Gemzar
Generic Name
Gemcitabine Hydrochloride
Manufacturer
Eli Lilly and Company
Country
USA (Original Manufacturer)
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
gemzar 1 gm injection | ৳ 10,916.00 | N/A |
Description
Overview of the medicine
Gemcitabine is a synthetic nucleoside analogue that exhibits antineoplastic activity. It is used in the treatment of various cancers, either alone or in combination with other chemotherapeutic agents.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on the type of cancer, patient's condition, and whether it's used as monotherapy or in combination. Typically, 1000-1250 mg/m² administered intravenously over 30 minutes, usually weekly for several weeks followed by a rest week. Consult specific treatment protocols.
Elderly
No specific dose reduction is generally recommended for elderly patients; however, treatment decisions should be individualized based on tolerance and renal function. Close monitoring for toxicity is advised.
Renal_impairment
Use with caution in patients with renal impairment. No specific dose adjustment guidelines are established, but monitoring of renal function and dose reduction if necessary, is crucial. Avoid in severe renal impairment (CrCl < 30 mL/min).
How to Take
Gemzar 1 gm Injection should be administered via intravenous infusion over 30 minutes. It must be reconstituted and diluted prior to use. Refer to specific instructions for reconstitution and dilution to ensure proper concentration and avoid precipitation.
Mechanism of Action
Gemcitabine is an antimetabolite that inhibits DNA synthesis. It is intracellularly phosphorylated to active diphosphate and triphosphate nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, leading to a reduction in deoxynucleotide pools required for DNA synthesis. Gemcitabine triphosphate is incorporated into DNA, causing chain termination and inhibiting DNA polymerase, ultimately leading to apoptosis.
Pharmacokinetics
Onset
Rapid (within minutes of infusion) for cellular uptake and metabolism.
Excretion
Primarily renal excretion (92-98% of the dose) within one week, predominantly as the inactive metabolite dFdU.
Half life
Plasma elimination half-life is dependent on the duration of infusion, patient age, and sex, typically ranging from 32 to 90 minutes.
Absorption
Administered intravenously, resulting in 100% bioavailability.
Metabolism
Rapidly and extensively metabolized intracellularly by cytidine deaminase to inactive 2'-deoxy-2',2'-difluorouridine (dFdU) and to active diphosphate and triphosphate nucleosides.
Side Effects
Contraindications
- Known hypersensitivity to gemcitabine or any excipients in the formulation.
- Severe myelosuppression prior to the start of a treatment cycle (unless deemed necessary by the physician and managed with aggressive supportive care).
Drug Interactions
Live Vaccines
Due to its immunosuppressive effects, administration of live vaccines to patients receiving gemcitabine may result in serious or fatal infections. Avoid live vaccines.
Radiation Therapy
Concurrent or sequential administration with radiation therapy may cause increased toxicity, including severe mucositis, especially with thoracic radiation. A modified gemcitabine schedule or dose reduction may be necessary.
Other Myelosuppressive Agents
Increased myelosuppression when used concurrently with other myelosuppressive chemotherapy agents. Dose adjustments and vigilant monitoring of blood counts are crucial.
Storage
Store intact vials at controlled room temperature (20°C to 25°C) and protect from light. After reconstitution, the solution is stable for 24 hours at controlled room temperature (20°C to 25°C). Diluted solutions may be stable for longer periods under refrigeration; consult package insert.
Overdose
There is no known antidote for gemcitabine overdose. Management should involve supportive care, including close monitoring of blood counts and aggressive supportive measures, such as blood transfusions, if severe myelosuppression occurs. Patients should be closely monitored for signs of toxicity.
Pregnancy & Lactation
Pregnancy Category D: Gemcitabine can cause fetal harm when administered to a pregnant woman. It is contraindicated during pregnancy. Lactation: It is unknown whether gemcitabine or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during Gemzar therapy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Refer to the manufacturer's label for specific shelf life. Reconstituted and diluted solutions have specific stability periods.
Availability
Hospitals, specialized pharmacies
Approval Status
FDA approved
Patent Status
Patent expired; generic versions available
WHO Essential Medicine
YesClinical Trials
Gemcitabine has been extensively studied in numerous clinical trials for its efficacy and safety in various cancer types, leading to its approval for multiple indications. Ongoing research continues to explore its use in new combinations and tumor types.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each dose to monitor for myelosuppression.
- Renal function tests (serum creatinine, BUN) and hepatic function tests (ALT, AST, alkaline phosphatase, bilirubin) periodically during treatment.
- Urinalysis to monitor for proteinuria/hematuria.
Doctor Notes
- Crucial to monitor CBC, renal, and hepatic function before each dose and throughout treatment.
- Dose modifications are often necessary based on hematologic toxicity and patient tolerance.
- Educate patients thoroughly about potential side effects, particularly myelosuppression and infection risk, and when to seek immediate medical attention.
- Consider prophylactic antiemetics and supportive care to manage common side effects.
Patient Guidelines
- Follow your doctor's instructions strictly regarding dose, schedule, and duration of treatment.
- Report any unusual bleeding, bruising, fever, chills, or signs of infection immediately.
- Maintain good hygiene to reduce the risk of infection.
- Stay well-hydrated during treatment by drinking plenty of fluids.
Missed Dose Advice
If a dose of Gemzar is missed, contact your healthcare provider immediately for advice. Do not double the dose to catch up.
Driving Precautions
Gemzar may cause fatigue, dizziness, or somnolence. Patients should be advised to exercise caution when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Avoid crowded places and contact with people who are sick, as your immune system may be weakened.
- Use soft toothbrushes and avoid vigorous flossing to prevent gum bleeding.
- Discuss any complementary or alternative medicines with your doctor before use.
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