Drug Detail:Rezafungin (Rezafungin [ re-za-fun-jin ])
Drug Class: Echinocandins
Usual Adult Dose for Candidemia
Loading dose: 400 mg once by IV infusion
Maintenance dose: 200 mg once a week by IV infusion
- Administer IV infusion over approximately one hour (250 mL/hr).
- For infusion-related reactions, slow or pause infusion, and restart at a lower rate.
Duration of therapy: Safety has not been established beyond 4 weekly doses
Comments:
- It is recommended to obtain cultures prior to initiating antifungal therapy; adjust treatment appropriately once culture results are known.
- For IV use only; dilute prior to administration.
Use: For the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative options; approval based on limited clinical safety and efficacy data.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
No adjustment recommended.
Precautions
CONTRAINDICATIONS:
- In patients with known hypersensitivity to this drug or other echinocandins.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions
Dialysis
Drug is highly protein bound and not expected to be dialyzable.
Other Comments
Administration advice:
- The manufacturer product information should be consulted prior to product administration.
- Day 1 of treatment begins with loading dose; maintenance dose begins on Day 8.
- Dilute product prior to administration and give by IV infusion only; infuse over 1 hour.
- If infusion-related reactions occur, slow or pause the infusion, and then restart at a reduced rate.
Missed doses:
- In general, administer missed doses (those not given on assigned day) as soon as possible.
- If a missed dose is given within 3 days of assigned day, then next weekly dose may be given on schedule.
- If a missed dose is given beyond 3 days after assigned day, revise dosing schedule to ensure at least 4 days before next dose.
- If restarting after 2 weeks of missed dosing, dosing schedule should begin with 400 mg loading dose.
Storage requirements:
- Vials: Store between 20C to 25C (68F to 77F); Brief excursions permitted to 5C to 30C (59F to 86F).
- Reconstituted solution: Store between 5C to 25C (41F to 77F) for up to 24 hours.
- IV infusion solution: Store between 5C to 25C (41F to 77F) for up to 48 hours; do not freeze.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted prior to preparation for administration.
- Reconstitute vial with sterile water and swirl to dissolve; avoid shaking or foaming.
- Inspect for particulate matter; do not use if solution cloudy or has precipitated.
- Dilute reconstituted product in 250 mL of 0.9% or 0.45% sodium chloride, or 5% dextrose.
General:
- This drug has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.
- Antifungal activity has been demonstrated (in vitro and clinically) for the following microorganisms: C. albicans, C. glabrata, C. parapsilosis, C. tropicalis
Monitoring:
- Monitor patients for infusion-related reactions during IV administration of this drug.
- Assess liver function and monitor patients who develop abnormal liver tests.
- Evaluate patients for hematological changes, such as anemia, during treatment.
Patient advice:
- Counsel patients this drug may cause photosensitivity during treatment; UV protection is recommended.