Drug class:
treatment of MS
Drug form:
120 and 240 mg enteric coated capsules
Drug composition:
dimethyl fumarate
Mechanism of action Diphosel:
The exact mechanism of action of this drug is unknown, but this molecule has shown that it can modulate the immune system activated against the nervous system. Also, by acting on some pathways, this drug can protect nerve cells against harmful agents.
Uses Diphosel
Diphosel is an oral drug that is used in the treatment of relapsing-remitting MS, which is associated with exacerbation and reduction of the patient’s symptoms.
Use in pregnancy and breastfeeding:
Pregnancy:
Classification of use in pregnancy: C
Adequate and well-controlled studies have not been conducted in pregnant women. Consumption of dimethyl fumarate in clinically relevant doses in animals during pregnancy and lactation caused the observation of side effects on infant survival, growth, sexual maturity and neurobehavioral function.
Dimethyl fumarate should be used during pregnancy if the benefits justify the possible harm to the fetus.
If you are pregnant, do not use dimethyl fumarate before consulting your doctor.
In male rats, oral administration of dimethyl fumarate (75, 250, 375 mg/kg/day) before and during the mating period had no effects on fertility, although an increase in immotile sperm was observed at middle and high doses. The ineffective dose for adverse effects on sperm is similar to the recommended human dose of 480 mg/day based on body surface area (mg/m2).
In female rats, the oral administration of dimethyl fumarate (20, 100, 250 mg/kg/day) before and during the mating period and then, on the seventh day of pregnancy, caused disturbance in the estrous cycle and increased fetal death in the highest dose. . The highest dose without side effects (mg/kg/day 100) is twice the recommended dose in humans based on body surface area (mg/m2).
Lactation: the secretion of the drug in milk is not known, but because many drugs are secreted in milk, the administration of dimethyl fumarate during breastfeeding should be done with caution. The doctor will guide you about stopping breastfeeding or stopping taking medicine.
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