Oxaliplatin 50mg/10ml Inj, 10ml
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-based Antineoplastic
Pregnancy Category
Category D
FDA Approved
Aug 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxaliplatin is a chemotherapy medicine used to treat certain types of colon and rectal cancer. It works by stopping the growth of cancer cells. It is given as an injection into a vein, usually with other chemotherapy drugs.
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 immediately 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 immediately to determine the best course of action.
Lifestyle & Tips
- Avoid contact with people who are sick or have infections, as your immune system may be weakened.
- Wash hands frequently to prevent infections.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid activities that could cause cuts or bruising due to increased bleeding risk.
- Use a soft toothbrush and be gentle when flossing to prevent mouth sores and bleeding.
- Stay well-hydrated and eat a balanced diet as tolerated.
- Avoid exposure to cold temperatures or cold objects (e.g., cold drinks, cold air) as this can worsen nerve pain (neuropathy). Wear gloves and warm clothing in cold weather.
- Avoid alcohol and tobacco.
- 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 hours, every 2 weeks (often in combination with fluorouracil and leucovorin for colorectal cancer)
Dose Range:
85 - 130 mg
Condition-Specific Dosing:
Adjuvant treatment of Stage III colon cancer:
85 mg/m² IV every 2 weeks for 12 cycles (6 months)
Metastatic colorectal cancer:
85 mg/m² IV every 2 weeks until disease progression or unacceptable toxicity. Can be used as initial treatment or for patients whose disease has progressed or recurred following prior therapy.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (CrCl ≥ 60 mL/min)
Moderate:
Consider dose reduction (e.g., 65 mg/m²) for CrCl 30-59 mL/min, monitor closely for toxicity. Specific recommendations vary.
Severe:
Not recommended (CrCl < 30 mL/min) due to insufficient data and potential for increased toxicity.
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.
Hepatic Impairment:
Mild:
No dose adjustment required (bilirubin ≤ 1.5 x ULN, AST ≤ 2.5 x ULN)
Moderate:
No specific dose adjustment recommended, but monitor closely for toxicity (bilirubin 1.5-3 x ULN, AST > 2.5 x ULN).
Severe:
No specific dose adjustment recommended, but monitor closely for toxicity (bilirubin > 3 x ULN). Use with caution due to 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) through covalent binding to DNA, primarily at the N7 position of guanine. This leads to inhibition of DNA replication and transcription, ultimately resulting in cell cycle arrest and apoptosis. 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, particularly red blood cells and plasma proteins)
ProteinBinding:
More than 90% (to plasma proteins and red blood cells, primarily to albumin and gamma-globulins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Terminal half-life of ultrafiltered platinum: approximately 391 hours (reflects slow elimination from tissues). Initial distribution half-life: 0.4-14 hours.
Clearance:
Not available (complex elimination kinetics)
ExcretionRoute:
Primarily renal (approximately 50% of the dose excreted in urine within 5 days, with the majority within 48 hours). Fecal excretion is minor.
Unchanged:
Less than 1% (excreted unchanged in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (cytotoxic effects begin shortly after administration)
PeakEffect:
Not directly applicable (cytotoxic effects are cumulative over treatment cycles)
DurationOfAction:
Effects persist as long as DNA adducts are present and repair mechanisms are overwhelmed. Clinical effects are observed over the course of treatment cycles.
Safety & Warnings
BLACK BOX WARNING
Anaphylactic Reactions: Fatal anaphylactic reactions have occurred. Oxaliplatin is contraindicated in patients with a history of anaphylactic reactions to oxaliplatin. Epinephrine, corticosteroids, and antihistamines should be available. Neurotoxicity: Oxaliplatin causes dose-limiting peripheral sensory neuropathy. Myelosuppression: Oxaliplatin causes myelosuppression (neutropenia, thrombocytopenia, and anemia).
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
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, trouble 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 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, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Chest pain or discomfort.
Excessive sweating or flushing.
Swelling.
A rare but serious muscle condition called rhabdomyolysis can occur with this medication, potentially leading to organ damage or 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, although many people may not experience any or may only have mild symptoms. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or sores.
Sleep disturbances.
Changes in taste.
Joint pain.
Numbness, tingling, or burning sensations in the feet, hands, mouth, or throat. Cold temperatures can exacerbate these symptoms. To minimize discomfort, avoid cold foods and drinks, drink through a straw, dress warmly, and cover your skin when exposed to cold temperatures. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
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, trouble 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 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, speech or thinking difficulties, balance changes, drooping on one side of the face, or blurred vision.
Chest pain or discomfort.
Excessive sweating or flushing.
Swelling.
A rare but serious muscle condition called rhabdomyolysis can occur with this medication, potentially leading to organ damage or 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, although many people may not experience any or may only have mild symptoms. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Gastrointestinal symptoms: constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.
Headache.
Fatigue or weakness.
Back pain.
Mouth irritation or sores.
Sleep disturbances.
Changes in taste.
Joint pain.
Numbness, tingling, or burning sensations in the feet, hands, mouth, or throat. Cold temperatures can exacerbate these symptoms. To minimize discomfort, avoid cold foods and drinks, drink through a straw, dress warmly, and cover your skin when exposed to cold temperatures. Wear socks or gloves when handling cold objects.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Numbness, tingling, or pain in fingers, toes, or around the mouth (peripheral neuropathy)
- Difficulty swallowing or breathing, jaw tightness, voice changes (acute neuropathy symptoms)
- Fever (100.4°F or 38°C or higher) or chills
- Unusual bleeding or bruising
- Extreme tiredness or weakness
- Severe nausea, vomiting, or diarrhea
- Signs of allergic reaction: rash, hives, itching, flushing, dizziness, shortness of breath, swelling of face/lips/tongue
- Yellowing of skin or eyes, dark urine, severe stomach pain (signs of liver problems)
- Shortness of breath, cough, chest pain (signs of lung 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:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to 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
If you are taking any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
If you are taking any medications that may increase the risk of kidney problems. Again, there are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
Pregnancy and Breastfeeding Considerations:
If you are pregnant or think you may be pregnant. This medication may harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm that you are not pregnant.
If you may become pregnant, you must use effective birth control while taking this medication and for a certain period after the last dose. Ask your doctor how long to continue using birth control.
If you do become pregnant while taking this medication, contact your doctor immediately.
If you are breastfeeding, do not breastfeed while taking this medication or for 3 months after the last dose.
Additional Precautions:
If your partner may become pregnant, use effective birth control while taking this medication and for a certain period after the last dose. Ask your doctor how long to continue using birth control.
If your partner becomes pregnant, contact the doctor right away.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all medications or health conditions that may interact with this medication.
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter medications, natural products, and vitamins, as well as any health conditions you have.
* It is crucial to 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. Be sure to 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
If you are taking any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
If you are taking any medications that may increase the risk of kidney problems. Again, there are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
Pregnancy and Breastfeeding Considerations:
If you are pregnant or think you may be pregnant. This medication may harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm that you are not pregnant.
If you may become pregnant, you must use effective birth control while taking this medication and for a certain period after the last dose. Ask your doctor how long to continue using birth control.
If you do become pregnant while taking this medication, contact your doctor immediately.
If you are breastfeeding, do not breastfeed while taking this medication or for 3 months after the last dose.
Additional Precautions:
If your partner may become pregnant, use effective birth control while taking this medication and for a certain period after the last dose. Ask your doctor how long to continue using birth control.
If your partner becomes pregnant, contact the doctor right away.
Interactions with Other Medications and Health Conditions:
This is not an exhaustive list of all medications or health conditions that may interact with this medication.
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter medications, natural products, and vitamins, as well as any health conditions you have.
* It is crucial to 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.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor.
Be aware that this medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving. Although rare, some bleeding complications can be life-threatening.
Immediately contact your doctor if you experience any signs of bleeding problems, including bruising, black or bloody stools, bleeding gums, blood in your urine, coughing up blood, prolonged bleeding from cuts, dizziness, extreme fatigue or weakness, nosebleeds, pain or swelling, vomiting blood or material that resembles coffee grounds, or severe headaches.
You may also have a higher risk of developing infections, some of which can be severe or life-threatening. To reduce this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Some patients may experience nerve problems that can significantly impact daily activities. In rare cases, these issues can lead to long-lasting or life-threatening complications. If you experience bothersome or debilitating numbness, tingling, or burning sensations, contact your doctor immediately. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, as well as symptoms like eye pain, jaw tightness, unusual tongue sensations, or chest pressure.
This medication has been associated with a rare but potentially fatal brain condition known as 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 fatal cases, in patients taking this medication. If you experience shortness of breath, worsening cough, or fever, seek medical attention 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 individuals without pre-existing heart conditions, it is essential to discuss your risks with your doctor.
There have been cases of leukemia, a type of blood cancer, reported in patients treated with this medication. If you have concerns or questions, discuss them with your doctor.
If you are 65 years 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 the potential risks and implications with your doctor before starting treatment.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor.
Be aware that this medication may increase your risk of bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving. Although rare, some bleeding complications can be life-threatening.
Immediately contact your doctor if you experience any signs of bleeding problems, including bruising, black or bloody stools, bleeding gums, blood in your urine, coughing up blood, prolonged bleeding from cuts, dizziness, extreme fatigue or weakness, nosebleeds, pain or swelling, vomiting blood or material that resembles coffee grounds, or severe headaches.
You may also have a higher risk of developing infections, some of which can be severe or life-threatening. To reduce this risk, wash your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Some patients may experience nerve problems that can significantly impact daily activities. In rare cases, these issues can lead to long-lasting or life-threatening complications. If you experience bothersome or debilitating numbness, tingling, or burning sensations, contact your doctor immediately. Also, seek immediate medical attention if you have difficulty walking, talking, swallowing, or speaking, as well as symptoms like eye pain, jaw tightness, unusual tongue sensations, or chest pressure.
This medication has been associated with a rare but potentially fatal brain condition known as 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 fatal cases, in patients taking this medication. If you experience shortness of breath, worsening cough, or fever, seek medical attention 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 individuals without pre-existing heart conditions, it is essential to discuss your risks with your doctor.
There have been cases of leukemia, a type of blood cancer, reported in patients treated with this medication. If you have concerns or questions, discuss them with your doctor.
If you are 65 years 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 the potential risks and implications 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, including close monitoring of hematologic and neurologic parameters, and symptomatic treatment of adverse effects. Contact a poison control center or emergency medical services immediately. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Live vaccines (e.g., yellow fever, MMR, varicella, rotavirus) - risk of severe or fatal infection due to immunosuppression.
- Phenytoin/Fosphenytoin - decreased phenytoin levels, increased risk of seizures.
Moderate Interactions
- Warfarin - increased risk of bleeding (monitor INR).
- Other myelosuppressive agents - increased risk of hematologic toxicity.
- Nephrotoxic agents (e.g., aminoglycosides, amphotericin B, NSAIDs) - increased risk of renal toxicity.
- Neurotoxic agents (e.g., paclitaxel, docetaxel, vincristine) - increased risk of peripheral neuropathy.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To assess baseline hematologic status and identify pre-existing myelosuppression.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - AST, ALT, bilirubin, alkaline phosphatase
Rationale: To assess baseline hepatic function and identify pre-existing impairment.
Timing: Prior to initiation of therapy
Renal Function Tests (RFTs) - Serum creatinine, BUN, creatinine clearance
Rationale: To assess baseline renal function and identify pre-existing impairment.
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, as imbalances can exacerbate neurotoxicity or be affected by treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
CBC with differential and platelets
Frequency: Before each cycle and as clinically indicated
Target: WBC > 2 x 10^9/L, ANC > 1.5 x 10^9/L, Platelets > 75 x 10^9/L
Action Threshold: Hold dose if below target; consider dose reduction or delay until recovery.
Liver Function Tests (LFTs)
Frequency: Before each cycle or as clinically indicated
Target: Within normal limits or acceptable for patient's condition
Action Threshold: Hold or reduce dose for significant elevations (e.g., bilirubin > 3 x ULN, AST/ALT > 5 x ULN).
Renal Function Tests (RFTs)
Frequency: Before each cycle or as clinically indicated
Target: Within normal limits or acceptable for patient's condition
Action Threshold: Hold or reduce dose for significant impairment (e.g., CrCl < 30 mL/min).
Neurological assessment (for peripheral neuropathy)
Frequency: Before each cycle and throughout treatment
Target: No new or worsening symptoms
Action Threshold: Hold or discontinue dose for severe or persistent neuropathy (e.g., Grade 3 or 4, or Grade 2 with functional impairment).
Electrolytes (Potassium, Magnesium, Calcium)
Frequency: As clinically indicated, especially if vomiting or diarrhea occurs
Target: Within normal limits
Action Threshold: Correct imbalances promptly.
Symptom Monitoring
- Peripheral neuropathy (paresthesia, dysesthesia, numbness, tingling, pain, cold sensitivity, motor weakness, jaw tightness, laryngeal/pharyngeal dysesthesia)
- Nausea and vomiting
- Diarrhea
- Fatigue
- Stomatitis/Mucositis
- Hypersensitivity reactions (rash, urticaria, pruritus, flushing, dyspnea, bronchospasm, hypotension, chest pain, anaphylaxis)
- Signs of myelosuppression (fever, chills, unusual bleeding/bruising, signs of infection)
- Signs of hepatotoxicity (jaundice, dark urine, abdominal pain)
- Signs of pulmonary toxicity (cough, dyspnea, 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 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 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 the breastfed infant.
Pediatric Use
The safety and effectiveness of oxaliplatin in pediatric patients have not been established. Its use is generally not recommended in this population.
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 adverse reactions, particularly diarrhea, dehydration, fatigue, and peripheral neuropathy. Close monitoring and careful dose adjustments may be necessary.
Clinical Information
Clinical Pearls
- Oxaliplatin is known for its dose-limiting peripheral sensory neuropathy, which can be acute (occurring during or shortly after infusion, often exacerbated by cold) or chronic (cumulative, sensory and sometimes motor).
- Acute neuropathy symptoms (e.g., cold dysesthesia, jaw tightness, laryngeal/pharyngeal dysesthesia) are transient and usually resolve within hours or days. Advise patients to avoid cold exposure (cold drinks, cold air, cold objects) during and for several days after infusion.
- Chronic neuropathy is cumulative and can be persistent, potentially leading to long-term functional impairment. Dose modifications or discontinuation may be necessary.
- Hypersensitivity reactions can occur, often after several cycles. Patients should be monitored closely during and after infusion. Premedication with antihistamines and corticosteroids may be considered for patients who have experienced mild reactions.
- Ensure adequate hydration before and after infusion to minimize renal toxicity, although oxaliplatin is less nephrotoxic than cisplatin.
- Administer antiemetics routinely to prevent and manage nausea and vomiting, which can be severe.
- Oxaliplatin is a vesicant/irritant; ensure proper IV access and monitor for extravasation.
Alternative Therapies
- Other platinum-based agents (e.g., Cisplatin, Carboplatin - though generally not interchangeable for specific indications)
- Fluoropyrimidines (e.g., Fluorouracil, Capecitabine)
- Irinotecan
- Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Trifluridine/Tipiracil) depending on tumor characteristics and line of therapy.
Cost & Coverage
Average Cost:
Not available (varies widely by supplier, contract, and region) per 50mg/10ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 4 (Specialty Drug) or Tier 5 (Specialty Drug) for most commercial and Medicare Part D plans, often requiring prior authorization.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. Some medications may have additional patient information leaflets available; check with your pharmacist for more information. If you have any questions or concerns about your medication, 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 information about the medication taken, the amount, and the time of ingestion to ensure prompt and effective treatment.