Gemcetin
Generic Name
Gemcitabine (as Hydrochloride)
Manufacturer
Reputable Pharmaceutical Company (e.g., Local Pharma Co.)
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| gemcetin 1 gm injection | ৳ 5,000.00 | N/A |
Description
Overview of the medicine
Gemcitabine is an antineoplastic agent used in the treatment of various cancers, including pancreatic, non-small cell lung, breast, ovarian, and bladder cancers. It interferes with DNA synthesis, leading to cell death.
Uses & Indications
Dosage
Adults
Dosage varies by indication and treatment regimen, typically 1000-1250 mg/m² infused intravenously over 30 minutes, once weekly for several weeks, followed by a rest period. Refer to specific protocol guidelines.
Elderly
No specific dose adjustments for elderly patients, but renal function should be considered. Monitor closely for myelosuppression and other toxicities.
Renal_impairment
Use with caution; dose reduction may be necessary in patients with severe renal impairment (creatinine clearance <30 mL/min). Official recommendations for dose reduction are not available, careful monitoring is advised.
How to Take
For intravenous use only. Administer as an intravenous infusion over 30 minutes. Do not administer as an IV bolus or intramuscularly.
Mechanism of Action
Gemcitabine is a pyrimidine antimetabolite. It is intracellularly phosphorylated to active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. dFdCTP competes with deoxycytidine triphosphate for incorporation into DNA, inhibiting DNA synthesis and repair. dFdCDP inhibits ribonucleotide reductase, an enzyme responsible for DNA synthesis, thereby reducing the intracellular concentration of deoxycytidine triphosphate.
Pharmacokinetics
Onset
Rapid onset of action due to intravenous administration.
Excretion
The primary inactive metabolite (dFdU) is excreted predominantly in the urine, accounting for 92-98% of the dose. Less than 10% of the dose is excreted as unchanged gemcitabine.
Half life
Plasma half-life of gemcitabine is short, typically 32-94 minutes, depending on dose and infusion duration.
Absorption
Administered intravenously, resulting in complete systemic absorption.
Metabolism
Rapidly and extensively metabolized intracellularly by cytidine deaminase to an inactive uracil metabolite (2'-deoxy-2',2'-difluorouridine, dFdU) and also phosphorylated to active diphosphate and triphosphate nucleosides.
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any excipient
- Severe bone marrow depression (unless disease-related)
Drug Interactions
Live Vaccines
Avoid concomitant administration of live vaccines due to immunosuppressive effects of gemcitabine.
Radiation Therapy
Concurrent or sequential gemcitabine and radiation therapy may result in increased toxicity.
Other Myelosuppressive Agents
Increased risk of bone marrow depression when used with other drugs that cause myelosuppression.
Storage
Store intact vials at controlled room temperature (20-25°C). Do not refrigerate reconstituted solution as crystallization may occur.
Overdose
There is no known antidote for gemcitabine overdose. Management involves symptomatic and supportive care, including monitoring blood counts and providing necessary transfusions or growth factors.
Pregnancy & Lactation
Pregnancy Category D. Gemcitabine can cause fetal harm when administered to a pregnant woman. Avoid use during pregnancy. It is unknown whether gemcitabine is excreted in human milk; due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any excipient
- Severe bone marrow depression (unless disease-related)
Drug Interactions
Live Vaccines
Avoid concomitant administration of live vaccines due to immunosuppressive effects of gemcitabine.
Radiation Therapy
Concurrent or sequential gemcitabine and radiation therapy may result in increased toxicity.
Other Myelosuppressive Agents
Increased risk of bone marrow depression when used with other drugs that cause myelosuppression.
Storage
Store intact vials at controlled room temperature (20-25°C). Do not refrigerate reconstituted solution as crystallization may occur.
Overdose
There is no known antidote for gemcitabine overdose. Management involves symptomatic and supportive care, including monitoring blood counts and providing necessary transfusions or growth factors.
Pregnancy & Lactation
Pregnancy Category D. Gemcitabine can cause fetal harm when administered to a pregnant woman. Avoid use during pregnancy. It is unknown whether gemcitabine is excreted in human milk; due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years, as indicated on the package. Reconstituted solution is stable for specific periods under recommended storage conditions.
Availability
Hospital Pharmacies, Specialized Oncology Centers
Approval Status
Approved (for various indications)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Gemcitabine has been extensively studied in numerous clinical trials for its efficacy and safety across various cancer types, both as a monotherapy and in combination with other agents.
Lab Monitoring
- Complete Blood Count (CBC) with differential prior to each dose
- Liver function tests (ALT, AST, bilirubin) periodically
- Renal function tests (creatinine, BUN) periodically
Doctor Notes
- Emphasize vigilant monitoring of complete blood counts, renal, and hepatic function before and during treatment.
- Educate patients on potential severe toxicities, including myelosuppression and pulmonary events, and when to seek immediate medical attention.
- Consider dose modifications based on patient's tolerance and severity of adverse reactions.
Patient Guidelines
- Report any unusual bleeding, bruising, fever, or signs of infection immediately.
- Avoid contact with people who have infections.
- Use effective contraception during treatment and for a period after.
- Stay hydrated and follow all doctor's appointments.
Missed Dose Advice
If a dose is missed, contact your doctor or healthcare provider immediately to reschedule your dose. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause fatigue, dizziness, or somnolence. Patients should be cautioned against driving or operating machinery if they experience these effects.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Eat a balanced diet as tolerated.
- Avoid strenuous activities if feeling fatigued or weak.
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