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Stelara for Male and Pregnancy

Hi,

I wanted to know if Stelara had any effect on the sperm quality if taken by man. Is there any risk to get a women pregnant while the male is on Stelara. Has anybody conceived a children while the man was on Stelara?


Thank you!
 
I don't know of anyone who has gotten pregnant from a man on Stelara. They may know something about that over in psoriasis-world, but here in Crohn's-land Stelara has not been approved for use in CD all that long.

But I will say that I can't think of anything in the biological mechanism of how Stelara works that would suggest that it could damage the quality of sperm. You can never say never, but I suspect the risk of sperm damage is quite low.

Studies on monkeys injected with Stelara showed no effect on sperm. Scroll down a bit:
http://www.medsafe.govt.nz/profs/datasheet/s/stelarainj.pdf
 
I'm not a medical professional, but I am a Crohn's patient currently taking Stelara and I am a new father. I was just coming off of Mercaptopurine (6MP) and transitioning onto Stelara when my wife got pregnant with our son. Now, it's really dependent person to person, but my doctor had warned me that being on 6MP could affect my fertility. He did not give me that warning for the Stelara. She actually got pregnant faster than we were expecting, because we started trying to have a kid a little sooner than we wanted because we thought we may have some issues due to my medications. Well, that wasn't the case, and she became pregnant almost immediately. If you are concerned, you could always get your sperm count done, but I wouldn't worry too much, I don't think Stelara affects sperm quantity or quality, I've never been warned by my doctor about it nor have I read anything about it doing so, and my personal experiences have been that it did not affect either.
 

my little penguin

Moderator
Staff member
There are no studies of STELARATM in pregnant women. STELARATM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No teratogenic effects were observed in the developmental and reproductive toxicology studies performed in cynomolgus monkeys at doses up to 45 mg/kg ustekinumab, which is 45 times (based on mg/kg) the highest intended clinical dose in psoriasis patients (approximately 1 mg/kg based on administration of a 90 mg dose to a 90 kg psoriasis patient).
Ustekinumab was tested in two embryo-fetal development toxicity studies. Pregnant cynomolgus monkeys were administered ustekinumab at doses up to 45 mg/kg during the period of organogenesis either twice weekly via subcutaneous injections or weekly by intravenous injections. No significant adverse developmental effects were noted in either study.
In an embryo-fetal development and pre- and post-natal development toxicity study, three groups of 20 pregnant cynomolgus monkeys were administered subcutaneous doses of 0, 22.5, or 45 mg/kg ustekinumab twice weekly from the beginning of organogenesis in cynomolgus monkeys to Day 33 after delivery. There were no treatment-related effects on mortality, clinical signs, body weight, food consumption, hematology, or serum biochemistry in dams. Fetal losses occurred in six control monkeys, six 22.5 mg/kg-treated monkeys, and five 45 mg/kg-treated monkeys. Neonatal deaths occurred in one 22.5 mg/kg-treated monkey and in one 45 mg/kg-treated monkey. No ustekinumab related abnormalities were observed in the neonates from birth through six months of age in clinical signs, body weight, hematology, or serum biochemistry. There were no treatment-related effects on functional development until weaning, functional development after weaning, morphological development, immunological development, and gross and histopathological examinations of offsprings by the age of 6 months.
From
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf
 
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