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Thursday, January 22nd 2009, 1:08pm

Information on Intralipids

Intralipids

Information gathered from Immunologysupport group discussions
http://groups.yahoo.com/group/immunologysupport/

Updated 9/15/08

Contents:

I. What is Intralipid?
II. Dosage and administration
III. Cost
V. The patient trial in progress
VI. Intralipid FAQs answered by Dr Coulam
VII. Patient experiences
VIII. Studies

I. What is Intralipid?

Taken from:
http://www.illinoisivf.com/recurrent-pre…plantation.html

Evidence from both animal and human studies suggest that intralipid administered intravenously may enhance implantation. Intralipid is a 20% intravenous fat emulsion used routinely as a source of fat and calories for patients requiring parental nutrition. It is composed of 10% soybean oil, 1.2% egg yolk phospholipids, 2.25% gylcerine and water. Intralipid stimulated the immune system to remove “danger signals” that can lead to pregnancy loss. The appeal of Intralipid lies in the fact that it is relatively inexpensive and is not a blood product.

II. Dosage and Administration
(Based on its designed treatment for fatty acid deficiency)

Prevention of Essential Fatty Acid Deficiency: The recommended minimum requirement is approximately 4% of the caloric intake. In most patients, this can be supplied as 500 mL of Intralipid 10% administered i.v. twice weekly.

Adults: Dosage should normally not exceed 2 g of fat/kg body weight/day (20 mL, 10 mL and 6.7 mL/kg of Intralipid 10%, 20% and 30%, respectively). In raised energy requirements, the supply of Intralipid can be increased but should not, without special precautions, exceed a quantity corresponding to 3 g fat (30 mL, 15 mL and 10 mL of Intralipid 10%, 20% and 30%, respectively)/kg body weight/day.

III. Cost
As of July 2006 the price of intralipid therapy was reported to be $350 for consult with Dr Coulam, $400 for the infusion for the first hour, $160/hr after that.
Cost of Intralipids has been reported to be about $100 a dose.

V. The patient trial in progress
Dr Coulam’s words taken from:
http://www.inciid.org/cgi-brd/getmsg.pl/38/6640

Re: intralipids and nk cells

Posted by Carolyn Coulam MD on 10:27 4/27/2006:
This is current work in progress. We have laboratory data that
intralipid is as effective as IVIg is suppressing NK cell killing
activity. We are currently testing the notion that it does the same
in patients. If anyone is interested in participating in the study,
they may call 312 944 2600 to make an appointment for consultation
to determine eligibility for the study.
Dr. Coulam

VI. Intralipid FAQs answered by Dr Coulam, Jan 2007
Taken from her discussion board:
http://www.inciid.org/forums/immune/index.html

Question: Why is it that some people can't get their levels below 10% with IVIG or intralipids?
Dr Coulam: Because their NK cells are so activated that they don’t suppress with the usual doses of medication. These results indicate that you would need an increased dose of either medicine.
Question: Even though intralipids are still in research stage for treatment of NK cells, would it make sense to treat my case with intralipids rather than IVIG, since neither got them to normal range, but intralipids got them lower, and would save considerable money?
Dr Coulam: Whether intralipid therapy is indicated for you would depend, not only on your lab results, but also the results of other laboratory tests and you medical history.
Question: Can one conceive with levels at 11-12% if that is the best I can get?
Dr Coulam: Yes, conception is possible.
Question: Is 16.9% dangerously high, or do you see higher?
Dr Coulam: 16.9% is moderately high
Question: Can my NK cells be higher after a failed IVF? If so, generally how long is recommended for them to normalize?
Dr Coulam: Elevated NK cells are usually the cause rather than the result of failed IVF.
Question: If one is getting sick (cold or viral infection) at beginning of IVF cycle, would it be prudent to cancel cycle for fear of NK cells being too high at transfer time? Or would uterine NK cells not be affected by cold?
Dr Coulam: NK cells are affected by viral infections.
Question: Would combining IVIG and Intralipids possibly get levels lower than the 11-12 % that was independently achieved with each sort of treatment?
Dr Coulam: Occasionally we combine the two medications if the higher doses of each do not work.
Question: How soon in advance of transfer is optimally recommended for intralipids infusion? How often should they be done? (any idea of their life?)
Dr Coulam: One week. Half life appears to be between 2 and 4 weeks at this time.
Question: What's the protocol for Intralipid IV? I have had it twice with different doctors and the first time it took 2 hours and the second time only 30 minutes. I developed pretty bad body aches and kind of flu like symptoms several days after the second (fast) treatment. Could it be related to the treatment?
Dr Coulam: We usually infuse it within 30 minutes. The flu like symptoms you experienced several days after the infusion were not related to the intralipid as we would expect any side effects to be immediate.
Question: What is the Intralipid protocol in an IVF cycle?
Dr Coulam: Depending on the specific situation, we usually give the first infusion of intralipid during stiumlation with gonaotropin and the second infusion with the first positive pregnancy test. We usually start lovenox with the first positive pregnancy test.

VII. Intralipid experiences

2/24/07: “I just found out today when i went in for my 1st beta that the nk test result from tx day went down only 0.7, they were 11.7 and are now 11. I did Intralipids 2 days before ER and had a 3 day tx.Today is my 1st beta day and i wont know the results till the 2nd test on Thurs.
Well my concern is...if it only went down .7 which means its still elevated would this prevent me from getting pg?? When i asked the nurse, she said they are more concerned about keeping the pgcy going.?!?!?My nurse kept saying, incase i get pg i would need another dose, so shouldnt i get the results right away and start another dose just incase im pg? This is the 1st time ive taken intralipids so dont know how they work and what the process is.
My hx- got pg after 3 tries in 2004 on a fresh IVF 4blast tx.
1 failed ivf in Sept tx 4blasts. currently 2ww on fresh ivf tx 4 embies. (did intralipids, taking heparin and ASA)”

5/24/07: “Hi, I'm new here and 9 weeks pregnant. Prior to becoming pregnant, my only elevated result (through Millenova) was CD19+56 at 12.6. This went up to 17.5 upon becoming pregnant, and fell to 15.5 and 13.5 after one dose of intralipids. I then had a second dose of
intralipids, but don't have the latest result.”

7/18/07: “I am about to do an IVF cycle using Intralipids instead of IVIg. This is through Dr. Acacio with SIRM in Orange County, CA
(www.haveababy.com). The pioneer of this alternative is Dr. Coulum in
Chicago (Dr. Acacio has collaborated with her and published some of
their research). Although it's still experimental, it looks very
promising and seems to work just as well as IVIg. The best part is
that it is REALLY cheap (under 100$ for an IV infusion as opposed to
2000-3000$ per infusion with IVIg). The main difficulty is finding
someone who will prescribe it for you. I am very lucky that I happen
to live a few miles away from Acacio's clinic. I know both he and Dr.
Coulum see patients from out of state and out of the country, so it
might be worth contacting them. In any case, I wish you the very best
luck with your next cycle!”

12/18/07: “Dr. Coulam doesn't push intralipids. It is a clinical trial. When I first found out I was going to need IVig, I wondered if there was another alternative because I did not want to do IVig both for the cost and because it's a blood product, bad side effects, etc. It just kind of scared me.
So someone on here told me about intralipids (thank you!). Dr. Coulam did a NK assay and found that both IVig and intralipids suppressed my killer cells.
So as of Jan 1 we are going to be switching to HMO IL which covers IVF up to 4 times (we live in WI). So I went to Dr. Coulam to see if she would do IVF with intralipids the beginning of Jan. and she agreed to do it. Well just a couple weeks after that, we found out we are pregnant (almost 6 weeks now). It is an absolute MIRACLE as we had been trying 2 1/2 yrs, had several failed IUIs, a couple failed IVF cycles, my husband also has low morphology, I have a killer cell problem, we didn't think there would be ANY chance of ever conceiving on our own. So when pregnancy was confirmed, I went to Dr. Coulam and she administered the intralipids.
Sorry for the long story. Here is what she explained as the difference between intralipids/IVig. IVig as you know is derived from blood, it takes 2-4 hours or so to administer, it is quite costly and there are not so good short term side effects.
Intralipids is a man-made product (I believe it's soybean oil and some other things like that), it only took 40 min. to administer, I didn't have any side effects, it cost $600 and lasts for about a month. And so far, knock on lots of wood, I'm still pregnant.
I hope that helps!”

VIII. Intralipid Studies

3. Am J Reprod Immunol. 2007 Apr;57(4):262-9

Natural killer cell functional activity suppression by intravenous immunoglobulin, intralipid and soluble human leukocyte antigen-g.
Roussev RG, Ng SC, Coulam CB.
Millenova Immunology Laboratories, Chicago, IL, USA.

The purpose of this study was to compare the ability of intravenous immunoglobulin (IVIg), intralipid and soluble human leukocyte antigen (sHLA)-G to suppress natural killer (NK) cell cytotoxicity in an in vitro assay. Method of study Blood samples taken from 275 women experiencing reproductive failure were analyzed for NK cytotoxicity and the suppression of NK cytotoxicity by IVIg 4 and 2 mg/mL (n = 275), intralipid 18 and 9 mg/mL (n = 275) and sHLA-G 70 and 35 ng/mL (n = 50) using immunofluorescent labeled K562 cells as targets and flow cytometry. Results Natural killer cytotoxicity was suppressed in all samples. Among patients with normal NK cell activity, IVIg suppressed NK cytotoxicity by 44.9 +/- 8.1%, intralipid suppressed NK killing by 45.2 +/- 8.3% and sHLA-G suppressed by 49.0 +/- 9.2%. When specimens with abnormal NK activity were observed for suppression of cytotoxicity, IVIg suppressed by 38.9 +/- 5.4%, intralipid suppressed by 39.8 +/- 6.2% and sHLA-G suppressed by 39.9 +/- 5.0%. Conclusion Intravenous immunoglobulin, intralipid and sHLA-G suppressed NK cell cytotoxicity with equal efficacy in an in vitro assay.
***************
3. American Journal of Reproductive Immunology 59 (2008) 463–517 ª 2008 The Authors
472 Journal compilation ª 2008 Blackwell Munksgaard

Pregnancy Outcome after Intralipid
Infusion among Women Experiencing
Recurrent Pregnancy Loss
CB Coulam1,2, B Acacio3, JS Rinehart1, L Rinehart1,
S Ng2, RG Roussev2
1Rinehart Center for Reproductive Medicine, Evanston, IL, USA; 2Millenova
Immunology Laboratories, Chicago, IL, USA; 3Sher Institute for
Reproductive Medicine, Orange County, CA, USA

Objective: We have previously reported that Intralipid
suppresses natural killer (NK) cell cytotoxicity
both in vitro and in vivo. The current study was
undertaken to determine whether Intralipid treatment
is associated with increased live birth rates.
Methods: 79 patients with elevated NK cell activity
and a history of recurrent pre- or post-implantation
pregnancy loss were treated with IV intralipid,
2-4 ml of 20% solution. Of the 79 women, 68 had a
diagnosis of recurrent implantation failure and 11
experienced recurrent pregnancy loss. Recurrent
implantation failure was defined in this study as a
cumulative total of 8 cleaved embryos transferred or
4 blastocysts transferred with human chorionic
gonadotropin (hCG) serum concentrations less than
5 mIU/ml at 14 days after embryo transfer. Recurrent
pregnancy loss consisted of at least 2 or more
consecutive spontaneous abortions.
Results: Among the 68 women with a history of
recurrent implantation failure, 27 (40%) became
pregnant after in vitro fertilization and embryo
transfer with intralipid treatment. Four of the 68
patients were over the age of 40 years and none of
these became pregnant. Of 64 women under the age
of 40 years who were experiencing recurrent
implantation failure with elevated NK cell activity,
the pregnancy rate per cycle was 42%. Ten of the 11
(91%) women experiencing recurrent pregnancy
loss had a successful pregnancy.
Conclusion: Intralipid is effective in enhancing live
birth rates among women with elevated NK cell
cytotoxicity and a history of recurrent implantation
failure and recurrent pregnancy loss.

*****************
4.Am J Reprod Immunol. 2008 Sep;60(3):258-63.
Duration of Intralipid's Suppressive Effect on NK Cell's Functional Activity.
Roussev RG, Acacio B, Ng SC, Coulam CB.
Millenova Immunology Laboratories, Chicago, IL, USA.
Background In vitro investigations have revealed the ability of intralipids to suppress natural killer (NK) cytotoxicity. Evidence from both animal and human studies suggests that intralipid administered intravenously may enhance implantation and maintenance of pregnancy when the patient has an abnormal NK cell level or function. Problem The aim of this study was to establish the duration and efficacy of Intralipids suppressive effect on NK cell functional activity. Method of study Fifty patients with abnormal NK activity results (NKa) received intralipid 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipid 20% diluted in 250 mL saline; or 18 mg/mL - corresponds to 4 mL of intralipid 20% diluted in 250 mL saline) infusions and their NKa were tested periodically. The determination of NK cell function was performed by flow cytometry using K562 cells as targets. Results Fifty women with abnormal NKa-testing received intralipid infusions. 39 (78%) showed NKa suppression within the normal range the first week after infusion, 11 (22%), showed suppression, but still above the normal threshold. They received second infusion 2-3 weeks later. In 10, the Nka activity was normalized the following week. Four patients had three intralipid infusions in 2-week periods in between and after the third infusion, and all showed NKa normal activity. In 47 patients the suppressive effect of the Intralipid after the normalization of NKa lasted between 6 and 9 weeks, in two patients this benefit lasted 5 weeks, and in one patient the effect was 4 weeks. Conclusion Intralipid is effective in suppressing in vivo abnormal NK-cell functional activity. The results suggest that Intralipid can be used successfully as a therapeutic option to modulate abnormal NK activity in women with reproductive failure.

kar1

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Thursday, January 22nd 2009, 8:27pm

my friend went for this today

sounds like it is the next best thing and more and more uk cons are prescribing

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Monday, February 2nd 2009, 12:42pm

Really useful info Blondie, thanks :)

Does anyone know how long you have to take Intralipids for? pre conception and during how many weeks of pregnancy???

and I know above it say's "Cost of Intralipids has been reported to be about $100 a dose." is that about £70 ? does that mean £70 a dose twice a week? £140 a week???

I have got an appointment with Dr Paul Armstrong on friday, (if the snow clears by then!) But I can't wait that long!!! I'm dying to know how much it will cost!!!

Thanks

Louloulouisa xxx

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Monday, February 2nd 2009, 1:00pm

my friend went to dr gorgy and paid £350 per go and had 2 before embryo transfer and none now til postive pregnancy test

the cost of the Intralipid's itself is very low and i believe as low as £15 the rest is nurses fees and profit!!

good luck with dr armstrong and up date us please

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Monday, February 2nd 2009, 1:09pm

Thanks Kara :)

Oh my goodness!
Did she get a BFP? Did they tell her if she may need more? and if so for how long?

Because I'm thinking (2x£350) £700 a week may just add up to as much as IVIG, not that I want to opt for IVIG, but just wondering how many doses in total 'one' would need!

sorry for all the questions, just desparate to know!

I will keep you up date...

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Monday, February 9th 2009, 10:38am

Just thought I would let people know, I just got through to a lovely lady called Claire at Healthcare at Home, she quoted me £285.41 per infusion of Intralipids. She said some women need this every 3 weeks, and some women need it every 4 weeks. The infusions takes 2-4 hours.

Dr Paul Armstrong told me I would need it up until 20 weeks of pregnancy, but Claire said, it is possible that some women need it for longer, depending on what your consultant reccommends.

Hope that helps

Lou x

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Wednesday, April 8th 2009, 2:19pm

Very useful information, Blondie. Lou, I had it today and the cost is same as quoted by healthcare at home. Infact one of their nurses did it for me today.




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