Momelotinib

Pronunciation: mo-me-lot-in-nib
Generic name: momelotinib
Brand name: Ojjaara
Dosage form: oral tablet
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 11, 2024.

What is momelotinib?

Momelotinib (brand name Ojjaara) may be used to treat adults with certain types of myelofibrosis (MF) who have anemia.

Myelofibrosis is a rare blood cancer where the bone marrow becomes scarred, preventing it from producing enough healthy blood cells. Over time, abnormal blood cells build up and replace normal ones. The exact cause is unknown, but it's linked to a problem with a specific cell signaling pathway, called the JAK-STAT pathway. Treatment usually involves managing symptoms such as anemia and an enlarged spleen.

Momelotinib's mechanism of action involves targeting and blocking specific enzymes called JAK1, JAK2, and a mutated form of JAK2. These enzymes are involved in regulating blood cell production and inflammation. Mutations in these enzymes have been associated with certain blood cancers like several leukemias, lymphomas, and myeloproliferative diseases. Momelotinib is not chemotherapy, it is a targeted treatment.

Momelotinib gained FDA approval on September 15, 2023, under the brand name Ojjaara. There is no Ojjaara generic. Momelotinib belongs to the drug class known as multikinase inhibitors; specifically, it is a Janus Kinase inhibitor.

Momelotinib side effects

The most common side effects of momelotinib include:

• low platelet counts
• dizziness
• bleeding
• diarrhea
• bacterial infections
• nausea
• tiredness.

See the Momelotinib (Ojjaara) Package Insert for a full list of side effects.

Serious side effects and warnings

Momelotinib may cause the following serious side effects.

Serious and fatal infections. People who take momelotinib may develop serious infections that can lead to death, such as bacterial and viral infections, including COVID-19. If you have an active infection, your healthcare provider should not start treatment with momelotinib until your infection is gone. If you have had hepatitis B for a long time (chronic), momelotinib may cause your hepatitis B to become active again, and your healthcare provider will check your blood for active hepatitis B before starting treatment. Your healthcare provider will monitor you and treat you for any infections that you get during treatment with momelotinib. Tell your healthcare provider right away if you develop any of the following symptoms of infection:

• fever
• diarrhea
• chills
• vomiting
• cough
• pain or burning feeling when passing urine
• breathing problems.

Low platelet and white blood cell counts. Momelotinib may cause new or worsening low platelet and white blood cell counts. Low platelet counts may increase your risk for bleeding and low white blood cell counts may increase your risk for infection. Your healthcare provider will do blood tests to check your blood counts before you start taking momelotinib, and during treatment. Tell your healthcare provider right away if you have any signs of bleeding during treatment with momelotinib, including:

• unusual bleeding
• bruising
• black or tarry stools.

Liver problems. Momelotinib may cause new or worsening increased liver enzymes and bilirubin in your blood. Your healthcare provider will check your liver enzymes before starting treatment, every month for the first 6 months of treatment, and then as needed during treatment with momelotinib. Your healthcare provider may stop treatment with momelotinib if your liver enzymes increase. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:

• tiredness
• dark urine
• loss of appetite
• yellowing of your skin or the white part of your eyes
• pain in your right upper stomach area (abdomen).

Major cardiovascular events such as heart attack, stroke, and death. Major cardiac events have happened, especially in people with cardiac risk factors and who are current or past smokers, taking another Janus kinase (JAK) inhibitor to treat rheumatoid arthritis. Momelotinib is in the JAK family of medicines. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking momelotinib, including:

• discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech.

Blood clots. Blood clots in the veins of the legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis, and may be life-threatening. Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with momelotinib, including:

• swelling, pain, or tenderness in one or both legs
• sudden, unexplained chest pain
• shortness of breath or difficulty breathing.

New cancers. New cancers, including lymphoma and other cancers, except non-melanoma skin cancer, have happened in some people taking another JAK inhibitor to treat rheumatoid arthritis. The risk of new cancers is further increased in people who smoke or who smoked in the past.

It is not known if momelotinib is safe and effective for children.

These are not all of the possible side effects of momelotinib. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Do not take momelotinib if you are allergic to momelotinib, Ojjaara, or any of the inactive ingredients in the Ojjaara tablets.

Taking momelotinib can increase your risk of life-threatening medical problems, including serious infections, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you've had:

• a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis B)
• any type of cancer
• chronic lung disease
• heart problems
• a heart attack, stroke, or blood clot
• liver disease
• if you've ever smoked
• if you are scheduled to receive any vaccine.

Before taking momelotinib, tell your healthcare provider about all of your medical conditions, including if
you:

• have an infection or have any of the following symptoms: fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination
• have or have had hepatitis B
• have or have had liver problems
• have had a heart attack, or have or have had other heart problems, or stroke
• have or have had a blood clot
• smoke or were a smoker in the past
• have or have had any other cancers
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Momelotinib may harm your unborn baby. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of momelotinib. Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment.

Breastfeeding

It is not known if momelotinib passes into your breast milk. You should not breastfeed during treatment and for 1 week after the last dose of momelotinib. Talk to your healthcare provider about the best way to feed your baby during this time

How should I take momelotinib?

Take momelotinib exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking momelotinib without first talking to your healthcare provider. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you have certain side effects.

• Momelotinib is a tablet that is taken by mouth once a day.
• Momelotinib tablets may be taken with or without food.
• Swallow the tablets whole. Do not cut, crush, or chew tablets.
• Your healthcare provider will do blood tests before you start taking momelotinib and during treatment.

Momelotinib dosing information

• The usual dosage is momelotinib 200mg once daily.
• In people with severe liver disease (Child-Pugh Class C), your healthcare provider may reduce your dose.

Related/similar drugs

Jakafi, ruxolitinib, momelotinib, Ojjaara, Vonjo, pacritinib

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose and take your next dose the following day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose.

What happens if I overdose?

If you take too much momelotinib, call your healthcare provider or go to the nearest emergency room right away and take your bottle of momelotinib with you.

What other drugs will affect momelotinib?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking momelotinib with certain other medicines may affect the amount of it or the other medicines in your blood and may increase your risk of side effects. Tell your doctor if you take:

• Organic Anion Transporting Polypeptide (OATP)1B1/B3 inhibitors, such as atazanavir, clarithromycin, cobicistat, cyclosporine
• Breast Cancer Resistance Protein (BCRP) substrates, such as prazosin, sulfasalazine, and rosuvastatin

Know the medicines you take. Keep a list of the medicines you take to show your healthcare provider and pharmacist when you get a new medicine. See the Momelotinib (Ojjaara) Prescribing Information (PI) for a full list of interactions.

Storage

Store momelotinib at room temperature between 68°F to 77°F (20°C to 25°C).

Keep it in its original bottle. The momelotinib bottle contains a desiccant packet to help keep your tablets dry (protect from moisture). Keep the desiccant in the bottle. Tightly close the bottle after you take your dose.

Keep out of the reach of children.

Momelotinib ingredients

Momelotinib is only available as the brand Ojjaara,

The ingredients of Ojjaara made by GSK are as follows:

Active ingredient: momelotinib dihydrochloride monohydrate

Inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, silicon dioxide, and sodium starch glycolate. Film coating: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

Available as momelotinib 100 mg tablets, momelotinib 150 mg tablets, and momelotinib 200 mg tablets.

Who makes momelotinib?

GSK makes momelotinib tablets under the brand name Ojjaara.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer