Camptosar 20mg/ml Inj, 2ml

Irinotecan is a prodrug that is converted to its active metabolite, SN-38, by carboxylesterase enzymes. SN-38 inhibits topoisomerase I, an enzyme crucial for DNA replication, transcription, and repair. By binding to the topoisomerase I-DNA complex, SN-38 prevents religation of DNA single-strand breaks, leading to accumulation of DNA damage, double-strand breaks during DNA synthesis, and ultimately, apoptosis of cancer cells.

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 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 of the palms of hands or soles of feet: 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 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 Side Effects

Most people do not experience severe side effects, and some may only have mild or no side effects at all. However, if you notice any of the following side effects, contact 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 side effects that concern you or do not improve, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, 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 allergic reaction you experienced, including any symptoms that occurred.
If you are undergoing dialysis, discuss this with your doctor to determine the best course of action.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. Certain medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication and should be avoided. There are numerous medications that are contraindicated with this drug, so it is crucial to disclose all medications you are taking.
If you are breast-feeding, as you should not breast-feed while taking this medication and for 1 week after your last dose.

This is not an exhaustive list of all potential drug interactions or health problems that may be affected by this medication. Therefore, it is vital to inform your doctor and pharmacist about all your medications (prescription and OTC), natural products, vitamins, and health problems to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in any activity that requires alertness and clear vision, ensure you understand how this medication 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 prior to initiating treatment with this medication. If you have 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 individuals who have infections, colds, or flu, as some infections can be life-threatening.

This medication may increase your risk of bleeding easily. Take precautions to avoid injury, and use a soft-bristled toothbrush and an electric razor for shaving.

Regular blood tests will be necessary to monitor your condition. Adhere to the schedule recommended by your doctor and discuss any concerns or questions you may have.

Prior to 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 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 the potential risks 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 you are not pregnant.

If you are a female patient who 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, contact the doctor right away.

• Live or live-attenuated vaccines (due to immunosuppression)
• St. John's Wort (strong CYP3A4/UGT1A1 inducer, significantly reduces SN-38 exposure)

• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease irinotecan and SN-38 exposure, leading to reduced efficacy.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): May increase irinotecan and SN-38 exposure, leading to increased toxicity.
• UGT1A1 inhibitors (e.g., atazanavir, indinavir): May increase SN-38 exposure, leading to increased toxicity, especially in patients with UGT1A1*28 allele.
• Laxatives/Diuretics: May exacerbate diarrhea and dehydration.
• Myelosuppressive agents (e.g., other chemotherapies, radiation therapy): Increased risk of severe myelosuppression.
• Corticosteroids (e.g., dexamethasone): May increase risk of hyperglycemia and infection; also used to manage delayed diarrhea.

• Antidiarrheals (e.g., loperamide): Essential for managing delayed diarrhea, but excessive use without medical supervision can lead to paralytic ileus.
• Neuromuscular blocking agents: Irinotecan can cause cholinergic syndrome, potentially affecting neuromuscular transmission.

• Not available

• Early diarrhea (within 24 hours of infusion, often accompanied by cholinergic symptoms like abdominal cramping, diaphoresis, salivation, rhinitis, flushing)
• Delayed diarrhea (more than 24 hours after infusion, can be severe and life-threatening)
• Neutropenic fever (fever with low ANC)
• Nausea and vomiting
• Fatigue
• Abdominal pain
• Alopecia
• Mucositis/Stomatitis
• Signs of infection (sore throat, chills, cough)

Category D. Irinotecan can cause fetal harm when administered to a pregnant woman. Based on animal studies and its mechanism of action, it is expected to cause serious adverse developmental effects. Avoid use during pregnancy. Women of childbearing potential should be advised to use effective contraception during treatment and for 6 months after the last dose. Men should use effective contraception during treatment and for 3 months after the last dose.

L5 (Contraindicated). It is not known whether irinotecan or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with irinotecan and for at least one month after the last dose.

Safety and effectiveness have not been established in pediatric patients. While not FDA-approved for pediatric use, irinotecan is used off-label in various pediatric oncology protocols for solid tumors (e.g., neuroblastoma, rhabdomyosarcoma, Ewing sarcoma). Dosing is highly variable and often adjusted based on toxicity and specific protocol. Pediatric patients may have different pharmacokinetic profiles and potentially different toxicity profiles.

Patients ≥ 65 years of age may be at increased risk for severe neutropenia and severe diarrhea compared to younger patients. Close monitoring and careful dose adjustments are recommended. Consider starting at a lower dose and titrating based on tolerance.

• Irinotecan is notorious for causing two distinct types of diarrhea: early (acute) and delayed. Early diarrhea is cholinergic and typically occurs within 24 hours, often managed with atropine. Delayed diarrhea is more common, severe, and potentially life-threatening, requiring aggressive loperamide management.
• UGT1A1 genotyping can help identify patients at higher risk for severe neutropenia and diarrhea (especially those homozygous for the UGT1A1*28 allele), allowing for proactive dose adjustments.
• Aggressive management of delayed diarrhea is crucial. Patients should be instructed to start loperamide at the first sign of loose stools (e.g., 4 mg initially, then 2 mg every 2 hours until diarrhea-free for 12 hours, not exceeding 16 mg/day).
• Neutropenic fever is a medical emergency. Patients should be educated to seek immediate medical attention if they develop a fever (≥100.4°F or 38°C) while on irinotecan.
• Hydration is key to managing gastrointestinal toxicities and preventing dehydration.
• Irinotecan is often used in combination regimens (e.g., FOLFIRI for colorectal cancer) where its dose is typically lower than monotherapy.

• Fluoropyrimidines (e.g., 5-fluorouracil, capecitabine)
• Oxaliplatin (another platinum-based chemotherapy)
• Targeted therapies (e.g., bevacizumab, cetuximab, panitumumab, regorafenib, encorafenib/binimetinib for specific mutations)
• Immunotherapy (e.g., pembrolizumab for MSI-H/dMMR colorectal cancer)
• Other topoisomerase inhibitors (e.g., topotecan, etoposide - though different topoisomerase targets)

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, 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. 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 offer drug take-back programs, which can be an alternative disposal option.

Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate 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 critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.