Gemcitabine-Phares
Generic Name
Gemcitabine
Manufacturer
Phares Pharmaceuticals
Country
Unknown (Often produced locally or globally)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| gemcitabine phares 200 mg injection | ৳ 2,110.00 | N/A |
Description
Overview of the medicine
Gemcitabine is a nucleoside analog antimetabolite used in the treatment of various cancers, including pancreatic, non-small cell lung, breast, ovarian, and bladder cancers. It interferes with DNA synthesis and repair, leading to cell death.
Uses & Indications
Dosage
Adults
Varies significantly based on cancer type and regimen. Typical doses range from 1000 mg/m² to 1250 mg/m² administered by intravenous infusion over 30 minutes, usually weekly for several weeks followed by a rest period. E.g., for pancreatic cancer: 1000 mg/m² weekly for 7 weeks, followed by 1 week rest. Subsequent cycles: 1000 mg/m² weekly for 3 weeks, followed by 1 week rest.
Elderly
No specific dose adjustment is generally required based solely on age, but close monitoring of organ function and hematologic parameters is advised, as older patients may have reduced renal or hepatic function.
Renal_impairment
Use with caution. There are no specific dose reduction guidelines for patients with renal impairment, but monitoring of renal function and dose reduction based on toxicity are recommended. Gemcitabine is generally not recommended for patients with baseline creatinine clearance <30 mL/min.
How to Take
Gemcitabine is administered by intravenous infusion. The recommended infusion time is 30 minutes. Prolonging the infusion time or increasing the frequency of administration may lead to increased toxicity.
Mechanism of Action
Gemcitabine is metabolized intracellularly to active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. dFdCDP inhibits ribonucleotide reductase, reducing the concentration of deoxynucleotides required for DNA synthesis. dFdCTP is incorporated into DNA, leading to chain termination and inhibition of DNA repair, ultimately causing apoptosis.
Pharmacokinetics
Onset
Rapid, typically within minutes of infusion.
Excretion
Primarily renal excretion (92-98% as the inactive metabolite dFdU; less than 10% as unchanged drug). A small amount is excreted in feces.
Half life
Plasma half-life of gemcitabine is approximately 32 to 94 minutes, depending on infusion time and patient's age and sex. The active metabolite dFdCTP has a longer intracellular half-life.
Absorption
Administered intravenously, gemcitabine demonstrates linear pharmacokinetics over a broad dose range. Peak plasma concentrations are reached shortly after the end of infusion.
Metabolism
Intracellularly metabolized by nucleoside kinases to active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Rapidly deaminated by cytidine deaminase to inactive difluorodeoxyuridine (dFdU).
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any excipients in the formulation.
- Pregnancy and lactation.
Drug Interactions
CYP2C8 Substrates
Gemcitabine's primary metabolite (dFdU) may have mild inhibitory effects on CYP2C8, though clinical significance is generally considered low.
Radiation Therapy
Concurrent or sequential radiation therapy with gemcitabine can enhance or prolong radiation toxicity, particularly affecting the esophagus, lungs, and skin. Careful consideration and dose adjustment are necessary.
Live Attenuated Vaccines
Increased risk of severe infection; avoid live vaccines during gemcitabine treatment.
Other Myelosuppressive Agents
Concurrent use with other myelosuppressive agents may exacerbate bone marrow suppression. Close monitoring of hematologic parameters is crucial.
Storage
Store unopened vials at controlled room temperature (20°C to 25°C). Protect from light. Do not freeze. Reconstituted solution should be used within 24 hours if stored at room temperature or within 7 days if refrigerated (2°C to 8°C).
Overdose
There is no known antidote for gemcitabine overdose. Management consists of supportive care and careful monitoring of blood counts and organ function. Dose-limiting toxicities observed with overdose are severe myelosuppression, paresthesia, and rash.
Pregnancy & Lactation
Gemcitabine can cause fetal harm when administered to a pregnant woman; it is contraindicated during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for at least 6 months after treatment. 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 treatment.
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any excipients in the formulation.
- Pregnancy and lactation.
Drug Interactions
CYP2C8 Substrates
Gemcitabine's primary metabolite (dFdU) may have mild inhibitory effects on CYP2C8, though clinical significance is generally considered low.
Radiation Therapy
Concurrent or sequential radiation therapy with gemcitabine can enhance or prolong radiation toxicity, particularly affecting the esophagus, lungs, and skin. Careful consideration and dose adjustment are necessary.
Live Attenuated Vaccines
Increased risk of severe infection; avoid live vaccines during gemcitabine treatment.
Other Myelosuppressive Agents
Concurrent use with other myelosuppressive agents may exacerbate bone marrow suppression. Close monitoring of hematologic parameters is crucial.
Storage
Store unopened vials at controlled room temperature (20°C to 25°C). Protect from light. Do not freeze. Reconstituted solution should be used within 24 hours if stored at room temperature or within 7 days if refrigerated (2°C to 8°C).
Overdose
There is no known antidote for gemcitabine overdose. Management consists of supportive care and careful monitoring of blood counts and organ function. Dose-limiting toxicities observed with overdose are severe myelosuppression, paresthesia, and rash.
Pregnancy & Lactation
Gemcitabine can cause fetal harm when administered to a pregnant woman; it is contraindicated during pregnancy. Women of childbearing potential should be advised to use effective contraception during and for at least 6 months after treatment. 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 treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Varies by manufacturer; typically 2-3 years for unopened vials when stored as recommended. Reconstituted solution generally stable for 24 hours at room temperature or up to 7 days refrigerated.
Availability
Hospitals, Specialized Pharmacies
Approval Status
Approved
Patent Status
Expired for generic
WHO Essential Medicine
YesClinical Trials
Gemcitabine has undergone extensive clinical trials across various cancer types, establishing its efficacy and safety profile both as monotherapy and in combination with other chemotherapeutic agents. Ongoing research continues to explore new indications, optimal dosing regimens, and its role in immunotherapy combinations.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each dose and periodically throughout treatment to monitor for myelosuppression.
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) before initiation and periodically.
- Renal function tests (serum creatinine, BUN) before initiation and periodically.
- Monitor for signs and symptoms of pulmonary and cardiac toxicity.
Doctor Notes
- Strict monitoring of complete blood counts (CBC) is paramount before each dose and during treatment to manage myelosuppression effectively. Dose modifications are frequently required.
- Be vigilant for signs of pulmonary toxicity, including dyspnea, and hepatic/renal impairment.
- Consider prophylactic antiemetics to manage nausea and vomiting effectively.
- Patients should be informed about potential flu-like symptoms and advised on symptom management.
Patient Guidelines
- Report any signs of infection (fever, chills, sore throat) or bleeding (unusual bruising, prolonged bleeding) to your doctor immediately.
- Avoid close contact with people who are sick or have infections, especially during periods of low blood counts.
- Do not receive any immunizations (vaccines) without your doctor's approval, especially live attenuated vaccines.
- Inform your healthcare provider about all other medications, supplements, and herbal products you are taking.
- Stay well-hydrated throughout your treatment.
Missed Dose Advice
As Gemcitabine is administered in a clinical setting by a healthcare professional, contact your doctor or treatment center immediately if you miss or are scheduled to miss an appointment.
Driving Precautions
Gemcitabine may cause drowsiness, dizziness, or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Practice good hand hygiene to minimize infection risk.
- Avoid activities that may cause injury or bleeding due to increased risk of bruising and bleeding.
- Discuss any changes in diet or exercise with your healthcare team.
- Use sun protection as skin may become more sensitive to sunlight.
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