Drugplain

Camptosar 20 mg/mL

irinotecan hydrochloride · INJECTION, SOLUTION · Pharmacia & Upjohn Company LLC

No Recall HistoryCurrently in Shortage
Plain English

Camptosar is a injection, solution containing irinotecan hydrochloride at 20 mg/mL, taken intravenous. Manufactured by Pharmacia & Upjohn Company LLC.

Key Facts

Brand Name
Camptosar
Generic Name
irinotecan hydrochloride
NDC Code (Product)
0009-7529
Manufacturer
Pharmacia & Upjohn Company LLC
Strength
20 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA020571
Marketing Start
06/14/1996

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea1,358 reports
off label use843 reports
nausea773 reports
vomiting695 reports
death671 reports
myelosuppression629 reports
disease progression569 reports
febrile neutropenia545 reports
neutropenia531 reports
fatigue445 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE • CAMPTOSAR 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. • CAMPTOSAR is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. CAMPTOSAR 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: CAMPTOSAR 125 mg/m 2 intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m 2 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: CAMPTOSAR 180 mg/m 2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m 2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m 2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m 2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30. ( 2.1 ) • Colorectal cancer single agent regimen 1: CAMPTOSAR 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: CAMPTOSAR 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 CAMPTOSAR as a 90-minute intravenous infusion followed by LV and 5-FU. The currently recommended regimens are shown in Table 1. A reduction in the starting dose by one dose l…

Contraindications

4 CONTRAINDICATIONS • CAMPTOSAR Injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. • Hypersensitivity to CAMPTOSAR or its excipients ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Strong CYP3A4 Inducers: Do not administer strong CYP3A4 inducers with CAMPTOSAR. ( 7.2 ) • Strong CYP3A4 Inhibitors: Do not administer strong CYP3A4 inhibitors with CAMPTOSAR. ( 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 in 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-inducing anticonvulsants phenytoin, phenobarbital, car…

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 Pfizer Inc, at 1-800-438-1985 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, mu…

Frequently Asked Questions

What is Camptosar used for?

Camptosar contains irinotecan hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Camptosar a controlled substance?

Camptosar is not classified as a controlled substance by the DEA.

What is the generic name for Camptosar?

The generic name for Camptosar is irinotecan hydrochloride. There are 11 other brand versions of irinotecan hydrochloride.

What is the NDC code for Camptosar 20 mg/mL?

The NDC (National Drug Code) for Camptosar 20 mg/mL is 0009-7529, listed by Pharmacia & Upjohn Company LLC.

Product NDC

0009-7529

Package NDC

0009-7529-05

Other Camptosar Dosages

Other Irinotecan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)