The US Food and Drug Administration’s (FDA) approval of 2 vaccines for coronavirus disease 2019 (COVID-19) was a groundbreaking advancement in the fight against the virus. As the global rollout of the vaccines continues, many nurse practitioners (NPs) and physician assistants (PAs) have been vaccinated in December 2020 and January 2021, benefitting both providers and patients. The FDA also approved additional medications of import to NPs and PAs, including new treatments for advanced prostate cancer and hereditary angioedema.

Vaccines for COVID-19

The FDA approved Pfizer and BioNTech’s COVID-19 vaccine for emergency use on December 11th, while Moderna’s COVID-19 vaccine was approved for emergency use 1 week later on December 18th. Both vaccines contain mRNA, are administered in a 2-dose series, and must be stored at low temperatures: Pfizer’s vaccine requires ultra-cold storage (-70 °C) and Moderna’s is stored frozen between -25 °C and -15 °C. There are some differences between the vaccines: of note, Pfizer’s vaccine can be given to patients as young as 16,1 while Moderna’s vaccine is only approved for patients aged 18 and older.2

The rollout of both approved vaccines has been slower than initially projected, though many healthcare workers and residents of long-term care facilities have received at least 1 dose. To weigh in on COVID-19 vaccines and let Clinical Advisor know how the rollout is going in your home city, click here.


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Orgovyx for Advanced Prostate Cancer

OrgovyxTM (relugolix) tablets were approved by the FDA for the treatment of advanced prostate cancer in adult patients.3 The medication is a gonadotropin-releasing hormone (GnRH) receptor antagonist, and is available in 120 mg doses taken orally once daily following a 360 mg loading dose.3

Data from the HERO trial (NCT03085095) indicates that at week 48, the castration rate was 96.7% for patients in the Orgovyxarm vs 88.8% for patients in the leuprolide acetate group.3 Additionally, 99% patients who received Orgovyx(n=622) had testosterone levels of less than 50 ng/dL compared with 82% patients who received leuprolide acetate (n=308).3

Orladeyo for Hereditary Angioedema

To prevent attacks of hereditary angioedema (HAE) in patients aged 12 and older, the FDA has approved OrladeyoTM (berotralstat),a 150 mg capsule taken orally once daily with food.4 The approval follows a multicenter, randomized, double-blind, placebo-controlled, study that included patients with both Type 1 and Type 2 HAE. Participants who received 150 mg Orladeyo once a day had an HAE attack rate of 1.31 per 28 days vs an attack rate of 1.65 for participants who received 110 mg of Orladeyo daily; patients in the placebo group had an attack rate of 2.35 per 28 days.4

The manufacturer warns against administering doses larger than 150 mg because of risk elevation for increased QT prolongation.4 Dose adjustment is also recommended for patients with hepatic or gastrointestinal impairments, as well as for patients with chronic administration of P-glycoprotein or breast cancer resistance protein (BCRP) inhibitors.4

References

  1. Fact sheet for healthcare providers administering vaccine (vaccination providers) Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). United States Food and Drug Administration. Accessed January 6, 2021. https://www.fda.gov/media/144413/download
  2. Fact sheet for healthcare providers administering vaccine (vaccination providers) Emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). United States Food and Drug Administration. Accessed January 6, 2021.  https://www.fda.gov/media/144637/download
  3. OrgovyxTM [package insert]. Basel, Switzerland: Myovant Sciences; 2020.
  4. OrladeyoTM [package insert]. Durham, NC: BioCryst; 2020.