OJJAARA

Momelotinib pharmacokinetic parameters are presented as mean (%CV) and were derived in patients with MF unless otherwise specified. The momelotinib steady-state C max is 479 ng/mL (61%) and AUC is 3,288 ng

• h/mL (60%) at the maximum recommended dosage. Momelotinib exposure (i.e., C max and AUC) increases dose proportionally from 100 mg to 300 mg (0.5 to 1.5 times the maximum recommended dosage), but less than dose‑proportional at doses from 400 mg to 800 mg (2 to 4 times the maximum recommended d...

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 9 /L in MOMENTUM and ≥50 × 10 9 /L in SIMPLIFY-1. MOMENTUM MOMENTUM (NCT0417349...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Risk of Infections and Hepatitis B Reactivation [see Warnings and Precautions ( 5.1 )]
• Thrombocytopenia and Neutropenia [see Warnings and Precautions ( 5.2 )]
• Hepatotoxicity [see Warnings and Precautions ( 5.3 )]
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )]
• Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.5 )]
• Thrombosis [see Warnings and P...

None. None. ( 4 )

• Risk of Infections: Do not initiate OJJAARA in patients with an active infection. Monitor for signs and symptoms of infection, including reactivation of hepatitis B, and initiate appropriate treatment promptly. ( 5.1 )
• Thrombocytopenia and Neutropenia: Manage by dose reduction or interruption. ( 5.2 )
• Hepatotoxicity: Obtain liver tests before initiation of and periodically throughout treatment with OJJAARA. ( 5.3 )
• Severe Cutaneous Adverse Reactions (SCARs): Monitor for signs and symptom...

7 DRUG INTERACTIONS

• Organic Anion Transporting Polypeptide (OATP)1B1/B3 inhibitors: Monitor for adverse reactions. ( 7.1 )
• Breast Cancer Resistance Protein (BCRP) substrates: Reduce rosuvastatin (BCRP substrate) dosage. Follow approved product information recommendations for other BCRP substrates. ( 7.2 ) 7.1 Effect of Other Drugs on OJJAARA Organic Anion Transporting Polypeptide (OATP)1B1/B3 ...