Gemcitabine-Ebewe 2 g / 50 mL

Gemcitabine 40 mg/mL — Concentrate / Solution for IV Infusion
50 mL Vial

Product Description

Gemcitabine-Ebewe contains gemcitabine, a pyrimidine nucleoside analogue and antimetabolite antineoplastic agent. The product contains 2,000 mg of gemcitabine in 50 mL, equivalent to 40 mg/mL.

Gemcitabine interferes with DNA synthesis and is used either alone or, more commonly for several indications, in combination with other anticancer medicines. It is administered intravenously under the supervision of an oncology specialist.

Active Ingredient & Strength

• Active ingredient: Gemcitabine
• Strength: 2,000 mg/50 mL
• Concentration: 40 mg/mL
• Dosage form: Solution/concentrate for intravenous administration
• Route: Intravenous infusion
• Presentation: 50 mL vial

Mechanism of Action

Gemcitabine is transported into cells and converted intracellularly into active metabolites, primarily gemcitabine diphosphate (dFdCDP) and gemcitabine triphosphate (dFdCTP).

These metabolites inhibit DNA synthesis through complementary mechanisms:

• dFdCDP inhibits ribonucleotide reductase, reducing the intracellular pool of deoxyribonucleotides required for DNA synthesis.
• dFdCTP is incorporated into newly synthesized DNA, producing masked chain termination and preventing further DNA elongation.
• The resulting inhibition of DNA replication can lead to cell-cycle arrest and apoptosis of susceptible rapidly dividing cells.

Indications & Clinical Uses

Gemcitabine is used, alone or in combination with other anticancer therapies, for several malignancies. Established uses include:

Pancreatic Cancer

• Used as a single agent for advanced pancreatic cancer, including disease that cannot be surgically removed or has metastatic spread.

Non-Small Cell Lung Cancer (NSCLC)

• Used in combination regimens, particularly with cisplatin, for advanced NSCLC.

Breast Cancer

• Used with paclitaxel for metastatic breast cancer in appropriate patients, including those previously treated with anthracycline-containing chemotherapy.

Ovarian Cancer

• Used with carboplatin for advanced ovarian cancer that has relapsed after an appropriate interval following platinum-based therapy.

Gemcitabine is also incorporated into combination chemotherapy regimens for other malignancies, including bladder/urothelial cancer, cervical cancer, biliary tract cancer, and malignant mesothelioma, depending on the applicable treatment protocol and regulatory approval.

Administration & Dosing

Gemcitabine should be administered intravenously by healthcare professionals experienced in cancer chemotherapy. The dosage and treatment schedule depend on the type of cancer, treatment combination, body surface area, blood counts, organ function, and response to treatment.

Common oncology regimens administer gemcitabine on specified days within repeating treatment cycles, often as a 30-minute IV infusion. For example, gemcitabine-containing regimens may use dosing on Days 1 and 8 of a cycle, although schedules vary substantially according to the malignancy and combination therapy.

The dose must be individually prescribed by the treating oncologist and should not be calculated or administered based solely on this product description.

Important Monitoring

Before and during treatment, healthcare professionals generally monitor:

• Complete blood count (CBC), particularly neutrophils and platelets
• Liver function
• Renal function
• Signs and symptoms of infection
• Clinical response and treatment-related toxicity

Treatment may need to be delayed, reduced, or discontinued according to blood-count abnormalities or other significant toxicities.

Important Warnings & Precautions

1. Bone marrow suppression
Gemcitabine can cause myelosuppression, including neutropenia, thrombocytopenia, and anemia. Severe cytopenias can increase the risk of infection, bleeding, or symptomatic anemia.

2. Serious infections
Reduced white blood-cell counts may increase susceptibility to infections. Fever or other signs of infection during chemotherapy require prompt medical assessment.

3. Hepatic toxicity
Gemcitabine can cause liver enzyme abnormalities and, rarely, serious hepatic toxicity. Particular caution is required in patients with significant hepatic impairment or underlying liver disease.

4. Renal toxicity
Renal abnormalities may occur, and rare serious renal complications have been reported. Renal function should be monitored when clinically appropriate.

5. Pulmonary toxicity
Gemcitabine has been associated with potentially serious pulmonary adverse reactions, including interstitial pneumonitis and pulmonary edema. New or worsening dyspnea, cough, or respiratory symptoms should be evaluated promptly.

6. Capillary leak syndrome
Rare cases of capillary leak syndrome have been reported and can cause edema, hypotension, hypoalbuminemia, and potentially serious systemic complications.

7. Posterior reversible encephalopathy syndrome (PRES)
Rare cases of PRES have been reported. Symptoms such as seizures, headache, confusion, visual disturbances, or altered mental status require urgent evaluation.

8. Pregnancy and reproductive toxicity
Gemcitabine can cause fetal harm. Pregnancy should be avoided during treatment, and appropriate contraception should be discussed with the treating healthcare professional. Fertility may also be affected.

Common Adverse Effects

The adverse-effect profile depends on the specific chemotherapy regimen. Reported reactions include:

• Nausea and vomiting
• Fatigue
• Fever
• Rash
• Headache
• Flu-like symptoms
• Peripheral edema
• Diarrhea or constipation
• Elevated liver enzymes
• Neutropenia
• Thrombocytopenia
• Anemia
• Increased susceptibility to infections

Because gemcitabine is frequently used in combination chemotherapy, some adverse effects may result from the combination rather than gemcitabine alone.

Preparation & Handling

Gemcitabine is a cytotoxic antineoplastic medicine and must be prepared and administered according to institutional cytotoxic-drug handling procedures.

The product should be inspected before administration, and appropriate aseptic technique and protective measures should be used by healthcare personnel. Preparation, dilution, compatibility, storage after preparation, and administration should follow the current manufacturer-approved product information for Gemcitabine-Ebewe.

Storage

Storage requirements should follow the manufacturer's current approved product information for the specific Gemcitabine-Ebewe presentation.

Unopened vials should be stored according to the labeled temperature conditions and protected as specified by the manufacturer. Any prepared infusion solution should be used within the manufacturer's specified stability period.

Patient Information

Patients receiving gemcitabine should immediately inform their healthcare team if they develop:

• Fever or signs of infection
• Unusual bleeding or bruising
• Severe weakness or fatigue
• Difficulty breathing or new cough
• Significant swelling
• Reduced urine output
• Severe abdominal symptoms
• Neurological symptoms such as seizures, confusion, severe headache, or visual changes

Patients should also inform their oncologist about all prescription medicines, over-the-counter medicines, supplements, and previous chemotherapy or radiotherapy.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to replace the advice of a qualified oncologist, hematologist, pharmacist, or other healthcare professional. Gemcitabine is a prescription cytotoxic chemotherapy medicine that must be prescribed, prepared, and administered by appropriately trained healthcare professionals. The appropriate dose and treatment schedule depend on the type and stage of cancer, treatment regimen, blood counts, kidney and liver function, and individual patient factors. Do not use, discontinue, or modify treatment without medical supervision. Always consult the current official product information and the treating oncology team before administration.

References

• National Cancer Institute (NCI) — Gemcitabine Hydrochloride.
• NCI Drug Dictionary — Gemcitabine Hydrochloride.
• NCI — Gemcitabine/Cisplatin.
• PubChem / NIH — Gemcitabine.
• PubMed — Gemcitabine pharmacology and mechanism.