Dimethyl fumarate tablets
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of dimethyl fumarate.
Drugs List
Therapeutic Indications
Uses
Moderate to severe plaque psoriasis
Dosage
Adults
The starting dose is 30mg once a day.
Dose is increased by 1 tablet weekly until treatment success or increase not tolerated. Following improvement of skin lesions gradual reduction of daily dose should be considered to achieve maintenance.
Week 1: 30mg once a day (evening).
Week 2: 30mg twice a day (morning and evening).
Week 3: 30mg three times a day (morning, noon, and evening).
Week 4: 120mg once a day (evening).
Week 5: 120mg twice a day (morning and evening).
Week 6: 120mg three times a day (morning, noon, and evening).
Week 7: 120mg twice a day and 240mg once a day (evening).
Week 8: 120mg once a day and 240mg twice a day (morning and evening).
Week 9 and beyond: 240mg three times a day (morning, noon, and evening).
If a dose increase is not tolerated it may be temporarily reduced to the last tolerated dose.
Contraindications
Children under 18 years
Leucocytes below 3 x 10 to power of 9/L at baseline
Lymphocytes below 1 x 10 to power of 9/L at baseline
Severe infection
Breastfeeding
Galactosaemia
Pregnancy
Severe gastrointestinal disorder
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Antibodies to JC virus
Females of childbearing potential
Glucose-galactose malabsorption syndrome
Lactose intolerance
Leucopenia
Lymphopenia
Administration of live vaccines is not recommended
Treatment to be initiated and supervised by a specialist
Contains lactose
A recent (within 3 months) MRI should be available prior to treatment
Monitor renal and hepatic function before and during treatment
Monitor serum transaminases (including ALT) before and during therapy
Perform full blood count before treatment
Monitor full blood counts every 3 months
Monitor monthly if lymphocyte count falls below 1x10 to power 9/L
Advise patient that flushing reactions may occur
Advise patient to report headaches, seizures, confusion, visual disturbance
Advise patient to report symptoms of infection immediately
Advise patient to seek medical advice if severe flushing occurs
Discontinue if anaphylactoid reaction occurs
Discontinue if leucocyte count falls below 3x10 to power of 9/L
Discontinue if lymphocyte count falls below 0.7x10 to power 9/L
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
Discontinue treatment if patient develops a serious infection
Advise patient to moderate alcohol intake during treatment
Female: Ensure adequate contraception during treatment
Female: Oral contraception may not be adequate during treatment
Prior to initiating treatment with dimethyl fumarate, a recent complete blood count (within 6 months) should be available. Assessments of complete blood counts are also recommended every 3 months and as clinically indicated.
Assessments of renal function (e.g. creatinine, blood urea nitrogen and urinalysis) are recommended prior to treatment initiation, after 3 and 6 months and then every 6 to 12 months thereafter as clinically indicated.
If lymphocyte counts are found to be below the normal range prior to treatment, assessments of the possible causes should be completed prior to the initiation of dimethyl fumarate treatment.
Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, treatment should be permanently discontinued.
Consider a short course of acetylsalicylic acid in cases of intolerable flushing.
Severe flushing as a result of dimethyl fumarate treatment may indicate hypersensitivity.
Pregnancy and Lactation
Pregnancy
Dimethyl fumarate is contraindicated during pregnancy.
The manufacturer does not recommend using dimethyl fumarate during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Dimethyl fumarate is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues dimethyl fumarate or discontinues breastfeeding. The presence of dimethyl fumarate in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Acute leukaemia
Alanine aminotransferase increased
Albuminuria
Allergic skin reactions
Anaphylaxis
Angioedema
Aspartate aminotransferase increased
Asthenia
Burning sensation
Constipation
Decreased appetite
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Eosinophilia
Erythema
Fanconi syndrome
Fatigue
Feeling hot
Flatulence
Flushing
Gastritis
Gastro-enteritis
Gastrointestinal disorder
Headache
Hot flushes
Hypersensitivity reactions
Hypotension
Hypoxia
Increases in hepatic enzymes
Ketonuria
Leucopenia
Leukocytosis
Lymphopenia
Nausea
Pancytopenia
Paraesthesia
Progressive multifocal leukoencephalopathy (PML)
Proteinuria
Pruritus
Rash
Renal failure
Serum creatinine increased
Upper abdominal pain
Vomiting
White blood cell count decreased
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2019
Reference Sources
Summary of Product Characteristics: Skilarence 30mg and 120mg gastro-resistant tablets. Almirall Ltd. Revised February 2022.
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