The FDA has authorized Monoclonal Antibody Infusions for ALL AGES with pre-existing medical conditions. Positive or Post Exposure.

Dec 3, 2021 – Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.

 

(Updated 3 December 2021) DH

Monoclonal Antibody Infusion

Treatment for COVID-19

Anchorage

Patient Request for Treatment

Please enter your name and all requested information after you pick your treatment time.

Remember you MUST fall within the 1-10 day timeline.

Physician Referral ONLY:

Please enter your Name and NPI number in the notes section. This appointment request will be accepted as your Physician Referral.
Your patient will be contacted via email and text message with their appointment confirmation.

MatSu Valley

WEKA is ONLY offering MOBILE Monoclonal Antibody Infusions in the MatSu Valley at this time. Treatments will be provided in home or in our mobile unit. 

 

 

For any further information, please call the statewide COVID helpline at 907-646-3322 for more information and talk to your health care provider.

Testing for COVID-19

Anchorage

Patient Request for Treatment

Please enter your name and all requested information after you pick your treatment time.

Remember you MUST fall within the 1-10 day timeline.

MatSu Valley

Located beside Animal Food Warehouse, (10233 E Palmer-Wasilla Hwy)

Drive up Testing

We offer both rapid and lab based testing. 

Rapid results in under 15 minutes.

Lab based results in 24-72 hours.

Vaccination for COVID-19

Anchorage

 

Co-Administration of Seasonal Flu and COVID 19 coming soon.

MatSu Valley

Located beside Animal Food Warehouse, (10233 E Palmer-Wasilla Hwy)

Vaccination coming soon

 
Each product under EUA also has an FDA fact sheet for providers and one for patients and caregivers
 

Bamlanivimab and etesevimab

 

(REGEN-COV)

 

Sotrovimab

 

COVID 19 Treatment (Monoclonal Antibody Infusion)

When the pandemic first began, no specific treatment for COVID-19 existed. Since this time, however, the FDA has granted Emergency Use Authorization (EUA) to several monoclonal antibody therapies as a treatment for COVID-19.

For the first eight months of the pandemic, there was very little that clinicians could do for those who tested positive for COVID-19 but did not require hospitalization — beyond taking a wait-and-see approach. If a person’s symptoms became severe, we could at that point manage and treat the resulting complications via oxygen therapy and other methods. But, the ideal scenario is to prevent severe symptoms from ever developing in the first place.

With monoclonal antibody therapy, physicians now have a way to help prevent severe symptoms from developing in those who are high risk.

How does monoclonal antibody therapy work?

Monoclonal antibody (mAb) therapy, also called monoclonal antibody infusion treatment, is a way of treating COVID-19. The goal of this therapy is to help prevent hospitalizations, reduce viral loads and lessen symptom severity.

This type of therapy relies on monoclonal antibodies. These are antibodies that are similar to the ones your body would naturally make in response to infection. However, monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of this virus — the spike protein on its outer shell.

By targeting the spike protein, these specific antibodies interfere with the virus’ ability to attach and gain entry into human cells. They give the immune system a leg up until it can mount its own response.

This therapy can be extremely effective, but it’s not a replacement for vaccination. The community still needs to step up and get vaccinated to break the virus’ chain of transmission.

Who is eligible to receive monoclonal antibody therapy?

Monoclonal antibody treatment is available to individuals who:

  • Are high risk** for developing severe COVID-19 and
  • Have a positive COVID-19 test and have not yet been admitted to the hospital and
  • Are 12 years of age or older (and at least 88 pounds) and
  • Suffering from mild to moderate COVID-19

 

AT THIS TIME WE ARE NOT OFFERING PROPHYLAXIS TREATMENT FOR PREVENTION OF COVID-19

 

What is considered “High Risk”? 

**High risk includes any of the following:

  • 65 years of age or older
  • Obesity (body mass index over 25)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes (Type 1 and Type 2)
  • Any Immunocompromising condition or Immunosuppressive treatment.
  • Cardiovascular disease/hypertension
  • Chronic lung disease
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Medical-related technological dependence
 
It is important to note that the likelihood of developing severe COVID-19 increases when a person has multiple high-risk conditions or comorbidities. Other factors (e.g., race or ethnicity) or medical conditions may also place individual patients at high risk for progression to severe COVID-19. The current EUAs state that the use of anti-SARS-CoV-2 monoclonal antibodies may be considered for many of these other patients. For additional information on medical conditions and factors that are associated with increased risks for progression to severe COVID-19, see the CDC webpage Extra Precautions: People With Certain Medical Conditions. Health care providers should consider the benefits and risks of using anti-SARS-CoV-2 monoclonal antibodies for each individual patient.
 

Do I still need monoclonal antibody therapy if I’m not feeling sick yet?

For monoclonal antibody therapy to be most effective, it needs to be taken as early in the disease course as possible. So, the sooner the better — even if you’re not feeling that bad yet.

In high-risk patients, receiving treatment earlier, when symptoms are less severe, may help prevent progression of the disease that would otherwise require hospitalization.

How is monoclonal antibody therapy administered?

Monoclonal antibody therapy is given through intravenous (IV) infusion. These infusions are given in one of our outpatient infusion centers and require about 30 minutes to administer, followed by an hour of observation and monitoring.

One possible side effect of monoclonal antibody therapy is an allergic reaction. These reactions typically only occur during infusion or soon after, and your care team will closely monitor for any signs of an allergic reaction. However, because an infusion reaction can also be delayed, contact your doctor immediately if you notice any of the following signs of an allergic reaction:

  • Fever and/or chills
  • Nausea
  • Headache
  • Shortness of breath
  • Low blood pressure
  • Wheezing
  • Swelling of lips, face or throat
  • Muscle aches
  • Hives or itchiness

Does receiving monoclonal antibody therapy mean I can cut my isolation short?

Anyone who has tested positive for COVID-19 needs to isolate — regardless of whether or not he or she has received monoclonal antibody therapy.

This means staying in your home and away from other household members for:

  • 10 days since testing positive or
  • 10 days after your symptoms first appear and
  • At least 24 hours after your symptoms have improved and you’ve been without fever (without the use of fever-reducing medications)

Only after meeting the above criteria can you return to work and leave your home (while still social distancing and wearing a mask).

 

Can children receive Monoclonal Antibody Infusion?

  • SARS-CoV-2 infection is generally milder in children than in adults, and a substantial proportion of children with the disease have asymptomatic infection.
  • Most children with SARS-CoV-2 infection will not require any specific therapy.
  • Children who have a history of medical complexity (e.g., due to neurologic impairment, developmental delays, or genetic syndromes including trisomy 21), obesity, chronic cardiopulmonary disease, or who are immunocompromised, as well as nonwhite children and older teenagers may be at increased risk for severe disease.
  • There are limited data on the pathogenesis and clinical spectrum of COVID-19 disease in children. There are no pediatric data from placebo-controlled randomized clinical trials and limited data from observational studies to inform the development of pediatric-specific recommendations for the treatment of COVID-19.
  • There is insufficient evidence for the Panel to recommend either for or against the use of anti-SARS-CoV-2 monoclonal antibody products for children with COVID-19 who are not hospitalized but who have risk factors for severe disease. Based on adult studies, bamlanivimab plus etesevimab or casirivimab plus imdevimab may be considered on a case-by-case basis for nonhospitalized children who meet Emergency Use Authorization (EUA) criteria for high-risk of severe disease, especially those who meet more than one criterion or are aged ≥16 years. The Panel recommends consulting a pediatric infectious disease specialist in such cases.
  •  

Can I receive a COVID-19 Vaccination after treatment?

SARS-CoV-2 vaccination should be deferred for ≥90 days in people who have received anti-SARS-CoV-2 monoclonal antibodies. This is a precautionary measure, as the antibody treatment may interfere with vaccine-induced immune responses.

For people who develop COVID-19 after receiving SARS-CoV-2 vaccination, prior vaccination should not affect treatment decisions, including the use of and timing of treatment with monoclonal antibodies.

Can I receive monoclonal antibody therapy if I’m pregnant or breastfeeding?

The use of anti-SARS-CoV-2 monoclonal antibodies can be considered in pregnant people with COVID-19, especially those who have additional risk factors for severe disease (see the EUA criteria for the use of these products above).

As immunoglobulin (Ig) G monoclonal antibodies, the authorized anti-SARS-CoV-2 monoclonal antibodies would be expected to cross the placenta. There is no pregnancy-specific data on the use of these monoclonal antibodies; however, other IgG products have been safely used in pregnant people when their use is indicated. Therefore, these products should not be withheld in the setting of pregnancy. When possible, pregnant and lactating people should be included in clinical trials that are evaluating the use of anti-SARS-CoV-2 monoclonal antibodies.

Is there anything I need to know about receiving monoclonal antibody therapy?

After receiving monoclonal antibody therapy, it’s recommended that you wait 90 days before receiving the COVID-19 vaccine. If you already received the first dose of vaccine before monoclonal antibody therapy, current CDC guidelines recommend you wait 90 days before receiving the second dose.