Version October 2024
Anaphylaxis has been observed with pemivibart in 0.6% (4/623) of participants in a clinical trial. Anaphylaxis was reported during the first and second infusion of pemivibart. Anaphylaxis can be life-threatening. Prior to administering pemivibart, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis. Administer pemivibart only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary. Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion. Discontinue pemivibart immediately if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.
COVID-19, preexposure prophylaxis (off-label use):
Patients with moderate to severe immune compromise who cannot be vaccinated or may have an inadequate response to vaccination:
Note: For patients who have received a COVID-19 vaccination, administer pemivibart ≥2 weeks after vaccination. Development of SARS-CoV-2 variants with reduced susceptibility to pemivibart may increase risk of treatment failure; consider local prevalence of variants when evaluating therapy options (Ref). Further information on variants may be found at https://covid.cdc.gov/covid-data-tracker/#variants-genomic-surveillance.
IV: 4.5 g as a single dose; may repeat dose every 3 months (Ref).
No dosage adjustment necessary (Ref).
No dosage adjustment necessary (Ref).
Refer to adult dosing.
(For additional information see "Pemivibart (United States: Authorized for use): Pediatric drug information")
COVID-19, preexposure prophylaxis: Note: Only for use in patients with moderate to severe immune compromise who cannot be vaccinated or may have an inadequate response to vaccination. Pemivibart has not been studied in pediatric patients; emergency use authorization from the FDA is based on likelihood of similar exposures in patients ≥12 years of age weighing ≥40 kg to those in adults (Ref).
Children ≥12 years and Adolescents, weighing ≥40 kg: IV: 4,500 mg every 3 months (Ref).
Children ≥12 years and Adolescents, weighing ≥40 kg: No dosage adjustment necessary. Kidney impairment is not expected to affect pemivibart exposure because pemivibart is not eliminated intact in the urine.
Children ≥12 years and Adolescents, weighing ≥40 kg: No dosage adjustment necessary; while the effect of liver impairment on pemivibart pharmacokinetics is unknown, liver impairment is not anticipated to impact pemivibart exposure because pemivibart is expected to be degraded into small peptides and amino acids via catabolic pathways.
The following adverse reactions and incidences are derived from the FDA-issued emergency use authorization (EUA) in adults.
1% to 10%:
Gastrointestinal: Nausea (2%)
Hypersensitivity: Hypersensitivity reaction (1% to 9%; including anaphylaxis [<1%], infusion-related reaction)
Infection: Viral infection (4%)
Local: Infusion-site reaction (2%; including bruise, injection-site reaction, localized erythema, localized rash)
Nervous system: Fatigue (3%), headache (2%)
Respiratory: Flu-like symptoms (3%), upper respiratory tract infection (6%)
Severe hypersensitivity (eg, anaphylaxis) to pemivibart or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity and infusion-related reactions: Hypersensitivity and infusion-related reactions, including severe or life-threatening reactions, have been observed during infusion and up to 24 hours after infusion of pemivibart. Hypersensitivity reactions occurring more than 24 hours after infusion have been reported with use of other SARS-CoV-2 monoclonal antibodies. Signs and symptoms of hypersensitivity and infusion-related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (eg, presyncope, syncope), dizziness, and diaphoresis. Anaphylaxis, including life-threatening reactions, has also been observed; manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia. Immediately discontinue administration and institute appropriate supportive therapy if signs and symptoms of clinically significant hypersensitivity or infusion-related reactions occur. Discontinue use permanently in individuals who experience anaphylaxis. Additionally, pemivibart contains polysorbate 80, an ingredient in some COVID-19 vaccines; polysorbate 80 is also structurally similar to polyethylene glycol, an ingredient in some other COVID-19 vaccines. Consider consultation with an allergist/immunologist prior to administering pemivibart to individuals who have experienced a severe hypersensitivity reaction or anaphylaxis to a COVID-19 vaccine (Ref). See also "Polysorbate 80" warning below.
Dosage form specific issues:
• Polysorbate 80: Contains polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Ref). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Ref). See manufacturer's labeling.
Other warnings/precautions:
• SARS-CoV-2 viral variants: Certain SARS-CoV-2 viral variants may emerge that are not neutralized by monoclonal antibodies such as pemivibart. Pemivibart may not be effective at preventing COVID-19 caused by these variants. If signs or symptoms of COVID-19 occur, advise patients to test for COVID-19 and seek medical attention, including treatment, as necessary (Ref).
Investigational agent; approved for emergency use authorization by the FDA March 2024.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Pemgarda: 500 mg/4 mL (4 mL) [contains polysorbate 80]
No
Solution (Pemgarda Intravenous)
500 mg/4 mL (per mL): $192.50
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Pemivibart is available under an emergency use authorization (EUA) from the FDA. As part of the EUA, fact sheets pertaining to emergency use of pemivibart are required to be available for health care providers and patients/caregivers, and certain mandatory requirements for pemivibart administration under the EUA must be met as outlined in the FDA EUA letter; the fact sheets and EUA letter may be accessed at https://www.pemgarda.com/. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with pemivibart use by either submitting a MedWatch form (https://www.fda.gov/medwatch/report.htm) or FDA form 3500 (health professional) by mail or fax (1-800-FDA-0178); a copy of all MedWatch forms should also be provided to Invivyd, Inc (https://invivyd.com).
IV: Administer only in settings with immediate access to medications to treat hypersensitivity reactions (eg, anaphylaxis) and the ability to activate the emergency medical system as necessary. Administer entire contents of prepared IV bag by IV infusion over 60 minutes through an infusion set including inline 0.2-micron filter. Flush line with NS after completion of infusion. If a mild infusion-related reaction occurs, consider slowing or stopping infusion and instituting appropriate medications and/or supportive care; discontinue infusion immediately and institute appropriate medications and/or supportive care if anaphylaxis or other clinically significant hypersensitivity or infusion-related reactions occur (Ref).
Note: Administer only in settings with immediate access to medications to treat hypersensitivity reactions (eg, anaphylaxis) and the ability to activate the emergency medical system if necessary.
IV: Administer entire contents of prepared bag by IV infusion over ≥60 minutes, using an infusion set containing an inline 0.2-micron filter. Flush line with NS after completion of infusion.
If a mild infusion-related reaction occurs, consider slowing or stopping infusion and instituting appropriate medications and/or supportive care; if anaphylaxis or other clinically significant hypersensitivity or infusion-related reactions occur, discontinue infusion immediately and institute appropriate medications and/or supportive care.
See "Use: Off-Label."
COVID-19, preexposure prophylaxis
Pemivibart may be confused with peramivir.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
COVID-19 Vaccines: Pemivibart may diminish the therapeutic effect of COVID-19 Vaccines. Management: Do not administer pemivibart for at least 2 weeks after receipt of COVID-19 vaccination. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Animal reproduction studies have not been conducted.
Pemivibart is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Ref).
Dose adjustments are not recommended in pregnant patients.
It is not known if pemivibart is present in breast milk.
Pemivibart is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Ref).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor for anaphylaxis, hypersensitivity, and infusion reactions during infusion and for at least 2 hours after infusion.
Pemivibart is a recombinant human IgG1λ monoclonal antibody that targets the spike protein receptor–binding domain of SARS-CoV-2, inhibiting attachment to the human ACE2 receptor on host cells (Ref).
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