Uses
What is Ojjaara used for?
Ojjaara is commonly used to treat certain types of myelofibrosis in people with anemia.
Ojjaara may also be used for other conditions as determined by your healthcare provider.
How does Ojjaara work (mechanism of action)?
In myelofibrosis, janus kinases (JAKs) are proteins that become overactive and can cause scar tissue to form in the bone marrow, which can cause low blood cells. Ojjaara is a JAK inhibitor that works to target JAKs in the bone marrow. Ojjaara also works to increase the number of red blood cells in the body by inhibiting a protein called activin A receptor type 1 (ACVR1) in your liver cells.
How is Ojjaara supplied (dosage forms)?
Ojjaara is available in the following dosage forms that are taken by mouth.
- 100 mg oral tablets
- 150 mg oral tablets
- 200 mg oral tablets
How should I store Ojjaara?
Ojjaara should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Store in the original bottle. Do not throw away the packet that comes inside your medicine bottle (desiccant). This helps keep your tablets dry.
Side Effects
What are the most common side effects of Ojjaara?
The most common side effects of Ojjaara are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Low platelet levels
- Bleeding
- Bacterial infection
- Tiredness
- Dizziness
- Diarrhea
- Nausea
There may be other side effects of Ojjaara that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Ojjaara?
While less common, the most serious side effects of Ojjaara are described below, along with what to do if they happen.
Severe Allergic Reactions. Ojjaara may cause allergic reactions, which can be serious. Stop taking Ojjaara and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Infection. Ojjaara can increase the risk of infections, including serious infections. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea, stomach pain, or vomiting
- Weight loss
Low Neutrophil Levels. Ojjaara may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Tell your healthcare provider if you have any of the following symptoms of low neutrophil levels.
- Fever, chills, or sweats
- Tiredness
- Sore throat, cough, or shortness of breath
- Mouth or throat sores
- Swollen lymph nodes
Low Platelet Levels. Ojjaara can cause you to have a low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Tell your healthcare provider if you have any of the following symptoms of low platelet levels.
- Easy bruising or bleeding
- Bleeding that does not stop
- Nosebleeds
- Black or tarry stools
Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Ojjaara. Keep all appointments to have your blood checked. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Heart Attack and Stroke. Ojjaara may increase your risk of a heart attack or stroke that can lead to death. This risk is increased in people with existing heart disease and with longer use of Ojjaara and higher doses. Do not take Ojjaara if you have had a recent heart attack without talking to your healthcare provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, nausea, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
Blood Clots. Ojjaara may cause blood clots in your veins or arteries and could cause a blood clot in a vein deep inside your body (deep vein thrombosis) or in the lungs (pulmonary embolism). Stop taking Ojjaara and get emergency help right away if you have any of the following signs of blood clots.
- Chest pain or pressure
- Trouble breathing
- Pain, swelling, or tenderness in your arm or leg that will not go away
New Cancers. New cancers including lymphoma and other cancers may occur while taking Ojjaara. Make sure you keep all appointments with your healthcare provider.
Warnings & Precautions
Who should not use Ojjaara?
Allergies to Ingredients. People who are allergic to any of the following should not take Ojjaara.
- Ojjaara
- Momelotinib
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Ojjaara.
What should I know about Ojjaara before using it?
Do not take Ojjaara unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Ojjaara with other people, even if they have the same condition as you. It may harm them.
Keep Ojjaara out of the reach of children.
Ojjaara is taken by mouth once a day, with or without food.
Swallow the tablet whole. Do not chew, cut, or crush the medicine.
Ojjaara can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Ojjaara affects you.
What should I tell my healthcare provider before using Ojjaara?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Ojjaara is right for you.
In particular, make sure that you discuss any of the following.
Smoking. Tell your healthcare provider if you currently smoke or have smoked in the past. This can increase your risk of developing a heart attack, stroke, or new cancers.
Infection. Tell your healthcare provider if you have an infection. Your healthcare provider may not start Ojjaara until your infection goes away.
Current and Past Health Conditions. Tell your healthcare provider if you have or have had any of the following.
- Hepatitis B
- Liver problems
- Heart problems (including heart attack)
- Stroke
- Blood clot
- Any other cancers
Other Medicines and Supplements. Ojjaara may interact with other medicines and supplements. Before taking Ojjaara, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Ojjaara may harm an unborn baby. Use effective contraception (birth control, condoms, etc.) while taking Ojjaara and for 1 week after the last dose. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Ojjaara while you are pregnant or trying to get pregnant.
Breastfeeding. It is not known if Ojjaara passes into breast milk. It is not recommended to take Ojjaara while you are breastfeeding and for one week after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
How can I get more information about Ojjaara?
For more information about Ojjaara, you can visit the manufacturer’s website at www.ojjaara.com or call them at 888-825-5249.
Interactions
Does Ojjaara interact with foods or drinks?
There are no known interactions between Ojjaara and foods or drinks.
There are no known interactions between Ojjaara and alcohol, but both Ojjaara and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
Does Ojjaara interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Ojjaara
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
- Rosuvastatin (Crestor), which is a medicine to lower cholesterol
Some other medicines may alter the blood levels of Ojjaara, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Ojjaara. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Ojjaara?
If you or someone else has used too much Ojjaara, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Ojjaara?
If you miss a dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take double or extra doses.