💊 DESCRIPTION
Gemcitabine is a cytotoxic antineoplastic agent used in chemotherapy. It is supplied as a lyophilized (freeze-dried) sterile powder in a vial, which is reconstituted and administered via intravenous (IV) infusion.
- Form: Powder for injection
- Strength: 1000 mg per vial
- Indications: Used in the treatment of:
- Non-small cell lung cancer (NSCLC)
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Sometimes off-label in other malignancies
✅ ADVANTAGES
- Effective in multiple solid tumors
- Can be used alone or in combination with other chemotherapy agents
- Well-tolerated relative to some traditional chemotherapies
- Often allows for outpatient administration
- Short infusion time (30 minutes typical)
🌿 NATURE
- Pharmacologic Class: Antimetabolite
- Chemical Nature: Pyrimidine nucleoside analog (related to deoxycytidine)
- Mechanism of Action:
- Gemcitabine is converted intracellularly into active diphosphate and triphosphate forms.
- These metabolites inhibit ribonucleotide reductase and are incorporated into DNA, leading to DNA synthesis inhibition and cell death in rapidly dividing cells.
- S-phase specific cytotoxicity.
⚠️ PRECAUTIONS
- Myelosuppression: Monitor complete blood counts frequently (may cause neutropenia, thrombocytopenia, anemia).
- Hepatic/Renal dysfunction: Use cautiously; monitor LFTs and renal function.
- Pulmonary toxicity: Watch for dyspnea, cough, or signs of interstitial lung disease.
- Hypersensitivity: Watch for signs of allergic reactions during infusion.
- Pregnancy & Lactation: Contraindicated—teratogenic and embryotoxic.
- Vaccination: Avoid live vaccines during and shortly after treatment.
- Elderly patients: Monitor more closely due to increased risk of toxicity.
🧊 STORAGE
- Before reconstitution:
- Store below 25°C
- Keep vial dry and protected from light
- After reconstitution:
- Solution should be used immediately or stored for up to 24 hours at 2–8°C
- Do not freeze
- Discard unused portion safely (cytotoxic waste procedures)
👨⚕️ PATIENT ADVICE
- Avoid infections: Stay away from crowds or people who are ill.
- Report immediately any fever, chills, cough, easy bruising/bleeding, or fatigue.
- Stay hydrated: Maintain adequate fluid intake.
- Use contraception: Both men and women should use effective birth control during and for a few months after therapy.
- Frequent monitoring: Expect routine blood tests and clinical evaluations.
- Side effects to expect: Fatigue, low blood counts, nausea, mild hair loss, rash—report any persistent or severe symptoms.
📦 PACKAGING
- Primary Packaging:
- Type I clear glass vial
- Stoppered with rubber closure and sealed with an aluminum cap
- Label: Includes strength (1000 mg), batch number, manufacturing/expiry dates, and storage instructions
- Secondary Packaging:
- Usually packed in a unit box with product leaflet (insert)
- Reconstitution requirement: Sterile water for injection or normal saline before IV use