GEMACTA
Manufacturer DetailsMACLEODS
Compositions:
Gemcitabine 200mg/1000mg injection,
Gemcitabine 200mg/1000mg injection,
| Strength | Rate | Packing Style |
|---|---|---|
| 200mg | 865.37 | 1 vial injection |
| 1000mg/ml | 3700.00 | 1 vial injection |
List of Related Indications:
- Metastatic Non-small Cell Lung Cancer (NSCLC)
List Of Drugs:
- Gemcitabine Hcl- @-Gemzar (1996)- Antineoplastics- (FDC-List )
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Antineuoplastic agents include-
Interferon ALFA 2a, Interferon ALFA -2b, Interferon ALFA -n3, Levamisole, Altretamine, Cladribine, Hydroxyurea, Aldesleukin, Paclitaxel, Docetaxel,Tretinion, Procarbazine,Dacarbazine, Gemcitabine, Mitotane, Asparaginase, Pegaspargase,Porfimer Sodium
Indication:
GEMZAR (gemcitabine for injection) Powder, Lyophilized, For Solution
For lutravenous Use
Initial U.S. Approval: 1996
Gemcitabine Hcl injection ready to use infusion bags
Gemcitabine Hcl equivalent to10mg per ml (100,120,130,140,160,170,180,190
and 200 ml ( Approved as Infusion bags)
Indication-
Ovarian cancer - Gemcitabine injection in combination with carboplatin is indicated
for the treatment of patients with advanced ovarian cancer that has replaced at least
6 months after completion of platinum based therapy.
LIST OF DRUGS DURING 2004
Sr.No- 236
Name of the Drug- Gemcitabine(1.4gm/vial) Pharmacological Classification- Anti-cancer
Date of Approval- 01-09-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
Breast cancer -Gemicitabine injection in combination with Placitaxel is indicated
for the first line treatment of patients with metastatic breast cancer after failure of
prior anthracycline containing containing adjuvant chemotheraphy , unless
antrhracycline were clinically contraindicated.
Non-small cell lung cancer - Gemcitabine injection is indicated in combination
with cisplatin for the first line treatmentof patients with inoperable , locally
Approved by FDA on 17--06-2014 (Ref- FDA approved List- 2014)
Adrenocarcinoma of pancreas
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Gemcitabine 1.4gm/vial Anti-cancer 01-09-2004
2.Gemcitabine HCl injection 18-12-2009
2gm/vial
(Addtl.stgth)
Same as approved
3.Gemicitabine Hcl injection 17-06-2014
Ready to use bags
Gemicitabine Hcl eqv.to
Gemicitabine 10mg/ml
(100,120, 130,140,150,160,170,180,190, and 200ml)
(approved as infusion bags)
Ovarian cancer -gemicitabine injection in combination with carboplatin
is indicated for treatment of patients with advanced ovarian cancer that
has replaced at least 6 months after completion of platinum based therapy
Breast cancer Gemcitabine injection in combination with placitaxel is
indicated for first line treatment of patients with metastatic breast cancer
after failure of prior anthracycline containing adjuvant chemotherapy,
unless anthracyclines were clinically contraindicated .
Non- small lung cancer -Gemicitabine injection in combination with cisplatin
is indicated for first line treatment of patients with inoperable , locally advanced
( stage IIIA or IIIB) , or metastatic (stage IV) non -small lung cancer
Pancreatic cancer -Gemicitabine injection is indicated as first line treatment for
patients with locally advanced (non-resectable stage II or stage III) or
metasatic (stage IV) adenocarcinoma of the pancrease.
Gemicitabine injection is indicated for patients previously treated with 5-FU
4. Gemicitabine injection 24-01-1996
In management of non-small cell lung cancer
5.Gemicitabine Injection 38mg/ml 05-12-2012
Ovarian -cancer-Gemicitabine injection in combination with cisplatin
is indicated for the treatment of patients with advanced ovarian cancer that
has replaced at least 6 months after completion of platinum based therapy
Breast cancer -Gemicitabine injection in combination with pacitaxel is indicated
for the first line treatment of patients with metastatic beast cancer after failure of
prior anthracycline treatment containing adjuvant chemotherapy, unless
anthracyclines were contraindicated
Non-small lung cancer-gemicitabine injection is indicated in combination with
cisplatin for the first line treatment of patients with inoperable locally advanced
(stage IIIA or IIIB) or metastatic (stage IV) non small lung cancer
Pancreatic cancer Gemicitabine injection is indicated as first line treatment for
patient with locally advanced (nonresectable stage III ) or metastatic (stage IV)
adrenocarcinoma of the pancreas
Gemicitabine injection is indicated for patients previously treated with 5-FU
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Gemcitabine in combination with Cisplatin
For Additional indication
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Gemicitabine Cancer/Oncology Eli Lily & Co 28-02-2006
Hcl
Adverse Reaction:
Mild parasthesis, severe paresthesias.
Rash, hair loss. Nausea, vomiting,
Transcient elevations of serum transaminases, Diarrhea, stomatistis.
Dyspnea, severe dyspnea. Mild proteinuria,
Hematuria, hemolytic uremic syndrome.
Perpipheral edema, -flu syndrome -, astenia,
Anorexia, headache, Cough, chills, Myalgia, insomnia, Rhinitis, sweating, Malaise.
Contra-Indications:
Known hypersens to the drug
Special precautions:
Patients receiving the drug must be monitored to receiving each dose with a complete blood count. (CBC), including differential count.
Dosages/ Overdosage Etc:
Indications:
Adrenocarcinoma of pancreas
Dosage:
IV use only Administered IV at a dose of 1000mg/m2 over 30 minutes once weekly for upto 7 weeks, followed by a week of rest from treatment.
Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of 4 weeks.
Patient Information:
PATIENT COUNSELING INFORMATION
1.Patients should be adequately informed of the risk of low blood cell counts and
instructed to immediately contact their physician should any sign of infection
develop including fever. Patients should also contact their physician if bleeding
or symptoms of anemia occur .
2. Pregnancy
There are no adequate and well-controlled studies of Gemzar in pregnant women.
Based on animal studies Gemzar can cause fetal harm when administered to a
pregnant woman.
If this drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the risks to the fetus need to be discussed with their physician (
2. Nursing Mothers
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from Gemzar, a decision should be
made whether to discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother
Pharmacology/ Pharmacokinetics:
Pharmacology:
Gemcitabine is a nucleoside analog that exhibits antitumor activity. Gemcitabine exhibits cell phase specificity primarily killing cells undergoing DNA synthesis,and blocking the progression of cells.
Pharmcokinetics:
The maximum plasma concentrations were acheived upto 30 minutes after discontinuation of the infusions and metabolite is excreted in urine without undergoing further biotransformation.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category D.
Gemzar can cause fetal harm when administered to a pregnant woman.
Based on its mechanism of action, Gemzar is expected to result in adverse reproductive
effects.
There are no adequate and well-controlled studies of Gemzar in pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking
this drug, the patient should be apprised of the potential hazard to the fetus.
2. Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are
excreted in human milk and because of the potential for serious adverse reactions
in nursing infants from Gemzar, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of the drug to the mother.
3. Pediatric Use
The safety and effectiveness of Gemzar in pediatric patients has not been established.
.
4. Geriatric Use
Gemzar clearance is affected by age . There is no evidence, however, that unusual dose
adjustments are necessary in patients over 65, and in general, adverse reaction rates
in the single-agent safety database of 979 patients were similar in patients above
and below 65.
Overall, there were no other substantial differences in toxicity profie of Gemzar plus
carboplatin based on age.
