Momelotinib
Generic Name: momelotinib
Brand Names:
Ojjaara
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS 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. OJJAARA is a kinase inhibitor 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. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Recommended dosage: 200 mg orally once daily with or without food. ( 2.1 ) • Severe hepatic impairment (Child-Pugh Class C): Reduce the starting dose to 150 mg orally once daily. ( 2.3 ) 2.1 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.
Side Effects
6 ADVERSE REACTIONS 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 Precautions ( 5.6 )] • Malignancies [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
Interactions
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 Inhibitors Momelotinib is an OATP1B1/B3 substrate. Concomitant use with an OATP1B1/B3 inhibitor increases momelotinib maximal concentrations (C max ) and area under the concentration-time curve (AUC) [see Clinical Pharmacology ( 12.3 )], which may increase the risk of adverse reactions with OJJAARA.
Warnings
5 WARNINGS AND PRECAUTIONS • 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 symptoms, and interrupt OJJAARA until etiology of reaction has been determined. ( 5.4 ) • Major Adverse Cardiovascular Events (MACE): Monitor for symptoms, evaluate and treat promptly. ( 5.5 ) • Thrombosis: Evaluate and treat symptoms of thrombosis promptly. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data on the use of OJJAARA in pregnant women are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. Based on animal reproduction studies conducted in rats and rabbits, momelotinib may cause embryo-fetal toxicity at exposures lower than the expected exposure in patients receiving 200 mg once daily (see Data) . OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING OJJAARA (momelotinib) tablets are available as follows: Table 6: OJJAARA Presentations NDC Number Strength Description Tablets per Bottle NDC 81864-103-30 100 mg Round-shaped brown film-coated tablet with “ M ” on one side and “100” on the other side.
Frequently Asked Questions
What is Momelotinib used for?▼
1 INDICATIONS 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. OJJAARA is a kinase inhibitor 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. ( 1 )
What are the side effects of Momelotinib?▼
6 ADVERSE REACTIONS 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 Precautions ( 5.6 )] • Malignancies [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.
Can I take Momelotinib during pregnancy?▼
8.1 Pregnancy Risk Summary Available data on the use of OJJAARA in pregnant women are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. Based on animal reproduction studies conducted in rats and rabbits, momelotinib may cause embryo-fetal toxicity at exposures lower than the expected exposure in patients receiving 200 mg once daily (see Data) . OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.
What are the important warnings for Momelotinib?▼
5 WARNINGS AND PRECAUTIONS • 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 symptoms, and interrupt OJJAARA until etiology of reaction has been determined. ( 5.4 ) • Major Adverse Cardiovascular Events (MACE): Monitor for symptoms, evaluate and treat promptly. ( 5.5 ) • Thrombosis: Evaluate and treat symptoms of thrombosis promptly. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.