Brand Name
Ojjaara
Generic Name
Momelotinib
View Brand Information FDA approval date: September 15, 2023
Classification: Kinase Inhibitor
Form: Tablet
What is Ojjaara (Momelotinib)?
OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis , including primary MF or secondary MF [post-polycythemia vera and post-essential thrombocythemia ], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis , including primary MF or secondary MF [post-polycythemia vera and post-essential thrombocythemia ], in adults with anemia.
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Brand Information
Ojjaara (Momelotinib)
1INDICATIONS AND USAGE
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.
2DOSAGE FORMS AND STRENGTHS
100 mg round tablet – brown with an underlined “M” debossed on one side and “100” on the other side.
150 mg triangular tablet – brown with an underlined “M” debossed on one side and “150” on the other side.
200 mg capsule-shaped tablet – brown with an underlined “M” debossed on one side and “200” on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Risk of Infections and Hepatitis B Reactivation
- Thrombocytopenia and Neutropenia
- Hepatotoxicity
- Severe Cutaneous Adverse Reactions
- Major Adverse Cardiovascular Events
- Thrombosis
- Malignancies
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of OJJAARA was evaluated in 215 patients in 2 clinical trials (MOMENTUM and SIMPLIFY-1 anemic subgroup [hemoglobin (Hb) <10 g/dL])
MOMENTUM
Patients in the MOMENTUM trial had been previously treated with a JAK inhibitor and were randomly assigned 2:1 to receive double-blind OJJAARA 200 mg orally once daily (n = 130) or danazol 300 mg orally twice daily (n = 65) for 24 weeks, after which they were eligible to receive open-label OJJAARA in an extended treatment phase. Among patients who received OJJAARA, 72% were exposed for 24 weeks or longer and 52% were exposed for 48 weeks or longer
Serious adverse reactions 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%).
Permanent discontinuation of OJJAARA due to an adverse reaction 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%). Dosage reduction or treatment interruption due to an adverse reaction 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%).
Among the 130 patients treated with OJJAARA during the randomized treatment period of MOMENTUM, the most common adverse reactions (≥20%) were thrombocytopenia, diarrhea, hemorrhage, and fatigue (
SIMPLIFY-1
Patients in the SIMPLIFY-1 trial were JAK inhibitor naïve and randomly assigned 1:1 to receive double-blind OJJAARA 200 mg orally once daily (n = 215) or ruxolitinib 5 to 20 mg orally twice daily (n = 217). Upon completion of the double-blind treatment phase, all patients were eligible to receive OJJAARA during the open-label phase. The safety of OJJAARA was evaluated in the population of patients with MF who were anemic at study entry. SIMPLIFY-1 enrolled 180 anemic patients who received OJJAARA (n = 85) or ruxolitinib (n = 95). Among these anemic patients who received OJJAARA, 78% were exposed for 24 weeks or longer and 61% were exposed for 48 weeks or longer
Serious adverse reactions occurred in 28% of the 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.
Permanent discontinuation of OJJAARA due to an adverse reaction 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%). Dosage reductions or treatment interruptions of OJJAARA due to an adverse reaction occurred in 21% of patients. Adverse reactions requiring dosage reduction and/or treatment interruption (≥2%) were thrombocytopenia (8%), pneumonia (4%), bacterial infection (2%), abdominal pain (2%), elevated liver enzymes (2%), and hypotension (2%).
Among the 85 anemic patients treated with OJJAARA during the randomized treatment period of SIMPLIFY-1, the most common adverse reactions (≥20%) were dizziness, fatigue, bacterial infection, hemorrhage, thrombocytopenia, diarrhea, and nausea (
Other Adverse Reactions
Clinically relevant adverse reactions occurring in <5% of anemic patients in the MOMENTUM and SIMPLIFY-1 studies include:
Eye Disorders
Infections and Infestations: Fungal infection (excludes opportunistic infections).
Musculoskeletal and Connective Tissue Disorders: Arthralgia.
Nervous System Disorders: Neuralgia, peripheral neuropathy, peripheral motor neuropathy, polyneuropathy, syncope.
Vascular Disorders: Flushing.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of OJJAARA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis (TEN).
5OVERDOSAGE
There is no known antidote for overdose with OJJAARA. If overdose is suspected, the patient should be monitored for signs or symptoms of adverse reactions or effects, and appropriate supportive treatment should be instituted immediately. Further management should be as clinically indicated. Hemodialysis is not expected to enhance the elimination of momelotinib.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
6DESCRIPTION
OJJAARA contains momelotinib dihydrochloride monohydrate, which is a kinase inhibitor with the chemical name N‑(Cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide dihydrochloride monohydrate. It has a molecular formula of C
Momelotinib dihydrochloride monohydrate is a light yellow to brown to reddish-brown solid and is slightly soluble in water and insoluble in aqueous buffers across a pH range of 2.1 to 9. Momelotinib free base has a molecular formula of C
OJJAARA (momelotinib) tablets are for oral administration. Each tablet contains 100 mg, 150 mg, or 200 mg of momelotinib, which is equivalent to 121.94 mg, 182.91 mg, or 243.88 mg, respectively, of momelotinib dihydrochloride monohydrate as the active ingredient. The core of each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, silicon dioxide, and sodium starch glycolate. The film coating of each tablet contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide.
7CLINICAL STUDIES
The efficacy of OJJAARA in the treatment of adults with intermediate 1, intermediate 2, or high-risk MF, including primary MF, post-PV MF or post-ET MF, as defined by the Dynamic International Prognostic Scoring System (DIPSS) or International Prognostic Scoring System (IPSS) for MF, was established in the MOMENTUM trial and in a subpopulation of adults with anemia in the SIMPLIFY-1 trial. All patients received a starting dosage of OJJAARA 200 mg once daily. Eligible patients had baseline platelet count of ≥25 × 10
MOMENTUM
MOMENTUM (NCT04173494) was a double-blind, 2:1 randomized, active-controlled trial in 195 symptomatic and anemic adults with MF who had previously received an approved JAK inhibitor therapy. Patients were treated with OJJAARA 200 mg once daily or danazol 300 mg twice daily for 24 weeks, then switched to open-label treatment with OJJAARA.
The median age was 71 years (range 38 to 86 years) with 79% of patients aged 65 years and older, and 63% of patients were male. Overall, 81% of patients were White, 9% of patients were Asian, 2% of patients were Black, and 6% of patients were Hispanic or Latino. Sixty-four percent of patients had primary MF, 19% had post-PV MF, and 17% had post-ET MF. Five percent of patients had intermediate-1 risk, 57% had intermediate-2 risk, and 35% had high-risk disease. Within the 8 weeks prior to treatment, 79% of patients had received red blood cell (RBC) transfusions (median of 4 RBC units; interquartile range: 1-6). At baseline, 13% and 15% of patients were transfusion independent (defined as no red blood cell transfusions in the 12 weeks before the first dose and Hb ≥8 g/dL) in the OJJAARA and danazol groups, respectively. The baseline median Hb count was 8 g/dL and the median platelet count was 96 × 10
Symptoms were measured using the Myelofibrosis Symptom Assessment Form (MFSAF v4.0) diary. The MFSAF v4.0 patient diary, completed throughout the randomized treatment period, captured the core symptoms of MF: fatigue (weariness and tiredness), night sweats (or feeling hot or flushed), itching, abdominal discomfort (feeling pressure or bloating), 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 Total Symptom Score (maximum score of 70). At baseline, the mean MFSAF v4.0 Total Symptom Score was 28 in the OJJAARA group and 26 in the danazol group.
The efficacy of OJJAARA in the treatment of patients with primary or secondary MF and anemia was established based on a significantly higher percentage of patients treated with OJJAARA compared to danazol achieving a MFSAF v4.0 Total Symptom Score reduction of 50% or more at Week 24 compared with their own baseline score (
Figure 1 shows the percentage of patients treated with OJJAARA and danazol who achieved a 50% or greater reduction from baseline for each individual symptom in the MFSAF v4.0.
Figure 1: Percent of Patients Achieving a 50% or Greater Reduction in Individual MFSAF v4.0 Symptom Scores at Week 24
BID = twice a day; QD = once daily.
a Thirty-six (27.7%) subjects treated with OJJAARA and 27 (41.5%) subjects treated with danazol discontinued treatment prior to Week 24.
SIMPLIFY-1
SIMPLIFY-1 (NCT01969838) was a double-blind, randomized, active-controlled trial in 432 adults with MF who had not previously received a JAK inhibitor. Patients were treated with OJJAARA 200 mg once daily or ruxolitinib adjusted dose twice daily for 24 weeks. Patients were eligible to switch to open-label OJJAARA after 24 weeks (without tapering of the JAK inhibitor received during the randomization period). The baseline characteristics and efficacy results provided are for the subset of patients who had anemia (Hb <10 g/dL) at baseline (n = 181).
The median age was 68 years (range 25 to 86 years) with 67% of patients aged 65 years and older, and 59% of patients were male. Eighty-one percent of patients were White, 8% of patients were Asian, 1% of patients were Black, and 2% of patients were Hispanic or Latino. Sixty-three percent of patients had primary MF, 13% had post-PV MF, and 24% had post-ET MF. Four percent of patients had intermediate-1 risk, 25% had intermediate-2 risk, and 71% had high-risk disease. At baseline, 29% and 44% of patients were transfusion independent in the groups treated with OJJAARA or ruxolitinib, respectively. The baseline median Hb measurement was 8.8 g/dL and the median platelet count was 193 × 10
The efficacy of OJJAARA in the treatment of patients with MF in SIMPLIFY-1 was based on spleen volume response (reduction by 35% or greater). A numerically lower percent of patients treated with OJJAARA (25%) achieved a Total Symptom Score reduction of 50% or more at Week 24 compared with ruxolitinib (36%).
The spleen volume reduction results are presented in
Figure 2 shows the percent change from baseline in spleen volume for each patient at Week 24 in SIMPLIFY-1.
Figure 2: Percent Change from Baseline in Spleen Volume for Each Patient at Week 24 in SIMPLIFY-1
- a Subset of patients with anemia (Hb <10 g/dL) at baseline.
b Missing data rates for OJJAARA and ruxolitinib were 19% and 8%.
8HOW SUPPLIED/STORAGE AND HANDLING
OJJAARA (momelotinib) tablets are available as follows:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dispense to patient in original bottle only. Store in original bottle to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA approved patient labeling (Patient Information).
Infections
Inform patients that OJJAARA can increase the risk of infections (including COVID-19) and instruct them to promptly report to their healthcare provider any signs and symptoms of infection
Thrombocytopenia and Neutropenia
Inform patients that OJJAARA can cause thrombocytopenia and neutropenia, and of the need to monitor complete blood count, including platelet and neutrophil counts, before and during treatment. Advise patients to observe for and report any bleeding to their healthcare provider
Hepatotoxicity
Inform patients that OJJAARA can cause hepatotoxicity, and of the need to monitor liver blood tests before and during treatment
Severe Cutaneous Adverse Reactions (SCARs)
Inform patients that SCARs have been reported in some patients treated with OJJAARA and instruct them to promptly report any signs and symptoms of SCARs to their healthcare provider
Major Adverse Cardiovascular Events (MACE)
Advise patients that events of MACE including myocardial infarction, stroke, and cardiovascular death have been reported in clinical studies with another JAK inhibitor used to treat rheumatoid arthritis, a condition for which OJJAARA is not indicated. Advise patients, especially current or past smokers and patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events and to report them to their healthcare provider
Thrombosis
Advise patients that events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in clinical studies with another JAK-inhibitor used to treat rheumatoid arthritis, a condition for which OJJAARA is not indicated. Advise patients to tell their healthcare provider if they develop any signs or symptoms of a DVT or PE
Malignancies
Advise patients, especially current or past smokers, that lymphoma and other malignancies (excluding non-melanoma skin cancers (NMSC) have been reported in clinical studies with another JAK inhibitor used to treat rheumatoid arthritis, a condition for which OJJAARA is not indicated
Pregnancy
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their prescriber of a known or suspected pregnancy
- Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for 1 week after the last dose of OJJAARA
Lactation
Advise patients not to breastfeed during treatment with OJJAARA and for at least 1 week after the last dose of OJJAARA
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