Momelotinib (oral route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of momelotinib in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of momelotinib in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alpelisib
• Ceftobiprole Medocaril
• Cyclosporine
• Darolutamide
• Elexacaftor
• Eltrombopag
• Gemfibrozil
• Irinotecan
• Methotrexate
• Rifampin
• Rosuvastatin
• Seladelpar
• Simvastatin
• Sofosbuvir
• Sulfasalazine
• Sunitinib
• Talazoparib
• Tenofovir Alafenamide
• Teriflunomide
• Topotecan
• Ubrogepant
• Voclosporin

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis), or history of or
• Cancer, or history of or
• Heart or blood vessel disease (eg, heart attack), or history of or
• Liver disease (eg, hepatitis B), or history of or
• Neutropenia (low number of white blood cells) or
• Stroke, history of or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Smoker, current or past—May increase risk for serious side effects.

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stools
• bloody or cloudy urine
• blurred vision
• chest pain or tightness
• confusion
• coughing up blood
• cough or hoarseness
• diarrhea
• difficult, burning, or painful urination
• difficulty in breathing or swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• fever or chills
• frequent urge to urinate
• headache
• increased menstrual flow or vaginal bleeding
• loss of taste or smell
• lower back or side pain
• muscle or body aches
• nausea or vomiting
• nosebleeds
• pale skin
• paralysis
• pinpoint red spots on the skin
• prolonged bleeding from cuts
• rapid weight gain
• red or dark brown urine
• sore throat
• stuffy or runny nose
• sweating
• tingling of the hands or feet
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Blue lips, fingernails, or skin
• burning, numbness, tingling, or painful sensations
• decreased urine output
• dilated neck veins
• nerve pain
• swelling of the face, fingers, feet, or lower legs
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Incidence not known

• Anxiety
• chest discomfort
• dark urine
• difficulty in speaking
• double vision
• general feeling of illness
• inability to move the arms, legs, or facial muscles
• inability to speak
• loss of appetite
• pain, redness, or swelling in the arm or leg
• pain or discomfort in the arms, jaw, back, or neck
• pains in the chest, groin, or legs, especially the calves of legs
• persistent non-healing sore
• pink growth
• reddish patch or irritated area
• severe headaches of sudden onset
• shiny bump
• slow speech
• stomach pain, severe
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• swollen glands
• white, yellow or waxy scar-like area
• yellow eyes or skin

More common

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• itching skin
• pain in the arms or legs

Less common

• Feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest