danazol (n=2/65)
CI=confidence interval; SVR=spleen volume reduction.
*Analysis stratified by baseline palpable spleen length below the left costal margin (<12 vs >12 cm).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Achievement of SVR greater than or equal to 35 percent from baseline was approximately seven times greater with OJJAARA, 22 percent, versus danazol, 3 percent, at Week 24.
On-screen – Dr Angela Fleischman + text
MOMENTUM Study Profile in JAKi-Experienced Patients
Well-characterized safety profile1
Adverse Reactions Occurring in >20% of Patients Receiving OJJAARA During Randomized Treatment in MOMENTUM
Adverse Reactions
OJJAARA (n=130)
danazol* (n=65)
Thrombocytopenia‡
OJJAARA (n=130)
All Grades† (%): 28; Grade ≥3 (%): 22
danazol* (n=65)
All Grades (%): 17; Grade ≥3 (%): 12
Diarrhea‡
OJJAARA (n=130)
All Grades† (%): 22; Grade ≥3 (%): 0
danazol* (n=65)
All Grades (%): 9; Grade ≥3 (%): 2
Hemorrhage‡
OJJAARA (n=130)
All Grades† (%): 22; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 18; Grade ≥3 (%): 8
Fatigue‡
OJJAARA (n=130)
All Grades† (%): 21; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 20; Grade ≥3 (%): 5
*Study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions across treatment groups.
†Adverse reactions graded using the National Cancer Institute CTCAE v.5.
‡Grouped term includes other related terms.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Safety was assessed in the MOMENTUM trial. OJJAARA has a well-characterized safety profile.
Among the 130 patients treated with OJJAARA during the randomized treatment period, the most common adverse reactions occurring in greater than or equal to 20 percent of patients were thrombocytopenia, diarrhea, hemorrhage, and fatigue.
On-screen – Dr Angela Fleischman + text
MOMENTUM Study Profile in JAKi-Experienced Patients
Well-characterized safety profile (cont’d)1
Adverse Reactions Occurring in >5% of Patients Receiving OJJAARA During Randomized Treatment in MOMENTUM
Adverse Reactions
Nausea‡
OJJAARA (n=130)
All Grades† (%): 16; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 9; Grade ≥3 (%): 3
Bacterial infection‡,§
OJJAARA (n=130)
All Grades† (%): 15; Grade ≥3 (%): 8
danazol* (n=65)
All Grades (%): 18; Grade ≥3 (%): 8
Abdominal pain‡
OJJAARA (n=130)
All Grades† (%): 13; Grade ≥3 (%): 1
danazol* (n=65)
All Grades (%): 18; Grade ≥3 (%): 3
Viral infection‡,§
OJJAARA (n=130)
All Grades† (%): 12; Grade ≥3 (%): 5
danazol* (n=65)
All Grades (%): 3; Grade ≥3 (%): 0
Pruritus‡
OJJAARA (n=130)
All Grades† (%): 11; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 11; Grade ≥3 (%): 0
Elevated liver enzymes‡
OJJAARA (n=130)
All Grades† (%): 10; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 9; Grade ≥3 (%): 3
Pyrexia‡
OJJAARA (n=130)
All Grades† (%): 10; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 8; Grade ≥3 (%): 0
Cough‡
OJJAARA (n=130)
All Grades† (%): 8; Grade ≥3 (%): 0
danazol* (n=65)
All Grades (%): 5; Grade ≥3 (%): 0
*Study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions across treatment groups.
†Adverse reactions graded using the National Cancer Institute CTCAE v.5.
‡Grouped term includes other related terms.
§Excludes opportunistic infections.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Additional adverse reactions included nausea, bacterial infection, abdominal pain, viral infection, pruritus, elevated liver enzymes, pyrexia, cough,
On-screen – Dr Angela Fleischman + text
MOMENTUM Study Profile in JAKi-Experienced Patients
Well-characterized safety profile (cont’d)1
Adverse Reactions Occurring in >5% of Patients Receiving OJJAARA During Randomized Treatment in MOMENTUM
Adverse Reactions
Paresthesia‡
OJJAARA (n=130)
All Grades† (%): 8; Grade ≥3 (%): 1
danazol* (n=65)
All Grades (%): 2; Grade ≥3 (%): 0
Dizziness‡
OJJAARA (n=130)
All Grades† (%): 8; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 2; Grade ≥3 (%): 0
Vomiting‡
OJJAARA (n=130)
All Grades† (%): 8; Grade ≥3 (%): 1
danazol* (n=65)
All Grades (%): 0; Grade ≥3 (%): 0
Rash‡
OJJAARA (n=130)
All Grades† (%): 6; Grade ≥3 (%): 0
danazol* (n=65)
All Grades (%): 11; Grade ≥3 (%): 0
Renal and urinary tract infection‡,§
OJJAARA (n=130)
All Grades† (%): 6; Grade ≥3 (%): 2
danazol* (n=65)
All Grades (%): 11; Grade ≥3 (%): 5
Arrhythmia‡
OJJAARA (n=130)
All Grades† (%): 5; Grade ≥3 (%): 1
danazol* (n=65)
All Grades (%): 6; Grade ≥3 (%): 2
Neutropenia
OJJAARA (n=130)
All Grades† (%): 5; Grade ≥3 (%): 5
danazol* (n=65)
All Grades (%): 3; Grade ≥3 (%): 3
*Study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions across treatment groups.
†Adverse reactions graded using the National Cancer Institute CTCAE v.5.
‡Grouped term includes other related terms.
§Excludes opportunistic infections.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
paresthesia, dizziness, vomiting, rash, renal and urinary tract infection, arrhythmia, and neutropenia.
On-screen – Dr Angela Fleischman + text
Serious adverse reactions1
Occurred in 35% of patients who received OJJAARA during the randomized treatment period of the MOMENTUM trial; the most common serious adverse reactions (>2%) included bacterial infection (8%), viral infection (5%), hemorrhage (4%), acute kidney injury (3%), pneumonia (3%), pyrexia (3%), thrombosis (3%), syncope (2%), thrombocytopenia (2%), and renal and urinary tract infection (2%). Fatal adverse reactions occurred in 12% of patients who received OJJAARA; the most common (>2%) fatal adverse reaction was viral infection (5%).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Serious adverse reactions occurred in 35 percent of patients who received OJJAARA during the randomized treatment period.
The most common serious adverse reactions included bacterial infection, viral infection, hemorrhage, acute kidney injury, pneumonia, pyrexia, thrombosis, syncope, thrombocytopenia, and renal and urinary tract infection.
Fatal adverse reactions occurred in 12 percent of patients who received OJJAARA. The most common fatal adverse reaction was viral infection.
On-screen – Dr Angela Fleischman + text
Permanent discontinuation of OJJAARA due to an adverse reaction1
Occurred in 18% of patients during the randomized treatment period of the MOMENTUM trial. Adverse reactions that resulted in permanent discontinuation (>2%) included viral infection (2%) and thrombocytopenia (2%).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Permanent discontinuation of OJJAARA due to an adverse reaction occurred in 18 percent of patients during the randomized treatment period of the MOMENTUM trial.
Adverse reactions that resulted in permanent discontinuation included viral infection and thrombocytopenia.
On-screen – Dr Angela Fleischman + text
Dosage reduction or treatment interruption of OJJAARA due to an adverse reaction1
Occurred in 34% of patients. Adverse reactions requiring dosage reduction and/or treatment interruption (>2%) included thrombocytopenia (13%), bacterial infection (2%), diarrhea (2%), and neutropenia (2%).
To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Angela Fleischman
Dosage reduction or treatment interruption of OJJAARA due to an adverse reaction occurred in 34 percent of patients.
Adverse reactions requiring dosage reduction and/or treatment interruption included thrombocytopenia, bacterial infection, diarrhea, and neutropenia.
On-screen – Dr Angela Fleischman
Audio – Dr Angela Fleischman
OJJAARA is a treatment option specifically indicated to treat MF patients with anemia.
In my practice, the majority of myelofibrosis patients are anemic.
A treatment like OJJAARA can help address the unmet need for myelofibrosis patients with anemia.
On-screen – Dr Angela Fleischman
Audio – Dr Angela Fleischman
For more information, including additional clinical data, please visit OJJAARAHCP.com. Please stay tuned for additional Important Safety Information to follow.
On-screen – Text
OJJAARA (momelotinib) logo
IMPORTANT SAFETY INFORMATION (cont’d)
Risk of Infections (cont’d)
Hepatitis B Reactivation
- Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine transaminase (ALT) or aspartate transaminase (AST), have been reported in patients with chronic hepatitis B virus (HBV) infection taking Janus Kinase (JAK) inhibitors, including OJJAARA. The effect of OJJAARA on viral replication in patients with chronic HBV infection is unknown. In patients with HBV infections, check hepatitis B serologies prior to starting OJJAARA. If HBsAg and/or anti-HBc antibody is positive, consider consultation with a hepatologist regarding monitoring for reactivation versus prophylactic hepatitis B therapy. Patients with chronic HBV infection who receive OJJAARA should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.
Thrombocytopenia and Neutropenia
- New or worsening thrombocytopenia, with platelet count less than 50 × 109/L, was observed in 20% of patients treated with OJJAARA. Eight percent of patients had baseline platelet counts less than 50 × 109/L.
- Severe neutropenia, absolute neutrophil count (ANC) less than 0.5 × 109/L, was observed in 2% of patients treated with OJJAARA.
- Assess complete blood counts (CBC), including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated. Interrupt dosing or reduce the dose for thrombocytopenia or neutropenia.
Audio – Voiceover Artist
IMPORTANT SAFETY INFORMATION, continued
Risk of Infections, continued
Hepatitis B Reactivation
- Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine transaminase (ALT) or aspartate transaminase (AST), have been reported in patients with chronic hepatitis B virus (HBV) infection taking Janus Kinase (JAK) inhibitors, including OJJAARA. The effect of OJJAARA on viral replication in patients with chronic HBV infection is unknown. In patients with HBV infections, check hepatitis B serologies prior to starting OJJAARA. If HBsAg and/or anti-HBc antibody is positive, consider consultation with a hepatologist regarding monitoring for reactivation versus prophylactic hepatitis B therapy. Patients with chronic HBV infection who receive OJJAARA should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.
Thrombocytopenia and Neutropenia
- New or worsening thrombocytopenia, with platelet count less than 50 × 109/L, was observed in 20% of patients treated with OJJAARA. Eight percent of patients had baseline platelet counts less than 50 × 109/L.
- Severe neutropenia, absolute neutrophil count (ANC) less than 0.5 × 109/L, was observed in 2% of patients treated with OJJAARA.
- Assess complete blood counts (CBC), including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated. Interrupt dosing or reduce the dose for thrombocytopenia or neutropenia.
On-screen – Text
OJJAARA (momelotinib) logo
IMPORTANT SAFETY INFORMATION (cont’d)
Hepatotoxicity
- Two of the 993 patients with MF who received at least one dose of OJJAARA in clinical trials experienced reversible drug-induced liver injury. Overall, new or worsening elevations of ALT and AST (all grades) occurred in 23% and 24%, respectively, of patients treated with OJJAARA; Grade 3 and 4 transaminase elevations occurred in 1% and 0.5% of patients, respectively. New or worsening elevations of total bilirubin occurred in 16% of patients treated with OJJAARA. All total bilirubin elevations were Grades 1-2. The median time to onset of any grade transaminase elevation was 2 months, with 75% of cases occurring within 4 months.
- Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated. When initiating OJJAARA, refer to dosing in patients with hepatic impairment.
- Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, modify OJJAARA dosage based upon Table 1 within the Prescribing Information.
Major Adverse Cardiovascular Events (MACE)
- Another JAK inhibitor increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke [compared with those treated with tumor necrosis factor (TNF) blockers] in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated.
- Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients receiving OJJAARA of the symptoms of serious cardiovascular events and the steps to take if they occur.
Thrombosis
- Another JAK inhibitor increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Evaluate patients with symptoms of thrombosis and treat appropriately.
Audio – Voiceover Artist
Hepatotoxicity
- Two of the 993 patients with MF who received at least one dose of OJJAARA in clinical trials experienced reversible drug-induced liver injury. Overall, new or worsening elevations of ALT and AST (all grades) occurred in 23% and 24%, respectively, of patients treated with OJJAARA; Grade 3 and 4 transaminase elevations occurred in 1% and 0.5% of patients, respectively. New or worsening elevations of total bilirubin occurred in 16% of patients treated with OJJAARA. All total bilirubin elevations were Grades 1-2. The median time to onset of any grade transaminase elevation was 2 months, with 75% of cases occurring within 4 months.
- Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated. When initiating OJJAARA, refer to dosing in patients with hepatic impairment.
- Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, modify OJJAARA dosage based upon Table 1 within the Prescribing Information.
Major Adverse Cardiovascular Events (MACE)
- Another JAK inhibitor increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke [compared with those treated with tumor necrosis factor (TNF) blockers] in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated.
- Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients receiving OJJAARA of the symptoms of serious cardiovascular events and the steps to take if they occur.
Thrombosis
- Another JAK inhibitor increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Evaluate patients with symptoms of thrombosis and treat appropriately.
On-screen – Text
OJJAARA (momelotinib) logo
IMPORTANT SAFETY INFORMATION (cont’d)
Malignancies
- Another JAK inhibitor increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Current or past smokers were at increased risk.
- Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
Adverse Reactions
- The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
Organic Anion Transporting Polypeptide (OATP)1B1/B3 Inhibitors
- Momelotinib is an OATP1B1/B3 substrate. Concomitant use with an OATP1B1/B3 inhibitor increases momelotinib maximal concentrations (Cmax) and area under the concentration-time curve (AUC), which may increase the risk of adverse reactions with OJJAARA. Monitor patients concomitantly receiving an OATP1B1/B3 inhibitor for adverse reactions and consider OJJAARA dose modifications.
Breast Cancer Resistance Protein (BCRP) Substrates
- Momelotinib is a BCRP inhibitor. OJJAARA may increase exposure of BCRP substrates, which may increase the risk of BCRP substrate adverse reactions. When administered concomitantly with OJJAARA, initiate rosuvastatin (BCRP substrate) at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed. Follow approved product information recommendations for other BCRP substrates.
Audio – Voiceover Artist
Malignancies
- Another JAK inhibitor increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Current or past smokers were at increased risk.
- Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
Adverse Reactions
- The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
Organic Anion Transporting Polypeptide (OATP)1B1/B3 Inhibitors
- Momelotinib is an OATP1B1/B3 substrate. Concomitant use with an OATP1B1/B3 inhibitor increases momelotinib maximal concentrations (Cmax) and area under the concentration-time curve (AUC), which may increase the risk of adverse reactions with OJJAARA. Monitor patients concomitantly receiving an OATP1B1/B3 inhibitor for adverse reactions and consider OJJAARA dose modifications.
Breast Cancer Resistance Protein (BCRP) Substrates
- Momelotinib is a BCRP inhibitor. OJJAARA may increase exposure of BCRP substrates, which may increase the risk of BCRP substrate adverse reactions. When administered concomitantly with OJJAARA, initiate rosuvastatin (BCRP substrate) at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed. Follow approved product information recommendations for other BCRP substrates.
On-screen – Text
OJJAARA (momelotinib) logo
IMPORTANT SAFETY INFORMATION (cont’d)
Pregnancy
- Available data in pregnant women are insufficient. OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.
Lactation
- It is not known whether OJJAARA is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed child, patients should not breastfeed during treatment with OJJAARA, and for at least 1 week after the last dose of OJJAARA.
Females and Males of Reproductive Potential
- Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for at least 1 week after the last dose of OJJAARA.
Hepatic Impairment
- Momelotinib exposure increased with severe hepatic impairment (Child-Pugh C). The recommended starting dose of OJJAARA in patients with severe hepatic impairment (Child-Pugh C) is 150 mg orally once daily. No dose modification is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).
Please click the link to see the full Prescribing Information, including Patient Information, for OJJAARA.
Audio – Voiceover Artist
Pregnancy
- Available data in pregnant women are insufficient. OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.
Lactation
- It is not known whether OJJAARA is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed child, patients should not breastfeed during treatment with OJJAARA, and for at least 1 week after the last dose of OJJAARA.
Females and Males of Reproductive Potential
- Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for at least 1 week after the last dose of OJJAARA.
Hepatic Impairment
- Momelotinib exposure increased with severe hepatic impairment (Child-Pugh C). The recommended starting dose of OJJAARA in patients with severe hepatic impairment (Child-Pugh C) is 150 mg orally once daily. No dose modification is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).
Please click the link to see the full Prescribing Information, including Patient Information, for OJJAARA.
On-screen – Text
References:
OJJAARA (momelotinib). Prescribing Information. GSK; 2023
Verstovsek S, Gerds AT, Vannucchi AM, et al; MOMENTUM Study Investigators.
Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study. Lancet. 2023;401(10373):269-280. doi:10.1016/S0140-6736(22)02036-0
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
Audio – [music]
On-screen – Text
Thanks for watching.
To learn more about OJJAARA, click the link to see the Prescribing Information or ask your GSK representative for additional videos.
Trademarks are owned by or licensed to the GSK group of companies.
©2024 GSK or licensor.
PMUS-MMLVID240017 November 2024
Produced in USA.
This promotional information is intended for US Healthcare Professionals only.
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
Audio – Voiceover Artist
Thanks for watching. To learn more about OJJAARA, click the link to see the Prescribing Information, or ask your GSK representative for additional videos.
On-screen – Text
OJJAARA Logo Animation to GSK Logo end frame.
END OF VIDEO
