Oxaliplatin 100mg 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, alkylating agent
Pregnancy Category
D
FDA Approved
Aug 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxaliplatin is a chemotherapy drug used to treat certain types of cancer, especially colon and rectal cancer. It works by damaging the DNA of cancer cells, which stops 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 out of your treatment, it's essential to use this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication is administered as an infusion into a vein over a specified period.
If you experience any gastrointestinal side effects, such as nausea, vomiting, diarrhea, or a decrease in appetite, consult with your doctor. They may be able to suggest ways to minimize these effects.
Before receiving any vaccinations, discuss this with 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 with 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 out of your treatment, it's essential to use this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication is administered as an infusion into a vein over a specified period.
If you experience any gastrointestinal side effects, such as nausea, vomiting, diarrhea, or a decrease in appetite, consult with your doctor. They may be able to suggest ways to minimize these effects.
Before receiving any vaccinations, discuss this with 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 with 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, as this can worsen nerve pain (neuropathy). Wear warm clothing, gloves, and scarves, especially in cold weather.
- Report any new or worsening numbness, tingling, pain, or weakness in your hands or feet immediately.
- Stay well-hydrated, especially if experiencing nausea, vomiting, or diarrhea.
- Maintain good oral hygiene to prevent mouth sores (mucositis).
- Avoid contact with people who are sick or have infections, as your immune system may be weakened.
- Discuss any planned vaccinations with your doctor, as live vaccines are generally not recommended during treatment.
- Use effective contraception during treatment and for at least 6 months after the last dose for both males and females, as oxaliplatin can cause harm to a fetus.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For adjuvant treatment of Stage III colon cancer: 85 mg/m² IV infusion over 2 hours every 2 weeks for 12 cycles (6 months). For metastatic colorectal cancer: 85 mg/m² IV infusion over 2 hours every 2 weeks (in combination with 5-fluorouracil/leucovorin) or 130 mg/m² IV infusion over 2 hours every 3 weeks (as monotherapy or in combination).
Dose Range:
85 - 130 mg
Condition-Specific Dosing:
adjuvant_colon_cancer:
85 mg/m² IV every 2 weeks for 12 cycles
metastatic_colorectal_cancer:
85 mg/m² IV every 2 weeks (combination) or 130 mg/m² IV every 3 weeks (monotherapy/combination)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl ≥ 60 mL/min).
Moderate:
Consider dose reduction by 25% (CrCl 30-59 mL/min). Closely monitor for toxicity.
Severe:
Not recommended (CrCl < 30 mL/min) due to insufficient data and potential for increased toxicity. Consider alternative treatments.
Dialysis:
Not available (Oxaliplatin is not dialyzable to a significant extent. Use in dialysis patients is not well-studied and generally not recommended.)
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
No dose adjustment required.
Pharmacology
Mechanism of Action
Oxaliplatin is a platinum-based antineoplastic agent. It forms inter- and intra-strand DNA adducts (cross-links) by binding to guanine and cytosine residues. These adducts inhibit DNA replication and transcription, leading to DNA damage and ultimately inducing apoptosis in cancer cells. It is cell cycle non-specific.
Pharmacokinetics
Absorption:
Bioavailability:
100% (administered intravenously)
Tmax:
End of 2-hour infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 440 L (for total platinum)
ProteinBinding:
Greater than 90% (primarily to albumin and gamma-globulins, irreversible binding to plasma proteins and red blood cells)
CnssPenetration:
Limited (low penetration into the central nervous system)
Elimination:
HalfLife:
Parent drug: 0.4-14 hours (initial distribution phase); Total platinum: 391 hours (terminal elimination phase)
Clearance:
Approximately 10-17 L/h (for ultrafilterable platinum)
ExcretionRoute:
Primarily renal (approximately 50% of the dose excreted in urine within 5 days, 2.7% in feces)
Unchanged:
Less than 1% (of parent drug)
Pharmacodynamics
OnsetOfAction:
Rapid (cytotoxic effects begin shortly after administration)
PeakEffect:
Not directly quantifiable in terms of a single peak effect for cytotoxic agents; cumulative effect over treatment cycles.
DurationOfAction:
Effects persist as long as platinum adducts remain bound to DNA, which can be prolonged due to irreversible binding.
Safety & Warnings
BLACK BOX WARNING
Hypersensitivity Reactions: Oxaliplatin can cause severe hypersensitivity reactions, including anaphylaxis, which may be fatal. These reactions may occur within minutes of administration and can occur at any cycle. Epinephrine, corticosteroids, and antihistamines should be available. Peripheral Sensory Neuropathy: Oxaliplatin causes dose-limiting peripheral sensory neuropathy. This neuropathy is characterized by paresthesia, dysesthesia, and hypoesthesia, and may be exacerbated by exposure to cold. Symptoms may persist for months or years following discontinuation of therapy. Myelosuppression: Oxaliplatin can cause myelosuppression (neutropenia, thrombocytopenia, and anemia). Febrile neutropenia has been reported. Complete blood counts should be monitored prior to each cycle and as clinically indicated.
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 immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Chest pain or discomfort.
Excessive sweating or flushing.
Swelling.
Muscle pain or weakness, which can be a sign of a rare but serious condition called rhabdomyolysis that can lead to organ damage and death.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or sores.
Difficulty sleeping.
Changes in taste.
Joint pain.
Numbness, tingling, or burning sensations in the hands, feet, mouth, or throat, which can be worsened by cold temperatures. To minimize discomfort, avoid cold foods and drinks, use a straw when drinking, dress warmly, and wear gloves or socks 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, consult 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 immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Chest pain or discomfort.
Excessive sweating or flushing.
Swelling.
Muscle pain or weakness, which can be a sign of a rare but serious condition called rhabdomyolysis that can lead to organ damage and death.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or sores.
Difficulty sleeping.
Changes in taste.
Joint pain.
Numbness, tingling, or burning sensations in the hands, feet, mouth, or throat, which can be worsened by cold temperatures. To minimize discomfort, avoid cold foods and drinks, use a straw when drinking, dress warmly, and wear gloves or socks 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, consult 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:
- Severe allergic reaction (rash, hives, itching, swelling of face/lips/tongue/throat, difficulty breathing, dizziness, feeling faint)
- Signs of infection (fever, chills, sore throat, cough, unusual aches)
- Unusual bleeding or bruising
- Severe or persistent numbness, tingling, pain, or weakness in hands or feet
- Severe nausea, vomiting, or diarrhea
- Severe fatigue or weakness
- Shortness of breath, chest pain, or cough (new or worsening)
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools
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:
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.
If you are pregnant or plan to become pregnant. 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. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately.
If you are breastfeeding. Do 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. Your doctor will advise you on the duration of birth control use. If your partner becomes pregnant, notify the 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. Ensure it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify any medication without consulting your doctor.
It is essential to inform your doctor about the following:
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.
If you are pregnant or plan to become pregnant. 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. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately.
If you are breastfeeding. Do 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. Your doctor will advise you on the duration of birth control use. If your partner becomes pregnant, notify the 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. Ensure it is safe to take this medication with your existing medications and health conditions. Do not initiate, 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. 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, fatigue, nosebleeds, pain or swelling, vomiting blood or coffee ground-like material, or severe headaches.
You may also be more susceptible to infections, some of which can be severe or life-threatening. To reduce this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
In some cases, this medication can cause nerve problems that may interfere with daily activities and, in rare instances, lead to long-lasting or life-threatening complications. If you experience burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. Also, seek medical attention right away if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, a strange sensation in your tongue, or chest pressure.
A rare but potentially life-threatening brain condition called posterior reversible encephalopathy syndrome (PRES) has been associated with this medication. If you exhibit symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headaches, contact your doctor immediately.
Some patients have developed lung problems while taking this medication, which can be fatal in some cases. If you experience shortness of breath, difficulty breathing, a new or worsening cough, or fever, seek medical attention right away.
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may also 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 anyone, it is essential to discuss your risk factors with your doctor.
There have been cases of leukemia, a type of blood cancer, in patients treated with this medication. If you have concerns or questions, 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.
Additionally, this medication may affect fertility, potentially leading to difficulty getting pregnant or fathering a child. If you plan to conceive, discuss this 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. 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, fatigue, nosebleeds, pain or swelling, vomiting blood or coffee ground-like material, or severe headaches.
You may also be more susceptible to infections, some of which can be severe or life-threatening. To reduce this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
In some cases, this medication can cause nerve problems that may interfere with daily activities and, in rare instances, lead to long-lasting or life-threatening complications. If you experience burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. Also, seek medical attention right away if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, a strange sensation in your tongue, or chest pressure.
A rare but potentially life-threatening brain condition called posterior reversible encephalopathy syndrome (PRES) has been associated with this medication. If you exhibit symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headaches, contact your doctor immediately.
Some patients have developed lung problems while taking this medication, which can be fatal in some cases. If you experience shortness of breath, difficulty breathing, a new or worsening cough, or fever, seek medical attention right away.
If the medication leaks from the vein during administration, it can cause tissue damage. Inform your nurse immediately if you notice any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
This medication may also 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 anyone, it is essential to discuss your risk factors with your doctor.
There have been cases of leukemia, a type of blood cancer, in patients treated with this medication. If you have concerns or questions, 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.
Additionally, this medication may affect fertility, potentially leading to difficulty getting pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before starting treatment.
Overdose Information
Overdose Symptoms:
- Exacerbated myelosuppression (severe neutropenia, thrombocytopenia)
- Severe peripheral neuropathy
- Severe gastrointestinal toxicity (nausea, vomiting, diarrhea, mucositis)
- Liver function abnormalities
What to Do:
There is no known antidote for oxaliplatin overdose. Management is supportive and symptomatic, focusing on managing myelosuppression, gastrointestinal toxicity, and neurological symptoms. Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222.
Drug Interactions
Major Interactions
- Live vaccines (due to immunosuppression)
- Yellow fever vaccine (due to immunosuppression)
- Other myelosuppressive agents (additive myelosuppression)
- Nephrotoxic drugs (potential for increased renal toxicity, though less nephrotoxic than cisplatin)
Moderate Interactions
- Phenytoin (reduced phenytoin levels reported with concomitant use of fluorouracil/leucovorin/oxaliplatin)
- Anticoagulants (increased risk of bleeding due to myelosuppression)
Minor Interactions
- Drugs that prolong QT interval (theoretical risk, monitor ECG if co-administered with other QT-prolonging agents)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To assess baseline bone marrow function and identify pre-existing myelosuppression.
Timing: Prior to initiation of each cycle of therapy.
Liver Function Tests (LFTs) including AST, ALT, bilirubin
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy and periodically during treatment.
Renal Function Tests (RFTs) including serum creatinine and creatinine clearance
Rationale: To assess baseline renal function and guide dosing adjustments.
Timing: Prior to initiation of each cycle of therapy.
Neurological examination (sensory and motor function)
Rationale: To establish baseline for peripheral neuropathy assessment.
Timing: Prior to initiation of therapy and before each cycle.
Electrolytes (Potassium, Magnesium, Calcium)
Rationale: To assess baseline electrolyte balance, as imbalances can exacerbate neuropathy or cardiac issues.
Timing: Prior to initiation of therapy and periodically.
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Prior to each cycle of therapy and as clinically indicated.
Target: ANC ≥ 1.5 x 10^9/L, Platelets ≥ 75 x 10^9/L
Action Threshold: Hold dose if ANC < 1.5 x 10^9/L or platelets < 75 x 10^9/L. Reduce dose for Grade 3/4 neutropenia or thrombocytopenia.
Renal Function Tests (serum creatinine, CrCl)
Frequency: Prior to each cycle of therapy.
Target: CrCl > 60 mL/min (for full dose)
Action Threshold: Consider dose reduction if CrCl 30-59 mL/min. Not recommended if CrCl < 30 mL/min.
Neurological examination (assessment of peripheral neuropathy)
Frequency: Prior to each cycle of therapy and as clinically indicated.
Target: No new or worsening symptoms of neuropathy.
Action Threshold: Hold or reduce dose for persistent Grade 2 or Grade 3/4 peripheral sensory neuropathy.
Liver Function Tests (AST, ALT, bilirubin)
Frequency: Periodically during treatment.
Target: Within normal limits or stable.
Action Threshold: Monitor closely; dose adjustment generally not required for hepatic impairment.
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: Periodically during treatment, especially if vomiting/diarrhea occurs.
Target: Within normal limits.
Action Threshold: Correct imbalances as needed; consider supplementation.
Symptom Monitoring
- Peripheral neuropathy (numbness, tingling, pain, cold sensitivity, difficulty with fine motor skills)
- Nausea and vomiting
- Diarrhea
- Fatigue
- Hypersensitivity reactions (rash, itching, flushing, shortness of breath, dizziness, hypotension)
- Signs of myelosuppression (fever, chills, unusual bleeding or bruising, signs of infection)
- Stomatitis/mucositis
- Abdominal pain
- Dyspnea, cough (signs of interstitial lung disease, rare)
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 a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 9 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 6 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and fetal loss due to its cytotoxic and DNA-damaging effects.
Second Trimester:
Continued risk of fetal toxicity, growth restriction, and organ damage.
Third Trimester:
Risk of fetal toxicity, growth restriction, and potential complications for the newborn.
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, women should be advised not to breastfeed during treatment with oxaliplatin and for 3 months after the last dose.
Infant Risk:
High risk of serious adverse effects (e.g., myelosuppression, growth inhibition, carcinogenicity) in breastfed infants.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
No overall differences in effectiveness were observed between elderly and younger patients. However, elderly patients (≥65 years) may be more susceptible to some adverse reactions, particularly peripheral neuropathy, diarrhea, and dehydration. Close monitoring and careful dose adjustments based on toxicity are recommended.
Clinical Information
Clinical Pearls
- Oxaliplatin-induced peripheral neuropathy is a key dose-limiting toxicity. It can be acute (cold-induced, reversible) or chronic (cumulative, persistent).
- Acute neuropathy often presents as dysesthesia/paresthesia exacerbated by cold exposure. Advise patients to avoid cold food/drinks and wear warm clothing.
- Chronic neuropathy is cumulative and can lead to functional impairment. Dose modifications or discontinuation may be necessary.
- Hypersensitivity reactions can occur early or late in treatment. Premedication with antihistamines and corticosteroids may be used, but reactions can still be severe. Have emergency equipment readily available.
- Ensure adequate hydration before and after infusion to minimize renal toxicity, although oxaliplatin is less nephrotoxic than cisplatin.
- Monitor for myelosuppression (neutropenia, thrombocytopenia) and manage with dose delays or reductions as per guidelines.
- Oxaliplatin is often given with leucovorin and 5-fluorouracil (FOLFOX regimen) for colorectal cancer.
Alternative Therapies
- Other platinum-based agents (e.g., Cisplatin, Carboplatin)
- Other cytotoxic agents used in colorectal cancer (e.g., 5-Fluorouracil, Capecitabine, Irinotecan)
- Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Encorafenib, Trifluridine/Tipiracil)
- Immunotherapy (e.g., Pembrolizumab, Nivolumab, Ipilimumab for MSI-H/dMMR colorectal cancer)
Cost & Coverage
Average Cost:
Varies widely based on dose, manufacturer, and pharmacy. Typically ranges from $500 - $2000+ per 100mg vial. per 100mg vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier / Tier 4 (for brand), Tier 2/3 (for generic). Often requires prior authorization and is covered under medical benefit for oncology.
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 safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional 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 discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional 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 discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.