Momelotinib

Momelotinib is a prescription medication indicated for intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post polycythemia vera and post essential thrombocythemia], in adults with anemia

• Momelotinib is available under the following different brand names: Ojjaara

Common side effects of Momelotinib include:

• diarrhea 
• nausea
• low platelet count 
• dizziness 
• bleeding 
• bacterial infection
• tiredness

Serious side effects of Momelotinib include:

• risk of infections - hepatitis B
• low platelet and white blood cell count
• liver problems include- tiredness, dark urine, loss of appetite, yellowing of the skin or the white part of your eyes, pain in the right upper stomach area (abdomen)
• blood clots include swelling, pain, or tenderness in one or both legs, sudden, unexplained chest pain, shortness of breath, or difficulty breathing

Rare side effects of Momelotinib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 100 mg
• 150 mg
• 200 mg

Myelofibrosis

Adult dosage

• 200 mg orally once a day with or without food

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Momelotinib has severe interactions with no other drugs
• Momelotinib has serious interactions with the following drug:
  • rimegepant
• Momelotinib has moderate interactions with at least 55 other drugs
• Momelotinib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Momelotinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Momelotinib?”

Cautions

• Serious (including fatal) infections (eg, bacterial and viral, including COVID-19) occurred; delay starting therapy until active infections have resolved; monitor patients for signs and symptoms of infection and initiate appropriate treatment promptly
• Hepatitis B viral load (HBV-DNA titer) increases, with or without associated AST/ALT, reported in patients with chronic hepatitis B virus (HBV) infection taking Janus kinase (JAK) inhibitors; treated patients with chronic HBV infection should have their chronic HBV infection treated and monitored according to clinical HBV guidelines
• Another JAK inhibitor increases the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis; evaluate if symptoms of thrombosis arise and treat appropriately
• May cause thrombocytopenia and neutropenia; assess CBC count, including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated; interrupt dosing or reduce the dose for thrombocytopenia or neutropenia
• Hepatotoxicity
  • Two patients with MF who received at least one dose in clinical trials experienced reversible drug-induced liver injury
  • Overall, new, or worsening elevations of ALT and AST (all grades) occurred in 23% and 24%, respectively, of treated patients
  • Median time to onset of any grade transaminase elevation was 2 months, with 75% of cases occurring within 4 months
  • Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated
  • Refer to dosing for hepatic impairment when initiating
  • Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated
  • If ALT, AST, or bilirubin increases during treatment, modify the dosage
• Major adverse cardiovascular events (MACE)
  • Another JAK inhibitor increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke
  • Consider the benefits and risks before initiating or continuing therapy, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors
  • Inform treated patients of the symptoms of serious cardiovascular events and steps to take if they occur
• Malignancies
  • Another JAK inhibitor increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) in patients with rheumatoid arthritis
  • Current or past smokers were at increased risk
  • Consider the benefits and risks before initiating or continuing therapy, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers
• Drug interaction overview
• Organic anion transporting polypeptide (OATP)1B1/B3 substrate
• Breast cancer resistance protein (BCRP) inhibitor
• OATP1B1/B3 inhibitors
  • Monitor and consider momelotinib dose modifications
  • OATP1B1/B3 inhibitor increases Momelotinib maximal concentrations and area under the concentration-time curve, which may increase the risk of adverse reactions with Momelotinib
• Breast cancer resistance protein (BCRP) substrates
  • Rosuvastatin: When coadministered 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
  • Momelotinib may increase exposure to BCRP substrates, which may increase the risk of BCRP substrate adverse reactions

Pregnancy and Lactation

• Insufficient data are available on use in pregnant women to determine whether there is a drug-associated risk for major birth defects or miscarriage
• Contraception
  • Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for at least 1 week after the last dose
• Lactation
  • There are no data on the presence of momelotinib or its metabolites in human milk, its effects on breastfed children, or milk production
  • It is not known whether momelotinib is excreted in human milk
  • Momelotinib was present in rat pups following nursing from treated dams with adverse effects observed in offspring
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk
  • Advise women not to breastfeed during treatment, and for at least 1 week after the last dose