4AP Anyone?

[LaMemChose]

Is anyone here taking 4AP? I have heard good things about it for SCI. I understand it is used primarily for MS, but also for SCI.

Pros and cons? I want to ask my doctor for a prescription for this next week.

I understand it is considered experimental so insurance will not pay for it. If you take 4AP, what are your costs per month? I've heard it's around $110 for a 30 day supply. What is your dosage?

If you took it and stopped, why?

TIA for any info.

Mem :)

[crazyskiier83]

I started taking 4AP to see if it had any positive effects on sensation or movement, and also possibly decrease spasms. I actually took it for about a year before I realized that it wasn't having much effect. At that point I backed off, and I still haven't noticed any difference.

[krajaxa]

Same thing here with hubby. He has taken it on two different occasions, then found out that it didn't do anything for him, first time it seemed to decrease his pain but then he found out it was something else. Second time he was off Neurontin and thought he would give it a shot to see what happens. He didn't notice any difference in motor or sensory... so he quit.

Good luck to ya!!!

krajaxa

[dan_nc]

what's the typical dosage and how much does it cost per month?

[LaMemChose]

Since posting this, I talked to a friend. He says he took 4AP for about six months post SCI, had increased sensation, but no functional return. The cost? Around $200 a month. He stopped taking it as 4AP caused major diarrhea.

He says he started slowly with 5 mg and slowly ramped it up per his doc's direction ... 5 mg per day with an weekly increase of 5 mg to a total of 80 mg per day.

Even with the difficulties he had, I want to give it a go. I'm hoping for increased sensation without gastrointestinal distress. If my doc says, "Yes!" I'll let you know how it goes.

[anty]

maryellen i have been on 4-AP for a year now. I think it works great for me. Everyone is different. I pay 80 dollars a month for it. I take 10MG-3 times a day. I tried to take i extra dose a day but it did not agree with me. I get more strength to do my therapy, i got extra sensations,etc. any questions PM ME anty :)

[IanTPoulter]

Could anyone tell me please, is the extra function some people are getting from taking this medication primarily bladder and bowel function?

[cheesecake]

I have a friend who participated in the clinical trial. At the end, she was told that infact she did receive 4-AP. If you want to talk to her, I can connect the two of you. Please send me a PT. My friend is almost 20 yrs post injury, incomplete C5/6 quad who did well on the 4-AP.

[Wise Young]

Could anyone tell me please, is the extra function some people are getting from taking this medication primarily bladder and bowel function?

Ian, the effect of 4-aminopyridine varies a great deal depending on what connections the person has and whether demyelination is present. Presumably, the main effect of 4-AP is improved conduction of demyelinated axons. It is one of the reasons why it has been so difficult to get statistically significant results on clinical trials of 4-AP in spinal cord injury. About a third of people will benefit from 4-AP and many of these peopl will have different effects on different systems. Some people have improved sensation, some will have improved motor function, some will have better bowel and bladder control, some have had better sexual function, and many may have no improvement at all.

Wise.

[Solan]

Ian, the effect of 4-aminopyridine varies a great deal depending on what connections the person has and whether demyelination is present. Presumably, the main effect of 4-AP is improved conduction of demyelinated axons. It is one of the reasons why it has been so difficult to get statistically significant results on clinical trials of 4-AP in spinal cord injury. About a third of people will benefit from 4-AP and many of these peopl will have different effects on different systems. Some people have improved sensation, some will have improved motor function, some will have better bowel and bladder control, some have had better sexual function, and many may have no improvement at all.

Wise.

What about side effects? What are they?

[LaMemChose]

So far, I've talked with two people from CC on the phone who have taken/take 4AP. I have one more phone call with another CC member familiar with 4AP and a doctor's appointment on March 20th. I'm going for it.

I'll keep you posted.

[jb]

does it interact w/zoloft?

[SCI-Nurse]

I would suggest reading Dr. Young's article about 4-AP and SCI.

http://carecure.org/index.php?page=viewarticle&afile=5_September_2005@4aminopyridine.htm

I believe about 30 mg. is the suggested maximum daily dose. 80 mg. daily is a huge dose. I would be surprised that diarrhea was your only side effect at that dose.

(KLD)

[singin_intherain]

I take it compounded with an eight our sustainer, and have found the quality of the sustainer really affects my degree of side effecfts--never anything serious but a sort of buzzing feeling in my face, a sort of over caffeinated feeling, tingling around my lips. No bowel effects at all for me. I started with 5mg 3x's a day and now take 20am+20pm+15 at bedtime.

The good effects are very subtle, nothing earth shattering, but the subtle differences put me on the positive isde of very big functional lines. The effect for me is better motor control in my ankles; clonus, spasms and tone are still terrible (but I don't think they're due to demyelination). I think it might actually make my vision worse, tied to the more hyped feeling in my head. Like I said, a new sustainer really made a difference and i barely notice the side effecds now. And I am super sensitive so the side effects may well be less for others. But if you're going to take it straight, not time released, I definitely would start low (maybe 2.5 mg even) and frequent (4-6 times/day), to avoid the spike and see how you react to it. If you feel bad, ask your (compounding) pharmacist to make it sustained release; PM me if you want me to ask mine the new sustainer he switched to that we both like more.

My insurance covers compounds and covers it; about $150-170 for 120 10mg capsules. And I think Wise has said the outlook is good for FDA approval for it to be marketed as a non-compound that insurance will cover sometime this year, and likely to have even a better sustained affect.

I don't fear taking too much like it would hurt me or anything, only at worst make me not feel so good for a few hours. You may want to avoid driving and stuff until you see how it effects you. In my experience it is definitely worth a try.

If you don't have a local compounding pharmacy, contact any one; I've never used one that won't ship to me. They're just one of many, but College pharmacy in CO does a lot of 4-AP and will ship anywhere:
(800) 888-9358

Good luck Mem! Please do keep us posted.

[Wise Young]

What about side effects? What are they?

Solan,

Fampridine or 4-aminopyridine (4-AP) has a variety of side-effects. Let me first describe the mechanism of 4-aminopyridine and perhaps the various potential complications of the drug will become understandable.

4-AP blocks the fast voltage-sensitive potassium channel. The fast voltage sensitive potassium (K) channel is responsible for limiting the duration of action potentials, the signals that nerves and muscles use to create excitation of the cells to conduct signals and to move muscles, including smooth muscle of the heart and blood vessels. By blocking the channel, 4-AP increases the duration of action potentials, resulting in better ability of action potentials to traverse demyelinated portions of the axons. It also increases the amount of neurotransmitters that are released per action potential that arrives at the end of the axons. So, 4-AP increases excitability of neurons. However, we should remember that not all axons and neurons are excitatory. Some are inhibitory and so 4-AP increases both excitation and inhibition simultaneously.
This balances the effects of 4-AP in the nervous system and its effect on peripheral organs such as muscle, heart, and smooth muscle of blood vessels.

The dose of 4-AP that is being recommended for "immediate-release" formulations is 10 mg four times a day. At these doses, the drug causes some increased excitability of the nervous system. The body accomodates to the drug over several days and side-effects such as sleeplessness, a buzzing feeling in the fingers and lips, increased heart rate, and feelings of nervousness tend to subside. That is why, it is recommended that the drug be taken in 5 mg doses at the beginning and gradually ramped up over a period of 2 weeks.

Overdoses of 4-AP are dangerous. This is because it can cause seizures and increased excitability of the heart and sympathetic nervous system. At doses of 10 mg four times a day, overdose should not happen. However, in people with urinary tract infections, clearance of the drug may slow down and the drug may accumulate to dangerously high levels. People who have a history of seizure activity should be particularly careful in making sure that they do not get overdoses of the drug. It can cause a condition called "status epilepticus" where the seizure continues for many minutes or even hours. Because of these potential complications, it is essential that the drug be taken under the supervision of an experienced physician who can admit the patient to the hospital for anti-seizure therapies.

The dose of 4-AP also varies depending on the formulation. At the present, there are two or three formulations being offered by compounding pharmacies. One is the immediate-release formulation which is just the drug put into capsules with some filler material. The other is timed release. The third are slow-release formulation made by mixing the drug with material that slow down its absorption, reducing the speed and amount of drug that is absorbed. Because of this, the dosing of so-called timed or slow release drugs often require higher amounts of the drug.

Acorda Therapeutics developed a formulation called sustained release which allows higher doses of the drug to be taken twice a day, up to 40 mg twice a day. This formulation allows sustained levels of the drug without the peak levels that cause the complications mentioned above. Fampridine SR is not yet approved and therefore not available yet but hopefully current clinical trials of the Fampridine SR for multiple scleroris turn out to be positive and the FDA approves of the drug, it should be prescribable by physicians. It should significantly reduce the side-effects of the drug. In the meantime, people can get 4-AP from compounding pharmacies, either the immediate release or the time-release formulations.

By the way, if one goes off the drug suddenly, it can cause cause some side-effects as well. Some people have increased spasticity and also feel tired and fatigued, because their bodies have gotten use to the drug. Thus, it is recommended that people ramp off the drug rather than going cold-turkey. Ramping up and down is a good idea for other neuroactive drugs as well, if one wants to reduce the side-effects.

Ramping up of the immediate formulation is relatively straightforward. Because the drug usually comes only in 5 or 10 mg capsules, the ramping up and down of the drug is relatively simple. You start by taking 5 mg per day, go to 5 mg twice a day, 5 mg three times a day, and 5 mg four times day. Then you substitute a 10 mg for one of the 5 mg. You keep substituting 10 mg until you achieve 10 mg four times a day. If you have an side-effects during the period, you should of course not go up to the next higher dose until the side-effects subside.

Wise.

[Solan]

Dr.Young,
Thank you for the info. I've never heard about this drug in Norway. Not even sure if the doctors can even subscribe it. I'm gonna check with my doctor at the hospital to see if this is something I can try out.

[TINAMARIE]

I have been taking 4ap for a little over a month now. I take 30 mg of the immediate release formula. Two - 5mg pills three times a day. One month supply cost me $62.99 from a compounding pharmacy. I ramped up the dosage over about 2 weeks, but even for another week or so after that it made me kind of shakey and I felt as if I was learning to walk in high heels all over again. I THINK it might have been because it gave me more feeling in my right foot and I was getting feedback that I wasn't used to. It does give me more sensation and I can straighten the fingers on my right hand more than normal (its normally at a C7 level). As for mobility, the results are not consistant. Some days I can walk with only a trace of a limp and other days there isn't much difference. At times it does increase spasms not only in my weaker right side, but throughout my whole body-which doesn't usually happen. It has improved my bowel program - I have bms more often and with less time spent. It has not done anything for my bladder though.

I haven't fully been convinced one way or the other yet, so I will continue to take it and see what happens. Hopefully the longer I take it the more consistant the results will be.

[Sally's Mom]

Tinamarie,
Ask your pharmacy for 10 mg capsules next time your presciption is refilled. It should be cheaper that way. When Sally switched to 10 mg. we saved about 25%!

Sandi

[nevada]

I was taking 4AP during the Phase II and Phase III studies when Acorda was trying to get it approved for SCI use here is a list of the things that I found changed while on the drug

Well it has been two months now that I have been on the Phase IV study. I am a C6/7 incomplete two years post as of yesterday April 20th some of the changes that have occurred are as follows

1 Daily bowel movement taking no longer than 10 minutes using only minimal digital stimulation. Anal sphincter muscle is as tight as a vice the last three weeks

2 No accidental urination or leakage at all. Nighttime cathing has been reduced

3 Increased sensation in my buttocks to the point that sitting in the chair for a eight hour day of work causes me to be unable to find a comfortable position the last hour or so of work.

4 Increase of warmth feeling to touch of the skin in my lower body. This feeling stops at my knees at the present time.

5 Nighttime erections, which I never had prior to the study.

6. Sleeping better at night

7. A muscle score of three in my ankles and toes were there was none previously. Trace of movement in my Quads, hip flexors, and hip extensors.

8. Increase in distance and reduction of time in my brace-walking endeavor


Now the cons as I see them

1 Increase in sensation has been a double-edged sword so to speak

2 Increase in naturopathic pain at my elbows to the point some nights that even the sheet touching them causes me to grimace


3 Itching of my hands and elbows that I can scratch until the cows come home and find little if any relieve. This is mostly early in the morning.

I will keep on posting as each month goes by

[gvinton]

I took 4AP back in 2003. Here's a link to my experiences:

http://carecure.org/forum/showthread.php?t=6125

[woman from Europe]

Dr.Young,
Thank you for the info. I've never heard about this drug in Norway. Not even sure if the doctors can even subscribe it. I'm gonna check with my doctor at the hospital to see if this is something I can try out.

I have asked the doctors at Sunnaas and at Ullevål about it but they have never heard about it when it comes to SCI. It has been used on people on MS but not anymore because the doctors thought it did not have any effect.

I am still trying to find out, I am going to Sunnaas in April and then I hope I can speak to Hjeltnes. Dr.Wise did speak with him in August and I got an appointment with him this spring because of this meeting.

[TINAMARIE]

Tinamarie,
Ask your pharmacy for 10 mg capsules next time your presciption is refilled. It should be cheaper that way. When Sally switched to 10 mg. we saved about 25%!

Sandi

Would I be able to request 10mg pills even though the scrip is written for 5mg pills? Or would I need to get a new prescription from the dr?

Also, is anyone else having inconsistant results from it? I can't figure out why I am.

[Solan]

I have asked the doctors at Sunnaas and at Ullevål about it but they have never heard about it when it comes to SCI. It has been used on people on MS but not anymore because the doctors thought it did not have any effect.

I am still trying to find out, I am going to Sunnaas in April and then I hope I can speak to Hjeltnes. Dr.Wise did speak with him in August and I got an appointment with him this spring because of this meeting.

Okey, I'm going up to St.Olav this spring to the spinal unit there and I will ask the specialists up there about the drug. Let you know how it goes.

[Sally's Mom]

Tinamarie,
I believe our pharmacy (mixtures pharmacy in Phoenix) called the doc to make the switch.

It does take time for your body to adjust to 4-AP. Your inconsistent results may be due to this adjustment period and you eventually will find your own best dose. Sally ramped up to 40 mg a day. However, we realized she was getting the same results using only 20 mg. Some people take much more, but apparently, one needs to (carefully) use the trial and error method to find the optimum dose.

Sandi