Eloxatin 200mg Information
Eloxatin 200mg (Oxaliplatin) Warning: Anaphylactic Reactions
Anaphylactic reactions to ELOXATIN have been reported, and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms of anaphylaxis
Eloxatin 200mg (Oxaliplatin) Indications And Usage
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for:
Eloxatin 200mg (Oxaliplatin) Dosage And Administration
ELOXATIN (oxaliplatin injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
Reconstitution or final dilution must never be performed with a sodium chloride solution or other chloride containing solutions.
The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg vial) or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5% Dextrose Injection, USP. The reconstituted solution must be further diluted in an infusion solution of 250–500 mL of 5% Dextrose Injection, USP.
After reconstitution in the original vial, the solution may be stored up to 24 hours under refrigeration [2–8°C (36–46°F)]. After final dilution with 250–500 mL of 5% Dextrose Injection, USP, the shelf life is
ELOXATIN is not light sensitive.
ELOXATIN is incompatible in solution with alkaline medications or media (such as basic solutions of 5-FU) and must not be mixed with these or administered simultaneously through the same infusion line.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
Needles or intravenous administration sets containing aluminum parts that may come in contact with ELOXATIN should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.
Eloxatin 200mg (Oxaliplatin) Dosage Forms And Strenghs
ELOXATIN is supplied in single-use vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution.
Eloxatin 200mg (Oxaliplatin) Contraindications
ELOXATIN should not be administered to patients with a history of known allergy to ELOXATIN or other platinum compounds .
Eloxatin 200mg (Oxaliplatin) Warnings And Precautions
See
Grade 3/4 hypersensitivity, including anaphylactic/anaphylactoid reactions, to ELOXATIN has been observed in 2–3% of colon cancer patients. These allergic reactions which can be fatal, can occur within minutes of administration and at any cycle, and were similar in nature and severity to those reported with other platinum-containing compounds, such as rash, urticaria, erythema, pruritus, and, rarely, bronchospasm and hypotension. The symptoms associated with hypersensitivity reactions reported in the previously untreated patients were urticaria, pruritus, flushing of the face, diarrhea associated with oxaliplatin infusion, shortness of breath, bronchospasm, diaphoresis, chest pains, hypotension, disorientation and syncope. These reactions are usually managed with standard epinephrine, corticosteroid, antihistamine therapy,and may require discontinuation of therapy. Drug-related deaths associated with platinum compounds from anaphylaxis have been reported.
ELOXATIN is associated with two types of neuropathy:
A persistent (>14 days), primarily peripheral, sensory neuropathy that is usually characterized by paresthesias, dysesthesias, hypoesthesias, but may also include deficits in proprioception that can interfere with daily activities (e.g., writing, buttoning, swallowing, and difficulty walking from impaired proprioception).
In the adjuvant colon cancer trial, neuropathy was graded using a prelisted module derived from the Neuro-Sensory section of the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale, Version 1, as follows:
Peripheral sensory neuropathy was reported in adjuvant patients treated with the ELOXATIN combination with a frequency of 92% (all grades) and 13% (grade 3). At the 28-day follow-up after the last treatment cycle, 60% of all patients had any grade (Grade 1=40%, Grade 2=16%, Grade 3=5%) peripheral sensory neuropathy decreasing to 39% at 6 months follow-up (Grade 1=31%, Grade 2=7%, Grade 3=1%) and 21% at 18 months of follow-up (Grade 1=17%, Grade 2=3%, Grade 3=1%).
In the advanced colorectal cancer studies, neuropathy was graded using a study-specific neurotoxicity scale, which was different from the NCI CTC scale, Version 2.0 (see below).
Overall, neuropathy was reported in patients previously untreated for advanced colorectal cancer in 82% (all grades) and 19% (grade 3/4), and in the previously treated patients in 74% (all grades) and 7% (grade 3/4) events. Information regarding reversibility of neuropathy was not available from the trial for patients who had not been previously treated for colorectal cancer.
Pregnancy Category D
ELOXATIN may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of ELOXATIN in pregnant women. Pregnant rats were administered 1 mg/kg/day oxaliplatin (less than one-tenth the recommended human dose based on body surface area) during gestation days 1–5 (pre-implantation), 6–10, or 11–16 (during organogenesis). Oxaliplatin caused developmental mortality (increased early resorptions) when administered on days 6–10 and 11–16 and adversely affected fetal growth (decreased fetal weight, delayed ossification) when administered on days 6–10. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ELOXATIN.
Standard monitoring of the white blood cell count with differential, hemoglobin, platelet count, and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended before each ELOXATIN cycle
There have been reports while on study and from post-marketing surveillance of prolonged prothrombin time and INR occasionally associated with hemorrhage in patients who received ELOXATIN plus 5-FU/LV while on anticoagulants. Patients receiving ELOXATIN plus 5-FU/LV and requiring oral anticoagulants may require closer monitoring.
Eloxatin 200mg (Oxaliplatin) Adverse Reactions
Serious adverse reactions including anaphylaxis and allergic reactions, neuropathy, pulmonary toxicities and hepatotoxicities can occur
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 practice.
More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer have been treated in clinical studies with ELOXATIN. The most common adverse reactions in patients with stage II or III colon cancer receiving adjuvant therapy, were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, fatigue and stomatitis. The most common adverse reactions in previously untreated and treated patients were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea
The following adverse reactions have been identified during post-approval use of ELOXATIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a whole:
angioedema, anaphylactic shock
Central and peripheral nervous system disorders:
loss of deep tendon reflexes, dysarthria, Lhermitte's sign, cranial nerve palsies, fasciculations
Liver and Gastrointestinal system disorders:
severe diarrhea/vomiting resulting in hypokalemia, colitis (including diarrhea), metabolic acidosis; ileus; intestinal obstruction, pancreatitis; veno-occlusive disease of liver also known as sinusoidal obstruction syndrome, and perisinusoidal fibrosis which rarely may progress.
Hearing and vestibular system disorders:
deafness
Platelet, bleeding, and clotting disorders:
immuno-allergic thrombocytopeniaprolongation of prothrombin time and of INR in patients receiving anticoagulants
Red Blood Cell disorders:
hemolytic uremic syndrome, immuno-allergic hemolytic anemia
Renal disorders:
Acute tubulo-interstitial nephropathy leading to acute renal failure.
Respiratory system disorders:
pulmonary fibrosis, and other interstitial lung diseases
Vision disorders:
decrease of visual acuity, visual field disturbance, optic neuritis
Eloxatin 200mg (Oxaliplatin) Drug Interactions
No specific cytochrome P-450-based drug interaction studies have been conducted. No pharmacokinetic interaction between 85 mg/m ELOXATIN and 5-FU/LV has been observed in patients treated every 2 weeks. Increases of 5-FU plasma concentrations by approximately 20% have been observed with doses of 130 mg/m ELOXATIN dosed every 3 weeks. Because platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds; although, this has not been specifically studied
Eloxatin 200mg (Oxaliplatin) Use In Specific Populations
The effectiveness of oxaliplatin in children has not been established. Oxaliplatin has been tested in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors (see below) and no significant activity observed.
In a Phase I/II study, oxaliplatin was administered as a 2-hour IV infusion on days 1, 8 and 15 every 4 weeks (1 cycle), for a maximum of 6 cycles, to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma. Twenty eight (28) pediatric patients in the Phase I study received oxaliplatin at 6 dose levels starting at 40 mg/m with escalation to 110 mg/m. The dose limiting toxicity (DLT) was sensory neuropathy at the 110 mg/m dose. Fifteen (15) patients received oxaliplatin at a dose of 90 mg/m IV in the Phase II portion of the study. At this dose, paresthesia (60%, G3/4: 7%), fever (40%, G3/4: 7%) and thrombocytopenia (40%, G3/4: 27%) were the main adverse events. No responses were observed.
In a second Phase I study, oxaliplatin was administered to 26 pediatric patients as a 2-hour IV infusion on day 1 every 3 weeks (1 cycle) at 5 dose levels starting at 100 mg/m with escalation to 160 mg/m, for a maximum of 6 cycles. In a separate cohort, oxaliplatin 85 mg/m was administered on day 1 every 2 weeks, for a maximum of 9 doses. Patients had metastatic or unresectable solid tumors mainly neuroblastoma and ganglioneuroblastoma. No responses were observed. The DLT was sensory neuropathy at the 160 mg/m dose. Based on these studies, oxaliplatin 130mg/m as a 2-hour IV infusion on day 1 every 3 weeks (1 cycle) was used in subsequent Phase II studies. A dose of 85 mg/m on day 1 every 2 weeks was also found to be tolerable.
In one Phase II study, 43 pediatric patients with recurrent or refractory embryonal CNS tumors received oxaliplatin 130 mg/m every 3 weeks for a maximum of 12 months in absence of progressive disease or unacceptable toxicity. In patients
In a second Phase II study, 47 pediatric patients with recurrent solid tumors, including Ewing sarcoma or peripheral PNET, osteosarcoma, rhabdomyosarcoma and neuroblastoma, received oxaliplatin 130 mg/m every 3 weeks for a maximum of 12 months or 17 cycles. In patients ≤ 12 months old the oxaliplatin dose used was 4.3 mg/kg. The most common adverse events reported were sensory neuropathy (53%, G3/4: 15%), thrombocytopenia (40%, G3/4: 26%), anemia (40%, G3/4: 15%), vomiting (32%, G3/4: 0%), nausea (30%, G3/4: 2%) and AST increased (26%, G3/4: 4%). No responses were observed.
The pharmacokinetic parameters of ultrafiltrable platinum have been evaluated in 105 pediatric patients during the first cycle. The mean clearance in pediatric patients estimated by the population pharmacokinetic analysis was 4.7 L/h/m. The inter-patient variability of platinum clearance in pediatric cancer patients was 41%. Mean platinum pharmacokinetic parameters in ultrafiltrate were C of 0.75 ± 0.24 mcg/mL, AUC of 7.52 ± 5.07 mcg∙h/mL and AUC of 8.83 ± 1.57 mcg∙h/mL at 85 mg/m of oxaliplatin and C of 1.10 ± 0.43 mcg/mL, AUC of 9.74 ± 2.52 mcg∙h/mL and AUC of 17.3 ± 5.34 mcg∙h/mL at 130 mg/m of oxaliplatin.
No significant effect of age on the clearance of ultrafilterable platinum has been observed. In the adjuvant therapy colon cancer randomized clinical trial, 723 patients treated with ELOXATIN and infusional 5-FU/LV were 65 years of age was not conclusive.
In the previously untreated for advanced colorectal cancer randomized clinical trial of ELOXATIN, 160 patients treated with ELOXATIN and 5-FU/LV were
Eloxatin 200mg (Oxaliplatin) Description
ELOXATIN™ (oxaliplatin for injection) is an antineoplastic agent with the molecular formula CHNOPt and the chemical name of -[(1 ,2 )-1,2-cyclohexanediamine-,'] [oxalato(2-)- ,'] 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. ELOXATIN is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.
Eloxatin 200mg (Oxaliplatin) Clinical Pharmacology
In vivo
in vitro
in vivo
The reactive oxaliplatin derivatives are present as a fraction of the unbound platinum in plasma ultrafiltrate. The decline of ultrafilterable platinum levels following oxaliplatin administration is triphasic, characterized by two relatively short distribution phases (t; 0.43 hours and t; 16.8 hours) and a long terminal elimination phase (t; 391 hours). Pharmacokinetic parameters obtained after a single 2-hour IV infusion of ELOXATIN at a dose of 85 mg/m expressed as ultrafilterable platinum were C of 0.814 mcg/mL and volume of distribution of 440 L.
Interpatient and intrapatient variability in ultrafilterable platinum exposure (AUC) assessed over 3 cycles was moderate to low (23% and 6%, respectively). A pharmacodynamic relationship between platinum ultrafiltrate levels and clinical safety and effectiveness has not been established.
Eloxatin 200mg (Oxaliplatin) Clinical Studies
An international, multicenter, randomized study compared the efficacy and evaluated the safety of ELOXATIN in combination with an infusional schedule of 5-FU/LV to infusional 5-FU/LV alone, in patients with stage II (Dukes' B2) or III (Dukes' C) colon cancer who had undergone complete resection of the primary tumor. The primary objective of the study was to compare the 3-year disease-free survival (DFS) in patients receiving ELOXATIN and infusional 5-FU/LV to those receiving 5-FU/LV alone. Patients were to be treated for a total of 6 months (i.e., 12 cycles). A total of 2246 patients were randomized; 1123 patients per study arm. Patients in the study had to be between 18 and 75 years of age, have histologically proven stage II (T–T N0 M0; Dukes' B2) or III (any T NM0; Dukes' C) colon carcinoma (with the inferior pole of the tumor above the peritoneal reflection, i.e., ≥15 cm from the anal margin) and undergone (within 7 weeks prior to randomization) complete resection of the primary tumor without gross or microscopic evidence of residual disease. Patients had to have had no prior chemotherapy, immunotherapy or radiotherapy, and have an ECOG performance status of 0,1, or 2 (KPS ≥ 60%), absolute neutrophil count (ANC) > 1.5x10/L, platelets ≥100×10/L, serum creatinine ≤ 1.25 × ULN total bilirubin
The following table shows the dosing regimens for the two arms of the study.
The following tables show the baseline characteristics and dosing of the patient population entered into this study. The baseline characteristics were well balanced between arms.
The following table and figures summarize the disease-free survival (DFS) results in the overall randomized population and in patients with stage II and III disease based on an ITT analysis.
In the overall study population DFS was statistically significantly improved in the ELOXATIN combination arm compared to infusional 5-FU/LV alone. A statistically significant improvement in DFS was noted in Stage III patients, but not in Stage II patients.
Figure 2 shows the Kaplan-Meier DFS curves for the comparison of ELOXATIN and infusional 5-FU/LV combination and infusional 5-FU/LV alone for the overall population (ITT analysis). Figure 3 shows the Kaplan-Meier DFS curves for the comparison of ELOXATIN and infusional 5-FU/LV combination and infusional 5-FU/LV alone for the Stage III Subgroup.
Survival data were not mature at the time of the analysis with a median follow-up of 47 months. No statistically significant difference in overall survival [Hazard Ratio 0.89 (95% CI 0.72, 1.09) p=0.236] was shown between the two treatment arms in the entire population or in the Stage II [Hazard Ratio 0.98 (95% CI 0.63, 1.53) p=0.94] or Stage III [Hazard Ratio 0.86 (95%CI 0.68, 1.08) p=0.196] subgroups.
A descriptive subgroup analysis demonstrated that the improvement in DFS for the ELOXATIN combination arm compared to the infusional 5-FU/LV alone arm appeared to be maintained across genders. The effect of ELOXATIN on disease free survival benefit in patients ≥65 years of age was not conclusive. Insufficient subgroup sizes prevented analysis by race.
A North American, multicenter, open-label, randomized controlled study was sponsored by the National Cancer Institute (NCI) as an intergroup study led by the North Central Cancer Treatment Group (NCCTG). The study had 7 arms at different times during its conduct, four of which were closed due to either changes in the standard of care, toxicity, or simplification. During the study, the control arm was changed to irinotecan plus 5-FU/LV. The results reported below compared the efficacy and safety of two experimental regimens, ELOXATIN in combination with infusional 5-FU/LV and a combination of ELOXATIN plus irinotecan, to an approved control regimen of irinotecan plus 5-FU/LV in 795 concurrently randomized patients previously untreated for locally advanced or metastatic colorectal cancer. After completion of enrollment, the dose of irinotecan plus 5-FU/LV was decreased due to toxicity. Patients had to be at least 18 years of age, have known locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent, histologically proven colorectal adenocarcinoma, measurable or evaluable disease, with an ECOG performance status 0,1, or 2. Patients had to have granulocyte count ≥ 1.5 × 10/L, platelets ≥ 100 × 10/L, hemoglobin ≥9.0 gm/dL, creatinine ≤ 1.5× ULN, total bilirubin ≤ 1.5 mg/dL, AST ≤ 5 × ULN, and alkaline phosphatase ≤ 5 × ULN. Patients may have received adjuvant therapy for resected Stage II or III disease without recurrence within 12 months. The patients were stratified for ECOG performance status (0, 1 vs. 2), prior adjuvant chemotherapy (yes vs. no), prior immunotherapy (yes vs. no), and age (
The following table presents the dosing regimens of the three arms of the study.
The following table presents the demographics of the patient population entered into this study.
The length of a treatment cycle was 2 weeks for the ELOXATIN and 5-FU/LV regimen; 6 weeks for the irinotecan plus 5-FU/LV regimen; and 3 weeks for the ELOXATIN plus irinotecan regimen. The median number of cycles administered per patient was 10 (23.9 weeks) for the ELOXATIN and 5-FU/LV regimen, 4 (23.6 weeks) for the irinotecan plus 5-FU/LV regimen, and 7 (21.0 weeks) for the ELOXATIN plus irinotecan regimen. Patients treated with the ELOXATIN and 5-FU/LV combination had a significantly longer time to tumor progression based on investigator assessment, longer overall survival, and a significantly higher confirmed response rate based on investigator assessment compared to patients given irinotecan plus 5-FU/LV. The following table summarizes the efficacy results.
Figure 4 illustrates the Kaplan-Meier survival curves for the comparison of ELOXATIN and 5-FU/LV combination and ELOXATIN plus irinotecan to irinotecan plus 5-FU/LV.
A descriptive subgroup analysis demonstrated that the improvement in survival for ELOXATIN plus 5-FU/LV compared to irinotecan plus 5-FU/LV appeared to be maintained across age groups, prior adjuvant therapy, and number of organs involved. An estimated survival advantage in ELOXATIN plus 5-FU/LV versus irinotecan plus 5-FU/LV was seen in both genders; however it was greater among women than men. Insufficient subgroup sizes prevented analysis by race.
A multicenter, open-label, randomized, three-arm controlled study was conducted in the US and Canada comparing the efficacy and safety of ELOXATIN in combination with an infusional schedule of 5-FU/LV to the same dose and schedule of 5-FU/LV alone and to single agent oxaliplatin in patients with advanced colorectal cancer who had relapsed/progressed during or within 6 months of first-line therapy with bolus 5-FU/LV and irinotecan. The study was intended to be analyzed for response rate after 450 patients were enrolled. Survival will be subsequently assessed in all patients enrolled in the completed study. Accrual to this study is complete, with 821 patients enrolled. Patients in the study hadto be at least 18 years of age, have unresectable, measurable, histologically proven colorectal adenocarcinoma, with a Karnofsky performance status >50%. Patients had to have SGOT(AST) and SGPT(ALT) ≤2× the institution's upper limit of normal (ULN), unless liver metastases were present and documented at baseline by CT or MRI scan, in which case ≤5× ULN was permitted. Patients had to have alkaline phosphatase ≤2× the institution's ULN, unless liver metastases were present and documented at baseline by CT or MRI scan, in which cases ≤5× ULN was permitted. Prior radiotherapy was permitted if it had been completed at least 3 weeks before randomization. The dosing regimens of the three arms of the study are presented in the table below.
Patients entered into the study for evaluation of response must have had at least one unidimensional lesion measuring ≥20mm using conventional CT or MRI scans, or ≥10mm using a spiral CT scan. Tumor response and progression were assessed every 3 cycles (6 weeks) using the Response Evaluation Criteria in Solid Tumors (RECIST) until radiological documentation of progression or for 13 months following the first dose of study drug(s), whichever came first. Confirmed responses were based on two tumor assessments separated by at least 4 weeks.
The demographics of the patient population entered into this study are shown in the table below.
The median number of cycles administered per patient was 6 for the ELOXATIN and 5-FU/LV combination and 3 each for 5-FU/LV alone and ELOXATIN alone.
Patients treated with the combination of ELOXATIN and 5-FU/LV had an increased response rate compared to patients given 5-FU/LV or oxaliplatin alone. The efficacy results are summarized in the tables below.
At the time of the interim analysis 49% of the radiographic progression events had occurred. In this interim analysis an estimated 2-month increase in median time to radiographic progression was observed compared to 5-FU/LV alone.
Of the 13 patients who had tumor response to the combination of ELOXATIN and 5-FU/LV, 5 were female and 8 were male, and responders included patients
Eloxatin 200mg (Oxaliplatin) . How Supplied/storage And Handling
ELOXATIN 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 lyophilized powder for reconstitution. Lactose monohydrate is also present as an inactive ingredient.
NDC 0024-0596-02: 50 mg single-use vial with green flip-off seal individually packaged in a carton.
NDC 0024-0597-04: 100 mg single-use vial with dark blue flip-off seal individually packaged in a carton.
As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of infusion solutions prepared from ELOXATIN. The use of gloves is recommended. If a solution of ELOXATIN contacts the skin, wash the skin immediately and thoroughly with soap and water. If ELOXATIN contacts the mucous membranes, flush thoroughly with water.
Procedures for the handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published . There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Eloxatin 200mg (Oxaliplatin) Patient Counseling Information
Patients and patients' caregivers should be informed of the expected side effects of ELOXATIN, particularly its neurologic effects, both the acute, reversible effects and the persistent neurosensory toxicity. Patients should be informed that the acute neurosensory toxicity may be precipitated or exacerbated by exposure to cold or cold objects. Patients should be instructed to avoid cold drinks, use of ice, and should cover exposed skin prior to exposure to cold temperature or cold objects.
Patients must be adequately informed of the risk of low blood cell counts and instructed to contact their physician immediately should fever, particularly if associated with persistent diarrhea, or evidence of infection develop.
Patients should be instructed to contact their physician if persistent vomiting, diarrhea, signs of dehydration, cough or breathing difficulties occur, or signs of allergic reaction appear.
PATIENT INFORMATION
ELOXATIN(OXALIplatin for injection)andELOXATIN(OXALIplatin injection)INJECTION
Read this information carefully as you start using ELOXATIN. It will help you learn more about ELOXATIN. This information does not take the place of talking to your doctor about your medical condition or your treatment. Ask your doctor about any questions you have.
What is ELOXATIN?
ELOXATIN (eh-LOX-ah-tin) is an anticancer (chemotherapy) medicine that is used with other anti-cancer medicines called 5-fluorouracil (5-FU) and leucovorin (LV):
ELOXATIN with infusional 5-FU and LV was shown to lower the chance of colon cancer returning when given to patients with stage III colon cancer after surgery to remove the tumor. It is not known if ELOXATIN increases survival in patients with stage III colon cancer. ELOXATIN with infusional 5-FU and LV was also shown to increase survival, shrink tumors and delay growth of tumors in some patients with advanced colorectal cancer.
The use of ELOXATIN in children has not been studied.
Who should not use ELOXATIN?
Do not use ELOXATIN if:
Tell your doctor if:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines and herbal supplements. ELOXATIN may affect how they work in your body.
How is ELOXATIN given to me?
ELOXATIN is given to you through your veins (blood vessels).
Your doctor will prescribe ELOXATIN in an amount that is appropriate for you. Your doctor will treat you with several medicines for your cancer. It is very important that you do exactly what your doctor and nurse have taught you to do. Some medicines may be given to you before ELOXATIN to help prevent nausea and vomiting.
ELOXATIN is given with 2 other chemotherapy drugs, leucovorin and 5-FU. Each treatment course is given to you over 2 days. You will receive ELOXATIN on the first day only. There are usually 14 days between each chemotherapy treatment course.
Treatment Day 1:
ELOXATIN and leucovorin are put into a vein through a thin plastic tube (intravenous infusion or I.V.) and given for 2 hours. You will be watched by a healthcare provider during this time.
Right after the ELOXATIN and leucovorin are finished, 2 doses of 5-FU will be given. The first dose is given right away into your I.V. tube. The second dose will be given into your I.V. tube over the next 22 hours, using a pump device.
Treatment Day 2:
You will not get ELOXATIN on Day 2. Leucovorin and 5-FU will be given the same way as on Day 1.
During your treatment with ELOXATIN:
The 5-FU will be given through your I.V. with a pump. If you have any problems with the pump or the tube, call your doctor, your nurse, or the person who is responsible for your pump. You should never allow anyone other than a healthcare provider to touch your infusion pump or tubing.
What activities should I avoid while under treatment with ELOXATIN?
See the end of this leaflet, ("How can I reduce the side effects caused by cold temperatures?").
You need to discuss your level of activity during treatment with your doctor and your nurse. You should follow their advice.
What are the possible side effects of ELOXATIN
ELOXATIN can cause allergic reactions.
Get emergency help right away if:
Call your doctor right away if you have any of the following:
Call your doctor if you get any of the following:
Tell your doctor
ELOXATIN can affect how your nerves work and make you feel (peripheral neuropathy). Tell your doctor right away if you get any signs of nerve problems listed below:
The first signs of nerve problems may occur with the initial treatment. The nerve problems can also start up to 2 days afterwards. If you develop nerve problems, the amount of ELOXATIN in your next treatment may be changed.
For information on ways to lessen or help with the nerve problems, see the end of this leaflet, "How can I reduce the side effects caused by cold temperatures?" Other common side effects from ELOXATIN include nausea, vomiting, diarrhea, constipation, mouth sores, stomach pain, fever, loss of appetite, and tiredness.
These are not all the possible side effects of ELOXATIN. For more information, ask your doctor or pharmacist.
How can I reduce the side effects caused by cold temperatures?
This list is not complete and your healthcare provider may have other useful tips for helping you with these side effects.
General information about the safe and effective use of ELOXATIN
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
This leaflet summarizes the most important information about ELOXATIN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ELOXATIN that is written for health professionals.
Paraplatin and Platinol are registered trademarks of Bristol-Myers Squibb Company.
Eloxatin 200mg (Oxaliplatin)
