Oxaliplatin 100mg/20ml Inj, 20ml
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 coordination complex
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 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, meaning it goes directly into your vein.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, take 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 intravenous infusion over a specified period of time.
If you experience gastrointestinal side effects such as nausea, vomiting, diarrhea, or decreased appetite, consult your doctor. They may be able to suggest ways to minimize these effects.
Before receiving any vaccinations, consult your doctor. The use of certain vaccines in conjunction with this medication may increase the risk of infection or reduce the vaccine's efficacy.
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.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To ensure safe and effective use, take 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 intravenous infusion over a specified period of time.
If you experience gastrointestinal side effects such as nausea, vomiting, diarrhea, or decreased appetite, consult your doctor. They may be able to suggest ways to minimize these effects.
Before receiving any vaccinations, consult your doctor. The use of certain vaccines in conjunction with this medication may increase the risk of infection or reduce the vaccine's efficacy.
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.
Missing a Dose
If you miss a dose, contact your doctor 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 treatment, as this can worsen nerve problems (neuropathy) like tingling, numbness, or pain. Wear warm clothing, gloves, and scarves.
- Report any new or worsening numbness, tingling, pain, or weakness in your hands or feet immediately.
- Stay well-hydrated by drinking plenty of fluids unless otherwise instructed by your doctor.
- Practice good oral hygiene to prevent mouth sores (mucositis).
- Avoid contact sports or activities that could cause injury due to increased risk of bleeding from low platelet counts.
- Avoid people who are sick to reduce your risk of infection due to low white blood cell counts.
- Discuss any planned vaccinations with your doctor, as live vaccines are generally not recommended during treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
85 mg/m² IV infusion over 2-6 hours every 2 weeks (e.g., for adjuvant treatment of colon cancer or metastatic colorectal cancer in combination with fluorouracil/leucovorin).
Dose Range:
85 - 130 mg
Condition-Specific Dosing:
adjuvant_colon_cancer:
85 mg/m² IV every 2 weeks for 12 cycles (6 months) in combination with fluorouracil and leucovorin.
metastatic_colorectal_cancer:
85 mg/m² IV every 2 weeks in combination with fluorouracil and leucovorin. For previously treated patients, 130 mg/m² IV every 3 weeks as a single agent or in combination.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients. Limited data suggest potential for dose-limiting toxicities similar to adults.)
Dose Adjustments
Renal Impairment:
Mild:
CrCl ≥ 60 mL/min: No dose adjustment required.
Moderate:
CrCl 30-59 mL/min: Consider a dose reduction (e.g., 65 mg/m²). Monitor for increased toxicity.
Severe:
CrCl < 30 mL/min: Not recommended due to insufficient data and potential for increased toxicity. If used, a significant dose reduction (e.g., 25 mg/m²) and close monitoring are necessary.
Dialysis:
Not available (Oxaliplatin is extensively protein-bound and rapidly converted to inactive metabolites, making dialysis unlikely to be effective for removal of active drug. Use in dialysis patients is not well-studied and generally not recommended.)
Hepatic Impairment:
Mild:
Bilirubin ≤ 1.5 x ULN, AST ≤ 2.5 x ULN: No dose adjustment required.
Moderate:
Bilirubin > 1.5 to 3 x ULN, AST > 2.5 x ULN: No specific dose adjustment recommended based on limited data, but caution and close monitoring for toxicity are advised.
Severe:
Bilirubin > 3 x ULN: No specific dose recommendations available. Use with extreme caution or avoid due to lack of data and potential for increased toxicity.
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 bases. This inhibits DNA replication and transcription, leading to DNA damage, cell cycle arrest (primarily in G2/M phase), and ultimately apoptosis in rapidly dividing cancer cells. Unlike cisplatin and carboplatin, oxaliplatin's DNA adducts are less susceptible to repair mechanisms, contributing to its activity in some platinum-resistant tumors.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (IV administration)
Tmax:
Not applicable (IV administration)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Not available (rapid and extensive distribution into tissues)
ProteinBinding:
Approximately 90% (of platinum in plasma, primarily to albumin and gamma globulins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma ultrafilterable platinum: Initial phase ~0.4-1.5 hours; terminal phase ~391 hours (reflects platinum bound to red blood cells and plasma proteins). Active drug half-life is much shorter.
Clearance:
Not available (complex elimination kinetics)
ExcretionRoute:
Primarily renal (approximately 50% of the dose excreted in urine within 48 hours, with the majority excreted within 5 days). Fecal excretion accounts for a small percentage.
Unchanged:
Negligible (less than 1% of the dose is excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (systemic exposure achieved immediately after IV infusion)
PeakEffect:
Not directly applicable (cytotoxic effects are cumulative over treatment cycles)
DurationOfAction:
Cellular effects persist as long as DNA adducts are present; clinical effects are observed over the course of treatment.
Safety & Warnings
BLACK BOX WARNING
Hypersensitivity Reactions: Oxaliplatin can cause severe hypersensitivity reactions, including anaphylaxis, which may be fatal. These reactions can occur within minutes of administration and can occur at any cycle. Patients should be monitored for signs and symptoms of hypersensitivity reactions during and after oxaliplatin infusion. Peripheral Sensory Neuropathy: Oxaliplatin causes peripheral sensory neuropathy that is cumulative and dose-dependent. Symptoms include paresthesia, dysesthesia, and hypoesthesia, which may be exacerbated by exposure to cold. Myelosuppression: Oxaliplatin can cause myelosuppression (neutropenia, thrombocytopenia, and anemia). 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 or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, 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 changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, rapid or irregular 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 changes, 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 or seek medical attention if they bother you or persist:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or mouth sores.
Difficulty 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 foods and drinks, use a straw when drinking, dress warmly, and cover your skin when going outside in cold weather. 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, 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 changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, rapid or irregular 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 changes, 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 or seek medical attention if they bother you or persist:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or mouth sores.
Difficulty 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 foods and drinks, use a straw when drinking, dress warmly, and cover your skin when going outside in cold weather. 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:
- Severe allergic reaction: rash, hives, itching, flushing, swelling of face/lips/tongue/throat, difficulty breathing, chest tightness, dizziness, feeling faint (seek immediate medical attention).
- New or worsening numbness, tingling, pain, or weakness in hands or feet.
- Severe nausea, vomiting, or diarrhea that doesn't improve with medication.
- Signs of infection: fever (100.4°F or higher), chills, sore throat, cough, burning with urination.
- Unusual bleeding or bruising.
- Severe fatigue or weakness.
- Shortness of breath or difficulty breathing.
- Severe 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:
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). There are many medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
Medications that may increase the risk of kidney problems. Again, there are many medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or think you might be pregnant. This medication may harm an unborn baby. A pregnancy test will be conducted before starting the medication to confirm you are not pregnant. If you may become pregnant, you must use birth control while taking this medication and for a certain period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant, contact your doctor immediately.
If you are breastfeeding. 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 while taking this medication and for a certain period after the last dose. Your doctor will advise you on the duration of birth control use. If your partner becomes pregnant, contact the doctor right away.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. You must verify that it is safe to take this medication with all 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:
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). There are many medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
Medications that may increase the risk of kidney problems. Again, there are many medications that can have this effect, so consult your doctor or pharmacist if you are unsure.
If you are pregnant or think you might be pregnant. This medication may harm an unborn baby. A pregnancy test will be conducted before starting the medication to confirm you are not pregnant. If you may become pregnant, you must use birth control while taking this medication and for a certain period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant, contact your doctor immediately.
If you are breastfeeding. 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 while taking this medication and for a certain period after the last dose. Your doctor will advise you on the duration of birth control use. If your partner becomes pregnant, contact the doctor right away.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. You must verify that it is safe to take this medication with all 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 material that resembles coffee grounds, 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. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, unusual sensations 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 right away.
There have been reports 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 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 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.
Additionally, this medication may affect fertility, potentially leading to difficulties in becoming 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 material that resembles coffee grounds, 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. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, or if you experience eye pain, jaw tightness, unusual sensations 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 right away.
There have been reports 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 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 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.
Additionally, this medication may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before starting treatment.
Overdose Information
Overdose Symptoms:
- Exacerbation of known toxicities, including severe myelosuppression (neutropenia, thrombocytopenia), severe peripheral neuropathy, severe nausea, vomiting, and diarrhea.
What to Do:
There is no known antidote for oxaliplatin overdose. Management is supportive and symptomatic, focusing on managing myelosuppression, neuropathy, and gastrointestinal toxicities. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Contraindicated Interactions
- Live or live-attenuated vaccines (due to risk of severe or fatal infection in immunocompromised patients)
Major Interactions
- Myelosuppressive agents (additive myelosuppression)
- Nephrotoxic agents (e.g., aminoglycosides, amphotericin B, cyclosporine, NSAIDs, loop diuretics - potential for increased renal toxicity)
- QT-prolonging drugs (theoretical risk, monitor ECG)
- Warfarin (increased INR/bleeding risk, monitor INR)
Moderate Interactions
- Phenytoin (decreased phenytoin levels, monitor)
- Immunosuppressants (e.g., azathioprine, cyclosporine, tacrolimus - increased risk of infection and myelosuppression)
- Other neurotoxic agents (additive neurotoxicity, e.g., paclitaxel, cisplatin)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To assess baseline hematopoietic function and identify pre-existing myelosuppression.
Timing: Prior to initiation of therapy
Renal function (Serum creatinine, BUN, CrCl)
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 status, especially if patient has risk factors for QT prolongation or is on diuretics.
Timing: Prior to initiation of therapy
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Before each cycle and as clinically indicated
Target: WBC ≥ 2 x 10^9/L, Platelets ≥ 75 x 10^9/L (for next dose)
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 if severe myelosuppression occurs.
Renal function (Serum creatinine, BUN)
Frequency: Before each cycle or as clinically indicated
Target: Within acceptable limits for dosing
Action Threshold: Consider dose adjustment or hold if significant decline in CrCl or increase in serum creatinine.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically or as clinically indicated
Target: Within acceptable limits
Action Threshold: Hold or reduce dose if significant abnormalities develop.
Neurological examination (assessment of peripheral neuropathy)
Frequency: Before each cycle and regularly throughout treatment
Target: No or mild symptoms
Action Threshold: Hold or discontinue therapy if severe or persistent peripheral neuropathy (e.g., paresthesia with pain, functional impairment) develops.
Signs and symptoms of hypersensitivity reactions
Frequency: During and immediately after infusion
Target: No reaction
Action Threshold: Stop infusion immediately and manage symptoms. Do not re-challenge if severe reaction occurs.
Symptom Monitoring
- Peripheral neuropathy (paresthesia, dysesthesia, numbness, pain, cold sensitivity, motor weakness, difficulty with fine motor skills)
- Nausea and vomiting
- Diarrhea
- Fatigue
- Stomatitis/mucositis
- Abdominal pain
- Fever, chills, signs of infection (due to myelosuppression)
- Bleeding/bruising (due to thrombocytopenia)
- Shortness of breath, cough (pulmonary fibrosis, rare)
- Signs of hypersensitivity reaction (rash, urticaria, pruritus, flushing, dyspnea, bronchospasm, hypotension, chest tightness, angioedema)
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 rapid cell division and organogenesis.
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, women should not breastfeed during treatment with oxaliplatin and for 3 months after the last dose.
Infant Risk:
L5 (Contraindicated - significant risk of adverse effects in infant)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Limited data suggest that oxaliplatin is not effective in pediatric solid tumors and may cause similar toxicities as in adults, including peripheral neuropathy and myelosuppression. Use is generally not recommended.
Geriatric Use
No overall differences in effectiveness were observed between elderly patients (≥65 years) and younger patients. However, elderly patients may be more susceptible to some toxicities, particularly peripheral neuropathy and myelosuppression. Renal function should be carefully monitored, as age-related decline in renal function may necessitate dose adjustments.
Clinical Information
Clinical Pearls
- Oxaliplatin-induced peripheral neuropathy has two forms: an acute, reversible form (often triggered or worsened by cold exposure) and a chronic, cumulative form. Educate patients about cold avoidance.
- Acute neuropathy symptoms (e.g., dysesthesia, paresthesia, jaw tightness, laryngeal dysesthesia) typically occur within hours of infusion and resolve within days. Chronic neuropathy is dose-dependent and can be debilitating.
- Pre-medication with antiemetics (e.g., 5-HT3 antagonist, dexamethasone) is crucial to manage nausea and vomiting.
- Hypersensitivity reactions can occur early or late in treatment. Ensure appropriate monitoring and immediate access to resuscitation equipment.
- Dose modifications are frequently required based on hematologic toxicity and peripheral neuropathy severity. Strict adherence to dose modification guidelines is essential to manage toxicity and maintain treatment efficacy.
- Oxaliplatin is often given in combination with fluoropyrimidines (e.g., 5-FU/leucovorin) for colorectal cancer.
Alternative Therapies
- Other platinum-based agents (e.g., Cisplatin, Carboplatin - though different toxicity profiles and indications)
- Other cytotoxic agents used in colorectal cancer (e.g., Irinotecan, Fluorouracil)
- Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Encorafenib, Binimetinib)
- Immunotherapy (e.g., Pembrolizumab, Nivolumab, Ipilimumab for MSI-H/dMMR colorectal cancer)
Cost & Coverage
Average Cost:
Varies widely by dose and supplier per 100mg/20ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty drug, often requires prior authorization and is covered under medical benefit for oncology indications)
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, never share your prescription medications with others, and do not take medications prescribed to someone else.
Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer 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 critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.
Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer 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 critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.