Momelotinib Dosage

Medically reviewed by Drugs.com. Last updated on Nov 7, 2023.

Usual Adult Dose for Myelofibrosis

200 mg orally once a day

Comment:

• Treatment should be discontinued in patients unable to tolerate 100 mg once a day.

Use: For the treatment of intermediate or high-risk myelofibrosis (MF), including primary or secondary MF (post-polycythemia vera and post-essential thrombocythemia) in patients with anemia

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C):

• Starting dose: 150 mg orally once a day

Hepatotoxicity (ALT and/or AST greater than 5 times the upper limit of normal [5 x ULN] [or greater than 5 x baseline, if baseline is abnormal] and/or total bilirubin greater than 2 x ULN [or greater than 2 x baseline, if baseline is abnormal]):

• Treatment should be interrupted until AST and ALT are 2 x ULN or less or at baseline (if baseline greater than 2 x ULN) and total bilirubin is 1.5 x ULN or less or at baseline (if baseline greater than 1.5 x ULN).
• Treatment should be restarted at a daily dose of 50 mg below the last given dose; therapy may be reinitiated at 100 mg if previously dosed at 100 mg.
• If reoccurrence of ALT or AST elevations is greater than 5 x ULN, this drug should be permanently discontinued.

Dose Adjustments

Thrombocytopenia:

• Daily dose should be reduced by 50 mg from the last given dose:
• If the baseline platelet count is 100 x 10(9)/L or greater, then decreases to 20 to less than 50 x 10(9)/L.
• Treatment should be interrupted until platelets recover to 50 x 10(9)/L, then treatment should be restarted at a daily dose of 50 mg below the last given dose. Therapy may be reinitiated at 100 mg if previously dosed at 100 mg:
• If the baseline platelet count is 100 x 10(9)/L or greater, then decrease to less than 20 x 10(9)/L.
• If the baseline platelet count is 50 to less than 100 x 10(9)/L, then decreases to less than 20 x 10(9)/L.
• Treatment should be interrupted until platelets recover to baseline, then treatment should be restarted at a daily dose of 50 mg below the last given dose. Therapy may be reinitiated at 100 mg if previously dosed at 100 mg:
• If baseline platelet count is less than 50 x 10(9)/L, then decreases to less than 20 x 10(9)/L.

Neutropenia (absolute neutrophil count [ANC] is less than 0.5 x 10[9]/L):

• Treatment should be interrupted until ANC is 0.75 x 10(9)/L or greater, then treatment should be restarted at a daily dose of 50 mg below the last given dose. Therapy may be reinitiated at 100 mg if previously dosed at 100 mg.

Other nonhematologic adverse reactions (grade 3 or higher):

• Treatment should be interrupted until the toxicity resolves to grade 1 or lower (or baseline).
• Treatment should be restarted at a daily dose of 50 mg below the last given dose. Therapy may be reinitiated at 100 mg if previously dosed at 100 mg.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult the WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• May be administered with or without food.
• Swallow whole; do not cut, crush, or chew tablets.
• If a dose is missed, the next scheduled dose should be taken the following day.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Keep in original bottle to protect from moisture.
• Dispense to patients in original bottle only; replace the cap securely after each opening.
• Do not discard desiccant.

Monitoring:

• Hematologic: CBC with platelets (prior to and periodically during therapy)
• Hepatic: Liver function (prior to and every 6 months during treatment); hepatitis B serologies in patients with hepatitis B virus infection (prior to and periodically during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• This drug can increase the risk of infections, report signs and symptoms of infection to your health care provider.
• Report any bleeding to your health care provider as this drug can cause abnormal platelet and white blood counts.
• Major cardiovascular events have been reported; current and past smokers and patients at risk for cardiac events should report all signs and symptoms.
• New cancers have been reported in some people taking other medications in the same class as this drug.
• Notify your health care provider if any signs/symptoms of a DVT or pulmonary embolism develop.
• Patients of childbearing potential should use highly effective contraception during therapy and for 1 week after the last dose.
• Notify your prescriber of a known/suspected pregnancy.
• Do not breastfeed during treatment and for at least 1 week after the last dose.

See also:

Further information

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

Medical Disclaimer