Oxaliplatin 100mg Inj, 20ml

Oxaliplatin is a platinum-based antineoplastic agent. It forms DNA adducts (inter- and intra-strand crosslinks) by binding to DNA, primarily at the N7 position of guanine. This inhibits DNA replication and transcription, leading to cell cycle arrest and apoptosis. It is active in various phases of the cell cycle but primarily affects cells in S-phase.

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, 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, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, rapid or abnormal 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, trouble 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 problems 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 symptoms that bother you or don't go away, 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
Trouble sleeping
Changes in taste
Joint pain
* Numbness, tingling, or burning sensations in the feet, hands, mouth, or throat, which can be worsened by cold temperatures; to manage this, avoid cold food and drinks, drink through a straw, dress warmly, and cover your skin when going out in the cold, and wear socks or gloves when handling cold objects

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Long QT interval on an electrocardiogram (ECG)
+ Low magnesium levels
+ Low potassium levels
Medications you are currently taking that may cause abnormal heart rhythms, specifically prolonged QT intervals. There are numerous medications that can cause this condition, so consult your doctor or pharmacist if you are unsure.
Medications that may increase the risk of kidney problems. Many medications can cause this, so ask your doctor or pharmacist if you have any concerns.
If you are pregnant or may become pregnant. This medication may harm an unborn baby, so 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, as advised by your doctor.
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, as advised by your doctor. If your partner becomes pregnant, notify your doctor immediately.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Ensure it is safe to take this medication with your other medications and health conditions before starting treatment. Do not initiate, stop, or modify 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. Although rare, some bleeding problems can be life-threatening. Immediately contact your doctor if you experience any signs of bleeding, such as bruising, black or bloody stools, bleeding gums, blood in your urine, coughing up blood, prolonged bleeding from cuts, dizziness, fatigue, nosebleeds, pain or swelling, vomiting blood or coffee ground-like material, or severe headaches.

You may also be at a higher risk of developing infections, some of which can be severe or life-threatening. To reduce this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.

Some individuals may experience nerve problems that interfere with daily activities, potentially leading to long-lasting or life-threatening complications. If you experience burning, numbness, or tingling that bothers you or interferes with your daily life, contact your doctor immediately. 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 experience 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, difficulty breathing, a new or 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 any redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.

This medication may cause abnormal heart rhythms, including a condition called long QT syndrome or torsades de pointes, which can be life-threatening. Although this is more likely to occur in people with pre-existing heart conditions, it has also happened in individuals without a history of heart problems. Discuss your risks with your doctor.

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

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

This medication may affect fertility, potentially leading to difficulty becoming pregnant or fathering a child. If you plan to become pregnant or father a child, discuss your options with your doctor before starting treatment.

• Live vaccines (e.g., yellow fever, MMR, varicella): Risk of severe or fatal infection due to immunosuppression.
• Phenytoin: Decreased phenytoin levels and increased risk of seizures (due to decreased absorption or increased metabolism of phenytoin, though mechanism not fully elucidated for oxaliplatin specifically, general caution with cytotoxic agents).

• Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, NSAIDs): Increased risk of renal toxicity.
• Myelosuppressive drugs (e.g., other chemotherapeutic agents, radiation therapy): Increased risk of myelosuppression.
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics): Potential for additive QT prolongation, though oxaliplatin's direct effect on QT is not primary.

• Peripheral neuropathy (numbness, tingling, pain, cold sensitivity, motor weakness, difficulty with fine motor skills)
• Nausea and vomiting
• Diarrhea
• Fatigue
• Mouth sores (mucositis)
• Signs of infection (fever, chills, sore throat)
• Bleeding or bruising
• Allergic reactions (rash, itching, shortness of breath, swelling of face/lips/tongue)
• Signs of liver dysfunction (yellowing of skin/eyes, dark urine, abdominal pain)
• Signs of renal dysfunction (decreased urine output, swelling)

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 9 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 6 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 3 months after the last dose.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

No overall differences in effectiveness were observed between elderly (≥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 is warranted.

• Oxaliplatin is highly emetogenic; ensure adequate antiemetic prophylaxis (e.g., NK1 receptor antagonist, 5-HT3 antagonist, dexamethasone).
• Peripheral neuropathy is a major dose-limiting toxicity. It can be acute (cold-induced, reversible) or chronic (cumulative, persistent). Counsel patients extensively on cold avoidance.
• Acute neuropathy symptoms (e.g., dysesthesia, paresthesia, laryngopharyngeal dysesthesia) often occur within hours of infusion and resolve within days. Chronic neuropathy is cumulative and can be debilitating.
• Hypersensitivity reactions can occur early in treatment or after multiple cycles. Have resuscitation equipment and medications readily available. Premedication with antihistamines and corticosteroids may be considered for patients with prior reactions.
• Ensure adequate hydration before and after infusion to minimize renal toxicity, although oxaliplatin is less nephrotoxic than cisplatin.
• Extravasation can cause severe local tissue damage. Administer via a central venous catheter if possible, or ensure careful monitoring of peripheral IV sites.

• Other platinum-based agents (e.g., Cisplatin, Carboplatin) for other cancer types or if oxaliplatin is not tolerated.
• Other cytotoxic agents used in colorectal cancer (e.g., Irinotecan, 5-Fluorouracil, Capecitabine).
• Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Encorafenib, Binimetinib) for specific molecular profiles.
• Immunotherapy (e.g., Pembrolizumab, Nivolumab, Ipilimumab) for specific molecular profiles (e.g., 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 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 a healthcare professional. If you are unsure about the best disposal method, consult your pharmacist, as they may 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.