As of: February 15, 2024, 4:46 a.m
By: Marcus Giebel
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Help against Covid-19: The drug Paxlovid is said to have negative interactions with some immunosuppressants.
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Paxlovid is one of the best-known drugs against Covid-19.
In combination with immunosuppressants, taking them can apparently have serious consequences.
Amsterdam – Paxlovid has been available for medical prescription in the EU for around two years.
The drug, which contains the active ingredients Nirmatrelvir and Ritonavir, is one of the best-known drugs for Covid disease.
It is used orally.
Paxlovid: Serious side effects possible when taken with certain immunosuppressants
But now a shadow could fall on the supposed miracle cure.
The European Medicines Agency (EMA) reports serious side effects when taking Paxlovid and certain immunosuppressants.
These were the topic at the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC).
Therefore, drug interactions could affect the body's ability to eliminate these drugs.
Even fatal consequences cannot be ruled out.
These are immunosuppressants that only have a small dosage range, including so-called calcineurin inhibitors such as tacrolimus and ciclosporin, as well as mTOR inhibitors such as everolimus and sirolimus, which reduce the activity of the immune system.
They are used to treat certain autoimmune diseases or to prevent the body from rejecting transplanted organs.
Video: Corona drug Paxlovid was apparently sold illegally
Paxlovid and side effects: There is a risk of a rapid increase in blood levels to toxic levels
The PRAC therefore recommends that Paxlovid should only be taken in combination with these immunosuppressants “if close and regular monitoring of their blood levels is possible”.
People in healthcare professions are advised to consult with various specialists in advance.
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Paxlovid must therefore not be administered in combination with medicines whose elimination from the body is highly dependent on liver enzymes - known as CYP3A - and which have a narrow dosage range.
This applies, for example, to the immunosuppressant voclosporin.
The PRAC believes that healthcare professionals should carefully consider the risk of serious adverse reactions before treating paxlovid with immunosuppressants.
In several cases reviewed, the interactions led to a rapid increase in blood levels to toxic levels.
The patient's life was therefore in danger.
Paxlovid and Covid-19: The RKI specialist group also pointed out interactions
The PRAC met from February 5th to 8th and the committee assesses all aspects of the risk management of human medicines.
For Germany, Martin Huber from the Federal Institute for Drugs and Medical Devices sits on the committee, of which he is deputy chairman.
Last November, the COVRIIN specialist group at the Robert Koch Institute (RKI) emphasized that the mechanism of action of the active ingredient ritonavir contained in Paxlovid requires special attention when using other drugs at the same time that are metabolized by the cytochrome P450 isoenzyme CYP3A4 or influence its activity .
Simultaneous use could alter the plasma levels of numerous drugs, resulting in significant drug toxicities or a relevant reduction in effectiveness.
If Paxlovid is used together with or immediately after strong CYP3A4 inducers, the effectiveness of the Covid drug risks being lost.
It was therefore advised to consider an alternative Covid-19 therapy if medicines have to be taken without an appropriate break and if they have serious side effects in combination with Paxlovid.
These include antiarrhythmics or medications for the treatment of pulmonary arterial hypertension.
What danger can Paxlovid pose: The European Medicines Agency (EMA) has to take a closer look at the Covid drug.
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Paxlovid in Germany: Hundreds of thousands of doses may have to be destroyed
Meanwhile, the Süddeutsche Zeitung (SZ)
reported
at the beginning of the year (article behind a paywall) that hundreds of thousands of doses of Paxlovid might have to be destroyed.
The Federal Ministry of Health confirmed that there were 427,000 doses in stock whose shelf life would expire at the end of January or the end of February.
It is being examined what should happen to them.
Even if there is no official information, according to the report it can be assumed that Germany had to pay several hundred million euros for the purchase of around one million units of Paxlovid from the US pharmaceutical company Pfizer, which was suggested by Health Minister Karl Lauterbach (SPD).
The Federal Republic is therefore likely to suffer a considerable financial loss.
Pharmacies are said to have illegally enriched themselves with the free Paxlovid - there is talk of a million-dollar fraud.
There are a few things to consider when storing medicines, for example to protect them from the heat.
Another corona drug lost its approval in spring 2023 because it was no longer said to have any benefit for patients.
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