Oxaliplatin 100mg/20ml Inj, 1 Vial

Manufacturer WINTHROP, US Active Ingredient Oxaliplatin(ox AL i pla tin) Pronunciation ox AL i PLA tin
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.
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Drug Class
Antineoplastic agent
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Pharmacologic Class
Platinum-based alkylating agent
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Pregnancy Category
Category D
FDA Approved
Aug 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Oxaliplatin is a chemotherapy medicine used to treat certain types of cancer, especially colon and rectal cancer. It works by damaging the cancer cells' DNA, which stops them from growing and multiplying.
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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 review 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 promptly to determine the best course of action.
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Lifestyle & Tips

  • Avoid exposure to cold temperatures, cold drinks, and cold objects, especially during and for a few days after infusion, as this can worsen nerve pain (neuropathy). Wear warm clothing, gloves, and scarves.
  • Stay well-hydrated by drinking plenty of fluids unless otherwise instructed by your doctor.
  • Report any new or worsening numbness, tingling, pain, or weakness in your hands or feet immediately.
  • Practice good oral hygiene to prevent mouth sores.
  • Avoid contact sports or activities that could cause injury due to increased risk of bleeding/bruising.
  • Avoid live vaccines during treatment.
  • Use effective contraception during and for a period after treatment (for both men and women).

Dosing & Administration

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Adult Dosing

Standard Dose: 85 mg/m² IV infusion over 2 hours every 2 weeks (often in combination with fluorouracil and leucovorin)
Dose Range: 85 - 130 mg

Condition-Specific Dosing:

adjuvant_colorectal_cancer: 85 mg/m² IV every 2 weeks for 12 cycles (6 months)
metastatic_colorectal_cancer: 85 mg/m² IV every 2 weeks (continue until disease progression or unacceptable toxicity)
gastric_cancer: 130 mg/m² IV every 3 weeks (in combination with capecitabine or fluorouracil)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (limited data, generally not recommended outside of clinical trials)
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment required (CrCl ≥ 60 mL/min)
Moderate: Consider dose reduction to 65 mg/m² (CrCl 30-59 mL/min) with close monitoring for toxicity. Use with caution.
Severe: Contraindicated (CrCl < 30 mL/min) due to insufficient data and potential for increased toxicity.
Dialysis: Not available (contraindicated in severe renal impairment, not studied in dialysis patients)

Hepatic Impairment:

Mild: No specific dose adjustment recommended
Moderate: No specific dose adjustment recommended
Severe: No specific dose adjustment recommended, but use with caution due to potential for increased toxicity and limited data.

Pharmacology

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Mechanism of Action

Oxaliplatin is a platinum-based antineoplastic agent. It forms inter- and intra-strand DNA adducts, leading to inhibition of DNA replication and transcription, ultimately resulting in cell death. It is cell-cycle non-specific.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV administration)
Tmax: Not applicable (IV infusion)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 440 L (for ultrafilterable platinum)
ProteinBinding: >90% (irreversible binding to plasma proteins and tissues, including red blood cells)
CnssPenetration: Limited

Elimination:

HalfLife: 391 hours (terminal half-life of ultrafilterable platinum)
Clearance: Not readily quantifiable due to extensive tissue binding and non-enzymatic metabolism
ExcretionRoute: Primarily renal (approximately 50% of the dose excreted in urine within 48 hours), minor fecal excretion.
Unchanged: <1% (of parent drug)
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Pharmacodynamics

OnsetOfAction: Rapid (cytotoxic effects begin shortly after administration)
PeakEffect: Not directly applicable as a single peak; cytotoxic effects are cumulative over treatment cycles.
DurationOfAction: Cellular effects persist as long as platinum adducts remain; clinical effects are observed over the treatment cycle.

Safety & Warnings

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BLACK BOX WARNING

Anaphylactic reactions, peripheral sensory neuropathy, and myelosuppression have been reported with oxaliplatin. Fatalities have occurred. Patients should be monitored closely for these toxicities.
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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 yellow skin and eyes
Signs of fluid and electrolyte imbalance: mood changes, confusion, muscle pain or weakness, irregular or rapid heartbeat, severe dizziness or fainting, increased thirst, seizures, extreme fatigue or weakness, decreased appetite, difficulty urinating or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Chest pain
Excessive sweating
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. 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 or any other unusual symptoms, contact your doctor or seek medical help:

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 food and drinks, drink through a straw, dress warmly, and cover your skin when exposed to cold

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.
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Seek Immediate Medical Attention If You Experience:

  • Numbness, tingling, burning, or pain in fingers, toes, or around the mouth, especially when exposed to cold.
  • Difficulty swallowing or breathing, especially after exposure to cold.
  • Fever (100.4°F or higher) or chills, which could indicate infection.
  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, petechiae).
  • Severe or persistent nausea, vomiting, or diarrhea.
  • Signs of an allergic reaction during or shortly after infusion (e.g., rash, itching, flushing, dizziness, shortness of breath, swelling of face/lips/tongue).
  • Severe fatigue or weakness.
  • Yellowing of skin or eyes (jaundice), dark urine, or light-colored stools.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Long QT interval on an electrocardiogram (ECG)
+ Low magnesium levels
+ Low potassium levels
Medications you are currently taking that may cause abnormal heart rhythms (prolonged QT interval). If you are unsure, consult your doctor or pharmacist for guidance.
Medications that may increase the risk of kidney problems. If you are unsure, consult your doctor or pharmacist for guidance.
If you are pregnant or plan to become pregnant. This medication may harm an unborn baby. A pregnancy test will be conducted before starting treatment to confirm you are not pregnant. If you may become pregnant, you must use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant, notify your doctor immediately.
If you are breastfeeding. 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 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to inform your doctor and pharmacist about:

All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have

Ensure that it is safe to take this medication with all your medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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, be cautious and avoid driving or engaging in 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 careful to avoid injuries, use a soft-bristled toothbrush, and consider using an electric razor. Although rare, some bleeding complications can be severe or even 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, 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, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

In some cases, this medication can cause nerve problems that may interfere with daily activities and, in rare instances, lead to long-lasting or life-threatening complications. If you experience burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. Additionally, seek medical attention right away 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.

A rare but potentially life-threatening condition called posterior reversible encephalopathy syndrome (PRES) has been associated with this medication. If you exhibit symptoms such as confusion, decreased alertness, changes in vision, loss of vision, seizures, or severe headaches, contact your doctor immediately.

Some individuals taking this medication have developed lung problems, which can be fatal in rare cases. 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 intervals on an electrocardiogram (ECG) and torsades de pointes. Although this can occur in anyone, it is essential to discuss your risk factors with your doctor.

There have been cases of leukemia, a type of blood cancer, in patients treated with this medication. If you have concerns or questions, discuss them with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Furthermore, 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.
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Overdose Information

Overdose Symptoms:

  • Exacerbated myelosuppression (severe neutropenia, thrombocytopenia)
  • Severe peripheral neuropathy
  • Severe gastrointestinal toxicity (nausea, vomiting, diarrhea)
  • Severe 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 toxicities. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Live or attenuated vaccines (risk of severe or fatal infection in immunocompromised patients)
  • Phenytoin (decreased phenytoin levels, increased risk of seizures)
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Moderate Interactions

  • Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, cyclosporine) - increased risk of renal toxicity
  • Ototoxic drugs (e.g., aminoglycosides, loop diuretics) - increased risk of ototoxicity
  • Myelosuppressive agents (e.g., other chemotherapies, radiation) - additive myelosuppression
  • Warfarin (potential for altered INR, monitor closely)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential and platelets

Rationale: To assess baseline bone marrow function and identify pre-existing cytopenias.

Timing: Prior to initiation of therapy

Renal function tests (Serum Creatinine, BUN, Creatinine Clearance)

Rationale: To assess baseline renal function and guide dosing adjustments if needed.

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

Rationale: To establish baseline for peripheral neuropathy assessment.

Timing: Prior to initiation of therapy

Electrolytes (Potassium, Magnesium, Calcium)

Rationale: To assess baseline electrolyte status, as imbalances can exacerbate neuropathy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Complete Blood Count (CBC) with differential and platelets

Frequency: Prior to each cycle of therapy and as clinically indicated

Target: ANC ≥ 1.5 x 10^9/L, Platelets ≥ 75 x 10^9/L

Action Threshold: Hold dose if ANC < 1.5 x 10^9/L or platelets < 75 x 10^9/L; consider dose reduction for subsequent cycles if prolonged or severe myelosuppression.

Renal function tests (Serum Creatinine, BUN)

Frequency: Prior to each cycle of therapy

Target: Within normal limits or stable

Action Threshold: Consider dose adjustment or discontinuation if significant decline in renal function.

Neurological examination (assessment of peripheral neuropathy)

Frequency: Prior to each cycle of therapy and as clinically indicated

Target: No new or worsening symptoms

Action Threshold: Hold or discontinue therapy for persistent Grade 2 or higher peripheral neuropathy; consider dose reduction for Grade 1 or 2 symptoms.

Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Prior to each cycle of therapy and as clinically indicated

Target: Within normal limits

Action Threshold: Correct electrolyte imbalances prior to administration; consider supplementation if persistent.

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Symptom Monitoring

  • Peripheral neuropathy (numbness, tingling, pain, cold sensitivity, difficulty with fine motor skills)
  • Hypersensitivity reactions (rash, urticaria, pruritus, flushing, dyspnea, bronchospasm, hypotension, chest pain)
  • Gastrointestinal toxicity (nausea, vomiting, diarrhea, stomatitis)
  • Myelosuppression (fever, chills, signs of infection, unusual bleeding or bruising, fatigue)
  • Hepatotoxicity (jaundice, dark urine, abdominal pain)
  • Pulmonary toxicity (cough, dyspnea, interstitial lung disease)
  • Fatigue

Special Patient Groups

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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. Women of childbearing potential should be advised to avoid becoming pregnant during treatment.

Trimester-Specific Risks:

First Trimester: High risk of major birth defects and fetal death due to rapid cell division during 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 complications during delivery.
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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 nursing infants, breastfeeding is contraindicated during oxaliplatin therapy and for a period after the last dose (e.g., 3 months).

Infant Risk: High risk of serious adverse effects, including myelosuppression, growth inhibition, and other toxicities.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended outside of specific clinical trials due to potential for significant toxicity and lack of efficacy data in most pediatric cancers.

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Geriatric Use

Elderly patients (≥65 years) may be at increased risk for severe diarrhea, dehydration, fatigue, and peripheral neuropathy compared to younger patients. Close monitoring and careful dose adjustments based on tolerance are recommended.

Clinical Information

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Clinical Pearls

  • Oxaliplatin-induced peripheral neuropathy has two forms: acute (cold-induced, reversible, often within hours to days) and chronic (cumulative, dose-limiting, sensory and motor, can be persistent).
  • Acute neuropathy can be triggered by cold exposure; advise patients to avoid cold food/drinks and wear warm clothing.
  • Hypersensitivity reactions can occur early in treatment or after several cycles; have resuscitation equipment readily available.
  • Pre-medication with antiemetics is crucial to manage nausea and vomiting.
  • Monitor for signs of myelosuppression (neutropenia, thrombocytopenia, anemia) before each cycle.
  • Ensure adequate hydration to minimize renal toxicity.
  • Oxaliplatin is incompatible with alkaline solutions (e.g., 5-FU, leucovorin in alkaline solutions, sodium chloride solutions containing chloride ions). It must be diluted in 5% Dextrose Injection, USP.
  • Extravasation can cause local pain and inflammation; manage according to institutional guidelines.
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Alternative Therapies

  • Other platinum agents (e.g., Cisplatin, Carboplatin) for different cancer types or in specific regimens.
  • Other cytotoxic agents (e.g., Irinotecan, Fluorouracil, Capecitabine).
  • Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab) in combination with chemotherapy or as monotherapy for specific tumor types/mutations.
  • Immunotherapy (e.g., Pembrolizumab, Nivolumab) for specific tumor types with MSI-H/dMMR.
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Cost & Coverage

Average Cost: Varies widely, typically several hundred to over a thousand USD per vial per 100mg/20ml vial
Generic Available: Yes
Insurance Coverage: Specialty Tier / Tier 4 (requires prior authorization, often covered under medical benefit for oncology)
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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 and effective use of your medication, never share your prescription with others, and do not take someone else's medication.

Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion or exposure. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by your pharmacist or healthcare provider, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs that provide a safe and environmentally responsible way to dispose of unwanted medications.

Some medications may have additional patient information leaflets available. Consult with your pharmacist to determine if this is the case for your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.