Gemcitabine Phares
Generic Name
Gemcitabine
Manufacturer
Phares Pharmaceutical
Country
Jordan
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| gemcitabine phares 1 gm injection | ৳ 7,025.00 | N/A |
Description
Overview of the medicine
Gemcitabine is a pyrimidine antimetabolite indicated for various types of cancer, including pancreatic cancer, non-small cell lung cancer, breast cancer, ovarian cancer, and bladder cancer.
Uses & Indications
Dosage
Adults
Dosage varies depending on the type of cancer and the treatment regimen (e.g., 1000 mg/m² to 1250 mg/m² intravenously over 30 minutes, once weekly for 3 weeks followed by a one-week rest period). Consult specific protocols.
Elderly
No specific dose adjustment is required solely based on age; however, monitor renal and hepatic function closely and adjust dose based on toxicity.
Renal_impairment
Use with caution. Gemcitabine should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). For moderate impairment, dose reduction may be necessary.
How to Take
For intravenous infusion only. Reconstitute the powder with sterile 0.9% sodium chloride injection and dilute further for infusion. Administer over 30 minutes.
Mechanism of Action
Gemcitabine acts as a nucleoside analog that inhibits DNA synthesis by incorporating into DNA and inhibiting ribonucleotide reductase, leading to DNA strand termination and reduced DNA repair.
Pharmacokinetics
Onset
Rapid distribution and cellular uptake following intravenous administration.
Excretion
Primarily renal; 92-98% of the dose is excreted in the urine as metabolites (mainly dFdU) within one week.
Half life
Plasma half-life of 42 to 94 minutes, depending on dose and duration of infusion.
Absorption
Administered intravenously, resulting in 100% bioavailability.
Metabolism
Rapidly metabolized intracellularly by cytidine deaminase to an inactive uracil metabolite, 2'-deoxy-2',2'-difluorouridine (dFdU), and its active di- and triphosphates.
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any component of the formulation
- Pregnancy and lactation
Drug Interactions
Radiation therapy
May enhance gemcitabine's toxicity, requiring careful monitoring and dose adjustment.
Live attenuated vaccines
Concomitant use is generally contraindicated due to the risk of severe, potentially fatal infections in immunosuppressed patients.
Other myelosuppressive agents
Increased risk of hematologic toxicity when used concurrently.
Storage
Store intact vials at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light. Reconstituted solutions are stable for 24 hours at room temperature.
Overdose
There is no known antidote for gemcitabine overdose. Management consists of supportive care and symptom management. Close monitoring of blood counts is essential.
Pregnancy & Lactation
Contraindicated in pregnancy due to potential for fetal harm. Women of childbearing potential should use effective contraception during treatment. It is not known whether gemcitabine is excreted in human milk, but due to potential adverse reactions in nursing infants, breastfeeding should be discontinued during therapy.
Side Effects
Contraindications
- Hypersensitivity to gemcitabine or any component of the formulation
- Pregnancy and lactation
Drug Interactions
Radiation therapy
May enhance gemcitabine's toxicity, requiring careful monitoring and dose adjustment.
Live attenuated vaccines
Concomitant use is generally contraindicated due to the risk of severe, potentially fatal infections in immunosuppressed patients.
Other myelosuppressive agents
Increased risk of hematologic toxicity when used concurrently.
Storage
Store intact vials at controlled room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Protect from light. Reconstituted solutions are stable for 24 hours at room temperature.
Overdose
There is no known antidote for gemcitabine overdose. Management consists of supportive care and symptom management. Close monitoring of blood counts is essential.
Pregnancy & Lactation
Contraindicated in pregnancy due to potential for fetal harm. Women of childbearing potential should use effective contraception during treatment. It is not known whether gemcitabine is excreted in human milk, but due to potential adverse reactions in nursing infants, breastfeeding should be discontinued during therapy.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when stored as recommended. Refer to the product's specific expiry date on the packaging.
Availability
Hospitals, Clinics, Specialized pharmacies
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of gemcitabine in various solid tumors, often leading to improved survival rates and disease control. Ongoing research explores new combination therapies.
Lab Monitoring
- Complete blood count (CBC) with differential, before each dose and periodically
- Renal function tests (serum creatinine, BUN)
- Liver function tests (ALT, AST, bilirubin, alkaline phosphatase)
Doctor Notes
- Monitor CBC weekly; dose adjustments are crucial based on hematologic toxicity. Educate patients on infection prevention and signs/symptoms to report immediately.
- Assess renal and hepatic function before and during treatment. Ensure adequate hydration to minimize renal toxicity.
Patient Guidelines
- Report any signs of infection (fever, chills) immediately.
- Stay well-hydrated during treatment.
- Avoid contact with people who are sick or have infections.
- Report any unusual bleeding or bruising.
Missed Dose Advice
If a dose is missed, contact your healthcare provider immediately to determine the next steps and reschedule the missed dose.
Driving Precautions
Gemcitabine may cause drowsiness, dizziness, or fatigue. Patients should be advised to avoid driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Practice good hand hygiene.
- Avoid raw or undercooked foods.
- Manage fatigue by prioritizing rest.
- Discuss any concerns about fertility with your doctor.
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