Camptosar 20mg/ml Inj, 5ml

Irinotecan is a prodrug that is converted to its active metabolite, SN-38, by carboxylesterase enzymes. SN-38 acts as a topoisomerase I inhibitor. Topoisomerase I is an enzyme that relieves torsional strain in DNA during replication and transcription by inducing transient single-strand breaks. SN-38 binds to the topoisomerase I-DNA complex, preventing re-ligation of the DNA strand. This leads to DNA damage, which ultimately triggers apoptosis in rapidly dividing cancer cells.

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:

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 uncontrollable bleeding.
Severe Dizziness or Fainting
Confusion
Redness or Irritation: Redness or irritation on the palms of your hands or soles of your feet. This medication may cause vein irritation, and if it leaks from the vein, it can 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 or difficulty breathing, new or worsening cough, or fever. These symptoms can be life-threatening, so seek medical attention immediately.
Blood Clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing. If you have a history of blood clots, inform your doctor and seek medical attention if you experience any of these symptoms.

Other Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is 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
* Stomach upset, vomiting, stomach pain, and decreased appetite are common side effects of this medication. Discuss ways to minimize these effects with your doctor. If these symptoms bother you, do not improve, or become severe, seek medical attention.

To avoid dehydration, it is crucial to stay hydrated. These are not all the possible side effects that may occur. If you have concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 concerns. 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 variations 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. 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 for scheduling 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 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 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, leading to reduced efficacy.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May significantly increase exposure to irinotecan and SN-38, leading to increased toxicity (especially myelosuppression and diarrhea).
• UGT1A1 inhibitors (e.g., atazanavir): May increase exposure to SN-38, leading to increased toxicity.

• Laxatives: Concurrent use may exacerbate diarrhea.
• Diuretics: May increase risk of dehydration due to diarrhea.
• Neuromuscular blocking agents: Irinotecan has anticholinesterase activity, potentially prolonging neuromuscular blockade.
• Other myelosuppressive agents: Increased risk of severe myelosuppression.

• Diarrhea (onset, frequency, severity, presence of fever or abdominal pain)
• Signs of infection (fever, chills, sore throat, unusual bruising or bleeding)
• Nausea and vomiting
• Abdominal cramping
• Fatigue/weakness
• Signs of cholinergic syndrome (early diarrhea, abdominal cramping, diaphoresis, flushing, bradycardia, miosis, increased salivation - treat with atropine)

Irinotecan can cause fetal harm when administered to a pregnant woman. It is teratogenic and embryotoxic in animal studies. Advise pregnant women of the potential risk to a fetus. Women of childbearing potential should be advised to use effective contraception during treatment and for 6 months after the last dose. Males with female partners of childbearing potential should use effective contraception during treatment and for 3 months after the last dose.

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 one month after the last dose.

Safety and effectiveness in pediatric patients have not been established. While it has been studied in some pediatric cancers, its use is generally investigational and not standard of care. Pediatric patients may be more susceptible to certain toxicities.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients in clinical trials, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to severe diarrhea and myelosuppression, requiring careful monitoring and dose adjustments.

• Irinotecan is notorious for causing two types of diarrhea: early (cholinergic, within 24 hours, treat with atropine) and late (delayed, >24 hours, treat aggressively with loperamide).
• Patients with UGT1A1*28 polymorphism are at significantly higher risk of severe neutropenia and diarrhea. Genotyping can help guide initial dosing, though not universally required.
• Aggressive management of late diarrhea with high-dose loperamide is crucial to prevent dehydration, electrolyte imbalance, and life-threatening complications.
• Myelosuppression, particularly neutropenia, is dose-limiting. Monitor CBC frequently and hold/reduce dose as per guidelines.
• Administer antiemetics prior to irinotecan to mitigate nausea and vomiting.
• Ensure patients understand the importance of reporting all side effects promptly, especially diarrhea and fever.

• Oxaliplatin (another chemotherapy agent used in colorectal cancer, often in FOLFOX regimen)
• 5-Fluorouracil (a pyrimidine analog, often used in combination)
• Capecitabine (oral prodrug of 5-FU)
• Targeted therapies (e.g., bevacizumab, cetuximab, panitumumab, regorafenib, encorafenib/binimetinib) depending on tumor molecular profile and line of therapy.

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 that has been prescribed to someone else.

All medications should be stored 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 method for disposal, as some communities may have drug take-back programs in place.

Additionally, some medications may come with a separate patient information leaflet; be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial to 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 emergency medical attention. Be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it was taken, to ensure prompt and effective treatment.