ABELCET (Page 4 of 4)

OVERDOSAGE

Amphotericin B desoxycholate overdose has been reported to result in cardio-respiratory arrest. Fifteen patients have been reported to have received one or more doses of ABELCET ® between 7-13 mg/kg. None of these patients had a serious acute reaction to ABELCET ®. If an overdose is suspected, discontinue therapy, monitor the patient’s clinical status, and administer supportive therapy as required. ABELCET ® is not hemodialyzable.

DOSAGE AND ADMINISTRATION

The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. ABELCET ® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.

Renal toxicity of ABELCET ® , as measured by serum creatinine levels, has been shown to be dose dependent. Decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient.

Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET ® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET ® and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100 mg vials. Insert the filter needle of the syringe into an IV bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 mg/mL. For pediatric patients and patients with cardiovascular disease the drug may be diluted with 5% Dextrose Injection to a final infusion concentration of 2 mg/mL. Before infusion, shake the bag until the contents are thoroughly mixed. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of ABELCET ® , since no bacteriostatic agent or preservative is present.

DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of ABELCET ® with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of ABELCET ® , or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER.

The diluted ready-for-use admixture is stable for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature.

HOW SUPPLIED

Single-use vials along with 5-micron filter needles are individually packaged.

100 mg of ABELCET ® in 20 mL of suspension NDC 57665-101-41

Storage

Prior to admixture, ABELCET ® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. ABELCET ® should be retained in the carton until time of use.

The admixed ABELCET ® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.

U.S. Patent Nos. 4,973,465

5,616,334

6,406,713

I-101-41-US-Q

Leadiant Logo

Manufactured by Exelead, Inc., Indianapolis, IN 46268

Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878

Revised 11/2018

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 57665-101-41

100 mg

ABELCET®
(Amphotericin B Lipid Complex Injection)

Lipid
Formulation

For Intravenous Use Only

5 mg/mL

Contents:
One 100 mg vial
One filter needle

Manufactured by:
Exelead, Inc.
Indianapolis, IN 46268

Distributed by: Leadiant
Biosciences, Inc.
Gaithersburg, MD 20878

U.S. PATENT NOS. 4,973,465 5,616,334 6,406,713

C-101-41-US-M

NDC 57665-101-41

100 mg

ABELCET®
(Amphotericin B Lipid Complex Injection)

For Intravenous Use Only

Each mL of ABELCET contains:
Amphotericin B USP 5 mg
L-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
L-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
Sodium Chloride USP 9 mg
Water for Injection USP, q.s. 1 mL

Preparation
ABELCET must be added to 5% Dextrose Injection USP
before intravenous infusion.
See package insert for complete directions.

Dosage
See package insert for dosage and administration information.

Storage
Store between 2° and 8°C (36° to 46°F). Do not freeze. Protect from light. Single-use vial.

Rx Only.

Principal Display Panel -- Carton Label
(click image for full-size original)
ABELCET amphotericin b, dimyristoylphosphatidylcholine, dl- and dimyristoylphosphatidylglycerol, dl- injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57665-101
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHOTERICIN B (AMPHOTERICIN B) AMPHOTERICIN B 5 mg in 1 mL
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL-) DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- 3.4 mg in 1 mL
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-) DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57665-101-41 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (57665-101-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050724 10/18/2010
Labeler — Leadiant Biosciences, Inc. (068301431)
Establishment
Name Address ID/FEI Operations
Xellia Pharmaceuticals ApS 305814345 api manufacture (57665-101)
Establishment
Name Address ID/FEI Operations
Exelead, Inc. 961822389 manufacture (57665-101)

Revised: 11/2020 Leadiant Biosciences, Inc.

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