Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
oxaliplatin (UNII: 04ZR38536J) (OXALIPLATIN - UNII:04ZR38536J)
Apotex Corp.
oxaliplatin
oxaliplatin 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Oxaliplatin Injection USP, in combination with infusional fluorouracil and leucovorin, is indicated for: - adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. Oxaliplatin Injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. Reactions have included anaphylaxis [see Warnings and Precautions (5.1)] . Risk Summary Based on its direct interaction with DNA, oxaliplatin injection can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin injection. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see Data) . Advise a pregnant woman of the potential risk to a
Oxaliplatin Injection USP is supplied in clear, glass, single-dose vials with gray elastomeric stoppers and aluminum flip-off seals containing 50 mg, 100 mg or 200 mg of oxaliplatin as a clear, colorless, sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. NDC 60505-6132-6: 50 mg/10 mL single-dose vial with flip-off seal individually packaged in a carton. NDC 60505-6132-7: 100 mg/20 mL single-dose vial with flip-off seal individually packaged in a carton. NDC 60505-6132-8: 200 mg/40 mL single-dose vial with flip-off seal individually packaged in a carton. Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Do not freeze and protect from light (keep in original outer carton). Discard unused portion. Oxaliplatin Injection USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 The use of gloves is recommended. If a solution of Oxaliplatin Injection USP contacts the skin, wash the skin immediately and thoroughly with soap and water. If Oxaliplatin Injection USP contacts the mucous membranes, flush thoroughly with water.
Abbreviated New Drug Application
OXALIPLATIN- OXALIPLATIN INJECTION, SOLUTION APOTEX CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXALIPLATIN INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXALIPLATIN INJECTION. OXALIPLATIN INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2002 WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. SERIOUS AND FATAL HYPERSENSITIVITY ADVERSE REACTIONS, INCLUDING ANAPHYLAXIS, CAN OCCUR WITH OXALIPLATIN INJECTION WITHIN MINUTES OF ADMINISTRATION AND DURING ANY CYCLE. OXALIPLATIN INJECTION IS CONTRAINDICATED IN PATIENTS WITH HYPERSENSITIVITY REACTIONS TO OXALIPLATIN AND OTHER PLATINUM-BASED DRUGS. IMMEDIATELY AND PERMANENTLY DISCONTINUE OXALIPLATIN INJECTION FOR HYPERSENSITIVITY REACTIONS AND ADMINISTER APPROPRIATE TREATMENT. (4, 5.1) INDICATIONS AND USAGE Oxaliplatin Injection USP is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. (1) treatment of advanced colorectal cancer. (1) DOSAGE AND ADMINISTRATION Administer oxaliplatin injection 85 mg/m as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle. Administer fluorouracil and leucovorin on Day 2 as recommended. (2.1) Adjuvant Treatment: Continue treatment for up to 12 cycles or unacceptable toxicity. (2.1) Advanced Colorectal Cancer: Continue treatment until disease progression or unacceptable toxicity. (2.1) DOSAGE FORMS AND STRENGTHS Injection: 50 mg (5 mg/mL), 100 mg (5 mg/mL) or 200 mg (5 mg/mL) in a single-dose vial. (3) CONTRAINDICATIONS History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs. (4, 5.1) WARNINGS AND PRECAUTIONS Peripheral Sensory Neuropathy: Acute and delayed neuropa Lugege kogu dokumenti