Dimethyl polysiloxane

Dimethyl fumarate delayed-release capsules are indicated 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. Dimethyl fumarate is indicated 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 ( 1 )

• Starting dose: 120 mg twice a day, orally, for 7 days Maintenance dose after 7 days: 240 mg twice a day, orally
• Swallow dimethyl fumarate delayed-release capsules whole and intact
• Do not crush, chew, or sprinkle capsule contents on food Take dimethyl fumarate delayed-release capsule with or without food Dosing Information The starting dose for dimethyl fumarate delayed-release capsules are 120 mg twice a day orally
• After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally
• Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose
• Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed
• Discontinuation of dimethyl fumarate delayed-release capsules should be considered for patients unable to tolerate return to the maintenance dose
• The incidence of flushing may be reduced by administration of dimethyl fumarate delayed-release capsules with food
• Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsule dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ]
• Dimethyl fumarate delayed-release capsules should be swallowed whole and intact
• Dimethyl fumarate delayed-release capsules should not be crushed or chewed and the capsule contents should not be sprinkled on food
• Dimethyl fumarate delayed-release capsules can be taken with or without food. …

Dimethyl fumarate is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules are white to off white colored enteric coated mini tablets filled in size "0" empty hard gelatin capsule shell with white opaque cap and white opaque body imprinted with "120 mg" with black ink. …

• Safety and effectiveness
• In pediatric patients have not been established

Clinical studies of dimethyl fumarate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

• Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of dimethyl fumarate when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily
• Inform patients to swallow dimethyl fumarate capsules whole and intact
• Inform patients to not crush, chew, or sprinkle capsule contents on food
• Inform patients that dimethyl fumarate can be taken with or without food [see Dosage and Administration ]. …

• Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate
• Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ]
• Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate

Anaphylaxis and angioedema: Discontinue and do not restart dimethyl fumarate if these occur. ( 5.1 ) Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl fumarate at the first sign or symptom suggestive of PML. ( 5.2 ) Herpes zoster and other serious opportunistic infections: Consider withholding dimethyl fumarate in cases of serious infection until the infection has resolved. ( 5.3 ) Lymphopenia: Obtain a CBC including lymphocyte count before initiating dimethyl fumarate, after 6 months, and every 6 to 12 months thereafter. Consider interruption of dimethyl fumarate if lymphocyte counts

The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema [see Warnings and Precautions (5.1) ]. Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.2) ]. Herpes Zoster and Other Serious Opportunistic Infections [ see Warnings and Precautions (5.3) ]. Lymphopenia [ see Warnings and Precautions (5.4) ]. Liver Injury [ see Warnings and Precautions (5.5) ]. Flushing [ see Warnings and Precautions (5.6) ]. Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MSN pharmaceuticals Inc. …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see Data] In the U.S. …

Cases of overdose with dimethyl fumarate have been reported. The symptoms described in these cases were consistent with the known adverse event profile of dimethyl fumarate. There are no known therapeutic interventions to enhance elimination of dimethyl fumarate nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.