Gemcitabine hydrochloride 200 mg/5mL
Gemcitabine hydrochloride · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Teyro Labs Private Limited
Gemcitabine hydrochloride is a injection, powder, lyophilized, for solution containing gemcitabine hydrochloride at 200 mg/5mL, taken intravenous. Manufactured by Teyro Labs Private Limited.
Key Facts
- Brand Name
- Gemcitabine hydrochloride
- Generic Name
- Gemcitabine hydrochloride
- NDC Code (Product)
82511-008- Manufacturer
- Teyro Labs Private Limited
- Strength
- 200 mg/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA078759
- Marketing Start
- 08/08/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) • in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) • as a single agent for the treatment of pancreatic cancer. ( 1.4 ) 1.1 Ovarian Cancer Gemcitabine for Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 1.2 Breast Cancer Gemcitabine for Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. 1.3 Non-Small Cell Lung Cancer Gemcitabine…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Gemcitabine for Injection is for intravenous use only. • Ovarian Cancer: 1000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1 ) • Breast Cancer: 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2 ) • Non-Small Cell Lung Cancer: 1000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3 ) • Pancreatic Cancer: 1000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle. ( 2.4 ) 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine for Injection is 1000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine for Injection administration. Refer to carboplatin prescribing information for additional information. Dosage Modifications Recommended Gemcitabine for Injection dosage modifications for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions (5.2) ] . Refer to the recommended dosage modificatio…
Contraindications
4 CONTRAINDICATIONS Gemcitabine for Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1) ]. Patients with a known hypersensitivity to gemcitabine. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity [see Contraindications (4) ] • Schedule-Dependent Toxicity [see Warnings and Precautions (5.1) ] • Myelosuppression [see Warnings and Precautions (5.2) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] • Pulmonary Toxicity and Respiratory Failure [see Warnings and Precautions (5.4) ] • Hemolytic Uremic Syndrome [see Warnings and Precautions (5.5) ] • Hepatic Toxicity [see Warnings and Precautions (5.6) ] • Exacerbation of Radiation Therapy Toxicity [see Warnings and Precautions (5.8) ] • Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] • Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.10) ] The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), neutropenia, increased alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea, and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 864-879-9994 or FDA at 1-800-…
Frequently Asked Questions
What is Gemcitabine hydrochloride used for?
Gemcitabine hydrochloride contains Gemcitabine hydrochloride. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Gemcitabine hydrochloride a controlled substance?
Gemcitabine hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Gemcitabine hydrochloride?
The generic name for Gemcitabine hydrochloride is Gemcitabine hydrochloride. There are 10 other brand versions of Gemcitabine hydrochloride.
What is the NDC code for Gemcitabine hydrochloride 200 mg/5mL?
The NDC (National Drug Code) for Gemcitabine hydrochloride 200 mg/5mL is 82511-008, listed by Teyro Labs Private Limited.
Other Gemcitabine hydrochloride Dosages
Other Gemcitabine Brands
See all →- Gemcitabine200 mg/5.26mL72485-221
- Gemcitabine2 g/52.6mL67457-618
- GEMCITABINE200 mg/116714-909
- Gemcitabine200 mg/5.26mL67457-616
- GEMCITABINE1 g/116714-930
- Gemcitabine2 g/52.6mL72485-223
- gemcitabine hydrochloride200 mg/5mL68083-148
- GEMCITABINE1 g/171288-114
- Gemcitabine38 mg/mL71288-117
- gemcitabine200 mg/5mL25021-234
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)