Momelotinib

Generic name: Momelotinib
Drug class: Multikinase inhibitors

Usage of Momelotinib

Momelotinib is used to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera myelofibrosis and post-essential thrombocythemia) in patients with anemia. Myelofibrosis is a life-threatening bone marrow problem which is manifested by the following symptoms: enlarged spleen (splenomegaly), severe itching, fever, night sweats, weight loss, bone pain, or unusual tiredness or weakness.

This medicine is available only with your doctor's prescription.

Momelotinib side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Momelotinib

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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.

Pediatric

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.

Geriatric

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

Breast Feeding

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.

Interactions with Medicines

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.

Cyclosporine

Eltrombopag

Gemfibrozil

Irinotecan

Methotrexate

Ozanimod

Rifampin

Rosuvastatin

Simvastatin

Sofosbuvir

Sulfasalazine

Sunitinib

Tenofovir Alafenamide

Teriflunomide

Topotecan

Ubrogepant

Interactions with Food/Tobacco/Alcohol

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.

Relate drugs

How to use Momelotinib

Take this medicine only as directed by your doctor. Your dose depends on your platelet count and needs to be changed several times in order to find out what works best for you. Do not use more medicine, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for as long as your doctor has told you to. Do not change your dose or stop taking this medicine without first talking with your doctor.

Take this medicine with or without food.

Swallow the tablet whole. Do not cut, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For myelofibrosis:

Adults—200 milligrams (mg) once a day, depending on your blood test results. Your doctor will adjust your dose as needed and tolerated.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment and for 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, hepatitis B). Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clipper.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis).

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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