Ojjaara Dosage
Generic name: MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE 100mg
Dosage form: tablet
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Sep 15, 2023.
Recommended Dosage
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.
Laboratory Monitoring for Safety
Obtain the following blood tests prior to starting treatment with OJJAARA, periodically during treatment, and as clinically indicated:
- •
- Complete blood count (CBC) with platelets
- •
- Hepatic panel
Dosage Modification for Hepatic Impairment
The recommended starting dosage in patients with severe hepatic impairment (Child-Pugh Class C) is 150 mg orally once daily. No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Dosage Modification for Adverse Reactions
Manage hematologic and non-hematologic adverse reactions as described in Table 1.
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). | ||
Thrombocytopenia |
Dose Modificationa |
|
Baseline Platelet Count |
Platelet Count |
|
≥100 × 109/L |
20 × 109/L to <50 × 109/L |
Reduce daily dose by 50 mg from the last given dose |
<20 × 109/L |
Interrupt treatment until platelets recover to 50 × 109/L Restart OJJAARA at a daily dose of 50 mg below the last given doseb |
|
≥50 × 109/L to <100 × 109/L |
<20 × 109/L |
Interrupt treatment until platelets recover to 50 × 109/L Restart OJJAARA at a daily dose of 50 mg below the last given doseb |
<50 × 109/L |
<20 × 109/L |
Interrupt treatment until platelets recover to baseline Restart OJJAARA at a daily dose of 50 mg below the last given doseb |
Neutropenia |
Dose Modificationa |
|
Absolute neutrophil count (ANC) <0.5 × 109/L |
Interrupt treatment until ANC ≥0.75 × 109/L Restart OJJAARA at a daily dose of 50 mg below the last given doseb |
|
Hepatotoxicity (unless other apparent causes) |
Dose Modificationa |
|
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 Modificationa |
|
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 |
Discontinue OJJAARA in patients unable to tolerate 100 mg once daily.
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