Irinotecan Hydrochloride 20 mg/mL
IRINOTECAN HYDROCHLORIDE · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Irinotecan Hydrochloride is a injection, solution containing irinotecan hydrochloride at 20 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Irinotecan Hydrochloride
- Generic Name
- IRINOTECAN HYDROCHLORIDE
- NDC Code (Product)
63323-193- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA077776
- Marketing Start
- 04/01/2009
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 a topoisomerase inhibitor indicated for: • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 ) • 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ) 2.2 Colorectal Single Agent Regimens 1 and 2 Administer irinotecan hydrochloride injection as a 90-minute intravenous infusion. The currently recommended regimens are shown in Table 3. A reduction in the starting dose by one dose level of irinotecan hydrochloride injection may be considered for patients with any of the following conditions: prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels. Dosing for patients with bilirubin >2 mg/dL cannot be recommended because there is insufficient information to recommend a dose in these patients. Table 3. Single-Agent Regimens of irinotecan hydrochloride injection and Dose Modifications a Subsequent doses may be adjusted as high as 150 mg/m 2 or to as low as 50 mg/m 2 in 25 to 50 mg/m 2 decrements depending upon individual patient tolerance. b Subseque…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to Irinotecan hydrochloride injection or its excipients ( 4 ) Irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients.
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with Irinotecan hydrochloride. ( 7.2 ) Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with Irinotecan hydrochloride. ( 7.3 ) 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-inducing anticonvulsants phenytoin, phenobarbital, carbamazepine, or St. John's wort. The appropriate starting dose for patients taking these or other strong inducers such as rifampin and rifabutin has not been defined. Consider substituting non-enzyme inducing therapies at least 2 weeks prior to initiation of irinotecan hydrochloride injection therapy. Do not administer strong CYP3A4 inducers with irinotecan hydrochloride injection unless there are no therapeutic alternatives. 7.3 Strong CYP3A4 or UGT1A1 Inhibitors Irinotecan and its active metabolite, SN-38, are metabolized via the human cytochrome P450 3A4 isoenzyme (CYP3A4) and uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1), respectively, [ see Clinical Pharmacology (12.3) ]. Patients receiving concomitant ketoco…
Adverse Reactions
6 ADVERSE REACTIONS 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 1-888-557-1212 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 single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, and alopecia. Serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia. Second-Line Single-Agent Therapy Weekly Dosage Schedule In three clinical studies…
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 63323-193, listed by Fresenius Kabi USA, LLC.