Expected side effects?

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

Expected side effects?

Postby NHE » Mon Sep 24, 2012 3:29 am

This is a description of the side effects associated with usage of dimethyl fumarate, or fumaderm, for psoriasis.

http://www.nelm.nhs.uk/en/NeLM-Area/Evi ... psoriasis/

Adverse effects, including diarrhoea, abdominal pain and facial flushing, are common at the start of treatment with Fumaderm® and lead to discontinuation and/or non-compliance in 30 to 40% of patients. Reversible leucopenia, lymphopenia and transient eosinophilia are frequently observed


and in more detail...

http://webcache.googleusercontent.com/s ... ge&ct=clnk

Adverse effects are common when starting Fumaderm® and lead to discontinuation and/or non-compliance in 30 to 40% of patients [2]. Two thirds of patients experience gastrointestinal symptoms of diarrhoea, abdominal pain and flatulence and one third report facial flushing lasting minutes to hours, sometimes associated with headache [2,4]. These adverse effect rates occur despite initial use of low doses and gradual dose increases as recommended by the manufacturer [3]. Dose reduction may alleviate symptoms but Fumaderm® should be stopped if no improvement is seen [2]. Fumaderm® can be stopped abruptly as relapse or rebound phenomena do not occur [12,28].

Reversible leucopenia, lymphopenia and transient eosinophilia are also frequently observed [2]. Leucopenia occurs in a quarter of patients [8,29]. A reduction in lymphocyte count occurs in around 70% of patients [6,8,25,29] and can exceed 50% in about 10% of patients [4]. The dose of Fumaderm® should be reduced if lymphocytes fall below 0.5x109/L or leucocytes fall below 3.0x109/L; if blood counts improve, treatment can continue at the reduced dose, but otherwise Fumaderm® should be stopped [9]. It has been reported that patients with lymphopenia are significantly more likely to show improvement in psoriasis than those whose lymphocyte count stays within the normal range [6,22,24]. Eosinophilia occurring between the fourth and tenth week of treatment [28], in up to a third of patients, generally lasts for one to two months and resolves without intervention [6-8,14,17,22-24,29]. The clinical significance of these changes is not known but long-term follow-up of patients with haematological abnormalities does not suggest they are at an increased risk of infection or cancer [22,29].

Observational studies following patients for up to 14 years do not indicate that Fumaderm® causes serious or permanent adverse effects [6-8,18,19,22,29]. There have been rare case reports of patients developing acute renal failure or proteinuria when given Fumaderm® [1,2,4,10]. Some studies report raised serum creatinine and/or the presence of urinary protein in up to 30% of patients; in the majority of patients the changes were transient and needed no intervention [8,14,17,19,25,27,29]. Transient and/or reversible increases in liver enzymes and hypercholesterolaemia have also been reported [2,6-8,14,17,22,29]. It is recommended that kidney and liver function should be monitored regularly during treatment [3].


Here's some info on the dosage of fumaderm used in psoriasis patients.

http://webcache.googleusercontent.com/s ... ge&ct=clnk

It is available in two strengths, Fumaderm® Initial 105mg tablets and Fumaderm® 215mg tablets. Patients start on 105mg once daily and the dose is increased weekly by one tablet to a maximum of 1,290mg daily in three divided doses [3].


NHE
User avatar
NHE
Volunteer Moderator
 
Posts: 3144
Joined: Sat Nov 20, 2004 4:00 pm

Advertisement

Re: Expected side effects?

Postby NHE » Mon Oct 08, 2012 2:21 am

Here are the expected side effects from a very rough Google translation of the German patients information document.

Original German: http://www.psoriasis-support.de/media/m ... 070228.pdf
Google translation: http://translate.googleusercontent.com/ ... eU-qP7EQug

I had difficulty getting a translation for "Osteomala-ziestehen" when it describes possible bone changes. Can anyone help with this?

4.1 Side Effects and Precautions

Skin:
Very common:
- Facial redness and flushing (reddening)
These symptoms are very common in the early therapy on and normally in the course of the treatment lower. Were severe but may also for demolition of the treatment.

Rare:
- An allergic skin reaction
Upon cessation of treatment, these symptoms reversible.

Gastrointestinal:
Very common:
- Diarrhea (diarrhea)

Common:
- Bloating
- Abdominal cramps
- Flatulence

Uncommon:
- Nausea
These adverse effects are too often initiation of therapy and go on in the course of treatment usually reversible. Usually, a dose reduction of the complaints mitigate. Nevertheless, should such side effects subside, so the treating physician about the continuation of treatment decisions.

Nervous System:
Uncommon:
- Fatigue
- Dizziness
- Headache

In the course of this treatment are undesired effects usually resolve. Most can dose reduction alleviate the discomfort. However, should not these side effects subside, so must the attending physician on the continuation treatment decisions.

Blood:
It occurred blood disorders such as leucocytes and lymphocytes phopenie and eosinophilia different from embossing to:

Very common:
- Mild forms of lymphopenia (50% of patients)
- Mild leukopenia (approximately 11% of patients)

Common:
- Severe forms of lymphopenia (approximately 3% of Patients)
Lymphopenias and leukopenia can retire form, but can also during treatment recur or permanently lost.
- Transient eosinophilia

Very rare:
- Persistent eosinophilia
So far there is no evidence that these hematological changes to opportunistic infections lead are o.g. after discontinuation of therapy blood count changes reversible.

Very rare:
- Acute Lymphoblastic Leukemia (ALL)
Individual cases:
- Irreversible pancytopenia

Kidney:
Uncommon:
- Protein excretion in the urine
- Increase in serum creatinine
In each serum creatinine above normal is the therapy cancel.

Liver:
Uncommon:
- Increase in liver enzymes (SGOT, SGPT, gamma-GT)

Other side effects:
Very rare:
- Occurrence of nonspecific bone pain and increase alkaline posphatase accompanied with the decrease of inorganic phosphate. This could be related to a Osteomala-ziestehen. Upon cessation of treatment, the symptoms and laboratory changes reversible.

You should tell your doctor or pharmacist if you notice any side effects not listed in this leaflet lists.

Date of information
January 2007
User avatar
NHE
Volunteer Moderator
 
Posts: 3144
Joined: Sat Nov 20, 2004 4:00 pm

Re: Expected side effects?

Postby CureOrBust » Tue Oct 09, 2012 12:18 am

I know it's lazy of me :oops: , but have you compared the dosages between Fumaderm and BG-12?
User avatar
CureOrBust
Family Elder
 
Posts: 2871
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia

Re: Expected side effects?

Postby NHE » Tue Oct 09, 2012 1:26 am

CureOrBust wrote:I know it's lazy of me :oops: , but have you compared the dosages between Fumaderm and BG-12?


BG-12: From the phase III study, 240mg 2 or 3 times daily

Oral drug BG-12 found promising in treatment of MS
http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1679

Fumaderm: Fumaderm® Initial 105mg tablets and Fumaderm® 215mg tablets. Patients start on 105mg once daily and the dose is increased weekly by one tablet to a maximum of 1,290mg daily in three divided doses [3].
User avatar
NHE
Volunteer Moderator
 
Posts: 3144
Joined: Sat Nov 20, 2004 4:00 pm


Return to Tecfidera (BG-12, dimethyl fumarate)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users