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 [see Warnings and Precautions (5.2)]
•: Hepatic panel [see Warnings and Precautions (5.3)]

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 [see Use in Specific Populations (8.6)]. 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.

Table 1: Dose Modifications for OJJAARA-Related Adverse Reactions
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