Drug Detail:Monomethyl fumarate (Monomethyl fumarate [ mon-oh-meth-il-fue-ma-rate ])
Drug Class: Selective immunosuppressants
Usual Adult Dose for Multiple Sclerosis
Initial dose: 95 mg orally 2 times daily for 7 days
Maintenance dose: After 7 days, increase the dose to 190 mg orally 2 times daily
- Temporary dose reductions to 95 mg 2 times daily may be considered for patients who do not tolerate the maintenance dose.
- Resume 190 mg 2 times daily within 4 weeks.
- Discontinue this drug in patients unable to tolerate return to the maintenance dose.
Comments:
- Prior to initiating therapy, obtain a complete blood cell count (CBC), including lymphocyte count and serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
- Administration of nonenteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing this drug may reduce the incidence or severity of flushing.
Use: For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
No adjustment recommended.
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients (reactions may include anaphylaxis or angioedema)
- In patients taking dimethyl fumarate or diroximel fumarate
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug may be taken with or without food.
- Capsules should be swallowed whole and intact; do not crush, chew, or mix capsule contents with food.
Storage requirements:
- Store unopened bottles in refrigerator at 2C to 8C (35F to 46F); do not freeze.
- Store opened bottles at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
- Protect the capsules from light.
- Store in original container.
- Capsules may become deformed if kept at high temperatures.
Monitoring:
- Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels during therapy with this drug, as clinically indicated.
Patient advice:
- Read the approved patient labeling each time you fill your prescription.
- Discontinue this drug and seek medical care if you develop signs of anaphylaxis or angioedema.
Frequently asked questions
- What are the new drugs used for multiple sclerosis (MS)?