1. Leqvio (inclisiran) is not an mRNA.
*This is extremely important.* Inclisiran does not use mRNA technology, and it does not work like the COVID-19 mRNA vaccines.
What it actually is:
Inclisiran is a *siRNA* (small interfering RNA) drug.
It does not enter the nucleus, does not alter DNA, and does not cause the immune response patterns seen with mRNA vaccines.
Its mechanism is gene silencing of PCSK9 in the liver only, which reduces LDL.
So the concerns about persistent mRNA side effects or “autoimmune reactions like COVID vaccines” do not apply to inclisiran.
2. Can inclisiran cause long-lasting side effects?
Most inclisiran side effects are mild and limited to the injection site.
Common ones:
Redness.
Itching.
Swelling.
These usually resolve within hours to a few days, rarely weeks.
Months of redness/itchiness at the injection site is unusual, and your nurse was right to pause the second dose until examined.
3. What about the other symptoms?
The symptoms you listed are not typical side effects of inclisiran:
Muscle/joint stiffness or pain.
Weakness.
Rib discomfort.
Leg/foot cramps.
Hoarse voice.
Oily hair.
New osteoarthritis.
Severe fatigue.
These are not known side effects from inclisiran in clinical trials or post-marketing safety monitoring.
In particular:
Autoimmune-type reactions have not been associated with inclisiran.
Systemic inflammation or multi-system symptoms have not been reported with inclisiran in the way some people reported after COVID vaccines.
So the pattern you’re describing does not match inclisiran’s known safety profile.
4. What is possible?
Several possibilities worth discussing with your doctor:
A. Delayed or exaggerated local hypersensitivity (likely for the red itchy patch).
Some people develop:
Prolonged redness.
Local inflammatory reactions.
Injection-site dermatitis.
This can last weeks, occasionally longer.
B. Coincidental illness*
Things like:
Viral infections.
Thyroid issues
Vitamin deficiencies (B12, D, magnesium).
Autoimmune conditions unrelated to the drug.
Perimenopause/menopause.
Stress-related disorders.
These can all cause exactly the systemic symptoms you listed.
C. Statin intolerance (if you’re also on a statin)*
Statins can cause muscle pains, weakness, fatigue, and cramps. If inclisiran was started at the same visit as a statin adjustment, people often misattribute the symptoms.
D. A separate rheumatologic issue:
New osteoarthritis or joint problems and fatigue have nothing to do with inclisiran.
5. Is inclisiran known to trigger autoimmune disease?
No.
There is no evidence in trials or pharmacovigilance data that inclisiran causes:
Autoimmune disease.
Systemic inflammatory responses.
Autoimmune flares.
Chronic fatigue-type syndromes.
*This is very different from the rare autoimmune reactions reported after COVID mRNA vaccination.*
6. Is it good that they told you to delay the second dose?
Yes. That’s the correct and cautious approach.
Before your next injection, your doctor should:
Examine the injection site.
Review blood work (CBC, inflammation markers, liver function, thyroid, B12, vitamin D, CK, etc.).
Consider whether the symptoms align with another diagnosis.
Decide if continuing inclisiran is safe.
Most doctors would delay the next dose in this situation.
7. Should you be worried about permanent damage?
Inclisiran does not:*
Alter DNA.
Persist long-term, the way mRNA may in lymph nodes.
Trigger autoimmunity.
Your symptoms are concerning and deserve evaluation, but they do not fit inclisiran’s known risks or mechanism of action.
I hope this gives you a better perspective on this subject.
@tommy901 Thank-you for the info. One question please: do we current.y have long term data on side effects? How long term? 2. (looks like I lied when I said « one » question)? How trustworthy is the data on people with autoimmune diseases like MS, since they were excluded from trials, I assume?