Source: FDA, National Drug Code (US) Revision Year: 2023
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.
The recommended dosage of OJJAARA is 200 mg orally once daily. OJJAARA may be taken with or without food.
Swallow OJJAARA tablets whole. Do not cut, crush, or chew tablets.
If a dose of OJJAARA is missed, the next scheduled dose should be taken the following day.
Obtain the following blood tests prior to starting treatment with OJJAARA, periodically during treatment, and as clinically indicated:
The recommended starting dosage in patients with severe hepatic impairment (Child-Pugh Class C) is 150 mg orally once daily [see Use in Specific Populations (8.6)]. No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Manage hematologic and non-hematologic adverse reactions as described in Table 1.
Table 1. Dose Modifications for OJJAARA-Related Adverse Reactions:
| Thrombocytopenia | Dose Modification a | |
| Baseline Platelet Count | Platelet Count | |
| ≥100 × 10 9/L | 20 × 10 9/L to <50 × 10 9/L | Reduce daily dose by 50 mg from the last given dose |
| <20 × 10 9/L | Interrupt treatment until platelets recover to 50 × 10 9/L Restart OJJAARA at a daily dose of 50 mg below the last given dose b | |
| ≥50 × 10 9/L to <100 × 10 9/L | <20 × 10 9/L | Interrupt treatment until platelets recover to 50 × 10 9/L Restart OJJAARA at a daily dose of 50 mg below the last given dose b |
| <50 × 10 9/L | <20 × 10 9/L | Interrupt treatment until platelets recover to baseline Restart OJJAARA at a daily dose of 50 mg below the last given dose b |
| Neutropenia | Dose Modification a | |
| Absolute neutrophil count (ANC) <0.5 × 10 9/L | Interrupt treatment until ANC ≥0.75 × 10 9/L Restart OJJAARA at a daily dose of 50 mg below the last given dose b | |
| Hepatotoxicity (unless other apparent causes) | Dose Modification a | |
| ALT and/or AST >5 × ULN (or >5 × baseline, if baseline is abnormal) and/or total bilirubin >2 × ULN (or >2 × baseline, if baseline is abnormal) | Interrupt treatment until AST and ALT ≤2 × ULN or baselinec and total bilirubin ≤1.5 × ULN or baselined Restart OJJAARA at a daily dose of 50 mg below the last given doseb If reoccurrence of ALT or AST elevations >5 × ULN, permanently discontinue OJJAARA | |
| Other Non-Hematologic | Dose Modification a | |
| Grade 3 or highere | Interrupt treatment until the toxicity resolves to Grade 1 or lower (or baseline) Restart OJJAARA at a daily dose of 50 mg below the last given doseb | |
ALT = alanine transaminase; AST = aspartate transaminase; ULN = upper limit of normal. |
a Reinitiate or escalate treatment up to starting dosage as clinically appropriate.
b May reinitiate treatment at 100 mg if previously dosed at 100 mg. |
c If baseline >2 × ULN.
d If baseline >1.5 × ULN.
e Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events per (CTCAE).
Discontinue OJJAARA in patients unable to tolerate 100 mg once daily.
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.
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.
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