On-screen Text - Dr Salman Fazal + Text
Salman Fazal, MD
Director of Cell Transplantation
Pittsburgh, PA
Dr Fazal has been compensated by GSK for participation in this program.
Audio - Dr Salman Fazal
My name is Salman Fazal. And I'm the Director of Cell Transplantation Program at my institution in the Pittsburgh area. I have been practicing for last 13 years. I treat patients with myeloid malignancies. And one of the areas of my expertise is patients with myelofibrosis.
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 SIMPLIFY-1 trial?
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
Audio - Voiceover Artist
OJJAARA was studied in a head-to-head myelofibrosis trial versus ruxolitinib in SIMPLIFY-1. SIMPLIFY-1 is supportive data and should be evaluated along with the pivotal MOMENTUM trial data, where OJJAARA was also studied in JAK inhibitor-experienced patients. Learn more at OJJAARAHCP.com.
On-screen Text - Dr Salman Fazal
Audio - Dr Salman Fazal
OJJAARA was studied in the JAK inhibitor-naïve myelofibrosis patients with anemia in SIMPLIFY-1.
On-screen Text
SIMPLIFY-1 Study Design in JAKi-Naïve Patients
SIMPLIFY-1: OJJAARA was studied in a head-to-head MF trial vs ruxolitinib1,2
JAKi-Naïve Patients (N=432)
JAKi-Naïve
With palpable splenomegaly*
Minimum platelet count of 50 x 109/L
Day 1
Double-Blind Treatment
Week 24
Open-Label Extended Treatment
Patients
N=432
1:1 randomization
200 mg daily
OJJAARA
ruxolitinib
5 to 20 mg 2x daily
Primary Endpoint
OJJAARA
200 mg daily
All patients were eligible to receive OJJAARA after Week 24.
SIMPLIFY-1 was a double-blind, randomized, active-controlled Phase 3 trial in 432 patients with primary MF, post-PV MF, or post-ET MF who had not previously received a JAK inhibitor.
Efficacy results were assessed in a subset of patients who had anemia (Hb <10 g/dL) at baseline (n=181).
- The efficacy of OJJAARA in the treatment of patients with MF in SIMPLIFY-1 was based on SVR (reduction ≥35%)†
- A numerically lower percent of patients treated with OJJAARA (25%) achieved a TSS reduction of ≥50% at Week 24 compared with ruxolitinib (36%)
ET=essential thrombocythemia; JAKi=Janus kinase inhibitor; MF=myelofibrosis; PV=polycythemia vera; SVR=spleen volume response; TSS=total symptom score.
*Palpable splenomegaly ≥5 cm below the left costal margin.2
†SVR at Week 24 was defined as the proportion of patients who had ≥35% reduction in spleen volume from baseline. Spleen volume was measured by magnetic resonance imaging (MRI) or computed tomography (CT).1
References: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023 2. Mesa RA, et al. J Clin Oncol. 2017;35(34):3844-3850.
Audio - Dr Salman Fazal
OJJAARA was studied in a head-to-head myelofibrosis trial versus ruxolitinib in SIMPLIFY-1.
SIMPLIFY-1 was a double-blind, randomized, active controlled phase 3 trial in 432 patients with primary myelofibrosis, post-PV myelofibrosis, or post-ET myelofibrosis, who had not previously received a JAK inhibitor. Patients had palpable splenomegaly.
Efficacy results were assessed in a subset of patients who had anemia, hemoglobin less than 10 grams per deciliter at baseline, n of 181 patients. The efficacy of OJJAARA in the treatment of patients with myelofibrosis and anemia at baseline in SIMPLIFY-1 was based on spleen volume response, a reduction by 35 percent or greater.
A numerically lower percent of patients treated with OJJAARA, 25 percent, achieved a total symptom score reduction of 50 percent or more at Week 24, compared with ruxolitinib, 36 percent.
On-screen - Dr Salman Fazal
Audio - Dr Salman Fazal
The patient population is quite relevant to my practice, because not infrequently, we see patients who are diagnosed with myelofibrosis, who have anemia at baseline.
On-screen Text - Dr Salman Fazal + Graph
SIMPLIFY-1 Study Design in JAKi-Naïve Patients
Baseline patient characteristics1
Characteristic
Patients With Baseline Hb <10 g/dL (n=181)
Median age, years (range)
68 (25 to 86)
≥65 years of age
67%
Male, Female
59%, 41%
White, Asian, Black, Hispanic or Latino
81%, 8%, 1%, 2%
Primary MF, Post-PV, Post-ET
63%, 13%, 24%
Intermediate-1 risk, Intermediate-2 risk, High-risk*
4%, 25%, 71%
Transfusion Independent (TI)†
29% in the OJJAARA treatment arm, 44% in the ruxolitinib treatment arm
ET=essential thrombocytopenia; Hb=hemoglobin; PV=polycythemia vera.
*As defined by the International Prognostic Scoring System (IPSS) for MF.1
†TI at baseline, defined as no RBC transfusions and all Hb ≥8 g/dL in the 12 weeks prior to randomization.2
References: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023. 2. Data on file, GSK.
Audio – Dr Salman Fazal
The baseline characteristics are shown on the screen. Some of the baseline characteristics in the subset anemic patients in SIMPLIFY-1 were, the median age of patients was 68 years, with a range of 25 to 86 years. Sixty-seven percent were 65 years of age or older.
Fifty-nine percent were male. And 41 percent were female. Sixty-three percent of patients had primary myelofibrosis. And 37 percent had secondary myelofibrosis. Four percent of patients had intermediate one risk disease. Twenty-five percent had intermediate two. And 71 percent had high-risk disease.
On-screen – Text
SIMPLIFY-1 Study Design in JAKi-Naïve Patients
Baseline patient characteristics1
Characteristic
Patients With Baseline Hb <10 g/dL (n=181)
Median age, years (range)
68 (25 to 86)
≥65 years of age
67%
Male, Female
59%, 41%
White, Asian, Black, Hispanic or Latino
81%, 8%, 1%, 2%
Primary MF, Post-PV, Post-ET
63%, 13%, 24%
Intermediate-1 risk, Intermediate-2 risk, High-risk*
4%, 25%, 71%
Transfusion Independent (TI)†
29% in the OJJAARA treatment arm, 44% in the ruxolitinib treatment arm
ET=essential thrombocytopenia; Hb=hemoglobin; PV=polycythemia vera.
*As defined by the International Prognostic Scoring System (IPSS) for MF.1
†TI at baseline, defined as no RBC transfusions and all Hb ≥8 g/dL in the 12 weeks prior to randomization.2
References: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023. 2. Data on file, GSK.
Audio – Voiceover Artist
29% of patients in the OJJAARA treatment arm and 44% in the ruxolitinib treatment arm were transfusion independent.
On-screen – Dr. Salman Fazal + Table
SIMPLIFY-1 Study Design in JAKi-Naïve Patients
Baseline patient characteristics (cont’d)1
8.8 g/dL
median Hb count in patients with Hb <10 g/dL
193 x 109/L
(range 54 x 109/L to 2865 x 109/L)
median platelet count in patients with Hb <10 g/dL
Characteristic
Patients With Baseline Hb <10 g/dL (n=181)
Median Hb, g/dL
8.8
Median platelet count, x 109/L (range)
193 (54 to 2865)
Median palpable spleen length
12 cm below the left costal margin
Median central spleen volume, MRI or CT, cm3 (range)
1843 (352 to 9022)
CT=computed tomography; Hb=hemoglobin; MRI=magnetic resonance imaging.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
The median hemoglobin measurement was 8.8 grams per deciliter. And the median platelet count was 193 by 10 raised to power of nine per liter.
Median palpable spleen length for patients in the study was 12 centimeter below the left costal margin.
On-screen – Text
SIMPLIFY-1 Study Design in JAKi-Naïve Patients
Baseline patient characteristics (cont’d)1
8.8 g/dL
median Hb count in patients with Hb <10 g/dL
193 x 109/L
(range 54 x 109/L to 2865 x 109/L)
median platelet count in patients with Hb <10 g/dL
Characteristic
Patients With Baseline Hb <10 g/dL (n=181)
Median Hb, g/dL
8.8
Median platelet count, x 109/L (range)
193 (54 to 2865)
Median palpable spleen length
12 cm below the left costal margin
Median central spleen volume, MRI or CT, cm3 (range)
1843 (352 to 9022)
CT=computed tomography; Hb=hemoglobin; MRI=magnetic resonance imaging.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – [music]
On-screen – Dr Salman Fazal + Graph
SVR in JAKi-Naïve Patients With Anemia
Comparable rates of SVR ≥35% were observed with OJJAARA and ruxolitinib1
Subset Analysis of Patients With Hb <10 g/dL at Baseline: Rate of SVR ≥35% From Baseline at Week 24
Percent of Patients
(95% Cl: 21.8, 42.3)
(95% Cl: 23.4, 43.0)
31%
OJJAARA (n=27/86)
33%
ruxolitinib (n=31/95)
SVR rate of ≥35% in both arms was similar
CI=confidence interval; SVR=spleen volume reduction.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
In the subset analysis of patients with anemia at baseline, thirty-one percent of patients treated with OJJAARA experienced a rate of spleen volume reduction of greater than or equal to 35 percent from baseline at Week 24, which was comparable with ruxolitinib.
On-screen – Dr Salman Fazal + Graph
SVR in JAKi-Naïve Patients With Anemia
SVR percent change for each patient1
Subset Analysis of Patients With Hb <10 g/dL at Baseline:
Percent Change in Spleen Volume for Each Patient From Baseline at Week 24*
% Change From Baseline
OJJAARA
ruxolitinib
35% decrease
Individual Patients in the Subset With Hb <10 g/dL at Baseline
*Missing data rates for OJJAARA and ruxolitinib were 19% and 8%.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
In the subset analysis of patients with anemia at baseline, SVR percent change for each patient is shown in the chart.
On-screen – Dr Salman Fazal + Graph
SIMPLIFY-1 Study Profile in JAKi-Naïve Patients With Anemia
Well-characterized safety profile1
Adverse Reactions Occurring in ≥20% of Anemic Patients Receiving OJJAARA During Randomized Treatment in SIMPLIFY-1
Adverse Reactions
Dizziness‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 24; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 15; Grade ≥3 (%): 2
Fatigue‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 22; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 25; Grade ≥3 (%): 1
Bacterial infection‡,§
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 21; Grade ≥3 (%): 8
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 12; Grade ≥3 (%): 2
Hemorrhage‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 21; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 18; Grade ≥3 (%): 2
Thrombocytopenia‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 21; Grade ≥3 (%): 11
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 34; Grade ≥3 (%): 6
Diarrhea‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 20; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 20; Grade ≥3 (%): 1
Nausea‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 20; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 3; Grade ≥3 (%): 1
*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 Common Terminology Criteria for Adverse Events (CTCAE) v.4.03.
‡Grouped term includes other related terms.
§Excludes opportunistic infections.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
Safety was assessed for OJJAARA in myelofibrosis patients with anemia in SIMPLIFY-1. OJJAARA has a well-characterized safety profile.
Adverse reactions occurring in greater than or equal to 20 percent of anemic patients receiving OJJAARA included dizziness, fatigue, bacterial infection, hemorrhage, thrombocytopenia, diarrhea, and nausea.
On-screen – Dr Salman Fazal + Graph
SIMPLIFY-1 Study Profile in JAKi-Naïve Patients With Anemia
Well-characterized safety profile (cont’d)1
Adverse Reactions Occurring in ≥5% of Anemic Patients Receiving OJJAARA During Randomized Treatment in SIMPLIFY-1
Adverse Reactions
Abdominal pain‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 18; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 14; Grade ≥3 (%): 1
Cough‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 14; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 11; Grade ≥3 (%): 0
Hypotension‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 14; Grade ≥3 (%): 2
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 0; Grade ≥3 (%): 0
Pain in extremity
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 12; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 5; Grade ≥3 (%): 0
Pyrexia‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 12; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 11; Grade ≥3 (%): 0
Rash‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 12; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 3; Grade ≥3 (%): 0
Renal and urinary tract infection‡,§
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 12; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 4; Grade ≥3 (%): 0
Elevated liver enzymes‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 11; Grade ≥3 (%): 4
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 9; 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 Common Terminology Criteria for Adverse Events (CTCAE) v.4.03.
‡Grouped term includes other related terms.
§Excludes opportunistic infections.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
Additional adverse reactions included abdominal pain, cough, hypotension, pain in extremity, pyrexia, rash, renal and urinary tract infection, elevated liver enzymes,
On-screen – Dr Salman Fazal + Graph
SIMPLIFY-1 Study Profile in JAKi-Naïve Patients With Anemia
Well-characterized safety profile (cont’d)1
Adverse Reactions Occurring in ≥5% of Anemic Patients Receiving OJJAARA During Randomized Treatment in SIMPLIFY-1
Adverse Reactions
Headache‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 11; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 16; Grade ≥3 (%): 0
Peripheral edema
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 11; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 8; Grade ≥3 (%): 0
Arrhythmia‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 8; Grade ≥3 (%): 2
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 2; Grade ≥3 (%): 1
Paresthesia‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 8; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 3; Grade ≥3 (%): 0
Pneumonia‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 8; Grade ≥3 (%): 8
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 5; Grade ≥3 (%): 3
Vomiting‡
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 8; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 5; Grade ≥3 (%): 0
Back Pain
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 7; Grade ≥3 (%): 1
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 2; Grade ≥3 (%): 0
Viral infection‡,§
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 6; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 13; Grade ≥3 (%): 2
Vitamin B1 deficiency
OJJAARA (n=85) Baseline Hb <10 g/dL
All Grades† (%): 6; Grade ≥3 (%): 0
ruxolitinib* (n=95) Baseline Hb <10 g/dL
All Grades† (%): 7; 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 Common Terminology Criteria for Adverse Events (CTCAE) v.4.03.
‡Grouped term includes other related terms.
§Excludes opportunistic infections.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
headache, peripheral edema, arrhythmia, paresthesia, pneumonia, vomiting, back pain, viral infection, and vitamin B-1 deficiency.
On-screen – Dr Salman Fazal + Text
Serious adverse reactions1
Occurred in 28% of anemic patients who received OJJAARA during the randomized treatment period of the SIMPLIFY-1 trial; the most common serious adverse reactions (≥2%) included bacterial infection (7%), pneumonia (6%), heart failure (4%), arrhythmia (2%), and respiratory failure (2%). A fatal adverse reaction (bacterial infection) occurred in 1 patient who received OJJAARA.
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
Serious adverse reactions occurred in 28 percent of the anemic patients who received OJJAARA during the randomized treatment period of the SIMPLIFY-1 trial.
The most common serious adverse reactions included bacterial infection, pneumonia, heart failure, arrhythmia, and respiratory failure.
A fatal adverse reaction, bacterial infection, occurred in one patient who received OJJAARA.
On-screen – Dr Salman Fazal + Text
Permanent discontinuation of OJJAARA due to an adverse reaction1
Occurred in 19% of the anemic patients during the randomized treatment period of the SIMPLIFY-1 trial. Adverse reactions that resulted in permanent discontinuation of OJJAARA (≥2%) included bacterial infection (2%), dizziness (2%), fatigue (2%), hypotension (2%), and thrombocytopenia (2%).
Reference: 1. OJJAARA (momelotinib). Prescribing Information. GSK; 2023.
Audio – Dr Salman Fazal
Permanent discontinuation of OJJAARA, due to an adverse reaction, occurred in 19 percent of the anemic patients during the randomized treatment period of the SIMPLIFY-1 trial.
Adverse reactions that resulted in permanent discontinuation of OJJAARA included bacterial infection, dizziness, fatigue, hypotension, and thrombocytopenia.
On-screen – Dr Salman Fazal + Text
Dosage reductions or treatment interruptions of OJJAARA due to an adverse reaction1
Occurred in 21% of patients. Adverse reactions requiring dosage reduction and/or treatment interruptions (≥2%) were thrombocytopenia (8%), pneumonia (4%), bacterial infection (2%), abdominal pain (2%), elevated liver enzymes (2%), and hypotension (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 Salman Fazal
Dosage reductions or treatment interruptions of OJJAARA, due to an adverse reaction, occurred in 21 percent of patients.
Adverse reactions requiring dosage reduction and/or treatment interruption were thrombocytopenia, pneumonia, bacterial infection, abdominal pain, elevated liver enzymes, and hypotension.
On-screen – Dr Salman Fazal
Audio – Dr Salman Fazal
Once patients are diagnosed with myelofibrosis, I discuss with my patients regarding their treatment goals.
OJJAARA is a treatment option specifically indicated to treat MF patients with anemia.
On-screen – Dr Salman Fazal
Audio – Dr Salman Fazal
For more information, including additional clinical data, please visit OJJAARAHCP.com. Please stay tuned for additional important safety information to follow.
On-screen – Text
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.
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
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
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.
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
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.
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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.
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
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.
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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.
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
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.
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References:
Mesa RA, Kiladjian JJ, Catalano JV, et al. SIMPLIFY-1: a phase III randomized trial of momelotinib versus ruxolitinib in Janus kinase inhibitor–naïve patients with myelofibrosis. J Clin Oncol. 2017;35(34):3844-3850. doi:10.1200/JCO.2017.73.4418
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
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PMUS-MMLVID230004 July 2024
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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.
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Ojjaara
(momelotinib)
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GSK
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