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 glass vials in the following package sizes:

40 mg/2 mL

NDC 0143-9702-01
100 mg/5 mL NDC 0143-9701-01

Store at 20° to 25° C (68° to 77° F). See USP Controlled Room Temperature (excursions permitted to 15° to 30° C (59°to 86° F)). Protect from light. Keep the vial in the carton until the time of use. Protect from freezing.

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 lightheadedness, 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. Advice patients to avoid becoming pregnant while receiving this drug.
  • Patients should be alerted to the possibility of alopecia.
  • Contains sorbitol.

Manufactured by:
THYMOORGAN PHARMAZIE GmbH
Schiffgraben 23
38690 Goslar
Germany

Distributed by:
WEST-WARD PHARMACEUTICAL CORP.
Eatontown, NJ 07724 USA

Revised: March 2015

127.207.001/02

PRINCIPAL DISPLAY PANEL

NDC 0143-9702-01
IRINOTECAN
HYDROCHLORIDE INJECTION, USP
40 mg/2 mL
(20 mg/mL)
as the trihydrate
MUST BE DILUTED — CYTOTOXIC AGENT
FOR IV USE ONLY
Rx ONLY
2 mL Single Dose Vial
USUAL DOSAGE: See package
insert.
PROTECT FROM LIGHT.
PROTECT FROM FREEZING.
Store at 20º to 25ºC (68º to 77ºF);
excursions permitted to 15º to
30ºC (59º to 86ºF) [See USPControlled Room Temperature].

NDC 0143-9702-01 IRINOTECAN HYDROCHLORIDE INJECTION, USP 40 mg/2 mL (20 mg/mL) as the trihydrate MUST BE DILUTED -- CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 2 mL Single Dose Vial USUAL DOSAGE: See package insert. PROTECT FROM LIGHT. PROTECT FROM FREEZING. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
(click image for full-size original)

NDC 0143-9702-01
1 x 2 mL Single Dose Vial
IRINOTECAN
HYDROCHLORIDE INJECTION, USP
40 mg/2 mL
(20 mg/mL)*
as the trihydrate
MUST BE DILUTED — CYTOTOXIC AGENT
FOR IV USE ONLYRx ONLY

NDC 0143-9702-01 1 x 2 mL Single Dose Vial IRINOTECAN HYDROCHLORIDE INJECTION, USP 40 mg/2 mL (20 mg/mL)* as the trihydrate MUST BE DILUTED -- CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9701-01
IRINOTECAN
HYDROCHLORIDE INJECTION, USP
100 mg/5 mL
(20 mg/mL)
as the trihydrate
MUST BE DILUTED — CYTOTOXIC AGENT
FOR IV USE ONLY
Rx ONLY
5 mL Single Dose Vial
USUAL DOSAGE: See package
insert.
PROTECT FROM LIGHT.
PROTECT FROM FREEZING.
Store at 20º to 25ºC (68º to 77ºF);
excursions permitted to 15º to
30ºC (59º to 86ºF) [See USPControlled Room Temperature].

NDC 0143-9701-01 IRINOTECAN HYDROCHLORIDE INJECTION, USP 100 mg/5 mL (20 mg/mL) as the trihydrate MUST BE DILUTED -- CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 5 mL Single Dose Vial USUAL DOSAGE: See package insert. PROTECT FROM LIGHT. PROTECT FROM FREEZING. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].
(click image for full-size original)

NDC 0143-9701-01
1 x 5 mL Single Dose Vial
IRINOTECAN
HYDROCHLORIDE INJECTION, USP
100 mg/5 mL
(20 mg/mL)*
as the trihydrate
MUST BE DILUTED — CYTOTOXIC AGENT
FOR IV USE ONLYRx ONLY

NDC 0143-9701-01 1 x 5 mL Single Dose Vial IRINOTECAN HYDROCHLORIDE INJECTION, USP 100 mg/5 mL (20 mg/mL)* as the trihydrate MUST BE DILUTED -- CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY
(click image for full-size original)
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9702
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 45 mg in 1 mL
LACTIC ACID 0.9 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9702-01 2 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091032 12/20/2010
IRINOTECAN HYDROCHLORIDE irinotecan hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9701
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 45 mg in 1 mL
LACTIC ACID 0.9 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9701-01 5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091032 12/20/2010
Labeler — West-Ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
THYMOORGAN GMBH PHARMAZIE 319029989 ANALYSIS (0143-9702), ANALYSIS (0143-9701), LABEL (0143-9702), LABEL (0143-9701), MANUFACTURE (0143-9702), MANUFACTURE (0143-9701), PACK (0143-9702), PACK (0143-9701)

Revised: 05/2015 West-Ward Pharmaceutical Corp

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