Irinotecan 500mg/25ml Inj, 25ml

Irinotecan and its active metabolite, SN-38, act as topoisomerase I inhibitors. Topoisomerase I is an enzyme that relieves torsional strain in DNA during replication and transcription by inducing transient single-strand breaks. Irinotecan and SN-38 bind to the topoisomerase I-DNA complex, preventing re-ligation of the DNA strand breaks. This leads to accumulation of DNA damage, ultimately triggering apoptosis and inhibiting cell proliferation.

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:

Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or wounds that won't heal.
Fluid and electrolyte imbalances: Mood changes, confusion, muscle pain or weakness, 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 nausea and vomiting.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, gum bleeding, abnormal vaginal bleeding, unexplained bruising or enlarging bruises, or uncontrollable bleeding.
Severe dizziness or fainting
Confusion
Redness or irritation of the palms or soles: This medication may cause vein irritation. If the medication leaks from the vein, it can also cause irritation around the affected area. Inform your nurse if you experience redness, burning, pain, swelling, or fluid leakage at the injection site.
Lung problems: Shortness of breath, trouble breathing, new or worsening cough, or fever. These symptoms can be life-threatening, so seek medical help immediately.
Blood clots: If you have a history of blood clots, inform your doctor. Seek medical help right away if you experience symptoms like chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in your legs or arms, or difficulty speaking or swallowing.

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

Hair loss
Dizziness, drowsiness, fatigue, or weakness
Sleep disturbances
Headache
Back pain
Excessive sweating
Weight loss
Gas
Mouth irritation or mouth sores
Constipation
* Nausea, vomiting, stomach pain, and decreased appetite (common side effects that can be managed with your doctor's guidance)

If these side effects bother you, don't improve, or become severe, contact your doctor for advice. It's crucial to stay hydrated to minimize the risk of dehydration.

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. Be sure to describe the symptoms you experienced.
If you are undergoing dialysis, discuss this with your doctor.
Any medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins, that may interact with this medication. Certain medications used to treat HIV, infections, seizures, and other conditions should not be taken with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 1 week after your last dose.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications, health problems, and any other relevant information. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm it is safe to do so in conjunction with this medication.

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 drug affects you.

Individuals with specific genetic types may have a higher risk of developing severe or life-threatening low white blood cell counts. Your doctor may recommend a genetic test before starting this medication. If you have questions or concerns, discuss them with your doctor.

While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu, as some infections can be life-threatening.

This medication may increase your risk of bleeding easily. Be cautious, avoid injuries, and use a soft toothbrush and an electric razor to reduce the risk of bleeding.

Regular blood tests will be necessary, as directed by your doctor. Be sure to follow their instructions and discuss any concerns or questions you may have.

Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.

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

This drug may affect fertility, potentially leading to difficulties in becoming pregnant or fathering a child. If you plan to conceive, discuss this with your doctor before starting the medication.

This medication can harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.

If you may become pregnant, use effective birth control during treatment and for 6 months after the last dose. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control during treatment and for 3 months after the last dose. If your partner becomes pregnant, contact the doctor right away.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort): May decrease irinotecan and SN-38 exposure, leading to reduced efficacy. Avoid concomitant use.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May increase irinotecan and SN-38 exposure, leading to increased toxicity (e.g., myelosuppression, diarrhea). Avoid concomitant use or reduce irinotecan dose.
• UGT1A1 inhibitors (e.g., atazanavir): May increase SN-38 exposure, leading to increased toxicity. Avoid concomitant use.
• Live vaccines: Increased risk of severe infection due to immunosuppression.

• Laxatives: May exacerbate diarrhea. Use with caution.
• Diuretics: May exacerbate dehydration from diarrhea.
• Neuromuscular blocking agents: Irinotecan may prolong the neuromuscular blockade of succinylcholine due to its anticholinesterase activity.
• Other myelosuppressive agents: Increased risk of myelosuppression.

• Severe diarrhea (early and late onset)
• Fever (especially with neutropenia)
• Signs of infection (sore throat, chills, cough)
• Nausea and vomiting
• Abdominal cramping
• Fatigue
• Hair loss
• Mouth sores (mucositis)
• Skin rash
• Shortness of breath (rare, interstitial lung disease)

Irinotecan can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Women of childbearing potential should be advised to avoid becoming pregnant during therapy and to use effective contraception during treatment and for at least 6 months after the last dose. Males 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 irinotecan 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 irinotecan therapy and for at least one week after the last dose.

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended outside of specific clinical trials.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Close monitoring for toxicity, especially diarrhea and myelosuppression, is recommended.

• Pre-medicate with antiemetics (e.g., dexamethasone, 5-HT3 antagonist) to prevent nausea and vomiting.
• Administer atropine 0.25-0.5 mg IV for acute cholinergic syndrome symptoms (e.g., sweating, abdominal cramping, diarrhea, bradycardia) that occur during or shortly after infusion.
• Aggressively manage delayed diarrhea with high-dose loperamide (e.g., 4 mg at first loose stool, then 2 mg every 2 hours until diarrhea-free for 12 hours, or maximum 16 mg/day).
• Patients with UGT1A1*28 allele homozygosity are at significantly increased risk of severe neutropenia and diarrhea; consider a starting dose reduction (e.g., 30%) for these patients.
• Monitor CBC frequently, especially during the first few cycles, as neutropenia can be severe and dose-limiting.
• Ensure adequate hydration, especially during periods of diarrhea or vomiting.
• Irinotecan is a vesicant/irritant; ensure proper IV access and monitor for extravasation.

• Oxaliplatin (another chemotherapy agent used in colorectal cancer, often in FOLFOX regimen)
• Capecitabine (oral fluoropyrimidine)
• Bevacizumab (VEGF inhibitor, often combined with chemotherapy)
• Cetuximab (EGFR inhibitor, for specific KRAS wild-type colorectal cancer)
• Panitumumab (EGFR inhibitor, for specific KRAS wild-type colorectal cancer)
• Regorafenib (multi-kinase inhibitor, for refractory colorectal cancer)
• Trifluridine/Tipiracil (TAS-102, for refractory colorectal cancer)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have drug take-back programs in place.

Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.