What is Regen Cov?
The Regen-Cov injection contains a mixture of casirivimab and imdevimab. It can be supplied in a single vial or two injection vials.Regen-Cov, an investigational medicine, is being studied to treat conditions caused by the coronavirus. Regen-Cov's safety and effectiveness are not known.Due to the high frequency of the Omicron BA.2 variant, this drug is currently not authorized in any US regions; therefore, it may not be administered to treat COVID-19 until further notice from the US FDA.
The use of Regen-Cov can also be used in the case of COVID-19 exposure and:
- You are not fully immunized against COVID-19.
- They may have received a vaccination but not enough immunity due to certain illnesses or medicines they use.
The use of Regen-Cov should be restricted to adults and children over 12 who weigh more than 88 pounds.
People who have:
- Are overweight;
- Have you got chronic renal disease?
- Diabetes is a serious disease.
- Have a weak immune response (caused either by disease or certain medicines);
- Have sickle cell disease
- Have a heart condition or high blood pressure?
- Have a neurodevelopmental condition such as cerebral palsy.
- Have asthma or another chronic breathing disorder?
- Have a tracheostomy or gastrostomy (not related to covid-19).
Also, pregnant women and adults 65 years of age and older may have a greater risk of experiencing severe COVID-19-related symptoms.Casirivimab is mixed with imdevimab to form a solution called Regen-Cov.Regen-Cov is not approved for the treatment of COVID-19 or coronavirus. These medicines can help prevent COVID-19-related hospitalizations or emergency medical treatment. The use of Regen-Cov in patients who are in the hospital or on supplemental oxygen due to COVID-19 is not approved.
Side effects of Regen-Cov
If you experience any of the following symptoms of an allergic reaction: itching, hives, or a severe allergic reaction, such as hives and hives; difficulty breathing; swelling in your face, lips, tongue, throat, or mouth, seek emergency medical attention.
Some side effects can occur with the Regen-Cov injection. Inform your caregiver immediately if you experience:
- The swelling of your throat or face;
- Dizziness, a feeling of light-headedness (like you could pass out);
- Chest pain, wheezing, and shortness of breath
- Fever, chills, and sweating; nausea; flushing (a sudden feeling of warmth, redness, or tingling);
- Heartbeats that are fast or slow, headaches, or a pounding sensation in the neck or ears
- Weakness, tiredness;
- Itching, rash
- Muscle pain.
If you experience new or worsening side effects after receiving the infusion, such as confusion, fatigue, weakness, fever, difficulty breathing, or rapid or slow heartbeats, call your doctor.Some side effects may be milder or even non-existent. It is impossible to know all possible side effects. Other side effects are possible. Call your doctor for medical advice about side effects. To report adverse effects, you can contact the FDA at 1-800-FDA-1088.
Warnings
Due to the high frequency of the Omicron BA.2 variant, this drug is currently not authorized in any US regions; therefore, it may not be administered to treat COVID-19 until further notice from the US FDA.
Before you take this drug
Tell your doctor about any of the following to ensure that Regen-Cov will be safe for you:
- A COVID-19 vaccine;
- An allergic reaction severe after receiving the COVID-19 vaccine;
- Any serious or chronic illness
- Allergy
- If you are breastfeeding or pregnant,
COVID-19 can cause severe illness or even death in pregnant women. Although not all risks have been identified, being treated with Regen Cov may be less harmful than contracting COVID-19 while pregnant.
How to take Regen-Cov?
A healthcare provider injects Regen-Cov under the skin or into a blood vessel.Regen-Cov must be injected slowly into a vein over a period of 20 to 50 minutes. Regen-Cov can be injected into the skin in 2–4 different places.After the injection, you will be monitored to ensure that there is no allergic reaction.Regen-Cov should be given in one dose as soon as you can after being exposed to COVID-19 or testing positive. This is usually within 10 days of the onset of symptoms. If you are exposed to COVID-19 on a regular basis, you may require additional monthly doses.Being treated by Regen-Cov does not make you any less contagious. Continue to use infection control measures such as self-isolation, social distance, hand washing, wearing protective face covers, disinfecting surfaces that you touch frequently, and not transferring personal items.It is also possible that Regen-Cov will not prevent you from getting infected again with the coronavirus. This drug combination may also alter your immune system's response to the coronavirus vaccination. Regen-Cov has not been fully studied, and its risks are unknown.
Details on dosage
Adult dose for COVID-19:
Only for investigational purposes
Minimum 40 kg:
IV infusion: Casirivimab and imdevimab are administered as one IV infusion.
Subcutaneous injection of Casirivimab and Imdevimab (600 mg each)
Adult dose for postexposure prophylaxis:
Only for investigational purposes
Minimum 40 kg:
Single Dose
IV infusion: Casirivimab and imdevimab are administered as one IV infusion.
Subcutaneous injection of Casirivimab and Imdevimab (600 mg each)
Repeat Dosing
-IV infusion:
Initial dose: casirivimab and imdevimab administered as a single intravenous infusion.
Subsequent Doses: Casirivimab and imdevimab are administered as a combined IV infusion once every four weeks for the duration of the exposure.
-Subcutaneous injection:
Initial dose: Casirivimab and imdevimab subcutaneously, 600 mg each.
Subsequent Doses: Casirivimab and imdevimab subcutaneously, every 4 weeks during the ongoing exposure.
The usual pediatric dose for COVID-19 is
Only for investigational purposes
Weight of at least 40 kg for 12 years old or older:
IV infusion: Casirivimab and imdevimab are administered as one IV infusion.
Subcutaneous injection of Casirivimab and Imdevimab: 600 mg each
The usual pediatric dose for postexposure prophylaxis ()
Only for investigational purposes
Twelve years and older, weighing at least 40 kg
Single Dose
IV infusion: Casirivimab and imdevimab are administered as one IV infusion.
Subcutaneous injection of Casirivimab and Imdevimab (600 mg each)
Repeat Dosing
-IV infusion:
Initial dose: casirivimab and imdevimab administered as a single intravenous infusion.
Subsequent Doses: Casirivimab and imdevimab are administered as a combined IV infusion once every four weeks for the duration of the exposure.
-Subcutaneous injection:
Initial dose: Casirivimab and imdevimab subcutaneously, 600 mg each.
Subsequent Doses: Casirivimab and imdevimab subcutaneously, every 4 weeks during the ongoing exposure.
Comments:
The US FDA has issued an EUA allowing the emergency use of casirivimab, imdevimab, or a co-formulated product (supplied as individual vials and to be administered in combination) for the post-exposure prophylaxis against COVID-19 for individuals who: are not fully vaccinated, OR are not expected to mount an adequate immunity response to complete SARS CoV-2 vaccination, AND have been exposed by someone who is infected, according to the US CDC,
This product cannot be used for the post-exposure prevention of COVID-19 in the EUA until the US FDA issues further instructions.
Limitations on Authorized Use
This product is not approved for post-exposure prophylaxis against COVID-19 in regions where it is likely that exposure was to a non-susceptible SARS-CoV-2 variant. The information available includes variant susceptibility and regional variant frequencies.
This product does not replace vaccination against COVID-19.
This product is not approved for pre-exposure prophylaxis to prevent COVID-19.
Injections can be given either intravenously or subcutaneously.
As soon as possible, casirivimab (Casiriv) and imdevimab (Imdevimab) should be given together after exposure to SARS-CoV-2.
Repeated dosing is appropriate for those who have been exposed to SARS-CoV-2 over a period of more than four weeks and are not expected to mount a sufficient immune response for the completion of the SARS-CoV-2 vaccine.
No dose adjustment is recommended for pregnant or nursing patients.
The optimal dose regimen for COVID-19 treatment has not yet been determined. However, the recommended dosage regimen could be revised as new data from clinical trials becomes available.
Use: To prevent severe COVID-19 infection, hospitalization, or death in patients at high risk.
Not fully vaccinated or not expected to mount a sufficient immune response for the complete SARS-CoV-2 vaccine (e.g., individuals with immunocompromising diseases, including those who take immunosuppressive drugs) AND
---have been in close contact with someone who is infected by SARS-CoV-2, as per the US CDC or
Due to the occurrence of SARS-CoV-2 in other individuals in the same institution, those at high risk of infection are also at risk.
What happens if I miss the dose?
If you're on a monthly injection schedule, call your doctor to get instructions if your appointment is missed.
What happens if I overdose?
In a medical setting, an overdose is treated immediately.
What should be avoided?
Follow your doctor's instructions if he or she prescribes restrictions on food, drink, and activity.
Interaction with other drug
Casirivimab or imdevimab may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the other medications you take.
