Camptosar 20mg/ml Inj, 15ml

Irinotecan is a prodrug that is converted to its active metabolite, SN-38, by carboxylesterase enzymes. SN-38 is a topoisomerase I inhibitor. It binds to and stabilizes the topoisomerase I-DNA cleavable complex, preventing the religation of DNA single-strand breaks. This leads to accumulation of DNA damage during DNA replication, ultimately triggering apoptosis (programmed cell death) in rapidly dividing cancer cells.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 with passing urine, 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 passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Bleeding: Vomiting or coughing up blood, vomit that looks like coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, bruises without a cause or that get bigger, or bleeding that cannot be stopped.
Severe Dizziness or Passing Out: Confusion, redness or irritation of the palms of hands or soles of feet.
Vein Irritation: If the medication leaks from the vein, it may cause irritation around the injection site. Inform your nurse if you experience redness, burning, pain, swelling, or leaking of fluid where the medication is being administered.
Lung Problems: Shortness of breath or other trouble breathing, cough that is new or worse, or fever. These lung problems can be severe and potentially life-threatening.
Blood Clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, change of color, or pain in a leg or arm, or trouble speaking or swallowing. Inform your doctor if you have a history of blood clots.

Other Side Effects

Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Hair loss
Feeling dizzy, sleepy, tired, or weak
Trouble sleeping
Headache
Back pain
Sweating a lot
Weight loss
Gas
Mouth irritation or mouth sores
Constipation
Upset stomach, vomiting, stomach pain, and 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 while taking this medication. If you experience any of these side effects, contact your doctor for advice on managing them.

Reporting Side Effects

If you have questions about side effects or want to report any side effects, contact your doctor or call the FDA at 1-800-332-1088. You can also report side effects 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 and its symptoms.
If you are undergoing dialysis, discuss this with your doctor.
Any medications you are 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 with this medication. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, health problems, and any other relevant information. This will help ensure your safety while taking this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to guarantee safe use.

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 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 this 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 the doctor right away.

• Live or live-attenuated vaccines (risk of severe or fatal infection)
• St. John's Wort (strong CYP3A4 inducer, significantly decreases SN-38 exposure)
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, phenobarbital) - concurrent use should be avoided or dose adjusted with extreme caution due to decreased SN-38 exposure and potential loss of efficacy.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir) - concurrent use should be avoided or dose adjusted with extreme caution due to increased SN-38 exposure and potential for increased toxicity.

• UGT1A1 inhibitors (e.g., atazanavir) - may increase SN-38 exposure and toxicity.
• Laxatives (concurrent use may exacerbate diarrhea)
• Diuretics (may exacerbate dehydration from diarrhea/vomiting)
• Neuromuscular blocking agents (irinotecan may prolong neuromuscular blockade of succinylcholine due to cholinesterase inhibition)
• Corticosteroids (may increase risk of hyperglycemia, especially with dexamethasone as antiemetic)

• Moderate CYP3A4 inducers/inhibitors (monitor closely, consider dose adjustment)
• Anticoagulants (e.g., warfarin) - monitor INR due to potential for altered coagulation parameters, especially with severe diarrhea.
• Myelosuppressive agents (additive myelosuppression)

• Not typically categorized as minor for this drug; most interactions are significant due to narrow therapeutic index.

• Diarrhea (onset, frequency, severity, associated symptoms like abdominal pain, fever)
• Fever (especially with chills, signs of infection)
• Nausea and vomiting
• Fatigue/weakness
• Abdominal pain/cramping
• Signs of dehydration (dry mouth, decreased urination, dizziness)
• Signs of cholinergic syndrome (rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, abdominal cramping, early diarrhea)

Irinotecan is classified as Pregnancy Category D. It 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. If a woman becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus.

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 a period after the last dose (e.g., 1 week).

Safety and effectiveness in pediatric patients have not been established. While investigational in some pediatric solid tumors, its use is generally limited to specific clinical trials or compassionate use protocols. Dosing and toxicity profiles may differ from adults.

Patients ≥65 years of age may be at increased risk for severe neutropenia and severe diarrhea. Careful monitoring of hematopoietic and gastrointestinal toxicities is essential. Dose adjustments may be necessary based on tolerance and comorbidities.

• Pre-medicate with antiemetics (e.g., 5-HT3 antagonist with dexamethasone) to prevent nausea and vomiting.
• For acute cholinergic syndrome (early diarrhea, sweating, abdominal cramps, etc., occurring within 24 hours of infusion), administer atropine (e.g., 0.25-1 mg IV).
• For late diarrhea (occurring >24 hours after infusion), aggressive management with loperamide is crucial. Start at the first sign of loose stools: 4 mg initially, then 2 mg every 2 hours until diarrhea-free for 12 hours. Do not exceed 16 mg/day. Hospitalization and IV fluids may be required for severe diarrhea.
• Patients with UGT1A1 *28/*28 genotype are at significantly increased risk of severe neutropenia and diarrhea. Consider a starting dose reduction (e.g., 30%) for these patients, especially in the every 3-week regimen.
• Monitor for signs of infection, especially during periods of neutropenia. Febrile neutropenia is a medical emergency requiring prompt evaluation and broad-spectrum antibiotics.
• Administer irinotecan as an IV infusion over 90 minutes to minimize the risk of acute cholinergic reactions.

• Oxaliplatin (another platinum-based chemotherapy for mCRC)
• 5-Fluorouracil (antimetabolite, backbone of many mCRC regimens)
• Capecitabine (oral fluoropyrimidine)
• Targeted therapies (e.g., Bevacizumab, Cetuximab, Panitumumab, Regorafenib, Encorafenib/Binimetinib for BRAF-mutated mCRC)
• Immunotherapy (e.g., Pembrolizumab, Nivolumab for MSI-H/dMMR mCRC)

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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, as they may be aware of drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. 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 contact 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 was taken to ensure prompt and effective treatment.