Drug Information

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.

Gemcitabine Hcl- @-Gemzar (1996)- Antineoplastics- (FDC-List )

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation