Oxaliplatin 50mg Inj, 1 Vial
WARNING: Allergic reactions have happened with this drug. Rarely, some allergic reactions have been deadly. Allergic reactions can happen within minutes of getting this drug or at any time during treatment with this drug. If you have questions, talk with the doctor.Other drugs may be given before this drug to help avoid side effects. @ COMMON USES: It is used to treat cancer.
Drug Class
Antineoplastic agent
Pharmacologic Class
Platinum analog
Pregnancy Category
Category D
FDA Approved
Aug 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxaliplatin is a chemotherapy medicine used to treat certain types of cancer, especially colon and rectal cancer. It works by damaging the cancer cells' DNA, which prevents them from growing and multiplying. It is given as an intravenous (IV) infusion, usually in combination with other chemotherapy drugs.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Before starting treatment, read all the information provided to you and follow the instructions precisely. This medication is administered as an intravenous infusion over a specified period.
If you experience gastrointestinal side effects such as nausea, vomiting, diarrhea, or a decrease in appetite, consult your doctor. They may be able to suggest ways to minimize these side effects.
Before receiving any vaccinations, consult your doctor. Certain vaccines may interact with this medication, either increasing the risk of infection or reducing the vaccine's effectiveness.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor immediately to determine the best course of action.
To ensure you get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Before starting treatment, read all the information provided to you and follow the instructions precisely. This medication is administered as an intravenous infusion over a specified period.
If you experience gastrointestinal side effects such as nausea, vomiting, diarrhea, or a decrease in appetite, consult your doctor. They may be able to suggest ways to minimize these side effects.
Before receiving any vaccinations, consult your doctor. Certain vaccines may interact with this medication, either increasing the risk of infection or reducing the vaccine's effectiveness.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult your doctor, nurse, or pharmacist for guidance on proper storage procedures.
What to Do If You Miss a Dose
If you miss a dose, contact your doctor immediately to determine the best course of action.
Lifestyle & Tips
- Avoid exposure to cold temperatures, cold drinks, and cold objects, especially during and for a few days after infusion, as this can worsen nerve pain (neuropathy). Wear warm clothing, gloves, and scarves.
- Stay well-hydrated by drinking plenty of fluids unless otherwise instructed by your doctor.
- Practice good oral hygiene to prevent mouth sores (mucositis).
- Report any signs of infection (fever, chills) immediately, as your immune system may be weakened.
- Avoid activities that could lead to cuts or bruises due to potential for low platelet counts.
- Discuss any new or worsening numbness, tingling, or pain in your hands or feet with your healthcare team.
- Use effective contraception during treatment and for at least 9 months after the last dose for women, and for at least 6 months after the last dose for men, as oxaliplatin can harm a developing baby.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
85 mg/m² IV infusion over 2-6 hours every 2 weeks (often in combination with fluoropyrimidines)
Dose Range:
85 - 130 mg
Condition-Specific Dosing:
adjuvant_colorectal_cancer:
85 mg/m² IV every 2 weeks for 12 cycles (6 months)
metastatic_colorectal_cancer:
85 mg/m² IV every 2 weeks (continued until disease progression or unacceptable toxicity)
gastric_cancer:
130 mg/m² IV every 3 weeks (in combination with capecitabine)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (limited data, generally not recommended outside of clinical trials)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl ≥ 60 mL/min)
Moderate:
Consider dose reduction to 65 mg/m² (CrCl 30-59 mL/min) with close monitoring for toxicity. Some guidelines recommend avoiding if CrCl < 50 mL/min.
Severe:
Contraindicated or not recommended (CrCl < 30 mL/min) due to increased toxicity and lack of clear dosing guidelines.
Dialysis:
Not recommended; oxaliplatin is not significantly removed by hemodialysis. Avoid use.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended, but use with caution and monitor for toxicity.
Severe:
No specific dose adjustment recommended, but use with caution and monitor for toxicity. Limited data available.
Pharmacology
Mechanism of Action
Oxaliplatin is a platinum-based antineoplastic agent. It forms DNA adducts (inter- and intra-strand crosslinks) by binding to guanine and adenine residues. This inhibits DNA replication and transcription, leading to cell cycle arrest and apoptosis. It is cell cycle non-specific.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
End of infusion (for ultrafilterable platinum)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Not precisely determined due to extensive and irreversible binding to tissues and red blood cells. Initial distribution phase is rapid.
ProteinBinding:
>90% (of platinum in plasma, primarily to albumin and gamma globulins)
CnssPenetration:
Limited (low penetration into CSF)
Elimination:
HalfLife:
Initial distribution half-life: 0.4-14 hours (for ultrafilterable platinum); Terminal elimination half-life: ~391 hours (reflects platinum bound to tissues and red blood cells)
Clearance:
Renal clearance is the primary route for ultrafilterable platinum.
ExcretionRoute:
Primarily renal (50% of platinum excreted renally within 48 hours), some fecal excretion.
Unchanged:
<1% (of parent drug)
Pharmacodynamics
OnsetOfAction:
Rapid (cytotoxic effects begin shortly after exposure)
PeakEffect:
Not directly measurable in terms of clinical effect; related to cumulative dose and duration of exposure.
DurationOfAction:
Effects persist due to irreversible DNA binding and long tissue retention of platinum. Clinical response is cumulative over cycles.
Safety & Warnings
BLACK BOX WARNING
Anaphylactic-like reactions to oxaliplatin have been reported and may occur within minutes of administration. Epinephrine, corticosteroids, and antihistamines have been required to treat these reactions. Patients should be observed for signs of anaphylaxis during and after oxaliplatin infusion. Peripheral sensory neuropathy is a common adverse reaction. Acute symptoms include transient paresthesia, dysesthesia, and hypesthesia, often exacerbated by cold exposure. Chronic symptoms include persistent paresthesia, dysesthesia, and hypesthesia, which may be associated with functional impairment. Myelosuppression (neutropenia, thrombocytopenia, and anemia) is common and dose-limiting. Monitor complete blood counts prior to each cycle and adjust dose as appropriate.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal or rapid heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Chest pain
Excessive sweating
Flushing
Swelling
A rare but serious muscle condition called rhabdomyolysis, which can lead to organ problems and death. If you experience muscle pain or weakness, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Fatigue
Back pain
Mouth irritation or mouth sores
Trouble sleeping
Changes in taste
Joint pain
Numbness, tingling, or burning sensations in the feet, hands, mouth, or throat (which can be worsened by cold temperatures). To minimize discomfort, avoid cold food and drinks, drink through a straw, dress warmly, and cover your skin when exposed to cold temperatures. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of fluid and electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain or weakness
+ Abnormal or rapid heartbeat
+ Severe dizziness or fainting
+ Increased thirst
+ Seizures
+ Feeling extremely tired or weak
+ Decreased appetite
+ Difficulty urinating or changes in urine production
+ Dry mouth
+ Dry eyes
+ Severe stomach upset or vomiting
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Chest pain
Excessive sweating
Flushing
Swelling
A rare but serious muscle condition called rhabdomyolysis, which can lead to organ problems and death. If you experience muscle pain or weakness, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Fatigue
Back pain
Mouth irritation or mouth sores
Trouble sleeping
Changes in taste
Joint pain
Numbness, tingling, or burning sensations in the feet, hands, mouth, or throat (which can be worsened by cold temperatures). To minimize discomfort, avoid cold food and drinks, drink through a straw, dress warmly, and cover your skin when exposed to cold temperatures. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Numbness, tingling, or pain in fingers, toes, or around the mouth, especially when exposed to cold.
- Difficulty swallowing or breathing, jaw tightness, or voice changes.
- Fever (100.4°F or 38°C or higher) or chills.
- Unusual bleeding or bruising.
- Severe nausea, vomiting, or diarrhea.
- Signs of an allergic reaction: rash, itching, hives, flushing, dizziness, shortness of breath, swelling of face/lips/tongue.
- Severe fatigue or weakness.
- Yellowing of skin or eyes (jaundice), dark urine, or right upper quadrant abdominal pain.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Long QT interval on an electrocardiogram (ECG)
+ Low magnesium levels
+ Low potassium levels
Medications you are currently taking that may cause abnormal heart rhythms (prolonged QT interval). If you are unsure, consult your doctor or pharmacist for guidance.
Medications that may increase the risk of kidney problems. If you are unsure, consult your doctor or pharmacist for guidance.
Pregnancy or potential pregnancy, as this medication may harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm you are not pregnant. If you may become pregnant, you must use birth control during treatment and for a specified period after the last dose, as advised by your doctor.
Breastfeeding, as you should not breastfeed while taking this medication or for 3 months after the last dose.
* If your partner may become pregnant, use birth control during treatment and for a specified period after the last dose, as advised by your doctor. If your partner becomes pregnant, notify your doctor immediately.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Long QT interval on an electrocardiogram (ECG)
+ Low magnesium levels
+ Low potassium levels
Medications you are currently taking that may cause abnormal heart rhythms (prolonged QT interval). If you are unsure, consult your doctor or pharmacist for guidance.
Medications that may increase the risk of kidney problems. If you are unsure, consult your doctor or pharmacist for guidance.
Pregnancy or potential pregnancy, as this medication may harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm you are not pregnant. If you may become pregnant, you must use birth control during treatment and for a specified period after the last dose, as advised by your doctor.
Breastfeeding, as you should not breastfeed while taking this medication or for 3 months after the last dose.
* If your partner may become pregnant, use birth control during treatment and for a specified period after the last dose, as advised by your doctor. If your partner becomes pregnant, notify your doctor immediately.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or modify any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor.
Be aware that this medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving. Although rare, some bleeding complications can be life-threatening. Immediately contact your doctor if you experience any signs of bleeding, such as bruising, black or bloody stools, bleeding gums, blood in your urine, coughing up blood, prolonged bleeding from cuts, dizziness, extreme fatigue or weakness, nosebleeds, pain or swelling, vomiting blood or material that resembles coffee grounds, or severe headaches.
You may also have a higher risk of developing infections, some of which can be severe or life-threatening. To reduce this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Some individuals may experience nerve problems that interfere with daily activities, potentially leading to long-lasting or life-threatening complications. If you experience bothersome or debilitating numbness, tingling, or burning sensations, contact your doctor immediately. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, unusual tongue sensations, or chest pressure.
This medication has been associated with a rare but potentially fatal brain condition called posterior reversible encephalopathy syndrome (PRES). If you exhibit symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headaches, contact your doctor right away.
There have been cases of lung problems, including some that were fatal, in people taking this medication. If you experience shortness of breath, worsening cough, or fever, contact your doctor immediately.
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you notice redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may cause abnormal and potentially life-threatening heart rhythms, including long QT intervals on an electrocardiogram (ECG) and torsades de pointes. Although this can occur in people without pre-existing heart conditions, discuss your risks with your doctor.
There have been reports of a type of blood cancer (leukemia) in people treated with this medication. If you have concerns, discuss them with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulty becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks and benefits with your doctor before starting treatment.
When starting this medication, avoid driving and other activities that require alertness and clear vision until you understand how it affects you.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor.
Be aware that this medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving. Although rare, some bleeding complications can be life-threatening. Immediately contact your doctor if you experience any signs of bleeding, such as bruising, black or bloody stools, bleeding gums, blood in your urine, coughing up blood, prolonged bleeding from cuts, dizziness, extreme fatigue or weakness, nosebleeds, pain or swelling, vomiting blood or material that resembles coffee grounds, or severe headaches.
You may also have a higher risk of developing infections, some of which can be severe or life-threatening. To reduce this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Some individuals may experience nerve problems that interfere with daily activities, potentially leading to long-lasting or life-threatening complications. If you experience bothersome or debilitating numbness, tingling, or burning sensations, contact your doctor immediately. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, unusual tongue sensations, or chest pressure.
This medication has been associated with a rare but potentially fatal brain condition called posterior reversible encephalopathy syndrome (PRES). If you exhibit symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headaches, contact your doctor right away.
There have been cases of lung problems, including some that were fatal, in people taking this medication. If you experience shortness of breath, worsening cough, or fever, contact your doctor immediately.
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you notice redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may cause abnormal and potentially life-threatening heart rhythms, including long QT intervals on an electrocardiogram (ECG) and torsades de pointes. Although this can occur in people without pre-existing heart conditions, discuss your risks with your doctor.
There have been reports of a type of blood cancer (leukemia) in people treated with this medication. If you have concerns, discuss them with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility, potentially leading to difficulty becoming pregnant or fathering a child. If you plan to conceive, discuss the potential risks and benefits with your doctor before starting treatment.
Overdose Information
Overdose Symptoms:
- Exacerbated peripheral neuropathy
- Severe myelosuppression (neutropenia, thrombocytopenia, anemia)
- Severe gastrointestinal toxicity (nausea, vomiting, diarrhea, mucositis)
- Renal dysfunction
- Liver dysfunction
What to Do:
There is no known antidote for oxaliplatin overdose. Management is supportive care, including close monitoring of hematologic and neurologic parameters, antiemetics, hydration, and potentially growth factors for myelosuppression. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Live or live-attenuated vaccines (due to immunosuppression)
Major Interactions
- Myelosuppressive agents (additive myelosuppression)
- Nephrotoxic agents (e.g., aminoglycosides, amphotericin B, cyclosporine, NSAIDs - potential for additive renal toxicity)
- QT-prolonging drugs (theoretical risk, monitor ECG if co-administered with other QT-prolonging agents, though oxaliplatin itself is not a primary QT prolonger)
- Phenytoin (decreased phenytoin levels reported with platinum agents)
Moderate Interactions
- Immunosuppressants (e.g., corticosteroids, cyclosporine, tacrolimus - increased risk of infection)
- Warfarin (monitor INR, potential for altered coagulation)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To assess baseline bone marrow function and identify pre-existing cytopenias.
Timing: Prior to initiation of therapy
Renal function (Serum Creatinine, Creatinine Clearance)
Rationale: To assess kidney function, as oxaliplatin is primarily renally eliminated and dose adjustments are needed for impairment.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, Bilirubin, Alkaline Phosphatase)
Rationale: To assess baseline hepatic function, as hepatotoxicity can occur.
Timing: Prior to initiation of therapy
Neurological examination
Rationale: To assess baseline peripheral neuropathy symptoms (e.g., cold dysesthesia, paresthesias, motor weakness).
Timing: Prior to initiation of therapy
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Prior to each cycle of therapy
Target: ANC ≥ 1.5 x 10^9/L, Platelets ≥ 75-100 x 10^9/L (varies by protocol)
Action Threshold: Dose reduction or delay if ANC < 1.5 x 10^9/L or Platelets < 75-100 x 10^9/L
Renal function (Serum Creatinine, Creatinine Clearance)
Frequency: Prior to each cycle or every other cycle, as clinically indicated
Target: Within normal limits or stable
Action Threshold: Dose adjustment or discontinuation if significant decline in CrCl
Neurological examination (assessment of peripheral neuropathy)
Frequency: Prior to each cycle and throughout therapy
Target: Maintain Grade 0-1 neuropathy
Action Threshold: Dose reduction, delay, or discontinuation if Grade 2 or higher neuropathy develops (e.g., persistent paresthesia, pain, functional impairment)
Liver function tests (ALT, AST, Bilirubin)
Frequency: Periodically, as clinically indicated
Target: Within normal limits or stable
Action Threshold: Dose modification or discontinuation if significant elevation
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: Periodically, especially if significant nausea/vomiting/diarrhea
Target: Within normal limits
Action Threshold: Supplementation if low
Symptom Monitoring
- Peripheral neuropathy (numbness, tingling, pain, cold sensitivity, difficulty with fine motor skills, jaw tightness, laryngeal dysesthesia)
- Nausea and vomiting
- Diarrhea
- Fatigue
- Hypersensitivity reactions (rash, pruritus, flushing, dyspnea, bronchospasm, hypotension)
- Signs of myelosuppression (fever, chills, unusual bleeding or bruising, signs of infection)
- Abdominal pain
- Stomatitis/mucositis
- Pulmonary symptoms (cough, dyspnea, interstitial lung disease)
- Hepatotoxicity (jaundice, dark urine, right upper quadrant pain)
Special Patient Groups
Pregnancy
Oxaliplatin can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 9 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and miscarriage due to rapid cell division and organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other developmental abnormalities.
Third Trimester:
Risk of fetal myelosuppression, growth restriction, and potential for premature birth.
Lactation
It is not known whether oxaliplatin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during oxaliplatin therapy and for at least 3 months after the last dose.
Infant Risk:
L5 (Contraindicated) - High risk of serious adverse effects to the infant, including myelosuppression and other toxicities.
Pediatric Use
The safety and effectiveness of oxaliplatin in pediatric patients have not been established. Limited data suggest that oxaliplatin is not effective in pediatric solid tumors and may cause significant toxicity. Use is generally not recommended outside of specific clinical trials.
Geriatric Use
No overall differences in effectiveness were observed between elderly and younger patients. However, elderly patients (≥65 years) may be more susceptible to certain toxicities, particularly myelosuppression (neutropenia, thrombocytopenia) and peripheral neuropathy. Close monitoring for adverse reactions and appropriate dose modifications are recommended.
Clinical Information
Clinical Pearls
- Oxaliplatin is unique among platinum agents for its characteristic acute peripheral neuropathy, often triggered or exacerbated by cold exposure (cold dysesthesia). Advise patients to avoid cold food/drinks and wear warm clothing.
- Pre-medication with antiemetics (e.g., 5-HT3 antagonists, dexamethasone) is crucial to manage nausea and vomiting, which can be severe.
- Hypersensitivity reactions can occur, often after several cycles. Patients should be monitored closely during and after infusion. Emergency equipment should be readily available.
- Cumulative peripheral neuropathy is a dose-limiting toxicity. Regular neurological assessments are essential, and dose modifications or discontinuation may be necessary to prevent irreversible damage.
- Oxaliplatin does not cause significant nephrotoxicity like cisplatin, but renal function should still be monitored, and dose adjustments are needed for moderate to severe renal impairment.
- Unlike cisplatin, oxaliplatin does not typically cause significant ototoxicity or alopecia.
Alternative Therapies
- Cisplatin (another platinum analog, different toxicity profile)
- Carboplatin (another platinum analog, different toxicity profile, primarily myelosuppression)
- Irinotecan (topoisomerase I inhibitor)
- 5-Fluorouracil (5-FU) (antimetabolite)
- Capecitabine (oral fluoropyrimidine)
- Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Trifluridine/Tipiracil) for colorectal cancer, often used in combination with or after chemotherapy.
Cost & Coverage
Average Cost:
Varies widely, typically several hundred to over a thousand USD per vial depending on strength and supplier. per 50mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug) or Medical Benefit (for IV administration)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it was ingested to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.
Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time it was ingested to ensure prompt and effective treatment.