Generic capsules for Biogen's Tecfidera Dimethyl Fumarate

Lupin gets USFDA approval for manufacturing generic capsules for Biogen's Tecfidera Capsules.

Dimethyl Fumarate is known under the name of Tecfidera patented by Biogen Inc. The drug is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 

Lupil company has received the tentative approval from USFDA to market generic version of Tecfidera to market in strengths of 120mg and 240mg.

New hope for MS patients having trouble with tremors

With new research on Focused ultrasound lesion surgery the clinical trial is promising for Multiple Sclerosis patients suffering tremors.

It is said that managing tremors among MS patients is difficult and it is categorized as intentional tremors. Whereas a tremor among Parkinson patient is known as unintentional tremor, these kind of tremors are seen while the patient is at rest. Fortunately unintentional tremors to some extent are can be treated and cured to lead a good life.

But tremors felt by MS patients are difficult to treat as it is intentional tremors. The patient suffers tremor while intending to do the job, for example trying to use a spoon or inserting a key into a key hole.

One of the risky procedure to manage serious tremors in MS patients now is perform Deep brain stimulation (DBS), this is considered a life threatening and can cause serious damage to brain nerves while performing the surgery in brain. Procedure involves implantation of medical device called neurostimulator which sends electrical impulses to manage the tremors.

Now the good news is with the research happening positive on Focused ultrasound lesion surgery on clinical trials done, it is promising.

The procedure is not as complicated it will be MRI guided focused ultrasound intervention for the treatment of the tremor.

Teriflunomide tablets to be marketed by Zydus Cadila in India

Zydus Cadila of India has received final approval to market Teriflunomide tablets from United States of Food and Drug Association (USFDA).

India pricing of Teriflunomide tablets is still not known. Though the market is now available with generic tablets for MS relapsing such as Teru MS 14mg and 7mg. We need to wait and see the tablet form Zydus Cadila for pricing.

Teriflunomide tablets is used to treat relapsing forms of multiple sclerosis (MS). However the tablets is not a cure for MS, it will work in decreasing certain immune system cells which could attack the nerve in brain and spinal cord. It will help in decreasing the number of relapses and help to slow down physical problems caused by multiple sclerosis.

Surprisingly Bone Marrow Transplantation is happening in India for MS - Should we take a chance?

As part of visiting hospitals for regular checkups and talk with Neurologist for my MS, i actively read the internet for any hope on Multiple Sclerosis.

One of the press release of Fortis hospital has caught my eye for performing Bone Marrow Transplantation (BMT) and they claim to have done more than 100 cases. It really good to hear this positive advancement to control Multiple Sclerosis and give MS patients a good life.

Fortis hospital doctors say that clinical processes only helps in the slow progression of diesease and not stop the myelin attack. 

According to Dr Rahul Bhargava said, “The reason for multiple sclerosis remains an enigma. The clinical processes only help slow the progression of the disease and do not offer a sure shot cure. In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body’s immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy.  After the surgery, the patient is kept under isolation for a few months to ensure they do not contract any infection.”

I am have moved from Primary to Secondary Progressive Multiple Scelorosis, i am not sure if Bone Marrow Transplantation will be of any help.

Please leave your comment. Great if any one can provide confidence to go for Bone marrow transplantation (BMT) in India.

Is it safe to have Natalizumab (Tysabri) or Ocrelizumab (Ocrevus) while you are tested JC Virus positive?

I had to under go the JC virus antibody test for CSF and Serum and found that i am JC virus positive. While my neurologist are evaluating my risk for undergoing the next level of treatment with Natalizumab (Tysabri) or Ocrelizumab (Ocrevus), i wanted to understand from other MS patients who are on these treatments.

I have heard a lot and seen video testimonials of patients going through Tysabri infusions and saying that they feel better. Also few of them are JC virus positive who are at risk of getting the PML (Progressive multifocal leukoencephalopathy) a rare disorder and fatal disease that affects the brain.

My understanding of breaking this medical acronym of PML is:

Progressive - Self understanding as Progressive

Multifocal - Lesions at multiple places in brain

Leuko - White matter of the brain

Encephalopathy - Disorder

When we visit these companies official websites the main page pops up with patient risk assessment. The information clearly mentions that MS patients who are undergoing treatment on Tysabri must be closely monitored for PML disease very often.

Let us understand how do we evaluate a patient before prescribing Tysabri:

1) He or she must undergo for JC Virus test (More information on this below). Few test to confirm are: JC Virus antibody, JC virus serum, IgG index values.

2) If you are JC virus positive, then the chances of getting PML disease is 1:1000 patients (Not sure from where this data is captured or mentioned in company website. Are they updating this regularly)

3) If you are JC virus negative, then the chances of getting PML disease is 1:10000 patients (But you cannot be happy that you are tested negative, you can get this virus anytime). So again you need to get tested every 6 months.

4) You cannot take Tysabri for life long like interferons (e.g Avonex). The company Biogen says it can be taken for 2 years safely, then every 6 months you must test JC virus activity in your body. Depending on the pros and cons the neurologist will decide whether to continue Tysabri or move on to some other disease modifying therapies.

More information about JC Virus:

JC Virus is present in most of the human population (approximately 90%). While this virus is harmless among people having good immunity (Majority of the population, except few MS patients) it is harmful among people having suppressed immunity. 

MS patients immunity is compromised since we have to undergo disease modifying therapies such as interferons and immuno suppressants. While you are on these therapies (Further adding Tysabri) your immunity is less and those people who are JC Virus positive tend to get PML since JC virus is main cause of it. JC Virus enters the blood brain barrier and affects the white matter.

It will be interesting to know from others real time experience and their confidence on taking Tysabri who are currently tested positive for JC Virus.

Can Biotin do the magic of Remyelination in Multiple Sclerosis?

While i have stopped injecting myself with Avonex weekly once till further evaluation is done for next DMT for multiple sclerosis, my neurologist feels that i should take Biotin tablets.

In my case i have lot of demyelination in CNS and brain. When we have lot of lesions around the brain the cells require lot of energy to perform simple activities. In simple ways, when we perform work such as walking the lesions flare up leading to fatigue and weakness.

Large doses of Biotin can help in increase in energy levels and to repair the myelin. 

Currently i am on 150 mg of biotin daily and going on for a week . So far i have not felt any change that i can appreciate. But the current research and clinical trials on Biotin for Multiple Sclerosis is promising.

I hope by continuing Biotin for few more days, i should positively note some good effect on my fatigue and imbalance. This will happen if my remyelination happens and that will be wonderful.

Currently Biotin is marketed as beauty and health vitamin tablets to help grow hair and getting a glowing skin.

Hope biotin will be a inner healer of damaged brain nerves for MS patients and for others it will be external factor of growing hair and beauty. Anyways if it happens it is beauty inner side and outer side. :-)

Stopped Avonex, Next Evaluation for Natalizumab and Ocrelizumab

As i had written in my previous post, I am having a tough time with fatigue and weakness in both limbs. I was admitted for a week and administered Methylprednisolone iv for 5 days.

Though my MRI does not show any new lesions since 2016, my walking, imbalance and tremors are not stable. It is getting worsen day by day. Apart from this I also had my part of UTI and low hemoglobin levels to add to it.

Had few antibiotics for UTI and iron shots for getting my hemoglobin levels to the range. Still my hemoglobin levels (10.3) are not anywhere near 13 normal range.

Coming to keep my Multiple Sclerosis in control, my neurologist was evaluating me for Natalizumab (Tysabri) or Ocrelizumab (Ocrevus). Before starting any of these, I need to perform few tests as below.

JC virus anti body, JC virus CSF (Cerebro Spinal Fluid) & JC virus serum.

I was thinking at least I will be lucky to be JC virus negative, but as feared I turned out be JC virus positive. Though I am not able to make sense about the pathological reports that has 34.50 ml/copies of JC virus found. Not sure whether it is good amount of JC virus present or less.

Anyways my hope for going to Natalizumab or Ocrelizumab started fading since these results are out. My doctor informed me that there is a huge risk of getting PML (Progressive multifocal leukoencephalopathy) which is fatal viral disease.

Mutiple Sclerosis patients testing positive for JC virus are at huge risk if they are on Natalizumab / Ocrelizumab  as they can be infected by PML.

So I am currently still under evaluation whether to go for these medications. My next appointment falls next month. Till then i am off from Avonex, since 2009.

Keeping my fingers crossed to know my next step of medications to keep my MS in control.

Avonex Beta interferon not working after 9 years.

As informed earlier, I have been living with Multiple Sclerosis since 2009. It was only my initial 1-2 months i was on Methylprednisolone, Solumedrol on IV. After which I showed signs of weakness in limbs and difficulty in walking.

Soon i was put on Avonex beta interferon weekly injection since 2009. Gradually my walking distance reduced. This was followed by walking with support, holding some ones hand and reaching out to walls. My movement was restricted inside the house. Regular MRI’s were done for evaluating new lesions or enhancing lesions. All my lesions were inactive and new ones were not appearing in the brain.

My neurologist advised me to take a break from Avonex as my condition are stable clinically as there are no new findings in MRI. This was a biggest mistake that had to happen ever. I had serious problems on the third month of absenting Avonex, experienced vertical tremors while getting up, unable to walk without support, vision problems with more hand tremors.

I was immediately hospitalized and administered 5 day course of Methylprednisolone Solumedrol through IV. Followed by Omnacortil 10mg orally for 2 weeks after my discharge from hospital. Then again from 2014, after a gap of 3 months i am on Avonex weekly.

Now after 9 years on Avonex, my conditions are not any better as my walking, tremor has not been any better. Avonex just made more holes in my wallet. My neurologist has given me two options Natalizumab and Rituximab.

Please let me know fellow MSers if any of you are undergoing treatment with Natalizumab or Rituximab. Your experience will be of great help and support.

Walking again after ten years with Multiple Sclerosis

This is really fantastic news and happy to find out that someone who was with Multiple Sclerosis was able to get back on his legs after ten years.

The recent research and development on Relapsing Multiple sclerosis has opened up new frontiers. Roy Palmer, 49 was diagnosed with Multiple Sclerosis ten years back. He and his doctor decided to go for HSCT (Hematopoietic stem cell transplantation) in the United Kingdom.

During the HSCT the patient’s stem cell is removed, frozen and stored. While this is being done. Removing a healthy stem cell is done from our own spinal cord, or if you have healthy sibling or going for a donor of stem cell.

Roy Palmer stem cell was harvested from the spinal cord and had to go through several rounds of Chemotherapy. This is done to bring down your immune system and to kill the unhealthy cells.

Precaution need to taken while your immune system is down, since even a small infection can prove to be fatal. Once the chemotherapy session is done, the healthy stem cell is transplanted again back to our human body.

HSCT (Hematopoietic stem cell transplantation) has proved to be very effective in case of Roy Palmer as today he is able to walk without any support.

The whole Multiple Sclerosis group and foundation is very happy on this break through treatment.

Does Avonex suppress the immune system and bring down your hemoglobin levels?

Avonex claims that it is not an immunity suppressant and it is an immunity modulator. But while you are on a long time therapy of Avonex beta interferons it brings down the immunity and infection fighting capability of the patient.

The most common infection Multiple Sclerosis patients suffer is Urinary tract infection due to less immunity. Bacteria thrives in the Urinary track and affects the bladder. Suppressed immunity creates less hemoglobin levels and RBC count. This leads to iron deficiency among the Multiple Sclerosis patients.

It is very much important to do the urine and blood routine among the MS patients. Also it is a good health check to get the liver function test (LFT) and  test among the  Serum glutamic pyruvic transaminase (SGPT) test among the MS patients to fing out if there has been a damage done on long time therapy of Avonex beta interferon injections.

Dalfampridine for Multiple Sclerosis

Dalfampridine is a drug used to improve imbalance and walking among multiple sclerosis.

Ampyra was the first approved branded oral tablet for Dalfampridine. Now recently from 2018 onwards USFDA approved Dalstep Dalfampridine 10mg extended release tablets are available from Sun Pharmaceuticals Pvt Ltd.

What is Dalfampridine?

Dalfampridine is a potassium channel blocker used to help multiple sclerosis patients to improve body imbalance and help in walking.

How does Dalfampridine work?

In multiple sclerosis the nerves are progressively demyelinated which exposes potassium channels. Due to this there is a leak of potassium which results in distortion of signals throughout the nerves. This results delay in signals and impairment of neuromuscular transmission.

Dalfampridine inhibits voltage-gated potassium channels in the Central Nerves System to maintain the transmembrane potential and prolong action potential. In simple language, dalfampridine works to make sure that the signal available is high enough to stimulate conduction in demyelinated nerves that are exposed in MS patients.

Is there a generic drug for Ampyra?

Yes, USFDA approved Dalstep Dalfampridine 10mg Extended Release tablets are now available as generic drug for Ampyra.

Dalfampridine Generic Drug Dalstep 10mg

Complete tiredness, legs paralyzed bedridden due to Multiple Sclerosis

Complete tiredness and fatigue. I have started feeling these symptoms happening with me for more often nowadays. Not able to move my legs really feel I am totally down.

These symptoms were usually experienced by me only after my weekly Avonex injection beta interferon. Next day of my injection I am kind of bedridden. Unable to walk or move my legs. I need support to more around my home.

Once I am administered avonex injection it has become habitual to go for Dolo 650 to bring down my fever that is caused by beta interferons. At times I need to continue medicine for fever the next day too.

When I am on Dolo 650 my muscles get relaxed and able to move around with less support. The tiredness nowadays hits from the second half of the day.

I have been told to go for blood routine test to find out if the cause of tiredness is something else.

Dalfampridine (Ampyra) Drug information available in India

Dalfampridine is a generic name for potassium blocker channel. This ingredient helps Multiple Sclerosis patients to improve imbalance and help them in walking.

Ampyra is the branded drug but now USFDA approved generic version of Dalfampridine (Ampyra) is now available as Dalstep 10mg Dalfampridine.

How does Dalfampridine work?

In healthy human body the electric signals pass through the nervous system to brain. As we all know that Multiple Sclerosis patients have lesions in their brain these electric signals do not reach on time or loose few signals before it reaches. Signals are basically set of commands sent by brain for doing some activities like walking and talking. These signals are in the form of potassium; hence they escape before arriving at their destination.

Dalfampridine helps in binding these signals and blocks the potassium and tries to rebuild the signals to reach the destination.

Is a generic version of Dalfampridine (Ampyra) available?

Yes the generic version of Dalfampridine is now available as Dalstep 10mg Dalfampridine.

First USFDA approved Generic drug for Ampyra is now available

A much awaited generic version of Ampyra is now available and it is developed by Sun Pharmaceuticals. The copy of Ampyra is known as Dalstep 10mg it is a USFDA approved drug Dalfampridine Extended Release Tablets.

It has been a long wait for Multiple sclerosis patients to get the generic medicine of Ampyra since it was very costly and mostly not covered by insurance companies.

The composition of Dalstep 10mg and Ampyra are same.

Dalstep 10mg is taken orally twice daily before food or after food. Dalstep 10mg helps MS patients in improving walking and imbalance.

What is Multiple Sclerosis? Living with MS

In simple language multiple sclerosis is an immune disease affecting the brain and central nerves system. Whenever an attack occurs it causes demyelination in those regions which affects the signals that pass through the human body. Once these nerves are demyelinated they leave a permanent scar in that specific regions. For e.g Cerebellum and so on. These scars are also called as lesions.

Depending upon the presence of these lesions people may have trouble living with Multiple Sclerosis. Some of the most common trouble living with MS are Muscle weakness, blurred vision, difficulty in moving; difficulties with coordination and balance (ataxia); problems with speech or swallowing, visual problems or double vision, feeling tired, bladder and bowel difficulties.

Generic drug for Ampyra, DALSTEP 10mg

It’s been a long time and search for the release of generic alternative drug for Ampyra.

Ampyra Dalfampridine is a patented drug for improving walking and imbalance among Multiple Sclerosis patients. It is available at a huge cost and mostly unaffordable if not covered by insurance.

To the big relief of Multiple Sclerosis patients now Sun Pharmaceutical Industries Ltd has started developing and made DALSTEP 10mg which is a copy of Ampyra Dalfampridine.

DALSTEP 10mg is now available in india with neurologist prescription. Most of the neurologists are still not aware of this generic drug alternative of Ampyra.

The composition and contents of DALSTEP 10mg is same as Ampyra Dalfampridine.

It is advised to have DALSTEP 10mg twice daily.

DALSTEP 10mg DALFAMPRIDINE contains 10 tablets by Sun Pharmaceuticals Ltd. Currently the drug cost around Indian Rupees 380/-

Reference image of DALSTEP 10mg DALFAMPRIDINE

Trouble walking with Multiple Sclerosis

Multiple Sclerosis is known to create walking trouble among MS patients. Few are lucky enough to be stable with their brain lesions and few unlucky have MS progressing throughout.

As Multiple sclerosis progresses the immune system attacks the nerves system and leaves the lesions. This become scars for life time, hence it is called as Multiple Sclerosis. 

Walking trouble is common among MS patients as they have several lesions in cerebellum. We humans walk, run and do our daily activities which are set of commands or signals passed by nerves system to brain. While MS patients have these scars or lesions in the brain it fails to capture these signals on time and hence they have difficulty in doing these activities.

Depending on which area the lesions are found it affects the Multiple Sclerosis patients. 

For e.g, a Multiple Sclerosis patient having lesions in Cerebellum will experience trouble in walking and keeping the posture correct. May experience dragging, swinging of foot and vertical tremors while getting up from chair.

Ampyra in India

Dalfampridine Ampyra is now available in India for Symptomatic management of Multiple Sclerosis.

The long wait for developing generic drug of Ampyra is being done by Sun Pharmaceuticals. The generic drug is called DALSTEP DALFAMPRIDINE 10mg Extended Release Tablets.

Dalfampridine Dalstep Extended Release Tablet

Dalstep Dalfampridine is now available in Indian medical stores, it costs around Rs.380/- for a strip.

Dosage: Dalstep 10mg is given twice daily for better coordination and improving imbalance. Please consult your neurologist for the prescription and right dosage. Advised to gradually increase from half tablet to one tablet in a weeks time.

DALFAMPRIDINE DALSTEP 10mg drug information

Dalfampridine Dalstep 10mg Extended Release Tablets

The First USFDA approved NEURO FUNCTIONAL MODIFIER to improve walking impairment in all types of Multiple Sclerosis.

Dalfampridine Dalstep 10mg is a new drug now available in India for managing the symptoms of Multiple Sclerosis. Significantly improves walking speed and restores functionality.

Better Pharmacokinetics

• Rapidly and completely absorbed from GIT
• 96% relative bioavailability
• Lower plasma protein binding (1-3%)
• Longer half life (6.4 hrs) & lower peak serum levels
• No interaction with CYP450 enzymes
• No drug interactions with commonly Rxed and Interferons

Dalfampridine DALSTEP Extended Release Tablet

Dalfampridine Ampyra available in India

Dalfampridine Ampyra a patented drug for Multiple Sclerosis is now available in India. The generic medicine is now marketed by Sun Pharmaceutical India under the brand name "DALFAMPRIDINE DALSTEP 10mg Extended Release Tablets".

One strip of Dalfampridine Dalstep 10mg cost around Rs.380/- only. Works out to Rs.38 for each tablet.

Its a big win for Sun Pharma to develop this generic medicine DALSTEP 10mg as it affordable for the needy patients suffering from MS as compared to Ampyra in the USA.

Dalfampridine Dalstep 10mg Extended Release Tablets

DALFAMPRIDINE DALSTEP from Sun Pharmaceuticals India

Dalfampridine Dalstep 10mg Extended Release Tablets are now available in India. Dalfampridine is sold under brand name as "Dalstep" by Sun Pharmaceuticals Pvt Ltd, India.

Dalstep Dalfampridine 10mg Extended release tablets now in India

DALFAMPRIDINE a potassium blocker drug that significantly improves stability among Multiple Sclerosis patients is now available in India.

DALSTEP DALFAMPRIDINE is developed by Sun Pharmaceuticals India and is now available in all leading medical stores. Now there is no need of getting the medicine from USA.

Please speak to your neurologist and get the prescription for DALSTEP DALFAMPRIDINE 10mg,

DALSTEP is a 10mg extended release tablets given twice daily for Multiple Sclerosis patients.

Significant improvements in walking were demonstrated in patients:

• With all 4 major types of MS
• With ages ranging from 25 to 73 years
• With or without use of disease modifying therapies
• With EDSS scores ranging from 2.5 to 6.5

Greater improvements in walking endurance, balance, hand function, verbal fluency & upper limb disability.

Significantly improves visual function, cognition, mood & reduces fatigue in patients with Multiple Sclerosis
Better pharmacokinetic profile & maximum recommended dosage is 10mg twice daily.

DALSTEP DALFAMPRIDINE is now available in India at a cost of Rs.380/- for 10 tablets. The drug is developed and marketed by Sun Pharmaceuticals India.

Information about Dalstep Dalfampridine 10mg Extended Release tablets.

Dalstep Dalfampridine uses
Dalstep Dalfampridine 10mg is used for multiple sclerosis (MS). It helps to improve walking ability and walking speed in people with multiple sclerosis.

How Dalstep Dalfampridine works
Dalfampridine is a potassium channel blocker. It works by strengthening the communication between nerves and muscles. This results in improved muscle activity – in this case, walking – in people with multiple sclerosis.

Common side effects of Dalstep Dalfampridine

Urinary tract infection, Sleep disturbance, Dizziness, Headache, Nausea, Weakness, Back pain, Balance disorder (loss of balance), Paresthesia (tingling or pricking sensation), Throat irritation, Nasal irritation, Constipation, Indigestion, Throat pain