Oxaliplatin for injection 50mg/100mg antineoplastic agent treatment
of stage III colon cancer&advanced colorectal cancer
Oxaliplatin is supplied in clear, glass, single-use vials with gray
elastomeric stoppers and aluminum flip-off seals containing 50 mg
or 100 mg of oxaliplatin as a sterile, preservative-free, aqueous
solution at a concentration of 5 mg/mL. Water for Injection, USP is
present as an inactive ingredient.
Oxaliplatin injection is an antineoplastic agent with the molecular
formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2
R)-1,2-cyclohexanediamine-N,N'] [oxalato(2)-O,O'] platinum.
Oxaliplatin is an organoplatinum complex in which the platinum atom
is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate
ligand as a leaving group .
The molecular weight is 397.3. Oxaliplatin is slightly soluble in
water at 6 mg/mL, very slightly soluble in methanol, and
practically insoluble in ethanol and acetone.
Oxaliplatin is supplied in vials containing 50 mg or 100 mg of
oxaliplatin as a sterile, preservative-free, aqueous solution at a
concentration of 5 mg/mL. Water for Injection, USP is present as an
Oxaliplatin, used in combination with infusional
5-fluorouracil/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.
Administer Oxaliplatin in combination with
5-fluorouracil/leucovorin every 2 weeks. For advanced disease,
treatment is recommended until disease progression or unacceptable
toxicity. For adjuvant use, treatment is recommended for a total of
6 months (12 cycles):
Day 1: Oxaliplatin 85 mg/m² intravenous infusion in 250-500 mL 5%
Dextrose injection, USP and leucovorin 200 mg/m² intravenous
infusion in 5% Dextrose Injection, USP both given over 120 minutes
at the same time in separate bags using a Y-line, followed by
5-fluorouracil 400 mg/m² intravenous bolus given over 2-4 minutes,
followed by 5-fluorouracil 600 mg/m² intravenous infusion in 500 mL
5% Dextrose Injection, USP (recommended) as a 22-hour continuous
Day 2: Leucovorin 200 mg/m² intravenous infusion over 120 minutes,
followed by 5-fluorouracil 400 mg/m² intravenous bolus given over
2-4 minutes, followed by 5-fluorouracil 600 mg/m² intravenous
infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a
22-hour continuous infusion.
Some people receiving a oxaliplatin injection have had a reaction
to the infusion within minutes after the medicine is injected into
the vein. Tell your caregiver right away if you feel dizzy, short
of breath, confused, sweaty, itchy, or have diarrhea, chest pain,
warmth or redness in your face, or feel like you might pass out.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue,
Call your doctor at once if you have a serious side effect such as:
- headache, confusion, change in mental status, vision problems,
- numbness, tingling, or burning pain that interferes with daily
- increased sensitivity to cold temperatures and cold objects;
- jaw or chest tightness, eye pain, strange feeling in your tongue,
problems with speech or swallowing;
- fever, chills, sore throat, mouth and throat ulcers, cough with
- dry cough, wheezing, feeling short of breath on exertion;
- pain or burning when you urinate;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum),
purple or red pinpoint spots under your skin;
- pale skin, feeling weak or tired, rapid heart rate, trouble
- pain, redness, swelling, or skin changes where the injection was
- feeling very thirsty or hot, being unable to urinate, heavy
sweating, or hot and dry skin.
Other common side effects may include:
- nausea, vomiting, stomach pain, loss of appetite;
- diarrhea, constipation;
- weight gain;
- muscle pain; or
- temporary hair loss.
Store at 25°C ,excursions permitted to 15-30°C Do not freeze and
protect from light (keep in original outer carton).