ce
New FDA Approved Drugs & Vaccines How Supplied: Nirsevimab-alip is available as a single-dose, pre-filled syringe in either a 50mg/0.5ml or a 100mg/mL injection. It should be stored in the refrigerator until ready to administer. If the syringe is pulled from the refrigerator, it must be used within 8 hours or discarded. Do not freeze or shake.
The combination of nirmatrelvir and ritonavir was shown in a clinical trial to lower the rate of disease progression by 89% compared to placebo. The trial included 2,113 people from around the world who tested positive for COVID-19, had symptoms of mild to moderate disease for 5 days or fewer, and with at least one risk factor for progression to severe disease. Nirmatrelvir is a 3C-like protease inhibitor that cleaves nonstructural proteins of the severe-acute-respiratory-syndrome-related corona- virus 2 (SARS-CoV-2) and inhibiting its replication. The oral bioavailability of nirmatrelvir is beneficial for dosing. Ritonavir is an antiretroviral used to increase the bioavailability of nirmatrelvir by inhibiting its inac- tivation by CYP3A4. They must be co-administered to decrease the occurrence of viral rebound and reemergence of COVID-19 symptoms. Administration and How Supplied: Nirmatrelvir- ritonavir should be administered as soon as possible after a diagnosis of COVID-19 and within 5 days of symptom onset. Nirmatrelvir tablets are co-pack- aged with ritonavir tablets in separate blister cavities within the same child-resistant blister card and are supplied in two different dose packs: a standard dose and a reduced dose for patients with moderate renal impairment (eGFR between 30-60 mL/min). The standard dose is 300 mg of nirmatrelvir (2 x 150 mg tablets) taken together with 100 mg of ritonavir (1 x 100 mg tablet) by mouth twice a day for 5 days, with or without food. For patients with moderate renal impairment, the reduced dose is 150 mg of nir- matrelvir (1 x 150 mg tablet) with 100 mg of ritonavir (1 x 100 mg tablet) by mouth twice a day for 5 days (Figure 3). The dose packs should be stored at room temperature. If a dose is missed, take it if less than 8 hours. If more than 8 hours, skip it and resume the next scheduled dose. Do not take more than 1 dose at a time. It is important that all doses (the full 5 days) are taken.
Additional Notes: Proper hygiene is essential in keeping infants and young babies healthy during the RSV season. Counsel parents and caregivers who are (especially) feeling ill to follow proper hygiene (e.g., hand washing with soap, covering nose and mouth when coughing or sneezing, and avoiding touching the eyes, nose, or mouth). It is important to note that there is also an RSV vac- cine (Abrysvo) available for pregnant women to be given between 32 through 36 weeks of pregnancy to prevent RSV in babies from birth through 6 months of age. Most newborns and infants will not need both; however, neonates born prior to 34 weeks gestation should receive a dose of nirsevimab-alip regardless of vaccine status of the mother. Paxlovid (nirmatrelvir-ritonavir) Indication and Mechanism of Action: Nirmatrelvir- ritonavir is the first oral antiretroviral therapy approved to treat mild to moderate COVID-19 infection in adults who are at risk for progression to severe COVID-19, including hospitalization and death. It is the fourth treatment to be approved for this indication. Several risk factors for progression to severe COVID-19 infection include age greater than 50 years, heart disease, type I and type II DM, being overweight or obese (BMI ≥ 25), lifestyle choices such as smoking, and physical and mental disabilities.
CPhT CONNECT
www.cphtconnect.com 36
Made with FlippingBook - PDF hosting