TLPH Molotinib momelotinib 200mg

Product Information

• Product name: Molotinib momelotinib 200mg
• Manufacturer / brand: Laos TLPH Pharma
• Active ingredient: Momelotinib
• Current strength: 200mg
• SKU: AM-ITEM-2
• Site category: general medicines, myelofibrosis, platelet disorders

Product Summary

Molotinib momelotinib 200mg is an AISTIKA-listed product supplied by Laos TLPH Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Momelotinib is the active ingredient used for this product page. Public prescribing information for Momelotinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Momelotinib is an inhibitor of wild type Janus Kinase 1 and 2 (JAK1/JAK2) and mutant JAK2 V617F , which contribute to signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. Momelotinib and its major human circulating metabolite, M21, have higher inhibitory activity for JAK2 compared to JAK3 and tyrosine kinase 2 (TYK2).

Reference Indications

Momelotinib 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. Momelotinib 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.

Reference Dosage and Administration

Recommended dosage: 200 mg orally once daily with or without food.

With this 200mg product, that corresponds to 1 x 200mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Risk of Infections: Do not initiate Momelotinib in patients with an active infection. Monitor for signs and symptoms of infection, including reactivation of hepatitis B, and initiate appropriate treatment promptly. Thrombocytopenia and Neutropenia: Manage by dose reduction or interruption. Hepatotoxicity: Obtain liver tests before initiation of and periodically throughout treatment with Momelotinib. Major Adverse Cardiovascular Events (MACE): Monitor for symptoms, evaluate and treat promptly. Thrombosis: Evaluate and treat symptoms of thrombosis promptly. Malignancies: Monitor for development of secondary malignancies, particularly in current or past smokers. Symptom Exacerbation Following Interruption or Discontinuation of Treatment: Manage with supportive care and consider restarting Momelotinib.

Common Adverse Reactions and Monitoring

The safety of Momelotinib was evaluated in 215 patients in 2 clinical trials (MOMENTUM and SIMPLIFY‑1 anemic subgroup [hemoglobin (Hb) <10 g/dL]) . MOMENTUM Patients in the MOMENTUM trial had been previously treated with a JAK inhibitor and were randomly assigned 2:1 to receive double‑blind Momelotinib 200 mg orally once daily (n = 130) or danazol 300 mg orally twice daily (n = 65) for 24 weeks, after which they were eligible to receive open‑label Momelotinib in an extended treatment phase. Among patients who received Momelotinib, 72% were exposed for 24 weeks or longer and 52% were exposed for 48 weeks or longer .

Drug Interactions and Special Populations

Breast Cancer Resistance Protein (BCRP) substrates: Reduce rosuvastatin (BCRP substrate) dosage. Follow approved product information recommendations for other BCRP substrates. When administered concomitantly with Momelotinib, initiate rosuvastatin (BCRP substrate) at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed. Follow approved product information recommendations for other BCRP substrates. Pregnancy: May cause fetal harm. Lactation: Advise not to breastfeed. 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) .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Ojjaara public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.