Exjade and pregnancy/conceiving

Hi everyone,

I came across this great site yesterday and am relieved to see so much info and discussions here to help fellow thals.


To give you some info about myself, I  am 29 and have thal intermedia. I had a spleenectomy 5 years ago and have been on exjade since last march sine my iron levels were approx 1500. I am not regulary transfused..usually about once a year since the operation. Before exjade I never took desfiral. I have been on folic acid since I was diagnosed aged 4 and penicillin twice a day since the spleenectomy.

I am from Malta and I am the first Maltese patient (known) to take exjade. I take 3 tablets of 500 mg a day.

No side effects excepts diarrohea.

My question is related to pregnancy. I got married in June and my husband and I are trying to conceive. He was tested and is clear of Thal. My doctors told me the effects of exjade on pregnancy and conception are not yet known and I am worried that this will be a problem for us. Is there anybody who was on exjade when they got pregnant? I would love to hear your feedback and it would be a help to know if there are other thal patients on exjade who have had a baby or are trying to conceive as well.

Thank you for this amazing site.

Hello Sabi and welcome to the site 

As taken from Novartis site
Can EXJADE be taken during pregnancy?

EXJADE has received an FDA pregnancy Category B rating. Reproduction studies have been performed in pregnant rats at oral doses up to 100 mg/kg per day (about 0.8 times the recommended human oral dose based on body surface area), and in pregnant rabbits at oral doses up to 50 mg/kg per day (about 0.8 times the recommended human oral dose based on body surface area). These studies have revealed no evidence of impaired fertility or harm to the fetus due to deferasirox. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, deferasirox should be used during pregnancy only if clearly needed.1

Can nursing mothers take EXJADE?
It is not known whether deferasirox is excreted in human milk. Deferasirox and its metabolites were excreted in breast milk of rats following a 10 mg/kg dose (about 0.08 times the recommended human oral dose based on body surface area). Because many drugs are excreted in human milk, caution should be exercised when deferasirox is administered to a nursing woman.1

http://www.us.exjade.com/health-care-professional/exjade-faqs.jsp?usertrack.filter_applied=true&NovaId=2229645052129857786

As you mentioned your ferritin is not that high and can be easily lowered below the 1000 in a short time if there is compliance and i think it will be safer at that time to have a break from exjade at that time to allow time for conception. It should be discussed with the doctor how long it should be stopped before conception.

As in pregnancy , it is known that chelators are stopped during the time of pregnancy even for a thal major patients that transfuse monthly

It will also be wise to start taking IP6 (natural iron chelator, atioxidant, food supplement) because it will help reduce any damge of iron on body cells. Also  don't forget having tea with meals to inhibit iron absoarption from food

Please feel free to discuss whatever you want

manal

Hi Sabi,

I contacted Shikha, whose daughter recently gave birth and asked about chelation during pregnancy. She was under the care of Dr Giardina, who is a top thalassemia specialist. Shikha told me the following.

...exjade was not used during Pregnancy.. she used Desferal .. but only after the first trimester..  but her SF did not go up that high, as I think the baby absorbed some of the iron..

Because it has not been tested and the safety of the baby must be ensured, it is unlikely that you will be allowed to use Exjade during pregnancy. I do know some mothers just stop chelating entirely during pregnancy, while others do use desferal, but I know of no other chelation drug that has been tested as safe during pregnancy (desferal has been tested). I agree with Manal, that natural chelation methods should be incorporated during the pregnancy as much as possible. Because the baby does cause an extra demand for iron, it does negate some of the iron that is absorbed while not chelating, so chelation is not as urgent, especially if the iron level is already low.

Hi Guys

Thank you for your helpful reply. I am aware that exjade should be stopped during pregnancy. My only worry is that exjade will stop me from conceiving since they are not yet aware of the effects of exjade on fertility. I would like to know if there are any women who got pregnant whilst they were taking exjade and if it is dangerous to conceive whist taking exjade. Will exjade harm the baby if conceived during administarion of the drug?

I appreciate your feeback greatly. One other quesion to manal, what is IP6? i have never heard of it until now. Is it a pill? I know that tea helps to remove iron, I also discoverd that green tea helps to remove iron form the liver and altough I dislike the taste I am training myself to drink more of it.

thanks again

sabi

if it is dangerous to conceive whist taking exjade

Since there are no studies on this issue, you should NOT conceive during the administration of exjade

As for IP6, it is Phytic acid (IP6), derived as an extract from rice bran, it is the most potent natural iron chelator and has strong antibiotic and antioxidant action. IP6 has been found to have similar  iron-chelating properties. It is very important to be taken on empty stomach because when it is taken with protein it loses its efficiency

IP6 is a food supplement so it can be found on shelf and you can check it on Puritan Pride
http://www.puritan.com/inositol-566/ip-6-inositol-hexaphosphate-005745?NewPage=1

Also you can read aout our members expierence with IP6 in the following links
http://www.thalassemiapatientsandfriends.com/index.php?topic=653.0;highlight=ip6

http://www.thalassemiapatientsandfriends.com/index.php?topic=2641.0;highlight=ip6

http://www.thalassemiapatientsandfriends.com/index.php?topic=819.0;highlight=ip6

http://www.thalassemiapatientsandfriends.com/index.php?topic=2914.0;highlight=ip6

http://www.thalassemiapatientsandfriends.com/index.php?topic=1177.0;highlight=ip6

http://www.thalassemiapatientsandfriends.com/index.php?topic=874.0;highlight=ip6

manal

I asked Shikha about Exjade use while trying to conceive and her daughter did use Exjade up until she was pregnant and discontinued during the pregnancy, sometime within the first 5 weeks of her pregnancy.

From http://www.exjade.com/PDF/Exjade_Swiss_PI_english_new.pdf

Reproductive toxicity was assessed in rats and rabbits. Deferasirox was not teratogenic [a drug or other substance capable of interfering with the development of a fetus, causing birth defects.], but caused an increased incidence of skeletal changes and stillbirths in rats given high doses that were severely toxic to the non-iron-overloaded mothers. Deferasirox did not cause other effects on fertility or reproductive function.

It may be more harmful to fertility if you don't chelate and allow your iron to go higher, as iron overload is known to affect fertility.

Hi Sabi,

I took advantage of my opportunity at the conference this week to ask Dr Giardina about this topic. This has never been studied in thals and probably for good reason. Because there is no history of problems of any sort unique to babies of moms with thal and no history of any birth defects, there is no priority to study whether taking a chelator while trying to conceive can do any harm to the baby. Dr Giardina said that in her many years of treating female patients she has seen no sign that there is any danger posed by chelating while trying to conceive. The only protocol followed concerning chelation is that it is stopped during the first trimester and chelation during the last 2/3 of the pregnancy is an optional thing that is usually up to the patient.

My opinion is that stopping chelation while trying to conceive may be counter-productive because rising iron levels might affect the ability to conceive.

Hi Sabi,

I came across two papers that dealt with chelation during pregnancy, though they talk about DFO and pregnancy and thought that this might provide some information. This also complements what Andy indicated regarding Shikha's daughter transitioning to DFO from Exjade during pregnancy. One paper was published from Children's Hospital Oakland in 1999 and the second one is a follow up paper from Greece .... these are a bit old but guess has some info ...

bostonian