Oxaliplatin (Lyophilisate, Concentrate) Instructions for Use
ATC Code
L01XA03 (Oxaliplatin)
Active Substance
Oxaliplatin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antineoplastic drug
Pharmacotherapeutic Group
Antineoplastic agents; other antineoplastic agents; platinum compounds
Pharmacological Action
Antineoplastic agent, platinum derivative. Oxaliplatin is a stereoisomer in which the central platinum atom is surrounded by oxalate and diaminocyclohexane in trans positions.
Like other platinum derivatives, Oxaliplatin interacts with DNA, forming intra- and interstrand cross-links, which blocks its synthesis and subsequent replication.
The formation of oxaliplatin bonds with DNA is rapid and reaches a maximum within 15 minutes (this process is biphasic for cisplatin with a slow 4-8 hour phase).
Disruption of DNA synthesis leads to inhibition of RNA and cellular protein synthesis.
Oxaliplatin is effective against some cisplatin-resistant cell lines.
Pharmacokinetics
Oxaliplatin is intensively metabolized and by the end of a 2-hour infusion at a dose of 130 mg/m2 is no longer detectable, with 15% of the administered dose remaining in the blood and the remaining 85% rapidly distributed in tissues (or excreted in urine).
Platinum binds to plasma albumin.
It is excreted in the urine within the first 48 hours.
By the fifth day, approximately 54% of the total dose is found in the urine and less than 3% in the feces.
In renal impairment, a significant decrease in clearance from 17.55±2.18 L/h to 9.95±1.91 L/h and Vd from 330±40.9 to 241±36.1 L was observed.
The effect of severe renal impairment on platinum clearance has not been studied.
Indications
Metastatic colorectal cancer as monotherapy or as part of combination therapy with fluoropyrimidines.
Ovarian cancer.
ICD codes
| ICD-10 code | Indication |
| C18 | Malignant neoplasm of colon |
| C19 | Malignant neoplasm of rectosigmoid junction |
| C20 | Malignant neoplasm of rectum |
| C56 | Malignant neoplasm of ovary |
| ICD-11 code | Indication |
| 2B90.Z | Malignant neoplasm of colon, unspecified |
| 2B91.Z | Malignant neoplasm of rectosigmoid junction, unspecified |
| 2B92.Z | Malignant neoplasm of rectum, unspecified |
| 2C73.Y | Other specified malignant neoplasms of ovary |
| 2C73.Z | Malignant neoplasms of ovary, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Determine the dosage individually based on the therapeutic regimen, disease stage, and patient’s hematological status.
Administer as an intravenous infusion over 2 to 6 hours. Do not administer as a bolus intravenous injection.
For metastatic colorectal cancer, the typical dose is 85 mg/m² every 2 weeks or 130 mg/m² every 3 weeks, in combination with fluoropyrimidines.
For ovarian cancer, use according to the specific protocol, often at a dose of 130 mg/m² every 3 weeks as monotherapy.
Pre-medicate with effective antiemetics to prevent nausea and vomiting.
Do not reconstitute or dilute with sodium chloride solutions or other chloride-containing solutions.
Use only 5% dextrose solution for dilution. The final concentration for infusion should be between 0.2 mg/mL and 0.7 mg/mL.
Monitor peripheral blood count before each cycle. Postpone administration if neutrophils are below 1.5 x 10⁹/L or platelets are below 100 x 10⁹/L.
Conduct regular neurological examinations before each cycle and upon patient report of symptoms.
Reduce the dose or discontinue therapy in case of severe persistent hematological toxicity or grade 3/4 peripheral sensory neuropathy.
For patients with moderate renal impairment (creatinine clearance 30-59 mL/min), exercise caution; initial dose reduction may be required.
Adjust the dose for severe toxicities according to the specific protocol’s guidelines.
Adverse Reactions
From the hematopoietic system: anemia, leukopenia, granulocytopenia, thrombocytopenia.
From the digestive system: nausea, vomiting, diarrhea.
From the CNS and peripheral nervous system: frequently – peripheral neuropathies characterized by paresthesia of the extremities; may be accompanied by cramps, dysesthesia of the perioral region or upper respiratory tract (which may mimic the clinical picture of reversible laryngospasm) and gastrointestinal tract.
The appearance of such symptoms is often caused by exposure to cold.
Paresthesia mainly regresses between treatment courses, but can become permanent and cause functional impairments usually after exceeding a total dose of 800 mg/m2 (6 courses).
Other: in some cases – fever, skin rash.
Contraindications
Myelosuppression before the start of the first course of therapy with neutrophil count less than 2×109/L and/or platelet count less than 100×109/L, peripheral sensory neuropathy before the start of the first course of therapy, severe renal impairment (creatinine clearance less than 30 ml/min), pregnancy, lactation (breastfeeding), hypersensitivity to oxaliplatin.
Use in Pregnancy and Lactation
Oxaliplatin is contraindicated for use during pregnancy and lactation.
Use in Renal Impairment
Contraindicated in severe renal impairment (creatinine clearance less than 30 ml/min).
Special Precautions
Oxaliplatin may only be used by a qualified physician experienced in anticancer chemotherapy.
Before starting treatment and before the next administration of oxaliplatin, a peripheral blood test must be performed; in addition, regular neurological examination should be performed, especially when used concomitantly with drugs that have potential neurotoxicity.
To prevent and treat nausea and vomiting, the use of antiemetics is recommended.
In cases of hematological disorders (leukopenia less than 2×109/L and/or thrombocytopenia less than 50×109/L), the next administration should be postponed until the blood count returns to normal.
Drug Interactions
When oxaliplatin is used in combination with 5-fluorouracil, a synergistic cytotoxic effect is observed in vitro and in vivo, and the severity of neutropenia and thrombocytopenia is increased.
Storage Conditions
Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Lyophilizate for preparation of concentrate for preparation of solution for infusion 50 mg: vial 1 pc.
Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc.
Marketing Authorization Holder
Belmedpreparaty RUP (Republic of Belarus)
Dosage Forms
 |
Oxaliplatin | Lyophilizate for preparation of concentrate for preparation of solution for infusion 50 mg: vial 1 pc. |
| Lyophilisate for the preparation of a concentrate for the preparation of an infusion solution 100 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilisate for preparation of concentrate for preparation of solution for infusion in the form of a powder or porous mass of white or almost white color.
| 1 vial | |
| Oxaliplatin | 50 mg |
Excipients: lactose monohydrate – 450 mg.
20 ml glass vials (1) – cardboard boxes.
50 ml glass vials (1) – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion in the form of a powder or porous mass of white or almost white color.
| 1 vial | |
| Oxaliplatin | 100 mg |
Excipients: lactose monohydrate – 900 mg.
50 ml glass vials (1) – cardboard boxes.
100 ml glass vials (1) – cardboard boxes.
Concentrate for solution for infusion 2 mg/1 ml: vial 25 ml or 50 ml
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
Jodas Expoim, Pvt. Ltd. (India)
Dosage Form
|
Oxaliplatin | Concentrate for solution for infusion 2 mg/1 ml: vial 25 ml or 50 ml |
Dosage Form, Packaging, and Composition
Concentrate for preparation of solution for infusion in the form of a clear liquid from colorless to light yellow.
| 1 ml | |
| Oxaliplatin | 2 mg |
Excipients: water for injections – up to 1 ml.
25 ml – dark glass vials (1) – plastic trays (1) – cardboard boxes.
25 ml – dark glass vials (1) – cardboard boxes.
50 ml – dark glass vials (1) – plastic trays (1) – cardboard boxes.
50 ml – dark glass vials (1) – cardboard boxes.
Concentrate for solution for infusion 5 mg/1 ml: vial 10 ml, 20 ml, 30 ml or 40 ml
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
Fareva Unterach, GmbH (Austria)
Dosage Form
|
Oxaliplatin Ebewe® | Concentrate for solution for infusion 5 mg/1 ml: vial 10 ml, 20 ml, 30 ml or 40 ml |
Dosage Form, Packaging, and Composition
Concentrate for preparation of solution for infusion in the form of a clear liquid, from colorless to light yellow.
| 1 ml | |
| Oxaliplatin | 5 mg |
Excipients: water for injections – up to 1 ml.
10 ml – colorless glass vials with a capacity of 10 ml (1) – cardboard boxes.
20 ml – colorless glass vials with a capacity of 20 ml (1) – cardboard boxes.
30 ml – colorless glass vials with a capacity of 50 ml (1) – cardboard boxes.
40 ml – colorless glass vials with a capacity of 50 ml (1) – cardboard boxes.
10 ml – colorless glass vials with a capacity of 10 ml (1) – “Onco-Safe” plastic containers (1) – cardboard boxes.
20 ml – colorless glass vials with a capacity of 20 ml (1) – “Onco-Safe” plastic containers (1) – cardboard boxes.
30 ml – colorless glass vials with a capacity of 50 ml (1) – “Onco-Safe” plastic containers (1) – cardboard boxes.
40 ml – colorless glass vials with a capacity of 50 ml (1) – “Onco-Safe” plastic containers (1) – cardboard boxes.
Concentrate for solution for infusion 5 mg/1 ml: fl. 10 ml, 20 ml, or 40 ml, 1 pc.
Marketing Authorization Holder
Medac, GmbH (Germany)
Manufactured By
Oncomed Manufacturing, A.S. (Czech Republic)
Packaging and Quality Control Release
Medac, GmbH (Germany)
Dosage Form
|
Oxaliplatin medac® | Concentrate for solution for infusion 5 mg/1 ml: fl. 10 ml, 20 ml, or 40 ml, 1 pc. |
Dosage Form, Packaging, and Composition
Concentrate for preparation of solution for infusion in the form of a clear, colorless liquid.
| 1 ml | |
| Oxaliplatin | 5 mg |
Excipients: water for injections – up to 1 ml.
10 ml – colorless glass vials (1) – cardboard boxes.
20 ml – colorless glass vials (1) – cardboard boxes.
40 ml – colorless glass vials (1) – cardboard boxes.
Lyophilisate for preparation of solution for infusion 50 mg: vial 10 ml 1 pcs.
Lyophilisate for preparation of solution for infusion 100 mg: vial 20 ml 1 pcs.
Lyophilisate for preparation of solution for infusion 150 mg: vial 30 ml 1 pcs.
Lyophilisate for preparation of solution for infusion 200 mg: vial 50 ml 1 pcs.
Marketing Authorization Holder
Amedart LLC (Russia)
Dosage Forms
|
Oxaliplatin-Amedart | Lyophilisate for preparation of solution for infusion 50 mg: vial 10 ml 1 pcs. |
| Lyophilisate for preparation of solution for infusion 100 mg: vial 20 ml 1 pcs. | ||
| Lyophilisate for preparation of solution for infusion 150 mg: vial 30 ml 1 pcs. | ||
| Lyophilisate for preparation of solution for infusion 200 mg: vial 50 ml 1 pcs. |
Dosage Form, Packaging, and Composition
Lyophilisate for preparation of concentrate for preparation of solution for infusion lyophilized compacted mass or powder of white, or almost white color.
| 1 vial | |
| Oxaliplatin | 50 mg |
Excipients: lactose monohydrate.
50 ml – colorless glass vials with a volume of 10 ml (1) – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion lyophilized compacted mass or powder of white, or almost white color.
| 1 vial | |
| Oxaliplatin | 100 mg |
Excipients: lactose monohydrate.
100 mg – colorless glass vials with a volume of 20 ml (1) – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion lyophilized compacted mass or powder of white, or almost white color.
| 1 vial | |
| Oxaliplatin | 150 mg |
Excipients: lactose monohydrate.
150 mg – colorless glass vials with a volume of 30 ml (1) – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion lyophilized compacted mass or powder of white, or almost white color.
| 1 vial | |
| Oxaliplatin | 200 mg |
Excipients: lactose monohydrate.
200 mg – colorless glass vials with a volume of 50 ml (1) – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion 50 mg/ml: vial
Lyophilisate for preparation of concentrate for preparation of solution for infusion 100 mg/ml: vial
Lyophilisate for preparation of concentrate for preparation of infusion solution 150 mg/ml: vial.
Lyophilisate for preparation of concentrate for preparation of infusion solution 200 mg/ml: vial.
Marketing Authorization Holder
Deko Company, LLC (Russia)
Dosage Forms
|
Oxaliplatin-Deco | Lyophilisate for preparation of concentrate for preparation of solution for infusion 50 mg/ml: vial |
| Lyophilisate for preparation of concentrate for preparation of solution for infusion 100 mg/ml: vial | ||
| Lyophilisate for preparation of concentrate for preparation of infusion solution 150 mg/ml: vial. | ||
| Lyophilisate for preparation of concentrate for preparation of infusion solution 200 mg/ml: vial. |
Dosage Form, Packaging, and Composition
Lyophilisate for preparation of concentrate for preparation of solution for infusion of white or almost white color.
| 1 vial | |
| Oxaliplatin | 50 mg |
Excipients: lactose monohydrate – 450 mg.
50 mg – vials – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion of white or almost white color.
| 1 vial | |
| Oxaliplatin | 100 mg |
Excipients: lactose monohydrate – 900 mg.
100 mg – vials – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion of white or almost white color.
| 1 vial | |
| Oxaliplatin | 150 mg |
Excipients: lactose monohydrate – 1350 mg.
150 mg – vials – cardboard boxes.
Lyophilisate for preparation of concentrate for preparation of solution for infusion of white or almost white color.
| 1 vial | |
| Oxaliplatin | 200 mg |
Excipients: lactose monohydrate – 1800 mg.
200 mg – vials – cardboard boxes.
Lyophilizate for the preparation of solution for infusion 50 mg: fl. 1 pc.
Marketing Authorization Holder
Ebewe Pharma Ges.m.b.H.Nfg.KG (Austria)
Dosage Form
|
Oxaliplatin-Ebewe | Lyophilizate for the preparation of solution for infusion 50 mg: fl. 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion (powder or compact mass) of white color.
| 1 vial | |
| Oxaliplatin | 50 mg |
Excipients: lactose monohydrate – 450 mg.
50 mg – vials of colorless glass with a capacity of 32 ml (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc.
Marketing Authorization Holder
Ebewe Pharma Ges.m.b.H.Nfg.KG (Austria)
Dosage Form
|
Oxaliplatin-Ebewe | Lyophilizate for the preparation of solution for infusion 100 mg: vial 1 pc. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion (powder or compact mass) of white color.
| 1 vial | |
| Oxaliplatin | 100 mg |
Excipients: lactose monohydrate – 900 mg.
100 mg – vials of colorless glass with a capacity of 60 ml (1) – cardboard packs.
Lyophilisate for preparation of infusion solution 50 mg: vial. 60 pcs.
Marketing Authorization Holder
Tsefarma LLC (Russia)
Manufactured By
Laboratorios Filaxis, S.A. (Argentina)
Dosage Form
|
Oxaliplatin-Filaxis | Lyophilisate for preparation of infusion solution 50 mg: vial. 60 pcs. |
Dosage Form, Packaging, and Composition
| Lyophilisate for the preparation of solution for infusion | 1 vial |
| Oxaliplatin | 50 mg |
50 mg – vials of dark glass (60) – cardboard boxes.
Lyophilizate for the preparation of solution for infusion 100 mg: vial.
Marketing Authorization Holder
Tsefarma LLC (Russia)
Manufactured By
Laboratorios Filaxis, S.A. (Argentina)
Dosage Form
|
Oxaliplatin-Filaxis | Lyophilizate for the preparation of solution for infusion 100 mg: vial. |
Dosage Form, Packaging, and Composition
| Lyophilizate for the preparation of solution for infusion | 1 vial |
| Oxaliplatin | 100 mg |
100 mg – vials of dark glass (60) – cardboard boxes.
100 mg – vials of dark glass – cardboard packs.
Lyophilisate for preparation of infusion solution 50 mg: vial. 1, 5, 10 or 50 pcs.
Lyophilisate for preparation of infusion solution 100 mg: vial. 1, 5, 10 or 50 pcs.
Lyophilisate for preparation of infusion solution 150 mg: vial. 1, 5, 10 or 50 pcs.
Lyophilisate for preparation of infusion solution 200 mg: vial. 1, 5, 10 or 50 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Oxaliplatin-Promomed | Lyophilisate for preparation of infusion solution 50 mg: vial. 1, 5, 10 or 50 pcs. |
| Lyophilisate for preparation of infusion solution 100 mg: vial. 1, 5, 10 or 50 pcs. | ||
| Lyophilisate for preparation of infusion solution 150 mg: vial. 1, 5, 10 or 50 pcs. | ||
| Lyophilisate for preparation of infusion solution 200 mg: vial. 1, 5, 10 or 50 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a powder or porous mass of white or almost white color; reconstituted solution – a clear colorless or light yellow liquid.
| 1 vial | |
| Oxaliplatin | 50 mg |
Excipients: lactose monohydrate.
50 mg – vials of colorless glass (1, 5 or 10) – cardboard packs.
50 mg – vials of colorless glass (50) – cardboard packs (for hospitals).
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a powder or porous mass of white or almost white color; reconstituted solution – a clear colorless or light yellow liquid.
| 1 vial | |
| Oxaliplatin | 100 mg |
Excipients: lactose monohydrate.
100 mg – vials of colorless glass (1, 5 or 10) – cardboard packs.
100 mg – vials of colorless glass (50) – cardboard packs (for hospitals).
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a powder or porous mass of white or almost white color; reconstituted solution – a clear colorless or light yellow liquid.
| 1 vial | |
| Oxaliplatin | 150 mg |
Excipients: lactose monohydrate.
150 mg – vials of colorless glass (1, 5 or 10) – cardboard packs.
150 mg – vials of colorless glass (50) – cardboard packs (for hospitals).
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a powder or porous mass of white or almost white color; reconstituted solution – a clear colorless or light yellow liquid.
| 1 vial | |
| Oxaliplatin | 200 mg |
Excipients: lactose monohydrate.
200 mg – vials of colorless glass (1, 5 or 10) – cardboard packs.
200 mg – vials of colorless glass (50) – cardboard packs (for hospitals).
Concentrate for solution for infusion 5 mg/1 ml: vial 10 ml, 20 ml, 30 ml or 40 ml 1 pc.
Marketing Authorization Holder
N.N. Blokhin Russian Cancer Research Center of the Ministry of Health of Russia (Russia)
Dosage Form
|
Oxaliplatin-RONC® | Concentrate for solution for infusion 5 mg/1 ml: vial 10 ml, 20 ml, 30 ml or 40 ml 1 pc. |
Dosage Form, Packaging, and Composition
Concentrate for the preparation of solution for infusion in the form of a transparent, colorless or almost colorless solution with a yellowish tint.
| 1 ml | |
| Oxaliplatin | 5 mg |
Excipients: lactose monohydrate – 45 mg, water for injections – up to 1 ml.
10 ml – vials (1) – cardboard packs.
20 ml – vials (1) – cardboard packs.
30 ml – vials (1) – cardboard packs.
40 ml – vials (1) – cardboard packs.
![Oxaliplatin [Lyophilisate, Concentrate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Oxaliplatin [Lyophilisate, Concentrate] 2")