report on SCIG - from Dale

[Guest guest]

from Dale, Mom to Katy, CVID age 16

This is the report from the focus forum held at the recent IDF meeting

concerning Sub-Cutaneous IgG infusions or (SCIG).

Now, let's qualify this before we even start. I am JUST a MOM! And this

was just a discussion forum to give some feedback to the industries as to

whether this is a procedure to pursue or not. Also - I took notes that

primarily pertained to what I wanted to learn - not comprehensive ones! You

are welcome to take all of this information and use it to ASK QUESTIONS - but

don't accept it as absolute TRUTH! Also it was at the end of a very LONG

day of work and everyone was rather tired so I may have heard what I wanted

to hear and skipped the other!!!! So here goes.

I attended the 5:30 to 6:30 p.m. discussion. My group was composed of about

15 IDF leaders, some people from Baxter, and this independent review

discussion leader.

The first speaker just put overheads up about summaries of papers dealing

with studies about sub-cutaneous IgG replacement (SCIG). She did it so

quickly it was impossible to write down the references, so we requested that

those be made available in the IDF office. Just as soon as I get those, I'll

post the references. The information given was that it was successful in

children as well as adults; had been used with infants as young as 6 months;

that it often was successful even when IVIG was not tolerated; that it

maintained a more constant level of IgG so that one would not experience the

typical 3 week drop off of energy and protection found with IVIG; that it has

been successfully used in Europe for about 12 years now, etc.

So, what is it? SCIG is administered with a little pump the size of a Sony

walkman that can hold 10 mg of IgG solution and can be carried about in a

" fanny pack " type pouch. Then a very tiny tubing runs to the site. The

site is usually in the hips or abdomen. The mechanism is simply a needle

that is premeasured in length that you insert, twist and remove the needle,

leaving the tubing just like an IV catheter, cover the site with Tagaderm and

you are ready for infusion. You don't have to aim for anything (no looking

for the right spot). We were told the needle is so tiny that there really

isn't any prolonged pain - just the jab of the needle and it's over. I told

Katy that the needle is arranged sorta' like a thumbtack and about that

length. You just insert it until the head is flat - twist the cap to remove

the needle and its done. I don't know if there would be different lengths

of needles for children versus adults - that would be a good question though

because there's quite a bit of difference in our sizes! I questioned the

Tagaderm issue because Katy has a reaction to the Tagaderm product. I was

assured that Hypofix or paper tape or whatever you currently used would be

appropriate - but only the Tagaderm cover would keep it waterproof -- but I

see no reason to need it to be waterproof!

Advantages: the patient or caregiver does this himself/herself. You don't

need a nurse, you don't need an appointment, etc. You infuse yourself with

no assistance needed. You can flex your schedule so that you infuse while

you sleep, do housework, work, go to school, watch TV, or play on the

Internet. You can take a walk to the park, go buy groceries, etc. There's

nothing tying you down.

But… various people commented that you also lose that ability to just sit and

do nothing during an IV or to set aside special movies to watch or activities

to do during that time.

Okay, it is my understanding that you can use any brand of IgG as long as

it is in liquid state. You would syringe 10 mls into the tube in the pump

and be ready to infuse. If this really catches on, pharmaceutical companies

will start manufacturing the tube itself filled with 10 mls and we'll just

order it pre-filled and pop it directly into the pump. When it is pumped

into the body it goes sub-cutaneous - or under the skin (about ½ deep).

Then that blob of liquid is very gradually absorbed by the body so that peak

concentration actually doesn't occur for about 3 days. The slower

absorption time is what makes it less likely to trigger a reaction.

The lady in our group who had been infusing for 3 years said that she no

longer notices the needle, that her little bleb doesn't bother her at all and

that there's nothing bulky under her pants to make her self-conscious - just

the fanny pack with tubing. Clothing would need access at the waist - not a

one-piece dress!

Okay now here's the drawbacks -- right now the recommendation is to infuse

only 10 ml/day to start and then increasing as tolerance permits. The good

news is that the lady who had infused this way for 3 years is currently

infusing 60 mls in ONE day so that she only infuses once a week. The lady

who has infused this way for a year and a half does 2 hours of infusion 3

times per week but her goal is to move to 2 times per week soon.

So…. Katy is taking 200 mls per month - which would translate in needing 50

mls per week and that would not make her a happy camper to have to start at

5 days per week! But, they say you can make major increases and be up to

your full dose within the first 3 months as long as your body agrees to that!

Neither of these ladies have had any problems with reactions. The 3 year

lady had previously used IVIG, but had major reactions and has experienced

none since infusing this way. The 1 ½ year user, had never had IVIG, and

just started SCIG because her doctor said that was how to do it!!!

Someone mentioned a friend who was using it who was having a lot of itching

and soreness at the site - but admitted that she also complained of itching

and soreness at the IV site. No other adverse reactions were indicated.

However, that does not mean that they do not exist.

Questions and Discussion that followed: We were asked to indicate our

interest as being 1 to 5 where 1 was NOT interested at all and 5 was very

interested in learning more. The group was certainly not neutral! We gave

them all 1's and 5's except for two 4's. The 2 4's were given (1 by me) by

two moms of teenagers who said, while we are very interested-- our teenagers

would have the final say! I would estimate that the room went about 2/3

very interested to 1/3 not interested at all. But the 1/3 that were not

interested said that a change in their ability to take IVIG would certainly

make them very interested in SCIG.

Reasons given to NOT take SCIG: one mom with a SCID son said that IVIG day

is once a month and they receive a full check-up and discussion (usually 45

minutes) with their doctor each time. She would not want to lose that

opportunity to stay in close contact with her doctor.

One Mom said that she could handle tying her toddler up once a month - but

not weekly and certainly not 3 times a week! That would just be too

traumatic for all!

One adult patient said that IVIG day for her is her day to not feel guilty

about putting her feet up and watching movies all day. Everyone knows it's

her day off - she would not enjoy being free to go buy groceries, continue to

do housework, etc. No thank you!!

One adult patient said that right now they have a procedure that works -

she's not changing ANYTHING!

We all expressed concern that the skin would eventually become intolerant to

this constant poking. But were reminded that diabetics have been poking for

years with no problems!

Reasons given TO TRY SCIG:

Convenience of not working around a nurse's schedule.

Convenience of being able to fit it in without giving up a day of your life

for IVIG.

Possibility of our off-to-college kids in being able to do it themselves in

the dorm without

having to pack a huge pump and major supplies.

Feeling of being in control of your life and not at the mercy of the

hospitals, nursing or

infusion centers.

No outside exposure to the hazards of those places.

No vein problems

Other things we discussed: Most insurances will go along with anything that

is cheaper for them. Some people assumed they would be denied by their

insurance because they could not get permission to home IV. Others felt

that insurance would jump at the cheaper possibility. Both ladies who were

currently using SCIG were covered by their insurance -- including purchase of

the pump, tubing, etc. Overall SCIG is cheaper because of cutting the cost

of the nurse.

She also asked us what kind of training and precautions would we want to get

started. We said 2 or 3 times in a medical facility (doctor's office,

infusion center, hospital) so that reactions could be handled. And then home

health care for an additional period of time depending on how quickly and

comfortable the patient was. Then independence.

My only remaining question is whether it is safe to be driving, walking the

mall, or away from medical care while infusing IgG in any form. We've heard

on this list about sudden unpredictable reactions - I certainly don't want

Katy driving and I would want her to carry complete identification and

explanation if she's going to be away from medical care. But, I really don't

see that as a problem as she would probably want to infuse while she was home

or in the dorm anyway.

Personally, I don't think Katy is interested in changing until we start

having trouble with veins again. I would certainly choose SCIG before a

port. The other thing that Barb Ballard and I discussed privately is that it

doesn't hurt to give SCIG a try. It is not feasible to give a port a try -

you are stuck with it for life (or at least the scar). This is something you

could try - if it didn't work out - you just go back to IVIG. That makes it

more possible that we will look into it. However, it will not be convenient

or easy at the beginning. You need to be prepared for that.

Hope that helps. Sorry it is so long. I just don't have time to polish it.

In His service,

Dale