Irinotecan Hydrochloride 20 mg/mL
Irinotecan Hydrochloride · INJECTION, SOLUTION · Qilu Pharmaceutical Co., Ltd.
Irinotecan Hydrochloride is a injection, solution containing irinotecan hydrochloride at 20 mg/mL, taken intravenous. Manufactured by Qilu Pharmaceutical Co., Ltd..
Key Facts
- Brand Name
- Irinotecan Hydrochloride
- Generic Name
- Irinotecan Hydrochloride
- NDC Code (Product)
67184-0511- Manufacturer
- Qilu Pharmaceutical Co., Ltd.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203380
- Marketing Start
- 05/03/2016
Recall History
Fresenius Kabi USA LLC (FK USA)
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
West-Ward Pharmaceutical Corp.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
West-Ward Pharmaceutical Corp.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Ingenus Pharmaceuticals Llc
Superpotent Drug: High out of specification assay value results for potency.
Areva Pharmaceuticals Inc
CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Ingenus Pharmaceuticals Llc
Superpotent Drug: High out of specification assay value results for potency.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum, ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Colorectal cancer combination regimen 1: Irinotecan hydrochloride injection 125 mg/m2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 with LV 20 mg/m2 intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks. (2.1) • Colorectal cancer combination regimen 2: Irinotecan hydrochloride injection 180 mg/m2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30. (2.1) • Colorectal cancer single agent regimen 1: Irinotecan hydrochloride injection 125 mg/ m 2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest. ( 2.2 ) • Colorectal cancer single agent regimen 2: Irinotecan hydrochloride injection 350 mg/ m 2 intravenous infusion over 90 minutes on day 1 every 3 weeks. ( 2.2 ) 2.1 Colorectal Cancer Combination Regimens 1 and 2 Administer irinotecan hydrochloride injection as a 90-minute intravenous infusion followed b…
Contraindications
4 CONTRAINDICATIONS • Irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. • Hypersensitivity to irinotecan hydrochloride injection or its excipients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with irinotecan hydrochloride injection. ( 7.2 ) • Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with irinotecan hydrochloride injection. ( 7.3 ) 7.1 5-Fluorouracil (5-FU) and Leucovorin (LV) In a phase 1 clinical study involving irinotecan, 5-fluorouracil (5-FU), and leucovorin (LV) in 26 patients with solid tumors, the disposition of irinotecan was not substantially altered when the drugs were co-administered. Although the C max and AUC 0-24 of SN-38, the active metabolite, were reduced (by 14% and 8%, respectively) when irinotecan was followed by 5-FU and LV administration compared with when irinotecan was given alone, this sequence of administration was used in the combination trials and is recommended [see Dosage and Administration (2)] . Formal i n vivo or in vitro drug interaction studies to evaluate the influence of irinotecan on the disposition of 5-FU and LV have not been conducted 7.2 Strong CYP3A4 Inducers Exposure to irinotecan or its active metabolite SN-38 is substantially reduced in adult and pediatric patients concomitantly receiving the CYP3A4 enzyme-induc…
Adverse Reactions
6 ADVERSE REACTIONS Common adverse reactions (≥30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia. ( 6.1 ) Common adverse reactions (≥30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, alopecia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Common adverse reactions (≥30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia…
Frequently Asked Questions
What is Irinotecan Hydrochloride used for?
Irinotecan Hydrochloride contains Irinotecan Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Irinotecan Hydrochloride a controlled substance?
Irinotecan Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Irinotecan Hydrochloride?
The generic name for Irinotecan Hydrochloride is Irinotecan Hydrochloride. There are 6 other brand versions of Irinotecan Hydrochloride.
What is the NDC code for Irinotecan Hydrochloride 20 mg/mL?
The NDC (National Drug Code) for Irinotecan Hydrochloride 20 mg/mL is 67184-0511, listed by Qilu Pharmaceutical Co., Ltd..