Caspofungin Acetate (Page 7 of 7)

14.5 Pediatric Patients

The safety and efficacy of caspofungin were evaluated in pediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials.

The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, double-blind study comparing caspofungin (50 mg/m² IV once daily following a 70-mg/m² loading dose on Day 1 [not to exceed 70 mg daily]) to AmBisome (3 mg/kg IV daily) in a 2:1 treatment fashion (56 on caspofungin, 26 on AmBisome) as empirical therapy in pediatric patients with persistent fever and neutropenia. The study design and criteria for efficacy assessment were similar to the study in adult patients [see Clinical Studies (14.1)]. Patients were stratified based on risk category (high-risk patients had undergone allogeneic stem cell transplantation or had relapsed acute leukemia). Twenty-seven percent of patients in both treatment groups were high risk. Favorable overall response rates of pediatric patients with persistent fever and neutropenia are presented in Table 15.

Table 15: Favorable Overall Response Rates of Pediatric Patients with Persistent Fever and Neutropenia

	Caspofungin	AmBisome*
Number of Patients	56	25
Overall Favorable Response	26/56 (46.4%)	8/25 (32.0%)
High risk	9/15 (60.0%)	0/7 (0.0%)
Low risk	17/41 (41.5%)	8/18 (44.4%)
* One patient excluded from analysis due to no fever at study entry.

The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in pediatric patients (ages 3 months to 17 years) with candidemia and other Candida infections, esophageal candidiasis, and invasive aspergillosis (as salvage therapy). The study employed diagnostic criteria which were based on established EORTC/MSG criteria of proven or probable infection; these criteria were similar to those criteria employed in the adult studies for these various indications. Similarly, the efficacy time points and endpoints used in this study were similar to those employed in the corresponding adult studies [see Clinical Studies (14.2, 14.3, and 14.4)]. All patients received caspofungin at 50 mg/m² IV once daily following a 70 mg/m² loading dose on Day 1 (not to exceed 70 mg daily). Among the 49 enrolled patients who received caspofungin, 48 were included in the efficacy analysis (one patient excluded due to not having a baseline Aspergillus or Candida infection). Of these 48 patients, 37 had candidemia or other Candida infections, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis. Most candidemia and other Candida infections were caused by C. albicans (35%), followed by C. parapsilosis (22%), C. tropicalis (14%), and C. glabrata (11%). The favorable response rate, by indication, at the end of caspofungin therapy was as follows: 30/37 (81%) in candidemia or other Candida infections, 5/10 (50%) in invasive aspergillosis, and 1/1 in esophageal candidiasis.

15 REFERENCES

1. Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22; 317(17): 1098 (letter).

16 HOW SUPPLIED/STORAGE AND HANDLING

Caspofungin Acetate for Injection is supplied as follows:

NDC	Caspofungin Acetate for Injection	Package Factor
68083-158-01	50 mg Single-Dose Vial	1 vial per carton
68083-159-01	70 mg Single-Dose Vial	1 vial per carton

Caspofungin Acetate for Injection is a lyophilized white to off-white powder/cake for intravenous infusion in a vial with an aluminum flip off seal and plastic cap.

Storage Conditions

Store refrigerated between 2° and 8°C (36° and 46°F).

Sterile, Nonpyrogenic, Lyophilized.

The container closure is not made with natural rubber latex.

There are no preservatives or bacteriostatic agents in this product.

17 PATIENT COUNSELING INFORMATION

Hypersensitivity
Inform patients that anaphylactic reactions have been reported during administration of caspofungin. Caspofungin can cause hypersensitivity reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm. Inform patients to report these signs or symptoms to their healthcare providers.

Hepatic Effects
Inform patients that there have been isolated reports of serious hepatic effects from caspofungin therapy.

Use in Pregnancy and Breastfeeding Mothers
Advise female patients of the potential risks to a fetus. Instruct patients to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant. Instruct patients to tell their healthcare provider if they plan to breastfeed their infant.

Brands listed are the trademarks of their respective owners.

Manufactured by:
Gland Pharma Limited
D.P.Pally, Dundigal Post
Hyderabad -500 043, India
Revised: January 2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68083-158-01

Caspofungin Acetate For Injection50 mg/vial*

FOR INTRAVENOUS USE ONLY

*Vial contains 50 mg caspofungin equivalent to 55.5 mg caspofungin acetate.
Reconstitute
with 10.8 mL of diluent to obtain a
concentration of 5 mg/mL.
Requires further dilution prior
to infusion.
Single Dose Vial
DO NOT USE DILUENTS
CONTAINING DEXTROSE (α-D-glucose)

Vial Label

Carton Label

NDC 68083-159-01
Caspofungin Acetate For Injection 70 mg/vial*

FOR INTRAVENOUS USE ONLY

*Vial contains 70 mg caspofungin equivalent to 77.7mg caspofungin acetate.
Reconstitute with 10.8 mL of diluent to obtain
a concentration of 7 mg/mL.
Requires further dilution prior
to infusion.
Single Dose Vial
DO NOT USE DILUENTS
CONTAINING DEXTROSE (α-D-glucose)

Vial Label

Carton Label

CASPOFUNGIN ACETATE caspofungin acetate injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-158 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASPOFUNGIN ACETATE (CASPOFUNGIN) CASPOFUNGIN ACETATE 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 2.4 mg in 1 mL ACETIC ACID SODIUM HYDROXIDE SUCROSE 3.6 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-158-01 01 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (68083-158-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207092 10/29/2017

CASPOFUNGIN ACETATE caspofungin acetate injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-159 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASPOFUNGIN ACETATE (CASPOFUNGIN) CASPOFUNGIN ACETATE 7 mg in 1 mL

Inactive Ingredients Ingredient Name Strength MANNITOL 3.3 mg in 1 mL ACETIC ACID SODIUM HYDROXIDE SUCROSE 5.0 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68083-159-01 1 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (68083-159-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207092 10/29/2017

Labeler — Gland Pharma Limited (918601238)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		918601238	ANALYSIS (68083-158), ANALYSIS (68083-159), MANUFACTURE (68083-158), MANUFACTURE (68083-159), PACK (68083-158), PACK (68083-159)

Revised: 01/2022 Gland Pharma Limited