Oxaliplatin 200mg/40ml Inj, 1 Vial

Oxaliplatin is a platinum-based antineoplastic agent. It forms DNA adducts (primarily inter- and intra-strand crosslinks) by binding to guanine and cytosine bases. This inhibits DNA replication and transcription, leading to DNA damage, cell cycle arrest (primarily in S-phase), and ultimately apoptosis. It is a derivative of cisplatin and carboplatin, but its mechanism of action is distinct, with activity against cisplatin-resistant cell lines.

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 immediate medical attention:

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 problems: 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 for advice:

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 manage this, avoid cold foods 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 not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 cause this; 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 cause this; consult your doctor or pharmacist if you are unsure.
If you are pregnant or think you may be pregnant. This medication may harm an unborn baby. A pregnancy test will be performed 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. Ask your doctor how long to use birth control.
If you are breastfeeding. Do not breastfeed while taking this medication or for 3 months after the last dose.
* If your partner may become pregnant. Use birth control while taking this medication and for a certain period after the last dose. Ask your doctor how long to use birth control. If your partner becomes pregnant, notify the doctor immediately.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. 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 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 for shaving. 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, 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, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

Some patients may experience nerve problems that interfere with daily activities, potentially leading 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, 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 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 syndrome and torsades de pointes. Although this can occur in individuals without a history of heart problems, it is essential to discuss your risk with your doctor.

There have been cases of leukemia, a type of blood cancer, in patients treated with this medication. If you have concerns, 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 the potential risks and benefits with your doctor before starting treatment.

• Live vaccines (e.g., yellow fever, MMR, varicella, rotavirus): Risk of severe or fatal infection due to immunosuppression.
• Strong CYP3A4 inducers/inhibitors: While oxaliplatin is not metabolized by CYP450, concomitant medications that affect bone marrow or renal function can indirectly impact toxicity.

• Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs, amphotericin B): May increase risk of renal toxicity.
• Myelosuppressive agents (e.g., other chemotherapy, radiation): May exacerbate myelosuppression.
• Anticoagulants (e.g., warfarin): Increased risk of bleeding due to myelosuppression (thrombocytopenia). Monitor INR closely.
• Phenytoin: Decreased phenytoin levels reported with concomitant fluorouracil, which is often given with oxaliplatin. Monitor phenytoin levels.

• Not available (most interactions are related to additive toxicities or general chemotherapy considerations)

• Peripheral neuropathy (numbness, tingling, pain, cold sensitivity, difficulty with fine motor skills)
• Nausea and vomiting
• Diarrhea or constipation
• Fatigue
• Mouth sores (mucositis)
• Hair thinning (alopecia, less common than with other agents)
• Hypersensitivity reactions (rash, itching, flushing, dyspnea, bronchospasm, hypotension)
• Signs of infection (fever, chills, sore throat)
• Bleeding or bruising (due to thrombocytopenia)
• Signs of liver dysfunction (jaundice, dark urine, abdominal pain)
• Signs of pulmonary fibrosis (cough, dyspnea)

Oxaliplatin can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose.

It is not known whether oxaliplatin or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during oxaliplatin treatment and for at least 3 months after the last dose.

Safety and effectiveness in pediatric patients have not been established. Limited data suggest potential for severe toxicities, including neurotoxicity and myelosuppression. Use is generally not recommended outside of specific clinical trials.

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 based on tolerability are recommended.

• Oxaliplatin-induced peripheral neuropathy has two forms: acute (occurring during or within hours of infusion, often triggered by cold) and chronic (cumulative, dose-limiting, sensory).
• Pre-medication with antiemetics (e.g., 5-HT3 antagonist + dexamethasone) is crucial to prevent nausea and vomiting.
• Hypersensitivity reactions can occur early in treatment but are more common after multiple cycles. Have epinephrine, corticosteroids, and antihistamines readily available.
• Ensure adequate hydration before and after infusion to minimize renal toxicity, although oxaliplatin is less nephrotoxic than cisplatin.
• Patients should be educated about cold avoidance to manage acute neuropathy symptoms.
• Dose reductions or delays are often necessary due to myelosuppression or neuropathy. Follow specific dose modification guidelines based on toxicity grade.
• Oxaliplatin is often given in combination regimens like FOLFOX (with 5-FU and leucovorin) or XELOX/CAPOX (with capecitabine).

• Other platinum-based agents (e.g., Cisplatin, Carboplatin - though with different toxicity profiles and indications)
• Other cytotoxic agents used in colorectal cancer (e.g., Irinotecan, 5-Fluorouracil, Capecitabine)
• Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Encorafenib, Binimetinib)
• Immunotherapy (e.g., Pembrolizumab, Nivolumab, Ipilimumab for MSI-H/dMMR colorectal cancer)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. 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 a healthcare professional. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.