Irinotecan 100mg/5ml Inj, 5ml

Irinotecan and its active metabolite, SN-38, act as topoisomerase I inhibitors. Topoisomerase I relieves torsional strain in DNA by inducing single-strand breaks. Irinotecan and SN-38 bind to the topoisomerase I-DNA complex, preventing re-ligation of the DNA strand. This leads to DNA damage, which triggers apoptosis and inhibits DNA replication and transcription, ultimately leading to cell death.

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 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.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color of sputum, pain while urinating, mouth sores, or a wound that will not heal.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrolled bleeding.
Severe Dizziness or Fainting
Confusion
Redness or Irritation: Redness or irritation on the palms of your hands or soles of your feet, which can be a sign of vein irritation. If you experience redness, burning, pain, swelling, or fluid leakage at the injection site, notify your nurse.
Lung Problems: Shortness of breath or difficulty breathing, new or worsening cough, or fever. These symptoms can be life-threatening, so seek medical attention immediately.
Blood Clots: If you have a history of blood clots, inform your doctor. Be aware of 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

Most people do not experience severe side effects, but some may encounter mild or moderate issues. If you notice any of the following side effects, consult your doctor or seek medical help if they bother you or persist:

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

To minimize the risk of dehydration, it is essential to stay hydrated. If you experience any of these side effects or have concerns, discuss them with your doctor.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor or report them to the FDA at 1-800-332-1088 or 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. There are many other medications that may also interact with this medication.
If you are breastfeeding. You should not breastfeed while taking this medication and for 1 week after your last dose.

This is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is crucial to:

Inform your doctor and pharmacist about all your medications (prescription and over-the-counter), natural products, vitamins, and health problems.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Do not start, stop, or change the dosage of any medication without first consulting your doctor.

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 initiating treatment with this medication. If you have questions or concerns, discuss them with your doctor.

While taking this medication, 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 also increase your risk of bleeding easily. Be cautious and take steps to prevent injury. Use a soft-bristled toothbrush and an electric razor to reduce the risk of bleeding.

Regular blood tests will be necessary to monitor your condition. Follow your doctor's instructions regarding the frequency and timing of these tests, and discuss any concerns or questions you may have.

Before receiving any vaccinations, consult with your doctor, as some 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 experiencing side effects.

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

This medication can cause harm to 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 methods while taking this medication and for 6 months after your last dose. If you become pregnant, notify your doctor immediately.

If your partner may become pregnant, use birth control while taking this medication and for 3 months after your last dose. If your partner becomes pregnant, inform your doctor right away.

• Strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort): May significantly decrease exposure to irinotecan and SN-38, reducing efficacy. Avoid concomitant use.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, grapefruit juice): May significantly increase exposure to irinotecan and SN-38, increasing toxicity. Avoid concomitant use.
• UGT1A1 inhibitors (e.g., atazanavir, gemfibrozil): May increase exposure to SN-38, increasing toxicity. Avoid concomitant use.
• Live vaccines: Increased risk of severe or fatal infection due to immunosuppression.

• Laxatives: May exacerbate diarrhea.
• Diuretics: May exacerbate dehydration from diarrhea.
• Neuromuscular blocking agents: Irinotecan may prolong neuromuscular blockade.
• Anticoagulants (e.g., warfarin): Increased risk of bleeding due to myelosuppression.

• Not available

• Severe diarrhea (early and late onset)
• Fever, chills, signs of infection (due to neutropenia)
• Unusual bleeding or bruising (due to thrombocytopenia)
• Fatigue, weakness (due to anemia)
• Nausea, vomiting, abdominal pain
• Hair loss
• Mucositis/stomatitis
• Cholinergic symptoms (diaphoresis, abdominal cramps, bradycardia, rhinitis, lacrimation, salivation, miosis)

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 treatment and to use effective contraception.

It is not known whether irinotecan or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during irinotecan treatment and for at least one month after the last dose.

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

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose selection for an elderly patient should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be more susceptible to diarrhea and myelosuppression.

• Irinotecan is a prodrug; its active metabolite SN-38 is responsible for most of its cytotoxic activity and toxicity.
• The most significant toxicities are severe diarrhea (early and late onset) and myelosuppression (neutropenia).
• Early diarrhea (within 24 hours) is cholinergic and can be managed with atropine. Late diarrhea (after 24 hours) is secretory and potentially life-threatening, requiring aggressive loperamide management.
• Patients with UGT1A1*28 allele homozygosity have reduced SN-38 glucuronidation, leading to higher SN-38 exposure and increased risk of severe neutropenia and diarrhea. Genotyping can help guide dose adjustments, though not universally mandated.
• Close monitoring of CBCs is crucial, especially during the first few cycles, due to the risk of delayed neutropenia.
• Hydration and electrolyte management are critical, especially with severe diarrhea.
• Drug interactions with CYP3A4 inducers/inhibitors and UGT1A1 inhibitors are clinically significant and should be avoided or managed with extreme caution.

• Oxaliplatin (another chemotherapy agent for colorectal cancer)
• 5-Fluorouracil (5-FU)
• Capecitabine (oral prodrug of 5-FU)
• Targeted therapies (e.g., bevacizumab, cetuximab, panitumumab, regorafenib, encorafenib/binimetinib for specific mutations)
• Immunotherapy (e.g., pembrolizumab for MSI-H/dMMR colorectal cancer)

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 treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the 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 a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.