Daptomycin (Page 10 of 10)

15 REFERENCES

1. Liu SL, Howard LC, Van Lier RBL, Markham JK: Teratology studies with daptomycin administered intravenously (iv) to rats and rabbits. Teratology 37(5):475, 1988.
2. Stroup JS, Wagner J, Badzinski T: Use of daptomycin in a pregnant patient with Staphylococcus aureus endocarditis. Ann Pharmacother 44(4):746-749, 2010.
3. Buitrago MI, Crompton JA, Bertolami S, North DS, Nathan RA. Extremely low excretion of daptomycin into breast milk of a nursing mother with methicillin-resistant Staphylococcus aureus pelvic inflammatory disease. Pharmacotherapy 2009;29(3):347–351.
4. Klibanov OM, Vickery S, Nortey C: Successful treatment of infective panniculitis with daptomycin in a pregnant, morbidly obese patient. Ann Pharmacother 48(5):652-655, 2014.
5. Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis 2000;30:633–638.

16 HOW SUPPLIED/STORAGE AND HANDLING

Daptomycin for Injection is supplied as follows:

NDC	Daptomycin for Injection	Package Factor
25021-174-15	500 mg Single-Dose Vial	1 vial per carton
25021-174-16	500 mg Single-Dose Vial	10 vials per carton

Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized cake.

Storage Conditions

Store original packages at refrigerated temperatures, 2° to 8°C (36° to 46°F); avoid excessive heat. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)].

Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Allergic Reactions

Advise patients that allergic reactions, including serious skin, kidney, lung, or other organ reactions, could occur and that these serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin [see Warnings and Precautions (5.1, 5.4, 5.5)].

Muscle Pain or Weakness (Myopathy and Rhabdomyolysis, Peripheral Neuropathy)

Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness [see Warnings and Precautions (5.2, 5.6)].

Cough, Breathlessness or Fever (Eosinophilic Pneumonia)

Advise patients to report any symptoms of cough, breathlessness, or fever [see Warnings and Precautions (5.3)].

C. difficile -Associated Diarrhea (CDAD)

Advise patients that diarrhea is a common problem caused by antibacterials including daptomycin, that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, including daptomycin, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.8)].

Antibacterial Resistance

Patients should be counseled that antibacterial drugs, including daptomycin, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When daptomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by daptomycin or other antibacterial drugs in the future.

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SAGENT^®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in India©2022 Sagent Pharmaceuticals, Inc.

Revised: January 2022

SAGENT Pharmaceuticals ^®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-174-15

Rx only

Daptomycin for Injection

500 mg per vial

For Intravenous Use Only

MUST BE REFRIGERATED

Discard unused portion

Single-Dose Vial

DAPTOMYCIN daptomycin injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25021-174 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength daptomycin (daptomycin) daptomycin 50 mg in 1 mL

Inactive Ingredients Ingredient Name Strength sodium hydroxide

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:25021-174-15 1 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (25021-174-15) 2 NDC:25021-174-16 10 VIAL in 1 CARTON contains a VIAL 2 10 mL in 1 VIAL This package is contained within the CARTON (25021-174-16)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207104 11/15/2019

Labeler — Sagent Pharmaceuticals (796852890)

Revised: 01/2022 Sagent Pharmaceuticals