Dosing Regimens
The doses listed here are for approved indications or from reported experiences or clinical trials. | Adverse Events | Monitoring Parameters | Drug-Drug Interaction Potential | Comments and Links to Clinical Trials |
The doses and indications listed below come from the FDA product information. Please see Therapeutic Management of Hospitalized Adults With COVID-19 for the Panel’s recommendations on when to use RDV. For Hospitalized Adults and Children (Aged ≥12 Years and Weighing ≥40 kg) For Patients Who Are Not Mechanically Ventilated and/or on ECMO: - RDV 200 mg IVa on Day 1, then RDV 100 mg IV on Days 2–5
- For patients who do not show clinical improvement after 5 days of therapy, treatment may be extended to up to 10 days.
For Mechanically Ventilated Patients and/or Patients on ECMO: - RDV 200 mg IVa on Day 1, then RDV 100 mg IV on Days 2–10
Suggested Dose in EUAb for Hospitalized Children For Patients Weighing 3.5 kg to <40 kg: - RDV 5 mg/kg IVa on Day 1, then RDV 2.5 mg/kg IV once daily starting on Day 2
- For patients who are not mechanically ventilated and/or on ECMO, the duration is 5 days. If patients have not shown clinical improvement after 5 days, treatment may be extended to up to 10 days.
- For mechanically ventilated patients and/or patients on ECMO, the recommended treatment duration is 10 days.
For Patients Aged <12 Years and Weighing ≥40 kg: | - Nausea
- ALT and AST elevations
- Hypersensitivity
- Increases in prothrombin time
- Drug vehicle is SBECD, which has been associated with renal and liver toxicity. SBECD accumulation may occur in patients with moderate or severe renal impairment.
- Each 100 mg vial of RDV lyophilized powder contains 3 g of SBECD, and each 100 mg/20 mL vial of RDV solution contains 6 g of SBECD.
- Clinicians may consider preferentially using the lyophilized powder formulation (which contains less SBECD) in patients with renal impairment.
| - Infusion reactions
- Renal function and hepatic function should be monitored before and during treatment as clinically indicated.
- In the FDA product information, RDV is not recommended when eGFR is <30 mL/min. See the Remdesivir section for a discussion on using RDV in people with renal insufficiency.
- RDV may need to be discontinued if ALT level increases to >10 times ULN and should be discontinued if there is an increase in ALT level and signs or symptoms of liver inflammation are observed.1
| - Clinical drug-drug interaction studies of RDV have not been conducted.
- In vitro, RDV is a substrate of CYP3A4, OATP1B1, and P-gp and an inhibitor of CYP3A4, OATP1B1, OATP1B3, and MATE1.1
- Minimal to no reduction in RDV exposure is expected when RDV is coadministered with dexamethasone (Gilead Sciences, written communication, July 2020).
- CQ or HCQ may decrease the antiviral activity of RDV; coadministration of these drugs is not recommended.1
- No significant interaction is expected between RDV and oseltamivir or baloxavir (Gilead Sciences, personal and written communications, August and September 2020).
| - RDV should be administered in a hospital or a health care setting that can provide a similar level of care to an inpatient hospital.
- RDV is approved by the FDA for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged ≥12 years and weighing ≥40 kg).
- An EUAb is available for hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg.
- A list of clinical trials is available here: Remdesivir
|
Adults:- The dose most commonly used in clinical trials is IVM 0.2–0.6 mg/kg PO given as a single dose or as a once-daily dose for up to 5 days.
| - Generally well tolerated
- Dizziness
- Pruritis
- GI effects (e.g., nausea, diarrhea)
- Neurological AEs have been reported when IVM has been used to treat parasitic diseases, but it is not clear whether these AEs were caused by IVM or the underlying conditions.
| - Monitor for potential AEs.
| - Minor CYP3A4 substrate
- P-gp substrate
| - Generally given on an empty stomach with water; however, administering IVM with food increases its bioavailability.2
- A list of clinical trials is available here: Ivermectin
|
发表于 2021-11-3 19:16:02
分享
收藏
