INDICATIONS AND USAGE（适应症）

AmBisome is indicated for the following:

•Empirical therapy for presumed fungal infection in febrile, neutropenic patients.

•Treatment of Cryptococcal Meningitis in HIV-infected patients.

•Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.

•Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites.

DOSAGE（服用剂量）

AmBisome is not interchangeable or substitutable on a mg per mg basis with other amphotericin B products. Different amphotericin B products are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing.

AmBisome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.

An in-line membrane filter may be used for the intravenous infusion of AmBisome, provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1.0 MICRON.

NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.

Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased.

The recommended initial dose of AmBisome for each indication for adult and pediatric patients is as follows:

Empirical therapy: 3 mg/kg/day

Systemic fungal infections(Aspergillus, Candida, Cryptococcus): 3 - 5 mg/kg/day

Cryptococcal meningitis in HIV-infected patients: 6 mg/kg/day

Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.

Doses recommended for visceral leishmaniasis are presented below:

Immunocompetent patients: 3 mg/kg/day (days 1 - 5) and 3 mg/kg/day on days 14, 21

Immunocompromised patients: 4 mg/kg/day (days 1 - 5) and 4 mg/kg/day on days 10, 17, 24, 31, 38

For immunocompetent patients who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful.

For immunocompromised patients who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended.

ADVERSE REACTIONS（不良反应）

Abdominal pain

Asthenia

Back pain

Blood product transfusion reaction

Chills

Infection

Pain

Sepsis

Chest pain

Hypertension

Hypotension

Tachycardia

Diarrhea

Gastrointestinal hemorrhage

Nausea

Vomiting

Alkaline phosphatase increased

ALT (SGPT) increased

AST (SGOT) increased

Bilirubinemia

BUN increased

Creatinine increased

Edema

Hyperglycemia

Hypernatremia

Hypervolemia

Hypocalcemia

Hypokalemia

Hypomagnesemia

Peripheral edema

Anxiety

Confusion

Headache

Insomnia

Cough increased

Dyspnea

Epistaxis

Hypoxia

Lung disorder

Pleural effusion

Rhinitis

Pruritus

Rash

Sweating

Hematuria

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f7be6506-4d20-401e-a0ff-02ad7c33158a/spl-doc?hl=AmBisome

AmBisomeinformation