Oxaliplatin

DRUG NAME: Oxaliplatin

SYNONYM(S): ACT-078, l-OHP, LOHP, oxalatoplatin, oxaliplatinum

COMMON TRADE NAME(S): ELOXATIN

CLASSIFICATION: Alkylating agent

Special pediatric considerations are noted when applicable, otherwise adult provisions apply.

MECHANISM OF ACTION:

Oxaliplatin belongs to a new class of platinum agent. It contains a platinum atom complexed with oxalate
and diaminocyclohexane (DACH). The bulky DACH is thought to contribute greater cytotoxicity than cisplatin
and carboplatin.1 The exact mechanism of action of oxaliplatin is not known. Oxaliplatin forms reactive
platinum complexes which are believed to inhibit DNA synthesis by forming interstrand and intrastrand
cross-linking of DNA molecules. Oxaliplatin is not generally cross-resistant to cisplatin or carboplatin,
possibly due to the DACH group and resistance to DNA mismatch repair.1,2 Preclinical studies have shown
oxaliplatin to be synergistic with fluorouracil and SN-38, the active metabolite of irinotecan.3 Oxaliplatin is a
radiation-sensitizing agent.4,5 It is cell cycle phase-nonspecific.6

PHARMACOKINETICS:
Interpatient variability inter- and intra-subject variability is low6
Distribution minimal in plasma; accumulation in erythrocytes does not diffuse into plasma or act as
a drug reservoir
cross blood brain barrier? no information found
volume of distribution ultrafilterable platinum*: 582 ± 261 L6
plasma protein binding 70-95%
Metabolism rapid nonenzymatic biotransformation to reactive platinum complexes7
active metabolite(s) DACH platinum species6
inactive metabolite(s) several conjugates,6 including the 1,2-DACH-platinum
dichloride (2%) associated with neurotoxicity3
Excretion platinum is mainly by renal excretion and tissue distribution,8 while platinum metabolites
are mainly by renal excretion1
urine 50% within 3 days9
feces minimal9
terminal half life ultrafilterable platinum*: 273 ± 19 h6
platinum elimination from erythrocytes: 48 days1
clearance ultrafilterable platinum*: 10.1 ± 3.07 L/h6
Adapted from reference1 unless specified otherwise.
∗Ultrafilterable platinum consists of oxaliplatin and free oxaliplatin metabolites.

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Revised: 1 March 2023
 Oxaliplatin

USES:
Primary uses: Other uses:
*Colorectal cancer10-12 Breast cancer13
Gastric cancer14
Germ cell cancer15
Head and neck cancer16
Lung cancer, non-small cell17
Lymphoma, non-Hodgkin’s18
Mesothelioma19,20
Ovarian cancer21,22
Pancreatic cancer23
Prostate cancer24
*Health Canada approved indication

No pediatric indications.

SPECIAL PRECAUTIONS:

Contraindications:
• history of hypersensitivity reaction to oxaliplatin or other platinum agents (e.g., cisplatin, carboplatin)6
• peripheral sensory neuropathy interfering with function or severe renal dysfunction (CrCl < 30 mL/min)6

Caution:
• QT prolongation and torsades de pointes are reported; use caution in patients with history of QT
prolongation or cardiac disease and those receiving concurrent therapy with other QT prolonging
medications. Correct electrolyte disturbances prior to treatment and monitor periodically.25,26

Special populations:
• elderly patients over 65 may be at higher risk of severe (grades 3-4) diarrhea11
• women may be at higher risk of severe (grades 3-4) neutropenia11

Carcinogenicity: Oxaliplatin is considered a probable carcinogen, although carcinogenic studies have not
been done.6

Mutagenicity: Mutagenic in mammalian in vitro mutation chromosome tests.6

Fertility: no information found

Pregnancy: Oxaliplatin produced embryo-fetal toxicity in rats.6

Breastfeeding is not recommended due to the potential secretion into breast milk.6

SIDE EFFECTS:

The table includes adverse events that presented during drug treatment but may not necessarily have a
causal relationship with the drug. Because clinical trials are conducted under very specific conditions, the
adverse event rates observed may not reflect the rates observed in clinical practice. Adverse events are
generally included if they were reported in more than 1% of patients in the product monograph or pivotal
trials, and/or determined to be clinically important. Incidence of adverse events is generally similar when
oxaliplatin is used as a single agent or in combination with fluorouracil and leucovorin, although severe
(grades 3-4) diarrhea, nausea and vomiting, and neurotoxicity are more common with combination
therapy.1,27

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 Oxaliplatin

ORGAN SITE SIDE EFFECT

Clinically important side effects are in bold, italics

allergy/immunology anaphylaxis (0.5-2%)6,28,29

blood/bone marrow anemia (64-83%, severe 4-5%)
febrile neutropenia febrile neutropenia (< 2%)
immune hemolytic anemia (rare)30
neutropenia: single agent (15%, severe 3%); with fluorouracil and leucovorin (66%,
severe 38%)
thrombocytopenia: single agent (41%, severe 3%); with fluorouracil and leucovorin (76%,
severe 4%)
constitutional symptoms fever (36%)
dermatology/skin alopecia (2%)
general disorders and extravasation hazard: irritant31-36; treat as vesicant37; see paragraph following Side
administration site Effects table
conditions infusion-related (vascular) pain38 (50-80%); see paragraph following Side Effects table
gastrointestinal emetogenic potential: high moderate39
diarrhea: single agent (41%, severe 5%); with fluorouracil and leucovorin (58%, severe
10%)
mucositis: single agent (4%, severe 2%); with fluorouracil and leucovorin (42%, severe
8%)
nausea, vomiting (69-71%, severe 12-14%)
hepatic liver function abnormalities (46%, severe 12%)
infection infection (23%)
investigations QT prolongation, torsades de pointes25,26,40,41
neurology central neurotoxicity/reversible posterior leukoencephalopathy syndrome (<1%)42-46; see
paragraph following Side Effects table
neuropathy, sensory (85-95%); see paragraph following Side Effects table
pharyngolaryngeal dysesthesia (1-2%); see paragraph following Side Effects table
renal/genitourinary renal dysfunction (3%, severe < 1%)
vascular thromboembolic events, including deep vein thrombosis47 (1-10%)47-49
Adapted from reference6 unless otherwise specified.

Extravasation of oxaliplatin may sometimes cause severe local inflammation and potentially tissue
necrosis.31-36 The optimal non-pharmacological management of oxaliplatin extravasation is unclear.
However, it has been suggested that warm compresses may be preferred over cool compresses33,50,51 which
may theoretically precipitate or worsen peripheral sensory neuropathy. For management of extravasation
reactions, see Systemic Therapy Policy Number III-20 Prevention and Management of Extravasation of
Chemotherapy.

Infusion-related (vascular) pain is reported to occur in 50-80% of patients treated with oxaliplatin via a
peripheral vein. Interventions such as adjusting the oxaliplatin solution pH, diluting or prewarming the
infusion solution, and warming the injection site with hot compresses have only had limited effects in
reducing vascular pain. Concurrent administration of dextrose 5% with peripheral venous administration of
oxaliplatin has been shown to significantly reduce the incidence of vascular pain.38 Refer to protocol by
which patient is being treated.52

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 Oxaliplatin

Peripheral sensory neuropathy is cumulative, dose-related and usually reversible a few months after
stopping treatment. Symptoms include sensory ataxia and dysesthesia of the limbs, mouth, throat and
larynx, and may be exacerbated by exposure to cold (e.g., touching cold surface, drinking cold liquid).1,39
The incidence of grade 2 neuropathy is 10% after 3 treatment cycles and 50% after 10 cycles. Grade 3
neuropathy occurs in 10% after 9 cycles and 50% after 14 cycles, is reversible in 74% of the cases, and
begins to recover after 13 weeks. Paresthesia interfering with function (e.g., buttoning clothing, holding
objects, writing) is seen in 16% of patients after 4 months of treatment and rarely leads to oxaliplatin
withdrawal.11 Unlike cisplatin, oxaliplatin neuropathy is related to injury to small rather than large sensory
fibres.17 The use of calcium gluconate or magnesium sulfate infusions pre- and/or post oxaliplatin treatment
do not appear to reduce or protect against oxaliplatin-induced neurotoxicity.53-56 Gabapentin PO 100 mg
twice daily, with increments of 100 mg PO daily as needed, may be effective in some patients to reduce
oxaliplatin neuropathy,57 while carbamazepine does not appear to be effective.58 Other agents used with
some success include alpha-lipoic acid IV 600 mg weekly for 3-5 weeks, then followed by oral 600 mg three
times daily.59 Oxaliplatin delivered according to 24-hour biologic rhythms (chronomodulated) appears to be
associated with less peripheral neuropathy than fixed rate infusion.1,12

Pharyngolaryngeal dysesthesia with sporadic reduced sensitivity of the larynx and pharynx is seen in
1-2% of patients shortly after drug infusion. Symptoms usually resolve within hours of onset but the feeling
of difficulty in breathing or swallowing may be distressing to the patient. Treatment is usually not needed,
although antihistamines and bronchodilators have been used. To prevent recurrence, infusion time should
be extended to 6 hours with subsequent treatments.1,6

Reversible posterior leukoencephalopathy syndrome (RPLS; also known as PRES) has been
associated with oxaliplatin,42-46 which may cause endothelial dysfunction and lead to vasogenic edema.43,44
Clinical presentation includes altered mental status, seizures, headache, and loss of vision with associated
radiographic abnormality on MRI or CT.43 Symptom onset may be delayed relative to treatment, with cases
reported 8 to 12 days after the first infusion and as long as 6 weeks post treatment.44,45,60 Management is
usually supportive, with control of hypertension, electrolyte replacement, seizure management, and
discontinuation of oxaliplatin.43,44 Although usually reversible, permanent disability and fatalities have been
reported.43,44

INTERACTIONS:

AGENT EFFECT MECHANISM MANAGEMENT

fluorouracil61 no influence on fluorouracil
pharmacokinetics
irinotecan62-64 induction of irinotecan- may potentiate irinotecan give prophylactic atropine
related cholinergic syndrome inhibition of acetylcholinesterase before irinotecan
topotecan65 no effects on topotecan
pharmacokinetics
warfarin66 significantly higher incidence unknown; possible synergy of for oxaliplatin/fluorouracil
of INR elevation when anticoagulant effect of based regimens only:
administered with fluorouracil by oxaliplatin monitor INR regularly
oxaliplatin/fluorouracil based during and for one month
regimens following completion of
treatment; adjust warfarin
dose as needed

Avoid concurrent use of QT/QTc-prolonging drugs if possible. Use caution with drugs that may disrupt electrolyte levels.
Correct electrolytes as needed and monitor as applicable.25

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 Oxaliplatin

SUPPLY AND STORAGE:

Injection:
sanofi-aventis Canada Inc. supplies oxaliplatin as 50 mg and 100 mg single-use vials of sterile lyophilized
powder and 50 mg, 100 mg, and 200 mg single-use vials of sterile preservative-free aqueous solution in a
concentration of 5 mg/mL. Store at room temperature. Do not freeze. Protect from light for long-term
storage.46

Sandoz Canada Inc. supplies oxaliplatin as 50 mg, 100 mg, 150 mg, and 200 mg single-use vials of
preservative-free aqueous solution in a concentration of 5 mg/mL. Store at room temperature. Do not freeze.
Protect from light.67

For basic information on the current brand used at BC Cancer, see Chemotherapy Preparation and
Stability Chart in Appendix.

SOLUTION PREPARATION AND COMPATIBILITY:

For basic information on the current brand used at BC Cancer, see Chemotherapy Preparation and
Stability Chart in Appendix.

Additional information:
• aluminum-containing IV needles, syringes or sets should not be used to prepare or administer oxaliplatin;
aluminum reacts with platinum from oxaliplatin to form a precipitate, resulting in loss of potency6
• oxaliplatin should not be combined with leucovorin or leucovorin containing trometamol in the same
infusion bag; however, oxaliplatin can be co-administered with leucovorin or leucovorin containing
trometamol using a Y-line placed immediately before the site of injection68,69

Compatibility: consult detailed reference

PARENTERAL ADMINISTRATION:
BC Cancer administration guideline noted in bold, italics
Subcutaneous no information found
Intramuscular no information found
Direct intravenous no information found
Intermittent infusion • duration of administration varies according to protocol:
o in 500 mL D5W over 2 h11; in 250-500 mL D5W over 30 min9, 3 h70, or 6 h12
• administer oxaliplatin before fluoropyrimidines (e.g., fluorouracil)6
• do not piggyback or flush lines with sodium chloride solution6
Continuous infusion chronomodulated infusion over 5 days using programmable-in-time pump12
Intraperitoneal hyperthermic intraperitoneal chemotherapy (HIPEC): pump solution into abdominal
cavity and circulate as per protocol using hyperthermia pump; solutions and dwell time
vary by protocol71-73
Intrapleural no information found
Intrathecal no information found
Intra-arterial investigational, over 4 h74
Intravesical no information found

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 Oxaliplatin

DOSAGE GUIDELINES:
Refer to protocol by which patient is being treated. Numerous dosing schedules exist and depend on
disease, response and concomitant therapy. Guidelines for dosing also include consideration of absolute
neutrophil count (ANC). Dosage may be reduced, delayed or discontinued in patients with bone marrow
depression due to cytotoxic/radiation therapy or in patients with other toxicities.

Adults:
BC Cancer usual dose noted in bold, italics
Cycle Length:
Intravenous: 1 week70: 35 mg/m² IV for one dose on day 1

2 weeks1,10,75: 85 mg/m² (range 80-100 mg/m²) IV for one dose on

day 1

3 weeks1,3,75: 130 mg/m² (range 85-135 mg/m²) IV for one dose on

day 1

30 mg/m²/day by continuous IV infusion for

5 consecutive days
(total dose per cycle 150 mg/m²)76

35 mg/m²/day by chronomodulated IV infusion for

5 consecutive days
(total dose per cycle 175 mg/m²)76

4 weeks: 85 mg/m² IV for one dose on days 1 and 15

(total dose per cycle 170 mg/m²)77

50 days: 50 mg/m² IV for one dose on days 1,8, 15, 22, 29,
and 36
(total dose per cycle 300 mg/m²)78

Concurrent radiation: investigational, 130 mg/m² IV on days 1 and 29 concurrent with radiation4

Dosage in myelosuppression: modify according to protocol by which patient is being treated; if no

guidelines available, refer to Appendix "Dosage Modification for
Myelosuppression"

Dosage in neurotoxicity:6
Duration of Neurotoxicity Severity Dose
>7 days6,11 troublesome reduce dose from: 130 mg/m² to 100 mg/m²;
or from 85 mg/m² to 65 mg/m²;
or from 65 mg/m² to 50 mg/m²
persists until next cycle6 no functional impairment reduce dose from 85 mg/m² to 65 mg/m²
>7 days11 functional impairment reduce dose from 85 mg/m² to 50 mg/m²
persists until next cycle6,11 functional impairment discontinue*
*if neurotoxicity improves following discontinuation, resumption of therapy may be considered6,79

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 Oxaliplatin

Dosage in renal failure: Creatinine clearance (mL/min) Dose

> 30 100%80
< 30 no information found

calculated creatinine clearance = N* x (140 - Age) x weight in kg

serum creatinine in micromol/L

* For males N=1.23; for females N=1.04

Dosage in hepatic failure: mild to moderate dysfunction: no adjustment required6;

severe dysfunction: no information found

Dosage in dialysis: no information found

Children: has been used; effectiveness has not been established46

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Revised: 1 March 2023
 Oxaliplatin

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Pharmacy.
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Revised: 1 March 2023
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Pharmacy.
Developed: 2001
Revised: 1 March 2023