Ojjaara

Generic name: Momelotinib
Dosage form: oral tablet
Drug class: Multikinase inhibitors

Usage of Ojjaara

Ojjaara (momelotinib) is a Janus Kinase inhibitor that may be used to treat intermediate or high-risk myelofibrosis (MF) in adults with anemia.

Includes primary MF or secondary MF (postpolycythemia vera [PV] and post-essential thrombocythemia [ET]).

Myelofibrosis is a rare type of bone marrow cancer that progressively impairs red blood cell production because of scarring. Abnormal blood cells eventually replace normal cells. It is thought to be driven by dysregulation of the JAK-STAT pathway.

Treatment usually involves managing symptoms such as anemia and an enlarged spleen.

Ojjaara works by inhibiting wild-type Janus Kinase 1 and 2 (JAK1/JAK2) and mUTAnt JAK2V617F, these are enzymes that are part of the Janus Kinase family, which are essential for cytokine signaling (cytokines are small proteins that affect the growth of blood cells and other cells that are involved in inflammation and the immune response). Mutations in JAK are associated with several leukemias, lymphomas, and myeloproliferative diseases including polycythemia vera (PV).

The activity of Ojjaara for JAK2 is higher than that for other Janus Kinases, JAK3, and tyrosine kinase (TYK2). It also inhibits activin A receptor type 1 (ACVR1, also called ALK2), which inhibits hepcidin, a hormone in your liver that regulates how your body uses iron. This increases the availability of iron and red blood cell production. Because Ojjaara inhibits ACVR1/ALK2 as well as JAK1 and JAK2, it has the potential to improve symptoms of anemia and splenomegaly, while preserving platelet count.

Ojjaara was FDA approved on September 15, 2023.

Ojjaara side effects

Ojjaara may cause serious side effects, including an increased risk of infections. Tell your doctor if you develop any signs of an infection such as:

fever

diarrhea

chills

vomiting

cough

pain or burning feeling when passing urine

breathing problems.

Ojjaara may affect your blood counts. Your healthcare provider will do blood tests to check your blood counts before you start treatment and during treatment. Tell your healthcare provider right away if you have any signs of bleeding during treatment with Ojjaara, including:

unusual bleeding

bruising

black or tarry stools.

Ojjaara 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. 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 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. (Ojjaara 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 Ojjaara, 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.

Tell your healthcare provider if you have had blood clots in the veins of your legs or lungs in the past or if you have any signs and symptoms of blood clots during treatment with Ojjaara, including:

swelling, pain, or tenderness in one or both legs

sudden, unexplained chest pain

shortness of breath or difficulty breathing

The most common side effects affecting at least 20% of people include:

low platelet count

dizziness

bleeding

diarrhea

bacterial infection

nausea

tiredness.

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

Before taking Ojjaara

You should not take Ojjaara if you are allergic to momelotinib or any of the inactive ingredients in the tablets. Discontinue if a clinically significant hypersensitivity reaction occurs.

Taking Ojjaara 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.

Tell your doctor if you've been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.

Females who can become pregnant

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

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Ojaara and for approximately for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

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How to use Ojjaara

Take Ojjaara exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ojjaara 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.

Ojjaara is a tablet that is taken by mouth once a day. The usual dosage is 200mg once daily.

May be taken with or without food.

Swallow tablets whole. Do not cut, crush, or chew tablets.

Your healthcare provider will do blood tests before you start taking Ojjaara and during treatment.

Warnings

Serious and fatal infections, including bacterial and viral infections, and COVID-19 have occurred in 13% of people treated with Ojjaara. The infection rate overall (regardless of grade) was 38%. Ojjaara should not be started until all active infections have resolved. Hepatitis B serology should also be checked before starting treatment. All patients should be monitored for signs and symptoms of infection, including HBV, during and after treatment.

Ojjaara can cause thrombocytopenia (low blood platelets) and Neutropenia (low levels of neutrophils). Your doctor will obtain a full blood count before treatment, and periodically thereafter. The dose may need to be reduced or temporarily withheld if abnormalities occur.

Liver function tests need to be obtained before initiation of, and every 6 months during, treatment, then periodically thereafter. Your doctor may modify your treatment if abnormalities occur.

There may be an increased risk of major cardiovascular events, including a heart attack or stroke, in past or current smokers and patients with other cardiovascular risk factors. There may also be an increased risk of thrombosis. Your doctor will monitor you for symptoms.

There may also be a higher risk for lymphoma and secondary malignancies, particularly in current or past smokers. Monitor.

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

What other drugs will affect Ojjaara

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Ojjaara 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.

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