Health Boards
This thread was edited by jiml on 8 Jan 2017 to add new information from the new leaflet
This is from the package leaflet but is not the complete document some contact details and ingredients have been omitted if unsure ask your prescribing dermatologist
1.. What is FUMADERM and what is it used for
2.. What you need to know before you take FUMADERM
3.. How to Take Fumaderm
4.. Possible side effects
5.. How to store fumaderm
6.. Contents of the pack and other information
1. What is FUMADERM and what is it used for
FUMADERM contains fumeric acid ester and is a medicine for the treatment of psoriasis
FUMADERM is used for the treatment of moderately severe to severe forms of psoriasis vulgaris if an exclusively external therapy alone is insufficient. Prior therapy with Fumaderm Initial is necessary to adjust the patients tollerance
2. What you need to know before you take FUMADERM
Do not take FUMADERM
If you are allergic to dimethyl fumerate, ethyl hydrogen fumerate, calcium salt , magnesium salt or zinc salt or any of the other ingredients listed in section 6.
If you suffer from severe gastrointestinal diseases, such as stomach or duodenal ulcers ( ulcus ventriculi and ulcus doudeni)
In the presence of Liver or kidney disorders
In mild forms of psoriasis vulgaris e.g. localised plaque psoriasis or chronic stationary plaque psoriasis covering less than 10% of the body surface due to treatment risks ( benefit / risk ratio)
In psoriasis pustulosa due to the lack of sufficient clinical experience. Whereas isolated case reports provide evidence of efficacy
In Patients below 18 years of age
During pregnancy and breastfeeding
Laboratory tests
Blood count .. Prior to initiation of treatment with FUMADERM, a blood count (including a differential blood count and platelet count ) must be performed . In the presence of values outside the normal range, treatment with FUMADERM must not be instituted. During the course of treatment full blood counts (leukocyte count and differential blood count) must be monitored on a regular basis
After starting the therapy. Laboratory testing should be performed every 14 days for the first 3 months. If laboratory findings remain normal, monthly performance of blood count is sufficient.
Blood and Urinary Measurements
To identify any adverse effects on liver and kidney, activity of SGOT,SGPT ,gamma-GT.AP, the level of the renal function value serum creatinine of the blood, as well as urine protein and sediment should be tested prior to the start of treatment and regularly during therapy (every 14 days during the first 4 weeks and every four weeks thereafter)
For possible damaging effects on the liver and kidneys
Fanconi Syndrome
Fanconi Syndrome is a rare kidney function disorder whereby absorption of certain substances ( e,g. Glucose, anorganic phosphorus, amino acids) in the kidney is disrupted
Early diagnosis of Fanconi Syndrome and withdrawal of Fumaderm therapy are important to prevent the onset of renal failure and other consequences of Fanconi Syndrome
The key signs of Fanconi Syndrome are typically abnormalities in the urine such as excretion of protein (proteinuria) and glucose ( glycosuria with normal blood sugar levels ) increased excretion of amino acids ( hyperaminoaciduria) excretion of phosphate ( phosphateuria) possibly accompanied by low blood levels of phosphate ( hypophosphataemia)
If Fanconi Syndrome remains untreated symptoms such as increased excretion of urine ( polyuria) excessive thirst and drinking increased volumes (polydipsia) and muscle weakness may occur. In rare cases, due to phosphate loss, there may be softening of the bones ( hypophosphataemic osteomalacia) with unspecified bone pain, an increase in a certain enzyme ( alkaline phosphatase) in the blood and fractures occurring under normal weight bearing for no apparent reason ( stress fractures) These disorders and changes in laboratory results are generally reversible once treatment is withdrawn
In the event of unexplained symptoms such as are outlined above. Fancini Syndrome should be considered
Contact your doctor so that he can arrange for further relevant investigations
Criteria for discontinuation of therapy
Leukopenia ( reduction of white blood cells) Treatment with FUMADERM must be discontinued immediately in the presence of a significant reduction in leukocyte count- particularly if values are below 3,000ul
Lymphopenia ( reduction in specific white cells if the lymphocyte count drops below 500ul treatment must be discontinued immediately
If the lymphocyte count drops below 700ul the dose should be halved. If during the follow up check after 2 to 4 weeks the absolute lymphocyte count remains below 700ul then treatment must be discontinued. Alternative causes of lymphopenia should be excluded .
If therapy is continued in presence of severe prolonged lymphopenia the risk of an opportunistic infection cannot be ruled out
Other blood diseases Treatment should be discontinued immediately and caution should be exercised if there are other pathological changes in blood count
In all cases, the blood count should be monitored until normalization
Other laboratory abnormalities Therapy must be discontinues in any case of increased creatinine levels above the normal range ( see section 4)
Other medicines and FUMADERM
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines
The medicines listed below must not be taken at the same time as FUMADERM
During treatment with FUMADERM concomitant external use of fumeric acid derivatives e.g in the form of ointments and or baths must be avoided because additional absorption of fumeric acid derivatives through the skin from externally applied baths or ointments may lead to intoxication by exceeding the maximum tolerable dosage
Methotrexate , retinoids, psoralenes and cyclosporine must not be used concomitantly with Fumaderm.
Pharmacological active ingredients which lead to suppression or reduction of the immune system reactivity (immunosuppression) medicines for cancer chemotherapy (cytostatics) and medicines with known harmful effects on the kidneys must not be administered concomitantly with Fumaderm
Pregnancy and Breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
Although there is no evidence of a teratogenic (malforming) effect on the basis of preclinical studies. Fumaderm should not be taken during pregnancy as there has been no experience so far in pregnant women . Women that become pregnant during the treatment must inform the treating doctor immediately
Breast feeding
It is not known if the ingredients in FUMADERM are excreted in breast milk. Therefore FUMADERM should not be taken during breast feeding
Driving and using machines
No impairment is to be expected during treatment with the recommended doses of FUMADERM
3 How to take fumaderm
Always take this medicine as the doctor has told you , check with your doctor if you are not sure
Unless your doctor has prescribed FUMADERM differently, the following instruction applies
Please follow the instruction for use , as otherwise FUMADERM cannot operate correctly....
After the tolerability improvement pretreatment with FUMADERM INITIAL, therapy is generally switched to FUMADERM at the end of the third week of treatment.
In the first week of therapy with FUMADERM take 1 x 1 gastro resistant tablet of FUMADERM once daily in the evening
in the second week of therapy take one gastro resistant tablet of FUMADERM one in the morning and one in the evening
Subject to individual tolerability increase the dose weekly by one gastro resistant tablet of FUMADERM according to the following regimen
Fumaderm dosing regime:
The maximum daily dosage of 3x2 gastro resistant tablets of FUMADERM must not be exceeded, however in many cases , administration of the maximum daily dosage is not required.
According to experience initial treatment effects will first become apparent after the fourth to sixth week of therapy
After abatement of skin reactions, gradual reduction of the daily dose intake to an individually required maintenance dose of FUMADERM should be attempted.
The gastro resistant tablets must be taken without chewing with plenty of fluid at or immediately after meals
Patients should take care to drink enough fluid (1.5 to 2 litres during the day)
The duration of therapy is determined by the treating physician. Sufficient experience from clinical trials is available for a treatment period of 4 months. In addition , experience with treatment periods of up to 36 months is available from observational studies.
Please talk to your doctor if you have the impression that the effect of FUMADERM is too strong or too weak
If you take more FUMADERM than you should
If you have taken too many gastro-resistant tablets talk to your doctor straight away.
Beside general measures to eliminate the harmful substances and reduce absorption in the gastrointestinal tract, symptomatic treatment is indicated... There is no KNOWN antidote (see section 4)
If you forget to take FUMADERM
Do not take a double dose to make up for a forgotten tablet
Continue to take this medicine exactly as described in the package leaflet, or as your Doctor has told you, check with your doctor or pharmacist if you are not sure
If you stop taking FUMADERM
If you stop taking or plan to stop taking the tablets, talk to your doctor or pharmacist
4 Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them
in the ratings of undesired effects, the following frequency classification is used
Very Common.....................................more than one in ten treated patients
Common..............................................less than 1 in 10but more than 1 in 100 treated patients
Uncommon..........................................less than 1 in 100 but more than 1 in 1,000treated patients
Rare …................................................less than 1 in 1,000 but more than 1 in 10,000 treated patients
Very rare............................................less than 1 in 10,000 or unknown
Skin and subcutaneous tissue disorders
Very common .Facial flushing and heat sensations (flushing)
These disorders are very common at the initiation of therapy and usually subside during further treatment. However severe forms may lead to treatment discontinuation
Rare allergic skin reaction
These symptoms are reversible after discontinuation of the therapy
Gastrointestinal disorders
Very common Diarrhoea
Common distention, upper abdominal cramps, flatulence
Uncommon Nausea
These side effects are very common at the initiation of therapy and normally subside during further treatment . In most cases dose reduction will alleviate the symptoms. If these side effects do not resolve, the treating physician must decide on continuation of the therapy
Nervous system disorders
Uncommon Fatigue, dizziness, headaches
These side effects normally subside during further treatment . In most case dose reduction will alleviate the symptoms. If these symptoms don't resolve, the treating physician must decide on the continuation of therapy
Blood and lymphatic system disorders
Alterations in blood cell counts such as leukopenia ( reduction of white blood cells)
lymphopenia (reduction of specific white blood cells) and
eosinophilia ( increase in specific white blood cells) appear in various degrees of severity
Very common
mild forms of lyphopenia (approximately 50% of patients)
Mild leukopenia (approximately) 11% of patients)
Common
severe forms of lymphopenia (approximately 3% of patients
transient eosinophilia
Very rare
Persistent eosinophilia
The above mentioned alterations of blood cell counts are reversible upon discontinuation of therapy
Very rare
Acute lymphocytic Leukaemia (ALL)
Isolated cases
irreversible pancytopenia ( reduction of all blood cells)
Renal and Urinary disorders
Uncommon
Protein excretion in the urine , increase of the renal function value creatinine in the blood
Therapy must be discontinued in all cases with serum creatinine levels increased beyond the normal range
Hepatobiliary disorders
Uncommon increased hepatic enzyme levels (SGOT0 [AST], SGPT [ALT], gamma GT)
Other undesirable effects
Very rare Non specific bone pains and increased alkaline phosphatase with concomitant reduction of inorganic Phosphate levels. These signs may be associated with osteomalacia ( softening of the bone)
These disorders and laboratory test alterations are reversible upon discontinuation of the therapy
Post marketing experience ( frequency unknown)
Renal failure
Isolated cases of opportunistic infections ( infections that occur due to immune system impairment) were reported in patients who had severe, prolonged lymphopenia on treatment with FUMADERM
Fumaderm Enteric-Coated Tablets for adults
This is from the package leaflet but is not the complete document some contact details and ingredients have been omitted if unsure ask your prescribing dermatologist
1.. What is FUMADERM and what is it used for
2.. What you need to know before you take FUMADERM
3.. How to Take Fumaderm
4.. Possible side effects
5.. How to store fumaderm
6.. Contents of the pack and other information
1. What is FUMADERM and what is it used for
FUMADERM contains fumeric acid ester and is a medicine for the treatment of psoriasis
FUMADERM is used for the treatment of moderately severe to severe forms of psoriasis vulgaris if an exclusively external therapy alone is insufficient. Prior therapy with Fumaderm Initial is necessary to adjust the patients tollerance
2. What you need to know before you take FUMADERM
Do not take FUMADERM
If you are allergic to dimethyl fumerate, ethyl hydrogen fumerate, calcium salt , magnesium salt or zinc salt or any of the other ingredients listed in section 6.
If you suffer from severe gastrointestinal diseases, such as stomach or duodenal ulcers ( ulcus ventriculi and ulcus doudeni)
In the presence of Liver or kidney disorders
In mild forms of psoriasis vulgaris e.g. localised plaque psoriasis or chronic stationary plaque psoriasis covering less than 10% of the body surface due to treatment risks ( benefit / risk ratio)
In psoriasis pustulosa due to the lack of sufficient clinical experience. Whereas isolated case reports provide evidence of efficacy
In Patients below 18 years of age
During pregnancy and breastfeeding
Laboratory tests
Blood count .. Prior to initiation of treatment with FUMADERM, a blood count (including a differential blood count and platelet count ) must be performed . In the presence of values outside the normal range, treatment with FUMADERM must not be instituted. During the course of treatment full blood counts (leukocyte count and differential blood count) must be monitored on a regular basis
After starting the therapy. Laboratory testing should be performed every 14 days for the first 3 months. If laboratory findings remain normal, monthly performance of blood count is sufficient.
Blood and Urinary Measurements
To identify any adverse effects on liver and kidney, activity of SGOT,SGPT ,gamma-GT.AP, the level of the renal function value serum creatinine of the blood, as well as urine protein and sediment should be tested prior to the start of treatment and regularly during therapy (every 14 days during the first 4 weeks and every four weeks thereafter)
For possible damaging effects on the liver and kidneys
Fanconi Syndrome
Fanconi Syndrome is a rare kidney function disorder whereby absorption of certain substances ( e,g. Glucose, anorganic phosphorus, amino acids) in the kidney is disrupted
Early diagnosis of Fanconi Syndrome and withdrawal of Fumaderm therapy are important to prevent the onset of renal failure and other consequences of Fanconi Syndrome
The key signs of Fanconi Syndrome are typically abnormalities in the urine such as excretion of protein (proteinuria) and glucose ( glycosuria with normal blood sugar levels ) increased excretion of amino acids ( hyperaminoaciduria) excretion of phosphate ( phosphateuria) possibly accompanied by low blood levels of phosphate ( hypophosphataemia)
If Fanconi Syndrome remains untreated symptoms such as increased excretion of urine ( polyuria) excessive thirst and drinking increased volumes (polydipsia) and muscle weakness may occur. In rare cases, due to phosphate loss, there may be softening of the bones ( hypophosphataemic osteomalacia) with unspecified bone pain, an increase in a certain enzyme ( alkaline phosphatase) in the blood and fractures occurring under normal weight bearing for no apparent reason ( stress fractures) These disorders and changes in laboratory results are generally reversible once treatment is withdrawn
In the event of unexplained symptoms such as are outlined above. Fancini Syndrome should be considered
Contact your doctor so that he can arrange for further relevant investigations
Criteria for discontinuation of therapy
Leukopenia ( reduction of white blood cells) Treatment with FUMADERM must be discontinued immediately in the presence of a significant reduction in leukocyte count- particularly if values are below 3,000ul
Lymphopenia ( reduction in specific white cells if the lymphocyte count drops below 500ul treatment must be discontinued immediately
If the lymphocyte count drops below 700ul the dose should be halved. If during the follow up check after 2 to 4 weeks the absolute lymphocyte count remains below 700ul then treatment must be discontinued. Alternative causes of lymphopenia should be excluded .
If therapy is continued in presence of severe prolonged lymphopenia the risk of an opportunistic infection cannot be ruled out
Other blood diseases Treatment should be discontinued immediately and caution should be exercised if there are other pathological changes in blood count
In all cases, the blood count should be monitored until normalization
Other laboratory abnormalities Therapy must be discontinues in any case of increased creatinine levels above the normal range ( see section 4)
Other medicines and FUMADERM
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines
The medicines listed below must not be taken at the same time as FUMADERM
During treatment with FUMADERM concomitant external use of fumeric acid derivatives e.g in the form of ointments and or baths must be avoided because additional absorption of fumeric acid derivatives through the skin from externally applied baths or ointments may lead to intoxication by exceeding the maximum tolerable dosage
Methotrexate , retinoids, psoralenes and cyclosporine must not be used concomitantly with Fumaderm.
Pharmacological active ingredients which lead to suppression or reduction of the immune system reactivity (immunosuppression) medicines for cancer chemotherapy (cytostatics) and medicines with known harmful effects on the kidneys must not be administered concomitantly with Fumaderm
Pregnancy and Breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
Pregnancy
Although there is no evidence of a teratogenic (malforming) effect on the basis of preclinical studies. Fumaderm should not be taken during pregnancy as there has been no experience so far in pregnant women . Women that become pregnant during the treatment must inform the treating doctor immediately
Breast feeding
It is not known if the ingredients in FUMADERM are excreted in breast milk. Therefore FUMADERM should not be taken during breast feeding
Driving and using machines
No impairment is to be expected during treatment with the recommended doses of FUMADERM
3 How to take fumaderm
Always take this medicine as the doctor has told you , check with your doctor if you are not sure
Unless your doctor has prescribed FUMADERM differently, the following instruction applies
Please follow the instruction for use , as otherwise FUMADERM cannot operate correctly....
After the tolerability improvement pretreatment with FUMADERM INITIAL, therapy is generally switched to FUMADERM at the end of the third week of treatment.
In the first week of therapy with FUMADERM take 1 x 1 gastro resistant tablet of FUMADERM once daily in the evening
in the second week of therapy take one gastro resistant tablet of FUMADERM one in the morning and one in the evening
Subject to individual tolerability increase the dose weekly by one gastro resistant tablet of FUMADERM according to the following regimen
Fumaderm dosing regime:
| Week | Morning | Midday | Evening |
|---|---|---|---|
| 1 | 0 | 0 | 1 |
| 2 | 1 | 0 | 1 |
| 3 | 1 | 1 | 1 |
| 4 | 1 | 1 | 2 |
| 5 | 2 | 1 | 2 |
| 6 | 2 | 2 | 2 |
The maximum daily dosage of 3x2 gastro resistant tablets of FUMADERM must not be exceeded, however in many cases , administration of the maximum daily dosage is not required.
According to experience initial treatment effects will first become apparent after the fourth to sixth week of therapy
After abatement of skin reactions, gradual reduction of the daily dose intake to an individually required maintenance dose of FUMADERM should be attempted.
The gastro resistant tablets must be taken without chewing with plenty of fluid at or immediately after meals
Patients should take care to drink enough fluid (1.5 to 2 litres during the day)
The duration of therapy is determined by the treating physician. Sufficient experience from clinical trials is available for a treatment period of 4 months. In addition , experience with treatment periods of up to 36 months is available from observational studies.
Please talk to your doctor if you have the impression that the effect of FUMADERM is too strong or too weak
If you take more FUMADERM than you should
If you have taken too many gastro-resistant tablets talk to your doctor straight away.
Beside general measures to eliminate the harmful substances and reduce absorption in the gastrointestinal tract, symptomatic treatment is indicated... There is no KNOWN antidote (see section 4)
If you forget to take FUMADERM
Do not take a double dose to make up for a forgotten tablet
Continue to take this medicine exactly as described in the package leaflet, or as your Doctor has told you, check with your doctor or pharmacist if you are not sure
If you stop taking FUMADERM
If you stop taking or plan to stop taking the tablets, talk to your doctor or pharmacist
4 Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them
in the ratings of undesired effects, the following frequency classification is used
Very Common.....................................more than one in ten treated patients
Common..............................................less than 1 in 10but more than 1 in 100 treated patients
Uncommon..........................................less than 1 in 100 but more than 1 in 1,000treated patients
Rare …................................................less than 1 in 1,000 but more than 1 in 10,000 treated patients
Very rare............................................less than 1 in 10,000 or unknown
Skin and subcutaneous tissue disorders
Very common .Facial flushing and heat sensations (flushing)
These disorders are very common at the initiation of therapy and usually subside during further treatment. However severe forms may lead to treatment discontinuation
Rare allergic skin reaction
These symptoms are reversible after discontinuation of the therapy
Gastrointestinal disorders
Very common Diarrhoea
Common distention, upper abdominal cramps, flatulence
Uncommon Nausea
These side effects are very common at the initiation of therapy and normally subside during further treatment . In most cases dose reduction will alleviate the symptoms. If these side effects do not resolve, the treating physician must decide on continuation of the therapy
Nervous system disorders
Uncommon Fatigue, dizziness, headaches
These side effects normally subside during further treatment . In most case dose reduction will alleviate the symptoms. If these symptoms don't resolve, the treating physician must decide on the continuation of therapy
Blood and lymphatic system disorders
Alterations in blood cell counts such as leukopenia ( reduction of white blood cells)
lymphopenia (reduction of specific white blood cells) and
eosinophilia ( increase in specific white blood cells) appear in various degrees of severity
Very common
mild forms of lyphopenia (approximately 50% of patients)
Mild leukopenia (approximately) 11% of patients)
Common
severe forms of lymphopenia (approximately 3% of patients
transient eosinophilia
Very rare
Persistent eosinophilia
The above mentioned alterations of blood cell counts are reversible upon discontinuation of therapy
Very rare
Acute lymphocytic Leukaemia (ALL)
Isolated cases
irreversible pancytopenia ( reduction of all blood cells)
Renal and Urinary disorders
Uncommon
Protein excretion in the urine , increase of the renal function value creatinine in the blood
Therapy must be discontinued in all cases with serum creatinine levels increased beyond the normal range
Hepatobiliary disorders
Uncommon increased hepatic enzyme levels (SGOT0 [AST], SGPT [ALT], gamma GT)
Other undesirable effects
Very rare Non specific bone pains and increased alkaline phosphatase with concomitant reduction of inorganic Phosphate levels. These signs may be associated with osteomalacia ( softening of the bone)
These disorders and laboratory test alterations are reversible upon discontinuation of the therapy
Post marketing experience ( frequency unknown)
Renal failure
Isolated cases of opportunistic infections ( infections that occur due to immune system impairment) were reported in patients who had severe, prolonged lymphopenia on treatment with FUMADERM
