Is Momelotinib approved by the FDA?

Momelotinib, marketed under the brand name Ojjaara, was approved by the FDA on September 15, 2023. Momelotinib is an oral medication used to treat adults with specific types of myelofibrosis who have anemia. Myelofibrosis is a type of bone marrow cancer that disrupts the body's normal production of blood cells.

Uses

Momelotinib is indicated for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis and secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia) in patients with anemia.

Administration

Momelotinib is taken orally once a day, with or without food. The usual adult dose is 200 mg per day. Patients are advised to swallow the tablet whole and not to crush, chew, or break it. The treatment should be discontinued in patients unable to tolerate 100 mg once daily.

Side Effects

Common side effects of momelotinib may include:

• Diarrhea, nausea
• Signs of infection
• Dizziness
• Tiredness
• Easy bruising, unusual bleeding, purple or red spots under the skin

Serious side effects can occur and may include:

• Signs of infection such as fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding
• Liver problems indicated by symptoms such as loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• Heart attack symptoms such as chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating
• Signs of a stroke such as sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance
• Signs of a blood clot in the lung such as chest pain, sudden cough or shortness of breath, dizziness, coughing up blood
• Signs of a blood clot deep in the body such as pain, swelling, or warmth in one leg

Patients are advised to get emergency medical help if they experience signs of an allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Warnings and Precautions

• Momelotinib should not be used in individuals with an active infection, heart attack, stroke, blood clots, other cancers, or liver disease.
• It may harm an unborn baby, so effective birth control is necessary during treatment and for at least one week after the last dose.
• Breastfeeding should be avoided while using momelotinib and for at least one week after the last dose.

Interactions

Patients should inform their doctor about all other medications they are using, including prescription, over-the-counter medicines, vitamins, and herbal products, as they may affect momelotinib. Certain medicines can affect blood levels of other drugs, increasing side effects or making them less effective.

Conclusion

Momelotinib (Ojjaara) is FDA-approved for treating intermediate or high-risk myelofibrosis in patients with anemia. The approval date is September 15, 2023. Patients should adhere to prescribed guidelines and report any adverse effects to their healthcare provider.

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