Sunday, March 30, 2014

Advocacy- Tell the FDA what you think

Today I sent an email to the FDA explaining my position and asking them to reconsider their decision on Lemtrada. I know many others including our neurologists have done the same.

Your voice does matter- make it heard- write to the FDA at:

http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

or

Lemtrada Post Infusion Monitoring

Here is a basic list of labs you need for 4+ years after your last dose of Lemtrada, see below chart for my notes, as you read the reason WHY these tests are needed you will understand why follow up with your doctor is so important after Lemtrada: 

CBC with diff- means a Complete Blood Count including platelets. This test monitors for Idiopathic thrombocytopenic purpura (ITP) and your white blood cell count (WBCs). 

Idiopathic thrombocytopenic purpura is a bleeding disorder in which the immune system destroys platelets, which are necessary for normal blood clotting. Persons with the disease have too few platelets in the blood. ITP is sometimes called immune thrombocytopenic purpura.

Your white cell count will initially be low or non-existent after Lemtrada. WBCs are monitored as a sign your immune system is starting to recover and you will be able to fight off more infections as this # returns to your baseline. 

CMP, Creatinine- Complete Metabloic Panel, which includes Creatinine. This is to monitor liver and kidney function. 

Urinalysis- to monitor for protein in the urine and occult blood- aka- blood you cannot see. This test is done to monitor for Goodpasture Syndrome. 

Goodpasture syndrome is an autoimmune disorder. It occurs when the immune system mistakenly attacks and destroys healthy body tissue. Persons with this syndrome develop substances that attack a protein called collagen in the tiny air sacs in the lungs and the filtering units (glomeruli) of the kidneys.

In addition to these labs I plan to test my urine at home with a CLIA waived test strip for protein and blood (strips also monitor other things) due to the rare risk of Goodpasture Syndrome. This is a serious kidney disease that must be detected & treated within 3 days of onset. 

GoodPastures is rare with Lemtrada but does exist. This test is quick and easy to do at home so I am adding it to my personal protocol for safety.

Here is a good basic link for information on Goodpasture Syndrome:
http://www.nlm.nih.gov/medlineplus/ency/article/000142.htm

TSH- Thyroid Stimulating Hormone, if abnormal the test your doctor orders my also provide the count of your circulating T4 cells- thyroid cells. Lemtrada is know to cause hyper and hypo (high & low ) thyroid conditions in 25-30% of cases- this is a very high rate, so expect thyroid changes (you might be part of the 70% but it is always best to be prepared). Thankfully these changes are rarely emergencies and can be treated easily.

True Thyroid Storm- when circulating levels of thyroid hormone are very high, is a medical emergency- but highly treatable. See: http://www.nlm.nih.gov/medlineplus/ency/article/000400.htm

In most cases high levels of thyroid hormone will 'burn out' the thyroid gland leading to a low thyroid 'new normal' for the patient. The patient would then need to take thyroid replacement hormone (a pill) to replace the missing thyroid hormone.

For information on hypothyroidism see: http://www.nlm.nih.gov/medlineplus/ency/article/000353.htm


Medication you may want to have on hand for infusion

During Infusion

Day 1 start Acyclovir 200mg BID x 28days
            My finish date 5/5/14

Have on hand (the reason is in parenthesis)
·         Diflucan tab (yeast infection)
·         Nystatin oral suspension (oral yeast infection)
·         Benadryl IM/IV (rash)
·         Oral Motrin
·         Oral Tylenol

·         Miralax- for possible constipation r/t steriods

Lemtrada Infusion Protocol

I created this document myself when I was considering infusion in Mexico because they were not experiences with Lemtrada. Days 1-3 are the same except that you may decrease the time of the Lemtrada infusion if patient is tolerating the medication.

Lemtrada infusion protocol calls for 1gm Solumedrol on days 1-3 with no taper. If you have ever had Solumedrol without a taper it can be quite difficult on the body (at least for me personally). As a personal request, I asked to be stepped down from 1gm on Day 4 to 500mg and on Day 5 to 250mg. On day 6 I may switch or an oral taper or IM injection taper. My doctor in Germany has agreed to the taper protocol I requested.

Alemtuzumab Protocol

Day 1:

Treatment:
Solumedrol 1gm given over 1 hour infusion
Motrin 600-800mg oral initially and prn
Acetaminophen 550+mg orally initially and prn discomfort
Diphenhydramine IV 50 mg
Phenergan 25-50mg IV prn nausea

After other infusions above, Alemtuzumab must be mixed, used immediately and not combined with any other drugs in the IV line

            Alemtuzumab 12mg IV given over 4 hours, may extend time if patient is not doing well.

            Supportive measures such as pain medication may be needed
            Consider 2nd dose of IV Benadryl 50mg prior to discharge

Day 2:

Solumedrol 1gm given over 1 hour infusion
Motrin 600-800mg oral initially and prn
Acetaminophen 550+mg orally initially and prn discomfort
Diphenhydramine IV 50 mg
Phenergan 25-50mg IV prn nausea

After other infusions above, Alemtuzumab must be mixed, used immediately and not combined with any other drugs in the IV line

            Alemtuzumab 12mg IV may shorten infusion time to 2 hours if patient tolerated day 1
well, may extend time if Alemtuzumab was not tolerated well.

            Supportive measures such as pain medication may be needed
            Consider 2nd dose of IV Benadryl 50mg prior to discharge for rash

Day 3:

Solumedrol 1gm given over 1 hour infusion
Motrin 600-800mg oral initially and prn
Acetaminophen 550+mg orally initially and prn discomfort
Diphenhydramine IV 50 mg
Phenergan 25-50mg IV prn nausea

After other infusions above, Alemtuzumab must be mixed, used immediately and not combined with any other drugs in the IV line

            Alemtuzumab 12mg IV may shorten infusion time to 2 hours if patient tolerated day 1
well, may extend time if Alemtuzumab was not tolerated well.

            Supportive measures such as pain medication may be needed
            Consider 2nd dose of IV Benadryl 50mg prior to discharge for rash

Day 4:

Solumedrol 500mg given over 30 minute infusion* patient preference, not part of
official protocol. Patient requests a step down from high dose steroid treatment
Motrin 600-800mg oral initially and prn
Acetaminophen 550+mg orally initially and prn discomfort
Diphenhydramine IV 50 mg
Phenergan 25-50mg IV prn nausea

After other infusions above, Alemtuzumab must be mixed, used immediately and not combined with any other drugs in the IV line

            Alemtuzumab 12mg IV may shorten infusion time to 2 hours if patient tolerated day 1
well, may extend time if Alemtuzumab was not tolerated well.

            Supportive measures such as pain medication may be needed
            Consider 2nd dose of IV Benadryl 50mg prior to discharge for rash

Day 5:

Solumedrol 250mg given over 30 minute infusion* patient preference, not part of
official protocol. Patient requests a step down from high dose steroid treatment
Motrin 600-800mg oral initially and prn
Acetaminophen 550+mg orally initially and prn discomfort
Diphenhydramine IV 50 mg
Phenergan 25-50mg IV prn nausea

After other infusions above, Alemtuzumab must be mixed, used immediately and not combined with any other drugs in the IV line

            Alemtuzumab 12mg IV may shorten infusion time to 2 hours if patient tolerated day 1
well, may extend time if Alemtuzumab was not tolerated well.

            Supportive measures such as pain medication may be needed
            Consider 2nd dose of IV Benadryl 50mg prior to discharge for rash


Lemtrada Package Leaflet for Patients

Here is the Patient information provided by my doctor in Germany:

http://www.docstoc.com/docs/document-preview.aspx?doc_id=168306420

 I had difficulty uploading this PDF, but the link does work for the full document and it is downloadable

Questions Answered

Several people have emailed me questions, so I thought I would post the information here for everyone.

Just a bit about me- I am a retired Nurse Practitioner so I am used using medical jargon and my experience might be different from yours because I am able to order my own labs & monitor my care with my neurologist. Also, my name is not Emma- that is a pseudonym for the purposes of this blog. If you would like to use my name in talking with any of the doctors you call, just email me and I will respond.

Here are some of the Questions I have been asked:

Why Germany and not Canada?
Canada was my first choice for proximity and family ties. My husband was born in Canada and his father went to medical school there. Canada is not yet infusing. As of March 2014 they were meeting to set national standards for Canadians. I have a friend who was told doctors there were concerned about mal-practice coverage in seeing US patients. I did not have that experience but you might run into that. For a Great contact in Canada try:
Tony Traboulsee, MD
MS Society of Canada Research Chair
Associate Professor (Medicine/Neurology)
University of British Columbia
2211 Wesbrook Mall, room s-199
Vancouver, BC V6T 2B5  FAX +1 604-822-7703
Office +1 604-822-0788 


Lemtrada is made in Germany and doctors there have a LOT of experience with Lemtrada. Access to medication was easy. 

I did investigate Mexico but they do not have the drug and the clinic I was speaking with there had NO experience with Lemtrada. Mexico did not turn out to be cheaper when the med became available in late June. I was ready to go in early April so our time lines did not fit. 

How did you find a clinic willing to provide Lemtrada?

On the advice of my Neurologist I looked at sites that participated in the CARE MS I & CARE MS II clinical trials. You can see that list here :
http://clinicaltrials.gov/ct2/show/study/NCT00548405?show_locs=Y#locn
http://clinicaltrials.gov/ct2/show/study/NCT00530348?term=CARE+MS+I&rank=2&show_locs=Y#locn

I sent emails to all the clinics I could find emails for in Europe. I corresponded with approximately 5-7 doctors in the EU.

How did you pick your doctor in Germany?

Ultimately I chose Dr. Ziemssen in Dresden after we spoke on the phone. He asked me all the 'right' questions (compared to the people I spoke with in Mexico) and answered all my questions.

I felt the conversation was collaborative and was encouraged by his knowledge and experience. He participated in the EU panel that when before their "FDA" to provide information during the certification process of Lemtrada in the EU.

Is he expecting (and wanting)other calls?

I cannot speak for him but he is very kind in thanking me for choosing him for my care. I do know of another patient who will be traveling to Dresden the same time I am. We will be infused at the same hospital by Dr. Ziemssen. We will both be treated out-patient (spend night at hotel). Both our spouses are coming as well.

I am sure he would be open to hearing from other patients.

Is there a waiting list?

Not that I am aware of. Other clinics, specifically the one in Hanover & Prague, are willing to infuse with no stated delays.

How long did it take to get an appointment?

I first sent an email to Dr. Ziemssen on 3/7/14. My infusion date is 4/7/14. We could have possibly arranged for an earlier date but I took leave from my job starting the week of 4/7 so I didn't ask for any other time. You do needs some labs here and an MRI, possibly a LP (spinal tap)- you can do that here or there but I chose to do it here for my insurance to cover it- also if anything came up on the labs I wouldn't be wasting a trip.

What Medical records did he ask for?

That will depend on each patient- your history and other health issues. I needed a recent MRI because I am JCV Ab+ previously on Tysabri so I needed to rule out PML.

I put together an overview of my MS treatment- diagnosis, medications, why I switched, if I failed therapy, etc. I also attacked a copy of my most recent office visits, labs, MRI report, etc. We discussed other things over the phone.

Did he skype with your doctors?

No.

Did he want to know who will be monitoring you when you get home?

Yes. He understood that I understood the research and required monitoring.

DO NOT ask for Lemtrada if you are NOT PREPARED to follow the follow up protocol to the letter! I will post follow up care in another post here but you MUST commit to lab work every 4 weeks for up to 4 years after your last dose, possibly longer. If you are the kind of person to put off tests or have a relaxed attitude about timelines you should not take Lemtrada.

Some doctors (Prague for example) will want to include your doctor on all correspondence (cc them). My situation is a little different in that I can order my own labs and have copies sent to doctors.

I will post the Lemtrada Patient Instructions, which include the follow up requirements on another post.

Did he advise on flying after the treatment?

Of course I will have to fly home. I will depart the Saturday after the infusions are complete (4/12/14). I took no extra precautions besides sitting in an area of the plane with minimal exposure to other patients and separate bathroom facilities for just 12 people.

As part of the protocol you need to be taking the antiviral medication Valtrex (valacyclovir) 200mg twice daily. I will also bring an antibiotic with me.

Once I return home my goal is to not have any visitors (except my husband) and not leave the house except for blood draws until I see my white cell count start to rise. You will be Extremely susceptible to infection post transfusion.

Did he say what the next 6 - 12 months would be like?

No. For this information I would read the Lemtrada Patient Instructions posted on another page of this blog. David's Campath story is another good reference (keep in mind he took 20mg/day for 5 days. The current dosage is 12mg/day for 5 days. His story is here:
http://www.davidscampathstory.org/ Campath is the same drug, under a different name to treat CLL (a lukemia)
Here is another experience:
http://alemtuzumabmsandme.blogspot.com/
Here is another:
http://www.mslisasays.com/treatment-2/my-journey-with-ms-after-lemtrada/

I will post my own experience as internet access allows.

Saturday, March 29, 2014

Please 'like' this blog to help others


Share & Share Alike

If you have time can you 'like' this blog so it pops up higher in a google search?  I am trying to share this with as many patients as possible. 

Several patients have contacted me directly for the info contained here. I am sure there are many more MS patients out there who might be interested in the contents here.

To like the blog click on the G+ symbol below each post.

Thanks!

Friday, March 28, 2014

EU Summation of Lemtrada Clinical Trials up to June 2013

This is a review of medical literature used by the EU in deciding to approve Lemtrada in the EU. The text is quite technical but I believe it is an important read for all those considering Lemtrada treatment. It might also be useful to provide to your PCP or other doctors handling your medical conditions.

Lemtrada assessment European Medical Agency.pdf

Here are the notes I took on the paper for my own purposes. These passages are just cut out of the larger document: 

The active substance, alemtuzumab, is a humanized monoclonal antibody directed against CD52, one of several specific surface antigens acquired by cells of the hematopoietic system during leukocyte differentiation. Alemtuzumab binds to CD52 which is present at high levels on the surface of T and B lymphocytes and at lower levels on natural killer cells, monocytes and macrophages. There is little or no CD52 detected on neutrophils, plasma cells or bone marrow stem cells.

Alemtuzumab was approved until recently as MabCampath for the treatment of B-cell chronic lymphocytic leukemia. The posology, however, is considerably different for MS as compared to B- CLL: the cumulative dose in B-CLL was around 1100 mg, administered in a dose escalation scheme within 12 weeks, while in MS the cumulative dose is much lower: a maximum cumulative dose of 96 mg, administered in two cycles 12 months apart.

The mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown, but may involve immunomodulation through the depletion and repopulation of lymphocytes. Research suggests that alemtuzumab alters the number, proportions and properties of some lymphocyte subsets on repopulation. The proposed mechanism of action is antibody dependent cell-mediated cytolysis and complement-mediated cytolysis following cell surface binding of alemtuzumab to lymphocytes.

Lemtrada is supplied as a sterile, clear, colorless to slightly yellow, concentrate solution that must be diluted prior to IV infusion. It is presented as a single use vial containing 12 mg alemtuzumab in 1.2 ml solution (10 mg/ml).

Alemtuzumab is administered by I.V. infusion. This route of administration requires that the solution is further diluted with 0.9% Sodium Chloride Injection, or 5% dextrose solution. Studies have been performed to evaluate finished product quality and stability in both of these solutions.

Chemical and physical In-use stability has been demonstrated for 24 hours, when stored at 2- 8oC or at room temperature, and followed by an infusion period of 8 hours at room temperature. The Applicant recommends that the solution for infusion is prepared just prior to administration to minimize the potential for protein aggregate formation and for microbiological reasons since the product does not contain preservatives.

Alemtuzumab did not have significant complement-mediated depleting effects on monocytes, dendritic cells, basophils and lymphoid derived plasmacytoid dendritic cell.

In study BPAT/91/0062, alemtuzumab exposure had no observable effects on bone marrow progenitor cells, which suggested that alemtuzumab was unlikely to impair early hematopoietic development.

depletion of T and B cells was consistently observed at 24 hours following alemtuzumab administration. Depletion was noted in blood and selected lymphoid tissues (spleen and inguinal lymph nodes).

The results showed that depletion of total T cells, T helper cells, T cytotoxic cells and T regulatory cells in whole blood persisted at D28 following a 5-day cycle of dosing. In contrast, T cell levels in the spleen were similar to those observed in control animals at D28, suggesting that depletion in the spleen was shorter-lived. Depletion of B cells was noted in the blood and spleen at Day 7 and Day 14, but no significant decrease compared to control animals was seen at Day 28 for any B cell subset evaluated. In cynomolgus monkeys, following completion of a 5-day cycle of alemtuzumab, both B-cells and CD8+Tcells recovered to levels close to baseline by Day 60. This recovery to baseline levels at the end of the 60-day study period was not observed for CD4+T cells.

the applicant concluded that there were no apparent or biologically relevant changes in heart rate, blood pressure or qualitative electrocardiograms associated with administration of alemtuzumab at any of the doses tested in this study.

Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes.
The mechanism by which alemtuzumab exerts its therapeutic effects in MS is not fully elucidated. However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
- Alterations in the number, proportions, and properties of some lymphocyte subsets post- treatment
- Increased representation of regulatory T cell subsets
- Increased representation of memory T- and B-lymphocytes
- Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)

The reduction in the level of circulating B and T cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse, which ultimately delays disease progression.

Lymphocytes repopulated after depletion, with the time to reach repopulation milestones varying by lymphocyte subset. Approximately 40% and 80% of patients receiving the 12 mg/day dose had total lymphocyte counts reaching the LLN by 6 and 12 months, respectively, after each treatment cycle. Approximately 10 to 20% of patients had CD3+ and CD4+ counts reaching the LLN by 12 months after each treatment cycle in the Phase 3 studies. The proportion of patients with CD8+ repopulation over time was similar to that for total lymphocytes, with approximately 50% of patients having CD8+ counts reaching the LLN by 9 months following each cycle. Almost all patients (≥85%) had CD19+ counts that reached LLN by 6 months following a treatment cycle. NK cells were reduced to a lesser extent than T and B cells, with mean cell counts remaining within the normal range, which may relate to the greater expression of CD52 antigen on T and B lymphocytes as compared to NK cells.

Components of the innate immune system such as neutrophils, monocytes, eosinophils, basophils and natural killer cells were only transiently affected by alemtuzumab.

oral prophylaxis (acyclovir 200 mg BID) for herpes infection was administered 1 month post-treatment. Prophylactic administration of antiviral medication for herpes infection, starting on the first day of each treatment course and continuing for a minimum of one month, was also considered as an appropriate risk minimisation measure

Naive Study
Alemtuzumab was administered by daily i.v. infusions of approximately 2-4 h duration. At Month 0, alemtuzumab was administered IV over 5 consecutive days at a fixed total dose of 60 mg (12 mg/day), and at Month 12, alemtuzumab was administered over 3 consecutive days at a fixed total dose of 36 mg (12 mg/day). Premedication with methylprednisolone (1 g IV) immediately prior to alemtuzumab administration was required on the first 3 days of any treatment cycle. Further to a protocol amendment, all alemtuzumab patients received acyclovir 200 mg twice daily (or a therapeutic equivalent) starting on the first day of each alemtuzumab cycle and continuing for 28 days after the last day.

Alemtuzumab was administered by daily i.v. infusions of approximately 2-4 h duration. At Month 0, alemtuzumab was administered IV over 5 consecutive days at a fixed total dose of 60 mg (12 mg/day), and at Month 12, alemtuzumab was administered over 3 consecutive days at a fixed total dose of 36 mg (12 mg/day). Premedication with methylprednisolone (1 g IV) immediately prior to alemtuzumab administration was required on the first 3 days of any treatment cycle. Further to a protocol amendment, all alemtuzumab patients received acyclovir 200 mg twice daily (or a therapeutic equivalent) starting on the first day of each alemtuzumab cycle and continuing for 28 days after the last day.

Study 324
Initial infusions were given over a period of at least 4 hours. If the first 2 doses of each annual visit were well tolerated, subsequent daily infusions could be given more rapidly, but never over a period of less than 2 hours. If not well tolerated, the infusion period could be extended at the physician’s discretion, but the total infusion period on any day was not to exceed 8 hours. All alemtuzumab-treated patients received IV methylprednisolone (1 g/day) on Days 1, 2 and 3 at Month 0 and 12. Further to a protocol amendment, all alemtuzumab patients received acyclovir 200 mg twice daily (or a therapeutic equivalent) starting on the first day of each alemtuzumab cycle and continuing for 28 days after the last day.

Conclusions
In study CAMMS324, analyses of the EDSS-based endpoints (EDSS change from baseline and sustained reduction in disability) indicated that alemtuzumab treatment might not only reduce the risk of disease progression, but could potentially reverse pre-existing disability.

AEs
Thyroid
No consistent pattern was observed with regards to time of onset after treatment initiation, although the highest incidence of thyroid AEs was observed between 24 and 42 months after the first treatment cycle. Unlike the general trend observed for AEs, i.e. their decrease with the second cycle, there was an increase of AEs in the SOC ‘Endocrine disorders’ (4.6% incidence in Year 1 and 9.0% in Year 2). The observed increase in the incidence of ‘Endocrine Disorders’ at Year 2 was primarily driven by higher incidences of hypothyroidism, hyperthyroidism and Basedow’s disease when compared to Year 1. ‘Endocrine Disorders’ were reported more frequently for females (17.3%) compared to males (5.6%) in the alemtuzumab 12 mg/day group.
ITP
Immune Thrombocytopenic Purpura (ITP)
Over the 2-year follow-up in the active-controlled studies, ITP was reported in 0.9% of patients in the alemtuzumab 12 mg/day group, 2.2% of patients in the alemtuzumab 24 mg/day group and 1.6% patients in the IFNB-1a treatment group. Serious ITP AEs were reported for 0.7% patients in the alemtuzumab 12 mg/day group and 1.5% patients in the alemtuzumab 24 mg/day group; no serious ITP events were reported in IFNB-1a-treated patients (Table 34).
 The events occurred predominantly between 14 and 36 months after the start of alemtuzumab treatment (range 3 to 85 months after the first alemtuzumab dose). With regards to treatment cycles, the first occurrence of ITP was more common after the second treatment cycle.

Nephropathy Including Anti-Glomerular Basement Membrane (anti-GBM) Disease
Cases of nephropathies were reported in 5 (0.4%) patients in the 12 mg/day alemtuzumab dose group (0.3% in the pooled dose group, with no additional cases reported in the 24 mg/day group).The events occurred generally within up to 39 months following the last administration of alemtuzumab. These 5 cases included membranous glomerulonephritis and tubulointerstitial nephritis, glomerulonephritis (reported as anti-GBM glomerulonephritis), Goodpasture’s syndrome (reported as anti-GBM disease) and nephropathy. Both cases of anti-GBM disease were serious, were identified early through clinical and laboratory monitoring and had a positive outcome after treatment.

PML Pg 86

thyroid stimulating hormone levels, should be obtained prior to initiation of treatment and every 3 months thereafter until 48 months following the last infusion. After this period of time, testing should be performed based on clinical findings suggestive of thyroid dysfunction. 

complete blood counts (CBC) with differential should be obtained prior to initiation of treatment and at monthly intervals thereafter until 48 months after the last infusion. If ITP is suspected, a complete blood count should be obtained immediately

monthly urinalysis and serum creatinine monitoring through to 48 months after the last alemtuzumab dose as a marker to detect anti-GBM disease. 

implementation of prophylactic acyclovir during the phase 3 studies (starting on the first day of each alemtuzumab cycle and continuing for 28 days after the last day), the risk of herpes simplex infection was substantially reduced as compared to those who did not receive prophylaxis.

Fungal infections were also reported more frequently in alemtuzumab-treated patients with none of them being systemic. The most common fungal infections were oral candidiasis and vulvovaginal candidiasis.



Testing Required & Recommended Prior to Infusion

Vaccinations

Complete any needed vaccinations at least 6 weeks prior to treatment
If no history of exposure to Chicken Pox, consider Varicella Zoster Vaccine

General Pre-Testing

Complete Blood Count with Differential (showing platelets)
Serum Creatine levels, Liver Function tests (both part of a basic or complete metabolic panel)
TSH- thyroid stimulating hormone
Urinalysis with mycroscopy (to check for infection)
Tests to exclude infection: HIV, Hep A, B & C, Tuberculosis

For Tysabri patients with a positive JCV antibody

MRI- to check for JCV  activation to PML
Lumbar Puncture- some doctors recommend this, others do not

Wednesday, March 26, 2014

Countries approved, not yet infusing

Canada


In the process of setting up national infusion protocols. Those are expected to be finished in May.

France


Will not be infusing until October

Australia


Their pharmacy board has put infusions on hold

Please post here if you have updates to this information.

Where to Get Lemtrada, upated 3/26/14

With the help of many others I have some information on which countries are ready to provide Lemtrada to US patients and at what cost.

Mexico: 

Dr. Macias from Guadalajara will coordinate with Genzyme Mexico to have the drug in 2-3 weeks. Pricing pending

http://www.uag.edu/medicine/contact/


Dr. José Flores Rivera in Mexico City is another resource, he is a neurologist who participated in the CARE MS I and II Clinical Trials: 

 Av. Carlos Graef Fernández No. 154
Col. Tlaxala Santa Fe.
Delegación Cuajimalpa, CP. 05300
México, DF
Centro de Neurología Ortopedia y Rehabilitación
Consultorio 154
phone. 1664-7050 y 1664-7051
email: centroneurologico@abchospital.com


Czech Republic

Prof. Eva Havrdova, MD, PhD

MS Center, Dpt. of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University in Prague, Kateřinska 30, 120 00 Praha 2, Czech Republic Tel. + 420 2 2496 6422
Fax: + 420 2 2491 7907

From Professor Havrdova: "Lemtrada is registered in the Czech Republic, for our patients outside clinical trials it does not have reimbursement yet, therefore it takes some time to bring the product from Netherlands or Germany to my site.We have also one patient on commercial product, this patient has payed for his first five infusions and we administered them."

Cost: The price for the 5 day course of alemtuzumab would be 1366990 CZK, which is today 68675.71 USD.

Medical Tourism help with travel in Czech Republic:
Charlie Wauldbaum: charlie@meditourcz.com
Richard Kvech: richard@medicaltravelczech.com

UK

Dr Richard Nicholas; he's an excellent neurologist and has considerable MS expertise- I have not googled him or communicated with him. His name was given to me by another UK doctor.

Germany



Hannover:

Univ. Prof. Dr. med Martin Stangel
Leiter Abt. Klinische Neuroimmunologie und Neurochemie
Klinik für Neurologie
Medizinische Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Tel.: +49-511-532 6676
Fax: +49-511-532 3115
Email: stangel.martin@mh-hannover.de

Costs: Hospital and Medication fee: 55,000 €, In-patient costs 500 €, a companion can stay with you in the hospital for an additional 500 €

Bonn: 

Marcus Müller 
email: marcus_m.mueller@ukb.uni-bonn.de

Dresden: 

Prof. Dr. med. Tjalf Ziemssen
Professur für klinische Neurowissenschaften

E-Mail: Tjalf.Ziemssen@uniklinikum-dresden.de
Postadresse: Fetscherstr. 74, 01307 Dresden
Besuchsadresse: Blasewitzer Str. 43, 2. Etage (Haus 111, Abakusgebäude)
eFAX: +49 351 449 210 005

Sekretariat (Frau Ines Wolf)
Tel.: +49-351-458-4465
FAX: +49-351-458-5717

Zentrum für klinische Neurowissenschaften
Neurologische Klinik und Poliklinik
Universitätsklinikum Carl Gustav Carus
an der Technischen Universität Dresden
Anstalt des öffentlichen Rechts des Freistaates Sachsen
Fetscherstraße 74, 01307 Dresden
http://www.uniklinikum-dresden.de <http://www.uniklinikum-dresden.de/>

Cost:  53.000 € the out-patient visits and infusion would be 600 € in addition.
For an in-patient stay + spouse/friend stays with you in hospital 60,000 €

Sunday, March 23, 2014

Welcome to My Lemtrada Experience

In this blog, I hope to share my experience with Lemtrada with other people living with MS and the people who love and care about them. 

I want to thank "David" in the UK for sharing his Campath story over these past 10+ years. David your site has served to educate and provide hope for those of us waiting for the research and trials to be complete. Your account provides an invaluable glimpse into the world of Lemtrada from a patient's point of view- a rare gift and we all thank you for the time you took to catalog your journey.

In April I will travel to Dresden Germany to receive Lemtrada. Coming to this decision was not easy. Lemtrada has a lot of promise but also some significant side effects. I want to thank all of the thousands of MS patients world-wide who participated in the various clinical trails- your bravery lead to breakthroughs in this new treatment- in what dosage to use, what labs to monitor, what side effects to anticipate and ultimately the approval of this treatment in many countries around the world. 

In the coming days and months I hope to add an update to David's Campath Story with my own experience of receiving Lemtrada in 2014. I hope this information is useful to patients considering this treatment.