Product Intro:
Gempower is a prescription-only injectable chemotherapy drug. It is a lyophilized powder that must be reconstituted and administered intravenously by healthcare professionals. It is part of the antimetabolite class, which works by mimicking natural substances in the body to disrupt cancer cell growth.
Uses (Indications):
Gempower (Gemcitabine) is used to treat the following cancers:
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Non-Small Cell Lung Cancer (NSCLC): Alone or with cisplatin
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Pancreatic Cancer: First-line treatment for advanced or metastatic disease
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Breast Cancer: In combination with paclitaxel in anthracycline-pretreated metastatic cases
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Ovarian Cancer: Used with carboplatin for relapsed epithelial ovarian carcinoma
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Bladder Cancer: For advanced urothelial carcinoma with cisplatin
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Off-label Uses: Biliary tract cancers, cervical cancer, esophageal cancer (as per oncologist discretion)
Storage Instructions:
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Store unreconstituted vials at 20–25°C (68–77°F).
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Protect from light and moisture.
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Once reconstituted, the solution is stable for 24 hours when stored in a refrigerator at 2–8°C.
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Do not freeze reconstituted solution.
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Discard any unused solution after 24 hours or if discoloration/cloudiness occurs.
How It Works (Mechanism of Action):
Gemcitabine is a pyrimidine analog that mimics cytidine. Once inside cells, it is phosphorylated to its active diphosphate and triphosphate forms:
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Gemcitabine diphosphate inhibits ribonucleotide reductase, reducing the pool of nucleotides needed for DNA replication.
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Gemcitabine triphosphate incorporates into DNA, causing chain termination during DNA synthesis.
This dual mechanism leads to cell cycle arrest in the S-phase and apoptosis (programmed cell death) of rapidly dividing cancer cells.
Side Effects:
Common Side Effects:
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Myelosuppression (anemia, neutropenia, thrombocytopenia)
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Fatigue and weakness
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Fever and flu-like symptoms
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Nausea, vomiting, diarrhea
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Mild hair loss
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Skin rash or itching
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Elevated liver enzymes (AST, ALT)
Serious or Rare Side Effects:
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Pulmonary toxicity (interstitial pneumonitis, respiratory distress)
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Hemolytic-uremic syndrome (HUS)
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Thrombotic thrombocytopenic purpura (TTP)
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Hepatic or renal failure (especially with prolonged use)
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Capillary leak syndrome (rare but serious)
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Anaphylactic reactions or severe hypersensitivity
Dosage (Typical Recommended Dose):
Dosage depends on cancer type, body surface area (BSA), and treatment goals.
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Pancreatic Cancer: 1000 mg/m² once weekly for 7 weeks, then one week off; afterward, weekly for 3 of every 4 weeks
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NSCLC: 1000–1250 mg/m² on Days 1, 8, and 15 of a 28-day cycle
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Breast Cancer: 1250 mg/m² on Days 1 and 8 with paclitaxel
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Ovarian Cancer: 1000 mg/m² on Days 1 and 8 in a 21-day cycle with carboplatin
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Bladder Cancer: 1000 mg/m² on Days 1, 8, and 15 with cisplatin every 28 days
Dose adjustments may be needed based on blood counts, liver function, and kidney status.
Method of Administration:
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IV infusion only – must not be given by bolus or intramuscular route
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Reconstitute with 0.9% sodium chloride solution, using sterile technique
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Infuse over 30 minutes to minimize side effects
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Administer only under supervision of trained oncology staff
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Use closed system transfer devices (CSTDs) or proper biosafety precautions due to cytotoxicity
Precautions:
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Regular CBC monitoring is essential to detect myelosuppression
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Monitor hepatic and renal function before and during therapy
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Use contraception during and for 6 months after therapy (both men and women)
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Avoid live vaccines during treatment
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Not recommended in pregnancy or lactation
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Caution in patients with lung disease or recent radiation therapy
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Stop treatment if signs of organ toxicity or serious hypersensitivity occur
Drug Interactions:
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Cisplatin: Additive myelosuppression—use with caution and monitor CBC
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Paclitaxel: Risk of enhanced toxicity; adjust sequence of administration
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Live vaccines: Increased risk of infection—avoid during therapy
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Other nephrotoxic drugs (e.g., aminoglycosides): Risk of cumulative renal toxicity
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Fluorouracil (5-FU): Possible synergistic effect, but higher toxicity
Allergies (Warnings for Allergic Reactions):
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Contraindicated in patients with known hypersensitivity to Gemcitabine or excipients
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Allergic reactions may include rash, hives, swelling, difficulty breathing, hypotension
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Discontinue immediately in cases of anaphylaxis and administer appropriate treatment (e.g., epinephrine, corticosteroids)
Overdose Information:
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No antidote exists for Gemcitabine overdose
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Signs include severe myelosuppression, organ dysfunction (liver/kidney), mucositis, severe nausea or vomiting
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Provide symptomatic support: IV hydration, transfusions, antimicrobial therapy as needed
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Hospitalization and continuous monitoring required
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Early recognition and intervention improve outcome
Missed Dose Instructions:
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Contact your oncologist if a dose is missed
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Do not attempt self-administration or adjust schedule yourself
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The next dose may be rescheduled based on your lab values and condition
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Skipping doses may reduce efficacy; always follow up with your cancer care team
Additional Notes:
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Gempower is a cytotoxic drug and must be handled with extreme care
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Wear gloves and protective clothing if handling vials at home (e.g., caregiver situations)
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Infusion centers must follow strict protocols for disposal and administration
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Patients should report any new respiratory symptoms or unexplained bleeding/bruising
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Gempower may impair fertility—discuss sperm or egg preservation options before starting treatment
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Psychological support and nutritional guidance may be helpful during long-term use
