Rophylac

[Sara B]

We have the option of choosing Rophylac for our patients instead of the Rhogam that we've always used. Does anyone have experience with Rophylac? Any reason to not switch from Rhogam?

[donellda]

We have been using Rhophylac for about 3 years now and have had no complaints. The main reason for the switch was the price. We get it from FFF Enterprises and the service is excellent.

[SusanM]

We have been using it and did have 2 incidents where moms had a large bleed during delivery and we had to issue multiple doses and they had reactions to Rhophylac. With all other products we had no problems issuing multiple doses at the same time... After reporting back to ZLB, it was determined that if multiple doses are need, each vial must be issued 2 hours apart.

Susan

[apugh]

Susan, we had a patient that needed multiple vials (9) here and she also had a reaction. We ended up calling the company also. They sent us some articles about infusion rate, etc. Do you know of any studies or other hospitals that did some research on the infusion rate when multiple vials are needed. Thanks, Ann

[SusanM]

We have not had any issues since implementing the manufacturer's recommendation that we issue multiple vials 2 hours apart. I have not seen any other documentation on this.

[apugh]

We have implemented the 2 hour infusion rate also. Our Medical Director was asking if anyone had done any studies on this so I thought I would ask around. Thanks for taking the time to reply, Ann

[KKidd]

I have been told that we will be converting to Rhophylac. If I understand correctly, it may be given IV or IM. Were the reactions noted using the IV method? I am currently gathering information for my manager. Thanks!

[SusanM]

When we had the reactions, it was because the RN gave all doses (i think 6 and 10) at once IV. The manufacturer determined that it was too much at once and we now issue only 1 syringe at a time and if multiple doses are needed they are issued no less than 2 hours apart. They can be given either IV or IM. Since doing it this way, no problems.

[apugh]

We had a patient that needed 9 vials of Rhophylac. It was given IV. The RNs followed the package insert and gave all nine vials at once. The insert does not address the infusion rate when multiple vials are needed. The patient developed chest pain. She was transferred to acute care and monitored overnight. By the next morning she was fine and went home the next day. It wasn't until after the reaction and we notified the company that they sent us articles suggesting an infusion rate of 1vial every 2 hours. Our suggestion to them was that this should be addressed in the package insert.

[AMcCord]

When we had the reactions, it was because the RN gave all doses (i think 6 and 10) at once IV. The manufacturer determined that it was too much at once and we now issue only 1 syringe at a time and if multiple doses are needed they are issued no less than 2 hours apart. They can be given either IV or IM. Since doing it this way, no problems.

Good information. Thanks

[SusanM]

Our reactions were both gasping for air and chills. One became cyanotic.

I totally agree that information SHOULD be on the package insert. No one should have to learn it "the hard way"!

[Malcolm Needs ☆]

Some of you may have got a slight hint on this site that I am not a great fan of one of our accrediting agencies; namely the MHRA, however, this is exactly the kind of thing that they would come down on "like a ton of bricks" (i.e. nothing in the package insert); and quite right too.

:)

[BankerGirl]

One of our generalists' daugher-in-law had a massive fetal bleed which required 11 vials of RhIG to treat. We assumed her reaction was due to the large amount of fetal cell destruction occuring in vitro, as it calculates out to the equivalent of about 1unit of red cells. This makes me wonder if she received RhoGam or Rhophylac (she delivered in another facility). I have never heard of this issue before, and COMPLETELY AGREE that this should be a HUGE warning in the package insert!

[L106]

One of our generalists' daugher-in-law had a massive fetal bleed which required 11 vials of RhIG to treat. We assumed her reaction was due to the large amount of fetal cell destruction occuring in vitro, as it calculates out to the equivalent of about 1unit of red cells.

Surely you don't really mean "1 unit of red cells", do you? (Was the baby born alive?) So, are we talking about a massive amount of fetal blood from the placenta into the mother? (This sounds like another post from which I will learn something!)

[adiescast]

At another hospital I worked at many years ago, I had a patient who experienced a full term fetal demise and absorbed nearly all of the infant's blood volume. She had to receive a huge bolus of RhIg in several serial shots. I don't think I ever heard how that situation came about.

[BankerGirl]

OK, maybe 1/2 of a RC unit. If you figure 1 vial or RhIG is good for a 30 ml bleed, times 11 vials of RhIG, that is roughly 300 ml of fetal blood with an extra one for good measure. And yes, the baby was born alive, but with a 4.0 gram Hgb. The baby is now 1 year old and is apparently normal now, although she did have SERIOUS problems initially, and nearly died several times. We consider it a miracle that she survived! And three months after delivery, the mom had a negative antibody screen, as well.

[L106]

That's wonderful that both Mom & baby seemed to have a successful outcome. (Wow! 4 gram hgb in a newborn. Scary!)

[Malcolm Needs ☆]

I've never seen one like that, but a colleague of mine in Leeds, Yorkshire described a case with an FMH of 220mL, with the baby's birth Hb of 3.3g/dL.

The baby, who was bleeding chronically throughout most of the pregnancy, survived and is now well.

:):)

[bbbirder]

Thanks for the informative posts about large doses of Rhophylac. We use it, but never have given out large volumes. Did the manufacturer give you this information in writing? Do you know if it is on their web page?

Thanks,

Linda Frederick

[jlemmons]

We were switched to Rhophylac by our pharmacy without any input from us. We are gathering information regarding problems because of the lack of request for info from us. We are very concerned about the problems mentioned here. I too have noticed that there is nothing in their information regarding these problems. Any help along these lines would be appreciated.

[Kimster]

There is a great article by Dr Werch out of Ben Taub in Clinical Apheresis this month on this subject. I actually looked at the PI's for all the RhIg and none have information on how to give large doses. We have to remember that when we give large doses of RhIg we are treating these patients like they have ITP. Those patients are not post-partum with a new baby and know they will have some side effects from the treatment, they are usually pre-medicated with Benadryl and Tylenol to ward off some of these side effects from large doses of RhIg. The red blood cell hemolysis causes the side effects you mentioned from slight to severe. I believe in Dr Werch's paper they pre-medicated both patients, and used Rhophylac on both. It seems it depends on the situation how she would treat the patient.