Gembine
Generic Name
Gembine 200 mg Injection
Manufacturer
PharmaCo Global
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| gembine 200 mg injection | ৳ 1,600.00 | N/A |
Description
Overview of the medicine
Gembine 200 mg Injection is an antineoplastic agent (chemotherapy drug) used in the treatment of various cancers. It works by interfering with DNA synthesis, thereby inhibiting the growth and replication of cancer cells.
Uses & Indications
Dosage
Adults
Typically 1000 mg/m² infused over 30 minutes, once weekly for up to 7 weeks, followed by a week off. Subsequent cycles: once weekly for 3 weeks, followed by a week off. Dosage adjusted based on hematologic toxicity.
Elderly
No specific dose adjustments required based solely on age, but renal and hepatic function should be monitored due to increased prevalence of age-related impairment.
Renal_impairment
Use with caution; dose reduction may be necessary in patients with severe renal impairment (creatinine clearance <30 mL/min). Close monitoring of renal function and blood counts is advised.
How to Take
Administered intravenously (IV) over 30 minutes by a qualified healthcare professional. Reconstitution and dilution should follow aseptic techniques. Do not administer by intra-arterial or intramuscular route.
Mechanism of Action
Gembine acts as an antimetabolite. It is converted intracellularly to active diphosphate and triphosphate nucleosides. Gembine diphosphate inhibits ribonucleotide reductase, an enzyme essential for DNA synthesis. Gembine triphosphate is incorporated into DNA strands, leading to chain termination and inhibition of DNA replication and repair, ultimately inducing apoptosis (programmed cell death) in cancer cells.
Pharmacokinetics
Onset
Rapid onset, therapeutic effects typically observable within days or weeks of initiating treatment, depending on the cancer type.
Excretion
Primarily excreted renally. Approximately 92-98% of the dose is recovered in urine within one week, mainly as dFdU.
Half life
Approximately 42 to 94 minutes, dose and infusion rate dependent.
Absorption
Rapidly absorbed after intravenous administration, with peak plasma concentrations achieved at the end of infusion. Distributed extensively into tissues.
Metabolism
Metabolized intracellularly by nucleoside kinases to active phosphorylated metabolites. Deaminated by cytidine deaminase to an inactive uracil metabolite (dFdU).
Side Effects
Contraindications
- Known hypersensitivity to Gembine or any other component of the formulation
- Severe myelosuppression before starting therapy
- Pregnancy and breastfeeding
Drug Interactions
Radiation Therapy
Concurrent or sequential radiation therapy may potentiate Gembine-induced toxicity, including severe mucositis and myelosuppression.
Live Attenuated Vaccines
Avoid concomitant administration due to the risk of severe or fatal infections in immunocompromised patients.
Other Myelosuppressive Agents
Increased risk of severe bone marrow depression when used with other agents that suppress bone marrow function.
Storage
Store unreconstituted vials at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. Reconstituted solution should be used immediately or stored for up to 24 hours at room temperature.
Overdose
There is no known antidote for Gembine overdose. Management should involve careful monitoring of blood counts and appropriate supportive care for any resulting toxicities, such as severe myelosuppression.
Pregnancy & Lactation
Pregnancy Category D. Gembine can cause fetal harm when administered to a pregnant woman. It is recommended to avoid Gembine during pregnancy and advise women of reproductive potential to use effective contraception. It is unknown if Gembine is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment and for a period after.
Side Effects
Contraindications
- Known hypersensitivity to Gembine or any other component of the formulation
- Severe myelosuppression before starting therapy
- Pregnancy and breastfeeding
Drug Interactions
Radiation Therapy
Concurrent or sequential radiation therapy may potentiate Gembine-induced toxicity, including severe mucositis and myelosuppression.
Live Attenuated Vaccines
Avoid concomitant administration due to the risk of severe or fatal infections in immunocompromised patients.
Other Myelosuppressive Agents
Increased risk of severe bone marrow depression when used with other agents that suppress bone marrow function.
Storage
Store unreconstituted vials at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. Reconstituted solution should be used immediately or stored for up to 24 hours at room temperature.
Overdose
There is no known antidote for Gembine overdose. Management should involve careful monitoring of blood counts and appropriate supportive care for any resulting toxicities, such as severe myelosuppression.
Pregnancy & Lactation
Pregnancy Category D. Gembine can cause fetal harm when administered to a pregnant woman. It is recommended to avoid Gembine during pregnancy and advise women of reproductive potential to use effective contraception. It is unknown if Gembine is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment and for a period after.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored under recommended conditions.
Availability
Hospitals and specialized oncology pharmacies
Approval Status
Approved by regulatory authorities (e.g., DGDA, FDA equivalent)
Patent Status
Patent expired, generic versions available
WHO Essential Medicine
YesClinical Trials
Gembine has undergone extensive Phase I, II, and III clinical trials, demonstrating its efficacy and safety profile across various oncology indications. Ongoing studies continue to explore its role in combination therapies and novel treatment regimens.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each dose and periodically during treatment
- Liver function tests (LFTs) including bilirubin, AST, ALT, alkaline phosphatase
- Renal function tests (RFTs) including serum creatinine and BUN
- Electrolytes
Doctor Notes
- Carefully monitor patients for signs of myelosuppression and adjust dosage as per guidelines.
- Assess renal and hepatic function before and during treatment.
- Administer antiemetics routinely to manage nausea and vomiting.
- Educate patients on potential side effects and when to seek immediate medical attention.
Patient Guidelines
- Report any signs of infection (fever, chills), unusual bleeding or bruising, or severe fatigue to your doctor immediately.
- Avoid contact with people who have infections, especially chickenpox or measles, due to weakened immune system.
- Use effective contraception during and for at least 6 months after treatment for both male and female patients.
- Maintain good oral hygiene to prevent mouth sores.
- Stay well-hydrated throughout treatment.
Missed Dose Advice
If a dose is missed, contact your doctor immediately to reschedule. Do not double the dose to compensate for a missed one.
Driving Precautions
Gembine may cause fatigue, dizziness, or somnolence. Patients should be cautioned against driving or operating hazardous machinery if they experience these symptoms.
Lifestyle Advice
- Maintain a balanced and nutritious diet to support your immune system and overall health.
- Avoid alcohol consumption during treatment as it may exacerbate side effects, particularly liver toxicity.
- Limit sun exposure and use sunscreen as photosensitivity may occur with some chemotherapy agents.
- Engage in light physical activity if advised by your doctor to manage fatigue.
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