My wife was taking care of another person's baby two days ago and again today. Two days ago she brought the baby to our house and i didnt hold her but came close to her a number of times. Today while my wife was again helping with the baby (two years old) she saw the baby was sick with a light temperature of around 100.5. She and the Mother tested the kid with the Rapid Test from CVS, and the baby tested positive.
I'm not sure what to do. I've been vaccinated twice with Moderna and then a Booster with Pfizer, but tests have shown NO Antibodies. I called Boca Raton Hospital Emergency Room, because I know they have a separate section of the ER for Monoclonal Antibody infusion. I'd touched base with them a few months ago, and learned about this unit at that time. One of their nurses told me that severely immunocompromised individuals were eligible to get their infusions. When I told her I was a patient at their Cancer Center (Lynn Cancer Center) with CLL, she put my name on a list of those who would be eligible. I called an hour ago, and one of their nurses said I could come in 7am Saturday for an Infusion.
I searched Medicare to see if they cover it, and they do, but it seems the requirement is a Positive Test and those likely to have more severe response to exposure. Obviously I fit into the second category, but I havent yet tested to see if I'm positive. I think you are supposed to wait five to seven days after exposure. I'm thinking I should keep my 7am Saturday appointment for Infusion. Any thoughts are appreciated.
Carl
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wizzard166
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You don’t need to test positive, just be exposed if you have CLL.
FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COVTM (casirivimab and imdevimab) FOR CORONAVIRUS DISEASE 2019 (COVID-19)
You are being given a medicine called REGEN-COV (casirivimab and imdevimab) for the treatment or post-exposure prevention of coronavirus disease 2019 (COVID-19). SARS-CoV-2 is the virus that causes COVID-19. This Fact Sheet contains information to help you understand the potential risks and potential benefits of taking REGEN-COV.
Receiving REGEN-COV may benefit certain people with COVID-19 and may help prevent certain people who have been exposed to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection, or may prevent certain people who are at high risk of exposure to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection.
Read this Fact Sheet for information about REGEN-COV. Talk to your healthcare provider if you have questions. It is your choice to receive REGEN-COV or stop at any time.
WHAT IS COVID-19?
COVID-19 is caused by a virus called a coronavirus, SARS-CoV-2. People can get COVID-19 through contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, and other conditions including obesity, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID- 19.
WHAT ARE THE SYMPTOMS OF COVID-19?
The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to become worse.
WHAT IS REGEN-COV (casirivimab and imdevimab)?
REGEN-COV is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)) who are at high risk for severe COVID-19, including hospitalization or death for:
• treatment of mild to moderate symptoms of COVID-19
• post-exposure prevention of COVID-19 in persons who are:
o not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose vaccine [such as Johnson & Johnson’s Janssen vaccine]), or,
o are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising
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conditions, including someone who is taking immunosuppressive medications),
and
have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example). For additional details, go to cdc.gov/coronavirus/2019-nc... sick/quarantine.html, or
someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, as nursing homes, prisons,).
REGEN-COV is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using REGEN-COV to treat people with COVID-19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.
The FDA has authorized the emergency use of REGEN-COV for the treatment of COVID-19 and the post-exposure prevention of COVID-19 under an Emergency Use Authorization (EUA). For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
WHO SHOULD NOT TAKE REGEN-COV?
Do not take REGEN-COV if you have had a severe allergic reaction to REGEN-COV.
WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE I RECEIVE REGEN-COV?
Tell your healthcare provider about all of your medical conditions, including if you:
• Have any allergies
• Have had a severe allergic reaction including anaphylaxis to REGEN-COV previously
• Have received a COVID-19 vaccine.
• Have any serious illnesses
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Are taking any medications (prescription, over-the-counter, vitamins, and herbal
products)
HOW WILL I RECEIVE REGEN-COV (casirivimab and imdevimab)?
• REGEN-COV consists of two investigational medicines, casirivimab and imdevimab, given together at the same time through a vein (intravenous or IV) or injected in the
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tissue just under the skin (subcutaneous injections). Your healthcare provider will
determine the most appropriate way for you to be given REGEN-COV.
• Treatment: If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer. Your healthcare provider will determine the duration of your infusion.
o If your healthcare provider determines that you are unable to receive REGEN- COV as an intravenous infusion which would lead to a delay in treatment, then as an alternative, REGEN-COV can be given in the form of subcutaneous injections. If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time.
• Post-exposure prevention: If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time. If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer.
o After the initial dose, if your healthcare provider determines that you need to receive additional doses of REGEN-COV for ongoing protection, the additional intravenous or subcutaneous doses would be administered monthly.
WHAT ARE THE IMPORTANT POSSIBLE SIDE EFFECTS OF REGEN-COV (casirivimab and imdevimab)?
Possible side effects of REGEN-COV are:
• Allergic reactions. Allergic reactions can happen during and after infusion or injection of REGEN-COV. Tell your healthcare provider right away or seek immediate medical attention if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, feeling faint, dizziness and sweating. These reactions may be severe or life threatening.
• Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion or injection, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these symptoms occur, contact your healthcare provider or seek immediate medical attention as some of these symptoms have required hospitalization. It is unknown if these symptoms are related to treatment or are due to the progression of COVID-19.
The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site. The side effects of getting any medicine by subcutaneous injection may include pain, bruising of the skin, soreness, swelling, and possible infection at the injection site.
These are not all the possible side effects of REGEN-COV. Not a lot of people have been given REGEN-COV. Serious and unexpected side effects may happen. REGEN-COV is still being studied so it is possible that all of the risks are not known at this time.
It is possible that REGEN-COV could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, REGEN-COV may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.
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WHAT OTHER TREATMENT CHOICES ARE THERE?
Like REGEN-COV (casirivimab and imdevimab), FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to fda.gov/emergency- preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use- authorization for information on the emergency use of other medicines that are not approved by FDA that are used to treat people with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for.
It is your choice to be treated or not to be treated with REGEN-COV. Should you decide not to receive REGEN-COV or stop it at any time, it will not change your standard medical care.
WHAT OTHER PREVENTION CHOICES ARE THERE?
Vaccines to prevent COVID-19 are also available under Emergency Use Authorization. Use of REGEN-COV does not replace vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
There is limited experience using REGEN-COV (casirivimab and imdevimab) in pregnant women or breastfeeding mothers. For a mother and unborn baby, the benefit of receiving REGEN-COV may be greater than the risk of using the product. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
HOW DO I REPORT SIDE EFFECTS WITH REGEN-COV (casirivimab and imdevimab)?
Tell your healthcare provider right away if you have any side effect that bothers you or does not go away.
Report side effects to FDA MedWatch at fda.gov/medwatch or call 1-800-FDA-1088 or call 1-844-734-6643.
• Contact your local or state public health department.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made REGEN-COV (casirivimab and imdevimab) available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
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REGEN-COV has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA must determine, among other things, that based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. All of these criteria must be met to allow for the medicine to be used in the treatment of COVID-19 or prevention of COVID-19 during the COVID-19 pandemic.
The EUA for REGEN-COV is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
Manufactured by:
Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707
My advice is to go and get the infusion. Don’t wait until a positive test just go and get it Saturday and let us know how you are doing. Wishing the best.
Thank you so much Brian for replying to me. I just tried sent a message to Jennifer Brown through Patient Gateway Mass Gen Brigham, to see if she had any negative thoughts on my getting the infusion, but the chances she will see my message in time are likely very slim. I'm scheduled 7am this Saturday. I wouldnt imagine a physician would see any negative with a CLL patient getting this infusion (I'm still Watch and Wait), but I feel much better with your input now.
My Wife is double vaccinated with Moderna last Jan and Feb, and then had the Pfizer Booster a week ago. She is much younger (only 60) and never is sick since I've known her for fourteen years now, so I imagine her antibody level is very high. I didnt hold the two year old on Monday, but came fairly close and talk and sang to her. My wife of course had constant contact with her all day Monday, and then also yesterday when the child already was sick with a low fever. I never stayed away from my wife since Monday, so if she is now carrying it I guess I should already be somewhat infected. I have no symptoms yet.
If you've seen some of my posts, I've taken risks that I realize many would call stupid; yet, somehow I've never gotten sick or tested positive. I've wondered if there is something in our physiological or genetic makeup that results in an individual, even one with CLL and a very compromised immune system, that makes these individuals not susceptible to COVID. I've thought of spouses who were constantly exposed to their partner who got hospitalized and died from COVID; Yet, who never even turned positive. Then someone like me with 0 Antibodies after two vaccinations and then a Booster, who does what I've done and so far never got positive tests or symptoms. Maybe I'm just incredibly lucky, or maybe there is something in my blood or genes that keeps the COVID unable to penetrate.
Thank you again for helping me with your input on the infusion.
My Dr is Jennifer Brown and she told me twice during my visit in November if I got covid to get regeneron. My husband and I were being so careful but there is a surge in NH and I came down with it a few weeks later. I got the infusion on day 8 because of the delay reporting of test results then a weekend. I didn't feel bad but the covid nurse told me between day 9-11 is when people will suddenly turn for the worst. It never went into my lungs just stayed in my head like a bad sinus infection. Matter of fact the day of the infusion my eyes were red and a little teary. Better safe than saying I should of done it I guess. Angie
Thank you for the Input, and glad to realize you obviously came out of the attack from Covid well. Maybe the infusion saved you. I figured Dr Brown would agree, but I tried to message her yesterday anyway. Hearing from Dr Koffman in his reply to my post made me more relieved too.
I see from your post you had a positive result from the test, so I guess no worries with Medicare. I'm concerned because their web site indicates two requirements must be met for coverage. One is a positive test and the other is the person being at high risk. Unfortunately they don't count being exposed with high risk as qualifying for coverage.
Did you call the number on medicare card? I have Harvard Pilgrim advantage plan and she said they cover it fully. Only downside is it is experimental so they don't know if vaccine shots will work in the future or if your immune system will recognize the next covid exposure and your antibodies will kick in but the technology has been around for awhile. It's all in the brochure they hand you . I know 3 people who on day 11 crashed and went to the emergency room. One friend is still in hospital but out of ICU. Angie
I called Medicare and they simply ask for the name of the infusion and then search it on Medicare's site, which is what I did myself. The woman found the same thing I did, that there must be both a positive test result and also the recipient must be high risk.
I did see on the internet however that Monoclonal Antibody Infusion medication was being supplied by the government free to providers who are administering it, due to the declaration that it was being approved now on an Emergency Basis. In other words just like the Vaccines the government approved, they didnt go through normal FDA Approval; instead, Congress authorized the vaccines on an Emergency Authorization. Apparently because Congress gave both Vaccines and Monoclonal Infusions Emergency Authorization, they are both being given to us at no charge by the government. The only charge is thus the providers being allowed to charge for the administration of vaccine shots and also the actual infusion, but not for either medication.
If I'm understanding this correctly, then the worst thing I'll be hit with is the hospital ER charge for administration of the Infusion but not the medication, and possibly Medicare will pay for the Infusion. I think they might have to pay for the infusion administration, because an ER Doctor saw me and agreed it was an Emergency.
In San Francisco, you can self refer to UCSF who is doing a great job with COVID research and providing the MAB treatments for all of the community, regardless of who your usual provider is. Sorry that it is not as available elsewhere. For anyone here, this link will give you a document describing the process as well as your self referal document to fill out and email or fax to the spot at the top of the form. Then you will be contacted for a brief video call and then will be given your appointment for infusion. The question Loren and I have is .. how do we get to the infusion center once accepted? Assuming we both will get the infusion as, if one gets it, the other is considered significantly exposed. Cannot Uber and expose the driver. Hoping one of us will feel healthy enough to drive. Here is the link infectioncontrol.ucsfmedica...
My CLL dr said if I’m ever exposed, to call her office and they will start me on MAB immediately. Get the infusion 😉😉Can you call your CLL doc to get an order for it - would that help with Medicare?
I don't think an order for the infusion by a doctor would bypass Medicare's requirement. If Medicare rejects the claim, I'm planning to appeal based on extreme risk due to being classified as immunocompromised along with Exposure.
Wizard. I just recovered from covid. I was vaccinated and still got it. You should qualify for monoclonal antibodies. I was told most peoe feel better after a few hours of having the treatment. The antibodies are man made and cure nearly everyone that gets covid but you must get them early after symptoms start (within 10 days). If you have cll you can get monoclonal treatment even if you don't test positive but have been exposed.
I believe monoclonal I'd the best treatment available and you keep the antibodies for mo the after you get the treatment which is given by IV drip. Quite simple. Good luck.
The Hospital ER Staff is qualifying me for Infusion based on having CLL and being Immunocompromised and having been exposed to someone who tested positive. Unfortunately Medicare's current rules don't agree with those two factors as justification. Medicare states that both of two criteria must be met for coverage of MAB. One is testing Positive and the other is High Risk.
My understanding in FL is, an immune compromised person in FL qualifies for the infusion, period. And DeSantis has made sure there is a lot available in FL. Go get it Sat AM!
Thank you Sofia and also everyone else who has replied. I'm choosing the Hospital ER over the sites in parks under tents that Desantis and McGuire Corporation have set up, but it might cost me due to Medicare. I reviewed Medicare's rules and its very clear that two requirements must be met: 1) test positive 2) be at high risk.
The reason I'm choosing the hospital is because of a few reasons: 1) they are doing the infusion, which clearly is dramatically superior to four subcutaneous injections; 2) I trust what I'm getting more from a hospital; 3) if I go in shock or any other serious side effect, then of course I'm more likely to survive in the hospital ER. I'm happy that Desantis and McGuire Corp have made the shots available in the locations they've set up in, and if the offer at the hospital was not available, I was going to go to the Park in West Palm Beach for the shots.
My original appointment was tomorrow Saturday at 7am, and the ER Triage Nurse called yesterday Morning to alert me they received notice of a lack of supplies that was building at that time. She said the appointment on Saturday didn't have supplies earmarked for it at that moment of the phone call. Later that day she called me and said an opening had occurred for today at 2pm, so I took it. That was definitely scary, but it looks like this time its working out.
I still have no symptoms, and Monday was the time of exposure. So part of me says call to cancel, but the fear in me says keep the appointment. I guess symptoms can take longer to appear than three days, if we count Thursday being completed now as the third day from Monday.
Yes. It is four shots if this method of delivery is chosen as Palmetto wrote concerning her husband (one in each arm and one on each side of the abdomen).
I’m also seen at Dana Farber and my nurse practitioner told me in November to call and schedule the monoclonal antibody treatment if I got Covid. Dana Farber evidently has a clinic set up at their Chestnut Hill (Newton) facility. I know you are in Florida so that doesn’t help but as others have said CLL Specialists are recommending this treatment. At the Dana Farber clinic the treatment is given via IV. It seems this methodology is more effective than the shot series from what I’ve read. The other positive for you is the monoclonal antibodies are said to provide a prophylactic benefit for 6-8 months so this will be beneficial for you even if you don’t have Covid now.
Nov. 10, 2021 -- The pharmaceutical company Regeneron says a clinical trial shows that one dose of its antibody drug reduces an uninfected person's chances of contracting COVID-19 by 81.6% for up to eight months after the drug is taken, the company said in a news release.Nov 10, 2021
I'm going to intiate another post, so more people see it; instead of adding a comment of mine to this thread, but I'll mention it here too so you see it.
I got the infusion at Boca Regional yesterday as planned, and it went well. No side effects at all. It took around 25 to 30 minutes through the IV Drip, and then they put me in an observation room for about forty five minutes.
The main thing I'm a little concerned with, and maybe the larger numbers of others on our site will know more about this, is they told me I was not getting the Regeneron. They said their supplies were forcing a change, and instead I was getting the monoclonal antibody infusion they used "Before Regeneron". They told me the name and it is a combination of two monoclonal antibodies: Bamlanivimab and Etesevimab.
I asked the Nurse if this was not as effective as Regeneron and she didnt really know, but she said that it seems that Regeneron is not being very effective with the new Omicron Variant. She said the one I was getting might be better. Later I used Google to search Regeneron and Omicron Variant, and the news is populated with stories about it not working well with Omicron. Maybe the older version I received will actually be better with Omicron.
Thanks for letting me know about the shortage of Regeneron. Hopefully, the substitute is effective for you. It’s not surprising there are shortages after reflecting upon the situation for a moment. It’s difficult to manufacture and there is a surge in demand due to those who haven’t been vaccinated but find themselves infected with Covid.
I had been counting upon ready access to Regeneron as my ace in the hole but now hearing about shortages and the treatment’s likely ineffectiveness against the Omicron variant I’m getting concerned.
I may be in the same boat as you found yourself last week. My son has a cold that has come on strong this morning. He passed out and is weak. He passed a rapid Covid test but those don’t seem to always pick up infection early. My wife just took him to the doctor’s office and he will get a PCR test. Boy, this is getting old.
The good news Mark is that kids seem to handle covid fairly well. The latest statistics show that younger people now are in greater numbers of total hospital stays with Covid, but I'm sure that is only because so many older folks have been vaccinated. Still if your Son has symptoms you want to maybe get a PCR. In all liklihood it is only a regular winter cold.
He never developed Covid. Our daughter-in-law who was the one with Covid recovered very quickly after she received the Regeneron shots as she had recently been treated with chemotherapy and surgery for breast cancer
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Dr. Lamanna is the BEST of the best!
Mom was recently diagnoses
MABs - Encouraging, but not really
