IRINOTECAN BAXTER irinotecan hydrochloride trihydrate 40 mg/2 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 40 mg

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; lactic acid; sorbitol; hydrochloric acid; sodium hydroxide

Administration route:

Intravenous Infusion

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: Sterile, pale yellow, clear, aqueous solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-05-23

Summary of Product characteristics

Product Information – Australia
PI – APO-IRINOTECAN Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION –
APO-IRINOTECAN (IRINOTECAN HYDROCHLORIDE)
1 NAME OF THE MEDICINE
Irinotecan hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each concentrated injection vial contains 20 mg/1 mL irinotecan
hydrochloride, as the active ingredient.
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Concentrated injection
Irinotecan hydrochloride concentrated injection is supplied as a
sterile, light yellow or pale yellow, clear, aqueous
solution with pH 3.5.
It is intended for dilution with 5% glucose injection or 0.9% sodium
chloride injection prior to infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irinotecan hydrochloride is indicated as a component of first-line
therapy for patients with metastatic carcinoma of
the colon or rectum. Irinotecan hydrochloride is also indicated for
patients with metastatic carcinoma of the colon
or rectum whose disease has recurred or progressed following initial
therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
It is recommended that patients receive premedication with antiemetic
agents. Prophylactic or therapeutic
administration of atropine should be considered in patients
experiencing cholinergic symptoms (see section 4.4
Special warnings and precautions for use).
COMBINATION AGENT THERAPY
_DOSAGE REGIMENS _
Irinotecan hydrochloride injection in Combination with 5-Fluorouracil
(5-FU) and Leucovorin (LV)
Irinotecan hydrochloride should be administered as an intravenous
infusion over 90 minutes (see Preparation of
Infusion Solution). For all regimens, the dose of LV should be
administered immediately after irinotecan
hydrochloride, with the administration of 5-FU to follow immediately
after
the administration of LV.
The
recommended regimens are shown in Table 1.
TABLE 1:
COMBINATION AGENT DOSAGE REGIMENS & DOSE MODIFICATIONS
A
REGIMEN 1
6 week cycle
Treatment Resumes
Day 43
Irinotecan hydrochloride
LV
5-FU
125mg/m
2
IV over 90 min on day