Sibagem 1gm Injection
Brand Name | Sibagem 1gm Injection |
Salt Composition |
Gemcitabine (1000mg) |
Strength | 1000mg |
Product Form | Injection |
Pack | 1 Injection in 1 Vial |
Category |
Anti-Cancer |
SubCategory |
Lung Cancer |
Country of Origin | India |
Manufacturer |
Siba Lifesciences |
Manufacturer/Marketer Address | Siba Lifesciences,50, GF Bharat Nagar New Friend Colony New Delhi 110025 |
You Save : Rs.806.00 Inclusive of all taxes
- Pancreatic adenocarcinoma which is locally advanced or metastatic or unresectable
- Non-small cell lung cancer which is unresectable, locally advanced or metastatic
- Metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy
- Ovarian cancer which is advanced or recurrent
- if you are allergic to Sibagem 1gm (Gemcitabine 1gm) Injection or its constituents
- if you are pregnant
- if you are breastfeeding
- if you are less than 18 years of age
- if you have a blood disorder
- if you have renal disorder
- if you have lung disease
- if you have a liver disorder
- Allergic reactions - It can be mild hypersensitivity and angioedema to severe like Stevens-Johnson Syndrome and toxic epidermal necrolysis.
- Immunization with live vaccines
- Hemotoxicity - myelosuppression
- Bleeding disorder – easy bruising and bleeding
- Pulmonary toxicity
- Cardiotoxicity – MI
- Renal toxicity – renal failure/ hemolytic uremic syndrome
- Hepatotoxicity– monitor function before and during treatment
- Posterior reversible encephalopathy syndrome
- Pregnancy – causes embryo-fetal toxicity
- Breast feeding – causes side effects similar to adults
- Alcohol intake or Driving or operating heavy machinery – Sibagem 1gm Injection causes side effects thus caution is required. consult your physician
- Liver disorders – used with caution in severe liver diseases. Consult a physician before use
- Kidney disorders – used with caution in severe kidney diseases. Consult a physician before use
- Cardiac disorders – used with caution in heart failure and MI. Consult a physician before use
- Respiratory disorders – used with caution in respiratory distress. Consult a physician before use
- Blood disorders – used with caution in thrombocytopenia and anemia. Consult a physician before use.
- Drug.com. Gemcitabine Pregnancy and Breastfeeding Warnings. [Accessed 27 Mar. 2019] (online) Available from: https://www.drugs.com/pregnancy/gemcitabine.html
- Briggs GG, Freeman RK, editors. A Reference Guide to Fetal and Neonatal Risk: Drugs in Pregnancy and Lactation. 10th ed. Philadelphia, PA: Wolters Kluwer Health; 2015. pp. 617-18.
- Gemcitabine Injection: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2017 [cited 10 May 2017]. Available from: https://medlineplus.gov/druginfo/meds/a696019.html
- DailyMed - Gemcitabine hydrochloride injection, powder, lyophilized, for solution [Internet]. Dailymed.nlm.nih.gov. 2017 [cited 10 May 2017]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d16907e7-a8c8-4039-ace4-cf4e24ba68c0
Medical Description of Sibagem 1gm Injection
Sibagem 1gm Injection contains Gemcitabine 1gm it’s a nucleoside metabolic inhibitor. It has antineoplastic activity. It is used in the treatment of pancreas, lung, breast and ovarian cancer. It is used as an orphan drug in the case of bladder and gallbladder cancer. This medication is recommended only for adults.
Sibagem 1gm Injection Uses
Sibagem 1gm Injection is used in the treatment of pancreatic cancer, non-small cell lung cancer, breast cancer and ovarian cancer. It is not used in children.
Sibagem 1gm Injection Benefits
Sibagem 1gm Injection is used in the treatment of pancreatic cancer, non-small cell lung cancer, breast cancer and ovarian cancer. It is used as a monotherapy or in combination with chemotherapy medications. It is recommended only in adults.
Sibagem 1gm Injection Indication
Sibagem 1gm Injection is used in the treatment of:
It is used as an orphan drug in the treatment of Transitional cell carcinoma, cholangiocarcinoma, cutaneous T cell lymphoma, Hodgkin’s lymphoma, mesothelioma, and head and neck carcinoma
Mechanism of action of Sibagem 1gm Injection
Gemcitabine is an antineoplastic and an antimetabolite. It is a pyrimidine analogue. It is phosphorylated to Gemcitabine monophosphate which is converted to Gemcitabine diphosphate and Gemcitabine triphosphate. Gemcitabine triphosphate incorporates into DNA thus inhibits DNA chain elongation and causes masked DNA chain termination, DNA fragmentation and apoptosis of abnormal cancer cells. Thus Gemcitabine inhibits proliferation and induces apoptosis of abnormal cancer cells.
How Sibagem 1gm Injection works
Sibagem 1gm Injection that phosphorylates into gemcitabine triphosphate an active metabolite that incorporates into DNA molecule thus terminates elongation and causes fragmentation of DNA. It inhibits proliferation and induces apoptosis of abnormal cancer cells.
Sibagem 1gm Injection Contraindication
Absolute contraindication:
Relative contraindication:
Sibagem 1gm Injection Side Effects
Common side effects that occur 1:10 patients: Anemia, Elev LFTs, Neutropenia, Leukopenia, Pain, Proteinuria, Fever, Hematuria, Rash
Uncommon side effects that occur 1:100 patients: Thrombocytopenia, Dyspnea, Constipation, Diarrhea, Flu-like syndrome, Hemorrhage, BUN increased, Infection, Alopecia, Edema, Elev bilirubin
Rare side effects that occur 1:1,000 patients: Paresthesia, Creatinine increased, Inj site reactions, Bronchospasm, CHF, MI, arrhythmias, supraventricular arrhythmias, Peripheral vasculitis, gangrene, capillary leak syndrome, Cellulitis, desquamation and bullous skin eruptions, Hepatic failure, Interstitial pneumonitis, pulmonary fibrosis, pulmonary edema, ARDS, Pulmonary eosinophilia, Thrombotic microangiopathy
FAQs for Sibagem 1gm Injection
Is Sibagem 1gm (Gemcitabine 1gm) Injection safe during pregnancy?
No, taking Sibagem 1gm Injection during pregnancy is not recommended thus inform your physician if you are pregnant or plan to get pregnant
Can Sibagem 1gm Injection be taken while breastfeeding?
No, in general it is suggested that drugs and their metabolites can pass via breastfeeding thus it is suspected that Sibagem 1gm Injection can also pass via breastfeeding.
Can Sibagem 1gm Injection be taken while alcohol consumption?
The interaction is unknown but Sibagem 1gm Injection causes side effects. Thus, consult your physician.
Can I take a drive or operate heavy machineries while on Sibagem 1gm Injection?
Sibagem 1gm Injection causes side effects thus caution is used while driving or operating machineries.
Precautions and general warning of Sibagem 1gm Injection
Alcohol
Intake of alcohol with Sibagem 1gm Injection causes side effects thus caution is required. consult your physician
Driving or operating machinery
Driving or operating heavy machinery with Sibagem 1gm Injection causes side effects thus caution is required. consult your physician
Pregnancy
Using Gemcitabine during pregnancy may cause embryo-fetal toxicity. Consult your physician
Breast Feeding
Using Gemcitabine during Breast feeding may cause side effects similar to adults. Consult your physician
Kidney Problem
Using Gemcitabine may lead to renal failure/ hemolytic uremic syndrome. Consult your physician
Liver Disease
During Gemcitabine therapy monitor liver function before and during treatment.Consult your physician
How to Take Sibagem 1gm Injection
Sibagem 1gm Injection is taken intravenously; It must be taken at the same time once a day as prescribed by your physician; It is taken with NaCl
After therapy has been initiated, do not take more or less of this drug than prescribed or stop taking it without your physicians’ approval. Skipping or changing your dose without approval may cause adverse effects making the condition more difficult to treat, or worsen side effects.
Use of Sibagem 1gm Injection in Adult
If you are pregnant or breastfeeding inform your physician as they are not advisable.
Use of Sibagem 1gm Injection in children
This injection is not recommended in children.
Use of Sibagem 1gm Injection in Elderly Patients
This injection has only been used in few patients 65 years or older. Dosage and usage are similar to adults. Discuss with your physician before usage.
Other general warnings
Talk to your doctor if
If you have any allergy
If you have a liver problem
If you have a heart problem
If you have a renal problem
If you are pregnant or breastfeeding
General instructions
Sibagem 1gm Injection is taken orally as prescribed dosage at a specific time regularly with or without food.
Drug Interaction of Sibagem 1gm Injection
Drug-Drug Interaction
IV Incompatibilities - acyclovir, amphotericin B, cefoperazone, cefotaxime, furosemide, ganciclovir, imipenem/cilastatin, irinotecan, methotrexate, methylprednisolone sodium succinate, mitomycin, piperacillin, piperacillin/tazobactam, prochlorperazine
Severity of adverse effects is increased by Allopurinol, Steroids, Erythropoietin, Interferon alfa
Serum levels are increased by Aceclofenac, Acetaminophen, Cetirizine
Serum levels are decreased by Methazolamide, Hydrochlorothiazide
Drug-Food Interaction
This injection can be taken with any type of food, if doubts arise kindly refer to your physician. It generally causes side effects thus it is advised not to be taken with alcohol. It is preferred to drive or operate heavy machinery with caution.
Drug-Disease Interaction
Over Dose
In the case of Overdosage with this injection. Contact your physician.
Missed Dose
You can take the missed dosage if you notice within 12 hours. If it is more than 12 hours, then skip the dosage and take the next doses as usual. Don’t take a double dose for a forgotten dose.
Storage and Disposal
Keep the medication out of children’s reach
Keep the medication away from pets
Once expired dispose immediately
Store at 30°C
Fast Tag
Sibagem 1gm Injection is an antineoplastic medication
Gemcitabine is an antimetabolic inhibitor
This injection is used to control and treat pancreatic cancer, lung cancer, breast cancer and ovarian cancer
Do not use this medication while pregnant and lactation period.
Don’t use this medication with liver disease or kidney diseases or.
References