Deroximel DR

Indications

Diroximel Fumarate is used to treat relapsing forms of multiple sclerosis (MS) in adults. MS is a long-term disease in which the immune system damages the protective covering of nerves in the brain and spinal cord. This medicine helps reduce the number of relapses (attacks) and slows the build-up of disability. It is started and supervised by a neurologist.

How It Works

In the body, Diroximel Fumarate is quickly changed into monomethyl fumarate, the same active substance produced by Dimethyl Fumarate. This substance activates a protective pathway (Nrf2) that helps cells cope with stress, and it calms the immune cells that attack nerve coverings. It tends to cause fewer stomach and bowel upsets than Dimethyl Fumarate.

Dosage and Administration

Take exactly as prescribed by the specialist. The usual adult schedule is 231 mg twice a day for the first 7 days, then 462 mg (two 231 mg capsules) twice a day. Swallow capsules whole; do not crush, chew or open them. They can be taken with or without food, but avoid a high-fat, high-calorie meal at the time of the dose. Do not take with alcohol at the same time.

Interactions

• Do not take together with Dimethyl Fumarate or other fumarate medicines.
• Other medicines that weaken the immune system (for example Methotrexate, Azathioprine or high-dose corticosteroids) may increase infection risk.
• Live vaccines are not recommended during treatment; ask your doctor before any vaccine.
• Aspirin taken about 30 minutes before a dose may reduce flushing, but only if your doctor advises it.
• Medicines that can harm the kidneys should be used with care.

Contraindications

• Allergy to Diroximel Fumarate, Dimethyl Fumarate or any ingredient
• Current treatment with Dimethyl Fumarate

Side Effects

Common side effects are flushing (warmth, redness or itching of the skin), stomach pain, diarrhoea, nausea, vomiting and indigestion, mostly in the first weeks. It can lower the number of white blood cells called lymphocytes, and may raise liver enzymes. Rarely, a serious brain infection called PML (progressive multifocal leukoencephalopathy) and shingles or other serious infections have occurred.

Get urgent medical help for signs of a severe allergic reaction (swelling of the face, lips or throat, difficulty breathing, widespread rash), new or worsening weakness on one side of the body, clumsiness, changes in vision, thinking or memory, signs of serious infection such as high fever, or yellowing of the skin or eyes with dark urine.

Pregnancy and Lactation

There is limited information on use in pregnancy. Tell your doctor if you are pregnant or planning a pregnancy; it is used only if clearly needed. It is not known whether it passes into breast milk, so discuss breastfeeding with your doctor before use.

Precautions and Warnings

• A blood count is needed before starting, after about 6 months and then regularly, because lymphocyte levels can fall.
• Liver tests are checked before and during treatment.
• Treatment may be paused if you develop a serious infection.
• Tell your doctor about kidney or liver disease, or any past serious infections.
• Report any new nervous system symptoms promptly.

Overdose

Overdose may cause stronger versions of the usual side effects such as flushing and stomach upset. Contact a doctor or the nearest hospital for advice.

Therapeutic Class

Immunomodulator, disease-modifying therapy for multiple sclerosis (fumarate).

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.