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Citafine (200mg / 1g) - Gemcitabine Injection

Citafine (200mg / 1g) - Gemcitabine Injection

Citafine is an injectable chemotherapy formulation containing Gemcitabine, a nucleoside analog used in the treatment of various solid tumors. It inhibits DNA synthesis, leading to the death of rapidly dividing cancer cells.

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Description Product Details
General Information:
Generic Name: Gemcitabine Hydrochloride
Brand Name: Citafine
Strengths Available: 200 mg and 1 g per vial
Packing: Single-use vials containing lyophilized powder
Manufacturer: Varies (Please confirm based on regional availability)
Form: Lyophilized powder for reconstitution and intravenous injection
Category: Antimetabolite, Pyrimidine analog, Antineoplastic agent
Product Introduction:
Citafine is a cytotoxic antimetabolite chemotherapy agent manufactured for the treatment of multiple types of cancer, including lung, pancreatic, breast, and bladder cancers. It is provided in sterile, lyophilized form for intravenous use and is considered a key agent in modern oncology regimens due to its broad-spectrum activity and tolerable toxicity profile.
Uses (Indications):
Citafine (Gemcitabine) is approved or used off-label for the treatment of the following malignancies:
  1. Non-Small Cell Lung Cancer (NSCLC) – as monotherapy or in combination with platinum agents
  2. Pancreatic Cancer – first-line therapy in locally advanced or metastatic disease
  3. Breast Cancer – particularly in metastatic cases, combined with paclitaxel
  4. Bladder Cancer – advanced or metastatic urothelial carcinoma
  5. Ovarian Cancer – recurrent or platinum-resistant disease
  6. Soft Tissue Sarcoma – in combination regimens
  7. Biliary Tract Cancers – including cholangiocarcinoma and gallbladder cancer
Storage Instructions:
  1. Store at 2°C to 8°C (refrigerated) before reconstitution
  2. Protect from light and moisture
  3. Once reconstituted, the solution should be used immediately or within 24 hours if stored at 2–8°C
  4. Do not freeze the reconstituted solution
  5. Keep away from children and pets
How It Works (Mechanism of Action):
Gemcitabine is a nucleoside analog of deoxycytidine. Its mechanism of action includes:
  1. After intravenous administration, it enters cells and undergoes intracellular phosphorylation to form active diphosphate and triphosphate metabolites.
  2. The diphosphate metabolite inhibits ribonucleotide reductase, reducing the pool of deoxynucleotides necessary for DNA synthesis.
  3. The triphosphate metabolite is incorporated into DNA, leading to premature chain termination.
  4. This dual mechanism results in inhibition of DNA synthesis, cell cycle arrest (S-phase), and ultimately apoptosis of cancer cells.
Side Effects:
Common Side Effects:
  1. Nausea and vomiting
  2. Flu-like symptoms (fever, fatigue, myalgia)
  3. Mild hair loss (alopecia)
  4. Anemia and mild neutropenia
  5. Rash and itching
  6. Elevated liver enzymes
Serious Side Effects:
  1. Severe bone marrow suppression – neutropenia, thrombocytopenia, anemia
  2. Hepatotoxicity – elevated bilirubin, hepatic failure (rare)
  3. Pulmonary toxicity – pneumonitis, interstitial lung disease
  4. Hemolytic uremic syndrome (HUS) – rare but life-threatening
  5. Capillary leak syndrome and systemic inflammatory response
  6. Renal dysfunction
Dosage (Typical Recommended Dose):
  1. NSCLC: 1000–1250 mg/m² IV over 30 minutes on days 1, 8, and 15 of a 28-day cycle
  2. Pancreatic Cancer: 1000 mg/m² IV weekly for 7 weeks, followed by 1-week rest, then weekly for 3 weeks every 4 weeks
  3. Breast Cancer: 1250 mg/m² on days 1 and 8 every 21 days (with paclitaxel)
  4. Bladder Cancer: 1000 mg/m² on days 1, 8, and 15 of each 28-day cycle
  5. Dose modifications are made based on hematologic parameters and patient tolerance
Method of Administration:
  1. Intravenous infusion only, not for intramuscular or subcutaneous use
  2. Reconstitute powder with sterile water for injection
  3. Further dilute in 0.9% normal saline before administering
  4. Infuse over 30 minutes; longer durations increase toxicity
  5. Administer under supervision of experienced oncology personnel
  6. Monitor vital signs and CBC before each dose
Precautions:
  1. Monitor blood counts before each dose – delay treatment if neutrophils <1000 or platelets <100,000
  2. Use with caution in patients with hepatic or renal impairment
  3. Avoid in pregnancy and breastfeeding – teratogenic
  4. Ensure adequate hydration to protect renal function
  5. Pulmonary symptoms must be evaluated promptly – discontinue if interstitial pneumonitis is suspected
  6. Avoid live vaccines during treatment
Drug Interactions:
  1. Platinum agents (cisplatin/carboplatin): may enhance myelosuppression
  2. Radiation therapy: concurrent use increases risk of tissue toxicity (radiation recall)
  3. Anticoagulants (e.g., warfarin): increased risk of bleeding – monitor INR
  4. Live vaccines: contraindicated during therapy due to immunosuppression
  5. Other nephrotoxic drugs: increase risk of renal toxicity
Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity to Gemcitabine or any component of the formulation
  2. Symptoms may include rash, itching, fever, shortness of breath, or anaphylaxis
  3. Discontinue immediately if severe allergic reaction occurs
  4. Pre-medication is generally not required unless prior reactions have occurred
Overdose Information:
  1. Symptoms of overdose may include severe myelosuppression, mucositis, vomiting, liver toxicity, and renal failure
  2. There is no specific antidote – treatment is supportive
  3. Hospitalization and intensive monitoring may be required
  4. Ensure hematologic and biochemical support with frequent monitoring
Missed Dose Instructions:
  1. Since it is administered in a clinical setting, missed doses are rare
  2. If a dose is missed due to low counts or adverse events, it may be rescheduled at the physician’s discretion
  3. Continue with treatment only after hematologic recovery
Additional Notes:
  1. Citafine offers a cost-effective generic alternative for Gemcitabine treatment in low-resource settings
  2. Considered one of the most important cytotoxic agents in treating pancreatic and lung cancer
  3. Patients should be informed about the potential for side effects and required lab monitoring
  4. Therapy may need to be combined with other agents for optimal effect
  5. Repeated cycles are often required – response assessment via imaging is necessary
  6. Encourage hydration and rest, and provide antiemetics if needed
  7. Always verify the reconstitution protocol and infusion guidelines in your institution’s clinical practice

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