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Hana Safah, MD
Professor of Clinical Medicine
New Orleans, LA
Dr Safah has been compensated by GSK for participation in this program.
Audio – Dr Hana Safah
Hi. I am Dr Hana Safah. I am a professor of clinical medicine. I've been in practice for the past 29 years. I focus on the treatment of heme malignancy and stem cell transplantation, and specifically on the treatment of myeloproliferative neoplasm, including myelofibrosis.
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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 (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.
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.
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About Myelofibrosis
Patients with MF may experience different manifestations of disease, including1:
Anemia
Low hemoglobin levels2
Splenomegaly
An enlarged spleen resulting from extramedullary hematopoiesis1
Constitutional symptoms
Including fatigue, fever, night sweats, pruritus, and weight loss1,2
Thrombocytopenia
Low platelet levels1,2
References: 1. Mughal TI, et al. Int J Gen Med. 2014;7:89-101. 2. Tefferi A. Am J Hematol. 2023;98(5):801-821.
Audio – Dr Hana Safah
Patients with myelofibrosis are likely to experience different manifestations of their disease, including anemia, splenomegaly, constitutional symptoms, and thrombocytopenia.
Certain manifestations of MF, like anemia, constitutional symptoms, and thrombocytopenia, are adverse prognostic factors.
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About Myelofibrosis
Many patients with MF become transfusion-requiring1
Within 1 year of diagnosis,
~60% of MF patients are anemic and ~45% are transfusion-requiring*
Anemic, defined as hemoglobin <10 g/dL. Transfusion-requiring, defined as needing red blood cell transfusions.
*A retrospective study based on 1000 consecutive patients with primary MF at time of referral to Mayo Clinic, seen between November 4, 1977, and September 1, 2011. Separate analyses were included for patients seen at time of referral (N=1000), at initial diagnosis (n=340), within 1 year of diagnosis (n=274), and after 1 year of diagnosis (n=386).
Reference: 1. Tefferi A, et al. Mayo Clin Proc. 2012;87(1):25-33.
Audio – Dr Hana Safah
Many patients with MF become transfusion-requiring. Within one year of diagnosis, approximately 60 percent of MF patients are anemic. And around 45 percent are transfusion-requiring.
While healthcare providers have different tools to treat MF, they may need an FDA approved MF treatment option for adults with anemia.
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What is OJJAARA (momelotinib)?
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
Audio – [music]
On-screen – Dr Hana Safah
Audio – Dr Hana Safah
OJJAARA was approved by the FDA on September 15th, 2023.
OJJAARA has been studied in patients who have myelofibrosis with anemia in two pivotal studies, MOMENTUM and SIMPLIFY-1.
OJJAARA was approved specifically for the treatment of MF in patients with anemia.
Why is this important? It’s very important in my practice, because it addresses patient population with an unmet need. And those are the patients who present with anemia as part of their myelofibrosis.
So, these patients usually suffer from not only the constitutional symptoms or symptoms related to their splenomegaly, but also the anemia.
OJJAARA, as an FDA-approved treatment for myelofibrosis with anemia may help in the management of symptoms related to myelofibrosis.
Please stay tuned for additional important safety information to follow.
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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.
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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.
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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.
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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.
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References:
Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113(13):2895-2901. doi:10.1182/blood-2008-07-170449
Gangat N, Caramazza D, Vaidya R, et al. DIPSS plus: a refined Dynamic International Prognostic Scoring System for primary myelofibrosis that incorporates prognostic information from karyotype, platelet count, and transfusion status. J Clin Oncol. 2011;29(4):392-397. doi:10.1200/JCO.2010.32.2446
Mughal TI, Vaddi K, Sarlis NJ, Verstovsek S. Myelofibrosis-associated complications: pathogenesis, clinical manifestations, and effects on outcomes. Int J Gen Med. 2014;7:89-101. doi:10.2147/IJGM.S51800
OJJAARA (momelotinib). Prescribing Information. GSK; 2023
Passamonti F, Cervantes F, Vannucchi AM, et al. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood. 2010;115(9):1703-1708. doi:10.1182/blood-2009-09-245837
Tefferi A. Primary myelofibrosis: 2023 update on diagnosis, risk-stratification, and management. Am J Hematol. 2023;98(5):801-821. doi:10.1002/ajh.26857
Tefferi A, Lasho TL, Jimma T, et al. One thousand patients with primary myelofibrosis: the Mayo Clinic experience. Mayo Clin Proc. 2012;87(1):25-33. doi:10.1016/j.mayocp.2011.11.001
OJJAARA (momelotinib) 200 mg – 150 mg – 100 mg tablets
Audio – [music]
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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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©2024 GSK or licensor.
PMUS-MMLVID230008 July 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.
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OJJAARA Logo Animation to GSK Logo end frame.
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