Eloxatin AQ 100mg Inj, 20ml

Oxaliplatin is a platinum-based antineoplastic agent. It forms inter- and intra-strand DNA adducts, leading to inhibition of DNA synthesis and function. This results in DNA damage, cell cycle arrest (primarily G2/M phase), and ultimately apoptosis. Unlike cisplatin and carboplatin, oxaliplatin's DNA adducts are formed more slowly and are less susceptible to repair mechanisms, contributing to its activity in some platinum-resistant tumors.

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 immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Painful urination or mouth sores
+ Wounds that will not heal
Signs of liver problems, such as:
+ Dark urine or tiredness
+ Decreased appetite or upset stomach (with or without stomach pain)
+ Light-colored stools or vomiting
+ Yellowing of the skin or eyes (jaundice)
Signs of fluid and electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain or weakness
+ Abnormal heartbeat or severe dizziness (which may lead to passing out)
+ Increased thirst or seizures
+ Feeling extremely tired or weak
+ Decreased appetite or inability to urinate
+ Dry mouth, dry eyes, or severe stomach upset (with or without vomiting)
Weakness on one side of the body, trouble speaking or thinking, balance changes, or facial drooping
Blurred vision or chest pain
Excessive sweating or flushing
Swelling
A rare but serious muscle condition called rhabdomyolysis, which can lead to organ problems and 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. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Gastrointestinal issues, such as constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache or feeling tired or weak
Back pain or mouth irritation (including mouth sores)
Difficulty sleeping or changes in taste
Joint pain or numbness, tingling, or burning sensations in the hands, feet, mouth, or throat (which may worsen in cold temperatures)
+ 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 for guidance. 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the 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.
Pregnancy or potential pregnancy. 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 during treatment 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.
Breast-feeding. Do not breast-feed while taking this medication or for 3 months after the last dose.
* If your partner may become pregnant. Use birth control during treatment 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 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. This will help ensure your safety while taking this medication. 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. Although rare, some bleeding problems can be severe or even fatal. 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 more susceptible to infections, some of which can be severe or life-threatening. To reduce this risk, frequently wash your hands and avoid close contact with people 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 conditions. 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, a strange sensation in your tongue, or chest pressure.

A rare but potentially fatal brain 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 right away.

Some individuals taking this medication have experienced lung problems, which can be fatal. If you notice signs of lung problems, such as shortness of breath, difficulty breathing, a new or 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 experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.

This medication may also cause abnormal and potentially fatal 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 risks 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 difficulty becoming pregnant or fathering a child. If you plan to conceive, discuss your options with your doctor before starting treatment.

• Live or live-attenuated vaccines (due to immunosuppression)

• Nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, cyclosporine, NSAIDs) - increased risk of renal toxicity
• Myelosuppressive agents (e.g., other chemotherapeutics, radiation therapy) - additive myelosuppression
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics) - theoretical risk of additive QT prolongation, though oxaliplatin's direct effect is minor
• Phenytoin (decreased phenytoin levels reported with combination chemotherapy, including oxaliplatin)

• Warfarin (monitor INR closely, as chemotherapy can alter coagulation parameters)
• Immunosuppressants (e.g., corticosteroids, azathioprine) - increased risk of infection

• Peripheral neuropathy (paresthesia, dysesthesia, numbness, pain, cold sensitivity, motor weakness, jaw tightness, laryngeal spasm)
• Hypersensitivity reactions (rash, urticaria, pruritus, flushing, dyspnea, bronchospasm, hypotension, anaphylaxis)
• Myelosuppression (fever, chills, signs of infection, unusual bleeding or bruising, fatigue)
• Gastrointestinal toxicity (nausea, vomiting, diarrhea, stomatitis, abdominal pain)
• Fatigue
• Hepatotoxicity (jaundice, dark urine, abdominal pain)
• Renal toxicity (decreased urine output, swelling)
• Pulmonary toxicity (cough, dyspnea, interstitial lung disease, pulmonary fibrosis - rare)

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 at least 9 months after the last dose. Advise males with female partners of reproductive potential to 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.

The safety and effectiveness of oxaliplatin in pediatric patients have not been established. Limited data from clinical trials in pediatric solid tumors did not demonstrate significant activity. Use in pediatric populations 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 certain adverse reactions, particularly diarrhea, dehydration, fatigue, and peripheral neuropathy. Close monitoring for toxicity is recommended, and dose adjustments may be considered based on individual tolerance and renal function.

• Oxaliplatin-induced peripheral neuropathy has two forms: an acute, reversible form (often cold-induced, occurring during or shortly after infusion) and a chronic, cumulative form (dose-limiting).
• Acute neuropathy symptoms (e.g., jaw tightness, laryngeal dysesthesia, paresthesia) can be managed by slowing the infusion rate or administering calcium/magnesium infusions (though evidence for efficacy is mixed).
• Patients should be educated to avoid cold exposure (cold drinks, cold food, cold air) for several days after infusion to minimize acute neuropathy symptoms.
• Hypersensitivity reactions can occur at any cycle, even after many uneventful cycles. Pre-medication with antihistamines and corticosteroids is often used, especially for subsequent cycles if a reaction occurred.
• Ensure adequate hydration before and after administration to support renal function and minimize toxicity.
• Oxaliplatin is incompatible with alkaline solutions (e.g., 5-FU, leucovorin should be administered separately or flushed between infusions) and chloride-containing solutions (e.g., normal saline) for reconstitution/dilution. D5W is the recommended diluent.
• Dose modifications for neuropathy are crucial to prevent irreversible damage. Consider dose reduction or discontinuation if neuropathy significantly impacts daily activities.

• 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, Capecitabine)
• Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab - often used in combination with chemotherapy)
• Immunotherapy (e.g., Pembrolizumab, Nivolumab - for specific MSI-H/dMMR colorectal cancers)

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, and do not take medication prescribed for 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper 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 call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.