Oxaliplatin 50mg Inj, 1 Vial Recon
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, DNA cross-linking agent
Pregnancy Category
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 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 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 closely. This medication is administered as an intravenous infusion over a specified period.
If you experience any 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 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 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 closely. This medication is administered as an intravenous infusion over a specified period.
If you experience any 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 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 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 acute neuropathy symptoms (e.g., throat tightness, difficulty breathing, jaw pain, tingling).
- Stay well-hydrated by drinking plenty of fluids unless otherwise instructed by your doctor.
- Maintain good oral hygiene to prevent mouth sores (mucositis).
- Report any signs of infection (fever, chills, sore throat) immediately, as your immune system may be weakened.
- Avoid contact sports or activities that could cause injury due to increased risk of bleeding/bruising.
- Use effective contraception during treatment and for a period after (e.g., 6 months for females, 3 months for males) as it can harm a fetus.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Adjuvant treatment of Stage III colon cancer: 85 mg/m² IV infusion over 2-6 hours every 2 weeks for 12 cycles (6 months). Advanced colorectal cancer: 85 mg/m² IV infusion over 2-6 hours every 2 weeks (in combination with 5-fluorouracil/leucovorin) or 130 mg/m² IV infusion over 2-6 hours every 3 weeks (monotherapy or in combination).
Dose Range:
85 - 130 mg
Condition-Specific Dosing:
colorectal_cancer_adjuvant:
85 mg/m² IV every 2 weeks for 12 cycles
colorectal_cancer_advanced:
85 mg/m² IV every 2 weeks or 130 mg/m² IV every 3 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl ≥ 50 mL/min).
Moderate:
Consider dose reduction (e.g., 65 mg/m² for CrCl 30-49 mL/min) with close monitoring for toxicity. Data are limited.
Severe:
Contraindicated (CrCl < 30 mL/min) due to increased toxicity and lack of clear dosing recommendations.
Dialysis:
Not recommended; Oxaliplatin is not dialyzable to a significant extent. Contraindicated in severe renal impairment.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended, but caution and close monitoring are advised.
Severe:
No specific dose adjustment recommended, but caution and close monitoring are advised.
Pharmacology
Mechanism of Action
Oxaliplatin is a platinum-based antineoplastic agent that forms DNA adducts (primarily inter- and intra-strand cross-links) by binding to DNA. 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
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 440 L (for ultrafilterable platinum)
ProteinBinding:
Extensively and irreversibly bound to plasma proteins and red blood cells (over 90% for ultrafilterable platinum)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ultrafilterable platinum: Biphasic, initial phase ~0.4-1.5 hours, terminal phase ~17-39 hours. Total platinum (bound): Days to weeks due to tissue binding.
Clearance:
Approximately 10-17 L/h (for ultrafilterable platinum)
ExcretionRoute:
Primarily renal (approximately 50% of dose excreted in urine within 48 hours), minor fecal excretion.
Unchanged:
Negligible
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of infusion)
PeakEffect:
Related to maximal DNA adduct formation, typically within hours to days post-infusion.
DurationOfAction:
Prolonged due to persistent platinum adducts in tissues (weeks to months for some effects like neuropathy).
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 for a period following oxaliplatin infusion. Peripheral sensory neuropathy is a common adverse reaction. Acute symptoms include transient paresthesia, dysesthesia, and hypoesthesia, often exacerbated by cold exposure. Chronic symptoms include persistent paresthesia, dysesthesia, and hypoesthesia, 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 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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal or rapid heartbeat
+ Severe dizziness or fainting
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Dry mouth, dry eyes, or severe stomach upset
Weakness on one side of the body
Trouble speaking or thinking
Balance changes
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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Fatigue or weakness
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 manage this, avoid cold food and drinks, drink through a straw, dress warmly, and cover your skin when going out in the cold. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of liver problems, such as:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal or rapid heartbeat
+ Severe dizziness or fainting
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Dry mouth, dry eyes, or severe stomach upset
Weakness on one side of the body
Trouble speaking or thinking
Balance changes
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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Fatigue or weakness
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 manage this, avoid cold food and drinks, drink through a straw, dress warmly, and cover your skin when going out in the cold. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- New or worsening numbness, tingling, burning, or pain in hands or feet (peripheral neuropathy)
- Difficulty swallowing or breathing, jaw tightness, or muscle spasms, especially when exposed to cold
- Fever (100.4°F or 38°C or higher) or other signs of infection (chills, sore throat)
- Unusual bleeding or bruising
- Severe nausea, vomiting, or diarrhea
- Signs of an allergic reaction (rash, hives, itching, swelling of face/lips/tongue, difficulty breathing, dizziness)
- Severe fatigue or weakness
- Dark urine, yellowing of skin or eyes (signs of liver problems)
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 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. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately.
Breast-feeding, as you should not breast-feed 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. This will help ensure it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of 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 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. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately.
Breast-feeding, as you should not breast-feed 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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. This will help ensure it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of 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 at 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 burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. Additionally, 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.
This medication has been associated with a rare but potentially life-threatening 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 immediately.
There have been reports of lung problems, including some that were fatal, in people taking this medication. If you experience shortness of breath, difficulty breathing, a new or worsening cough, or fever, contact your doctor 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 syndrome and torsades de pointes. Although this can occur in people without a history of heart problems, it is essential to discuss your risks with your doctor.
There have been cases of leukemia, a type of blood cancer, in people 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.
This medication may affect fertility, potentially leading to difficulty getting pregnant or fathering a child. If you plan to become pregnant or father a child, discuss your options 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 at 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 burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. Additionally, 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.
This medication has been associated with a rare but potentially life-threatening 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 immediately.
There have been reports of lung problems, including some that were fatal, in people taking this medication. If you experience shortness of breath, difficulty breathing, a new or worsening cough, or fever, contact your doctor 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 syndrome and torsades de pointes. Although this can occur in people without a history of heart problems, it is essential to discuss your risks with your doctor.
There have been cases of leukemia, a type of blood cancer, in people 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.
This medication may affect fertility, potentially leading to difficulty getting pregnant or fathering a child. If you plan to become pregnant or father a child, discuss your options with your doctor before starting treatment.
Overdose Information
Overdose Symptoms:
- Exacerbated myelosuppression (severe neutropenia, thrombocytopenia)
- Severe peripheral neuropathy
- Severe gastrointestinal toxicity (nausea, vomiting, diarrhea)
- Renal dysfunction
What to Do:
There is no known antidote for oxaliplatin overdose. Management is supportive, including close monitoring of hematologic and neurologic parameters, and treatment of symptoms. 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) - increased risk of nephrotoxicity
- Neurotoxic agents (e.g., paclitaxel, docetaxel, vincristine) - increased risk of peripheral neuropathy
Moderate Interactions
- QT-prolonging drugs (potential for additive QT prolongation, though less prominent for oxaliplatin than some other agents)
- Phenytoin (decreased phenytoin levels reported with platinum agents, monitor)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To assess baseline hematopoietic function and identify myelosuppression risk.
Timing: Prior to initiation of therapy
Renal function (Serum creatinine, Creatinine Clearance)
Rationale: To assess baseline kidney function and guide dosing adjustments.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Rationale: To assess baseline hepatic function.
Timing: Prior to initiation of therapy
Neurological examination (sensory and motor function)
Rationale: To establish baseline for peripheral neuropathy assessment.
Timing: Prior to initiation of therapy
Electrolytes (Potassium, Magnesium, Calcium)
Rationale: To assess baseline electrolyte balance, important for cardiac function and potential for nausea/vomiting.
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 x 10^9/L
Action Threshold: Hold dose if ANC < 1.5 x 10^9/L or Platelets < 75 x 10^9/L; consider dose reduction for subsequent cycles.
Renal function (Serum creatinine, Creatinine Clearance)
Frequency: Prior to each cycle or as clinically indicated
Target: CrCl ≥ 30 mL/min
Action Threshold: Hold or reduce dose if CrCl declines significantly; contraindicated if CrCl < 30 mL/min.
Neurological examination (assessment of peripheral neuropathy)
Frequency: Prior to each cycle and regularly during treatment
Target: Not applicable (monitor for worsening symptoms)
Action Threshold: Dose modification or discontinuation based on severity of neuropathy (e.g., NCI-CTC Grade 2 or higher).
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: As clinically indicated, especially with significant GI toxicity
Target: Within normal limits
Action Threshold: Supplement as needed to correct deficiencies.
Symptom Monitoring
- Peripheral neuropathy (acute: cold sensitivity, jaw tightness, dysesthesia; chronic: numbness, tingling, paresthesia, motor weakness)
- Nausea and vomiting
- Diarrhea
- Fatigue
- Hypersensitivity reactions (rash, urticaria, dyspnea, hypotension, anaphylaxis)
- Myelosuppression (fever, chills, signs of infection, unusual bleeding or bruising)
- Stomatitis/mucositis
- Abdominal pain
- Hiccups
- Dyspnea/cough (rare interstitial lung disease)
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. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and miscarriage due to its mechanism of action (DNA damage).
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other organ toxicities.
Third Trimester:
Risk of fetal growth restriction, myelosuppression, and other organ toxicities; potential for premature birth.
Lactation
It is not known whether oxaliplatin or its metabolites are 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 treatment and for at least 3 months after the last dose.
Infant Risk:
High risk of serious adverse effects (e.g., myelosuppression, growth inhibition, carcinogenicity) due to the cytotoxic nature of the drug.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Limited data suggest a lack of efficacy in some pediatric tumors and significant toxicity.
Geriatric Use
No overall differences in effectiveness were observed between elderly and younger patients. However, elderly patients (≥65 years) may be at increased risk for certain adverse reactions, including myelosuppression, dehydration, diarrhea, and peripheral neuropathy. Close monitoring is recommended.
Clinical Information
Clinical Pearls
- Acute peripheral neuropathy, often triggered or exacerbated by cold exposure, is a hallmark side effect. Advise patients to avoid cold food/drinks and cold environments.
- Chronic peripheral neuropathy can be dose-limiting and may persist for months or years after treatment cessation.
- Hypersensitivity reactions, including anaphylaxis, can occur, often after several cycles. Pre-medication and close monitoring during infusion are crucial.
- Oxaliplatin is highly emetogenic; aggressive antiemetic prophylaxis (e.g., 5-HT3 antagonist + dexamethasone + NK1 receptor antagonist) is essential.
- Ensure adequate hydration to minimize renal toxicity, although oxaliplatin is less nephrotoxic than cisplatin.
- Monitor for signs of myelosuppression (neutropenia, thrombocytopenia) before each cycle and adjust dose as needed.
Alternative Therapies
- Cisplatin (another platinum analog, but with different toxicity profile)
- Carboplatin (another platinum analog, generally less neurotoxic but more myelosuppressive)
- Irinotecan (topoisomerase I inhibitor, often used in combination with 5-FU/leucovorin)
- 5-Fluorouracil (pyrimidine analog antimetabolite)
- Capecitabine (oral prodrug of 5-FU)
- Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab) used in combination with chemotherapy for metastatic colorectal cancer.
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:
Specialty Tier / Tier 4 (often requires prior authorization and is covered under medical benefit for oncology treatment)
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 evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take someone else's medication. 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. 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 call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.
To ensure safe use, do not share your medication with others, and never take someone else's medication. 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. 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 call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.