Irinotecan Hydrochloride (Page 10 of 11)

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 brown glass vials in the following package sizes:

2 mL NDC 67184-0511-1

5 mL NDC 67184-0512-1

15 mL NDC 67184-0513-1

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and 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 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.
  • Embryo-Fetal Toxicity [see Warnings and Precautions (5.9), Use in Specific Populations (8.1 and 8.3), Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]

° Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy.

° Advise females of reproductive potential to use effective contraception during treatment with irinotecan hydrochloride injection and for 6 months after the final dose.

° Advise male patients with female partners of reproductive potential to use condoms during treatment and for 3 months after the final dose of irinotecan hydrochloride injection.

  • Lactation

° Advise women not to breastfeed during treatment with irinotecan hydrochloride injection and for at least 7 days after the final dose [see Use in Specific Populations (8.2)].

  • Infertility

° Advise females and males of reproductive potential that irinotecan hydrochloride injection may impair fertility [see Use in Specific Populations (8.3)].

  • Patients should be alerted to the possibility of alopecia.
  • Contains sorbitol.

Manufactured by: Qilu Pharmaceutical (Hainan) Co., Ltd.

Haikou, 570314, China

2ml container

NDC 67184-0511-1 Rx only

Irinotecan Hydrochloride Injection, USP

40 mg/2 mL (20 mg/mL)

FOR INTRAVENOUS USE ONLY
— must be diluted before use.
CAUTION: Cytotoxic Agent

Single-Dose: Discard unused portion
Usual Dosage: See accompanying prescribing information. Mfd. by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China

2ml-container
(click image for full-size original)

2ml carton

NDC 67184-0511-1

Rx only

Single-Dose: Discard unused portion

Irinotecan Hydrochloride Injection, USP

40 mg/2 mL

(20 mg/mL)

On basis of trihydrate

For Intravenous Use Only

Caution: Cytotoxic Agent

Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Retain in Carton. Discard unused portion.

IF CONTENTS ARE DAMAGED AND/ OR LEAKING INCINERATE ENTIRE PACKAGE.

Mfd. by:

Qilu Pharmaceutical (Hainan) Co., Ltd.

Haikou, 570314, China.

Sterile

Warning:

For intravenous use only — Must be diluted before use.

Usual Dosage:

See accompanying prescribing information.

Each mL contains irinotecan hydrochloride trihydrate, 20 mg;

inactives: sorbitolpowder, 45mg; lactic acid, 0.9 mg; water for injection, qs.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

2ml-carton
(click image for full-size original)

5ml container

NDC 67184-0512-1 Rx only

Irinotecan Hydrochloride Injection, USP

100 mg/5 mL (20 mg/mL)

FOR INTRAVENOUS USE ONLY
— must be diluted before use.
CAUTION: Cytotoxic Agent

Single-Dose: Discard unused portion
Usual Dosage: See accompanying prescribing information.

Store at 20° to 25°C (68° to 77°F) ; excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Retain in Carton.

Mfd. by: Qilu Pharmaceutical (Hainan) Co., Ltd. Haikou, 570314, China

5ml-container
(click image for full-size original)

5ml carton

NDC 67184-0512-1

Rx only

Single-Dose: Discard unused portion

Irinotecan Hydrochloride Injection, USP

100 mg/5 mL

(20 mg/mL)

On basis of trihydrate

For Intravenous Use Only

Caution: Cytotoxic Agent

Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Retain in Carton. Discard unused portion.

IF CONTENTS ARE DAMAGED AND/ OR LEAKING INCINERATE ENTIRE PACKAGE.

Mfd. by:

Qilu Pharmaceutical (Hainan) Co., Ltd.

Haikou, 570314, China.

Sterile

Warning:

For intravenous use only — Must be diluted before use.

Usual Dosage:

See accompanying prescribing information.

Each mL contains irinotecan hydrochloride trihydrate, 20 mg;

inactives: sorbitolpowder, 45mg; lactic acid, 0.9 mg; water for injection, qs.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

5ml-carton
(click image for full-size original)

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