Irinotecan Hydrochloride (Page 7 of 7)

15 REFERENCES

• NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
• OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
• American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
• Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

16 HOW SUPPLIED/STORAGE AND HANDLING

Irinotecan hydrochloride injection, USP is available in single-dose amber colored vials in the following package sizes:

• 2 mL NDC 72485-211-02
• 5 mL NDC 72485-212-05
• 15 mL NDC 72485-213-15

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature ]. Protect from light. Protect from freezing, Keep the vial in the carton until the time of use.

Inspect the vial for damage and visible signs of leaks before removing from the carton. If damaged, incinerate the unopened package.

17 PATIENT COUNSELING INFORMATION

• Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea. Patients should have loperamide readily available to begin treatment for late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride injection). Begin loperamide at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. One dosage regimen for loperamide is 4 mg at the first onset of late diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours. Loperamide is not recommended to be used for more than 48 consecutive hours at these doses, because of the risk of paralytic ileus. During the night, the patient may take 4 mg of loperamide every 4 hours. Patients should contact their physician if any of the following occur: diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as light headedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours.
• Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the administration of irinotecan hydrochloride injection.
• Explain the significance of routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever or infection.
• Irinotecan hydrochloride injection may cause fetal harm. Advise patients to avoid becoming pregnant while receiving this drug.
• Patients should be alerted to the possibility of alopecia.
• Contains sorbitol.

Manufactured by:

Shilpa Medicare Limited

Jadcherla-509301, INDIA

Distributed by:

Armas Pharmaceuticals, Inc.

Manalapan, NJ 07726 (US)

Revised: 09/2019

R_x only

Packaging

IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72485-213 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IRINOTECAN HYDROCHLORIDE (IRINOTECAN) IRINOTECAN HYDROCHLORIDE 20 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SORBITOL LACTIC ACID, UNSPECIFIED FORM WATER SODIUM HYDROXIDE HYDROCHLORIC ACID

Product Characteristics Color YELLOW (Clear Pale Yellow) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72485-213-15 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 15 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (72485-213-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208718 09/04/2020

Labeler — Armas Pharmaceuticals Inc. (098405973)

Revised: 09/2020 Armas Pharmaceuticals Inc.