Tixagevimab and Cilgavimab (Evusheld) information

[akajeanie1]

Has anyone had experience with Tixagevimab and Cilgavimab (Evusheld)?

[jimvan]

I had my Evusheld injections today. I had no negative reactions of any kind to this point. I feel a sense of psychological relief at having had the injections, but plan no changes to my rather sheltered routine.

[bkoffman CLL CURE Hero]

Non-event for me and most folks.

[dmmck]

I had Evusheld last Friday. No negative reactions at all. I had to wait for observation one hour after injections. Glad I had a good book with me! Uneventful wait.

[KMac1969]

Same here. I have had the first round and the follow up. So I have the full 300 mg each. No issues.

Now, if we only knew how much protection we have??

[CaptRon1976]

The PA who gave me my injections of EVUSHELD told me that he hoped I would go to LabCorp and get the quantitative Spike protein test. He said the EVUSHELD antibodies would be reflected in the test. I plan to do that when I return to the mainland from my boating vacation.Ron

[SeymourB]

akajeanie1 -

I had no trouble at all. The injections in the gluteus were virtually painless - the were so unlike the steroid injection I once had in the gluteus!

FDA FAQ:

fda.gov/media/154703/download

That FAQ has a link for the FDA EUA Fact Sheet for Healthcare Providers:

fda.gov/media/154701/download

Your doctor should read the above sheet before injecting. Usually, such sheets are packaged with the medication. Patients are allowed to download it, too, but the doctor does not have to personally give you a copy. So I always look for them. I caution that they can trigger fears, though. If so, that should trigger further discussion with your doctor, I think.

That sheet has the usual warnings for all MABs regarding hypersensitivity and anaphylactic possibilities, which is why they should have you wait awhile after injection.

"Serious hypersensitivity reactions, including anaphylaxis, have been observed with Human

immunoglobulin G1 (IgG1) monoclonal antibodies like EVUSHELD [see Adverse Reactions (6.1)]."

My infusion center made me wait for a whole hour! Anaphylactic reactions usually happen pretty quickly after exposure to the substance.

There's also a risk for any sort of injection if you have a bleeding disorder:

"As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder."

I emphasize thrombocytopenia, because more of us with advanced CLL experience that. I think it's the sort of thing where they watch for bruising and bleeding that shows up shortly after the injection.

The biggie was that there was a single fatal cardiovascular event during one of the 3 trials, and other significant cardiovascular events, largely in people who had known cardiovascular risks.

"In PROVENT there was a higher rate of cardiovascular serious adverse events (SAEs), including myocardial infarction (one fatal SAE) and cardiac failure, in subjects who received EVUSHELD compared to placebo [see Adverse Reactions (6.1)]. All subjects who experienced cardiac SAEs had cardiac risk factors and/or a prior history of cardiovascular disease, and there was no clear temporal pattern. A causal relationship between EVUSHELD and these events has not been established. There was no signal for cardiac toxicity or thrombotic events identified in the nonclinical studies. "

In Section 6, Adverse Reactions, Table 4 shows 22 cardiac SAEs (Significant Adverse Events) of any sort within 6 months of injection out of 3,461 patients in the Evusheld arm of the PROVENT trial, and 3 of 1,736 patients in the placebo arm. The arithmetic works out that among those patients the EVUSHELD arm was 3 times more likely to experience a significant cardio event, but it was still only about 1 or 2 per thousand experiencing such events more than the placebo arm.

The smaller (N=1,121) STORMCHASER trial had no cardiac SAEs, but the EUA notes that study was in a younger population with fewer cardio risk factors.

The TACKLE study was even smaller (N=903), but the dose was double. There were 2 acute myocardial infarctions in the EVUSHELD arm, one of which died. One placebo arm patient had an arrhythmia. All affected patients had cardiac risk factors or prior cardiovascular disease.

If you have cardiac risk factors, please discuss it with your doctor. I'm not posting this to strike fear in anyone's heart. I'm just reporting what the EUA said. You can and should read it yourself, and get medical advice.

My feeling as an anxious patient who has very few cardio risk factors and no history of anaphylaxis to another MAB is that the shots are safe for me, and I was thrilled to finally get the shots. I fear the complications and possible death due to COVID more than I fear other significant events.

What I want to know is if a doctor can even calculate my personal risk for a significant cardio event if I don't get the shot so that I can compare the risk with possible COVID infection in my community. I think there's probably not enough info to do that on a person by person basis with any mathematical confidence. So I think it's a judgement call by the doctor in such cases.

Best of luck,

=seymour=

[NoClew]

Had my first 1/2 dose of Evusheld on 2/9. No reaction. 4th Pfizer vax on 2/25. No reaction. 2nd 1/2 dose of Evusheld on 3/11. No reaction. Next week I'll get another antibody test. Sure hope I get a reaction there!Good luck akajeanie1.

[lexie]

Had my 2nd set of half dose Evusheld injections at noon today and at 10 hours later no side effects. This was a full day of driving to get these, 5 hours there, and hour to sit for observation after the shots, 5 hours drive home.

[BeckyLUSA]

Had 1st and 2nd doses. Nothing to write home about……

[Pinecrest]

I had both doses. Only a little itchy at the injection site.