Oncology
IFOSFAMIDE
(FOSFALEX)
OVERVIEW
DISCLAIMER: The following content is intended for healthcare professionals only. If you are a patient or general mass viewing this site, we advise you to clarify with your doctor any information you read herein.
FOSFALEX is a powerful chemotherapy medication containing Ifosfamide, a Nitrogen Mustard Analogue. Fosfalex combats germ cell testicular cancer, offering a promising third-line chemotherapy option to patients in need.
FOSFALEX (Ifosfamide) undergoes metabolic activation by microsomal liver enzymes to produce biologically active metabolites. This activation process involves hydroxylation at the ring carbon atom "4," resulting in the formation of the unstable intermediate 4-hydroxyifosfamide. These metabolites play a crucial role in the antineoplastic activity of Ifosfamide, ultimately inhibiting the growth and proliferation of cancer cells.
FOSFALEX, when used in combination with certain other approved antineoplastic agents, is indicated for the third-line chemotherapy of germ cell testicular cancer. It is essential to administer Fosfalex in conjunction with a prophylactic agent for hemorrhagic cystitis, such as mesna, to minimize the risk of adverse effects.
* Full prescribing information is available upon request
DESCRIPTION
Generic Name:
IFOSFAMIDE
Brand Name:
(FOSFALEX)
Sizes:
0
Notes:
________________________
Preparation:
1 g Lyophilized Powder for Concentrate for Solution for IV Infusion
Name of Manufacturer
Kemex Laboratory
Place of Manufacturer:
Argentina
Shelf Life
24 months
Storage Condition:
Store at a temperature not exceeding 30 ͦC
Packaging:
1 g USP Type 1 amber vial (box of 1s)
FDA Registration:
DRP-14002
FLUOROURACIL
(FLUORACILEX)
OVERVIEW
DISCLAIMER: The following content is intended for healthcare professionals only. If you are a patient or general mass viewing this site, we advise you to clarify with your doctor any information you read herein.
We are proud to introduce Fluorouracil, marketed under the brand name FLUORACILEX, a potent antineoplastic agent belonging to the class of Pyrimidine Analogue. Fluoracilex targets and combats various forms of cancer, offering hope and healing to patients nationwide.
Fluoracilex exerts its therapeutic effects by interfering with the synthesis of deoxyribonucleic acid (DNA) and, to a lesser extent, inhibiting the formation of ribonucleic acid (RNA). By disrupting these crucial processes, Fluoracilex effectively halts the growth and proliferation of cancer cells, ultimately leading to their demise.
Fluoracilex is indicated for the treatment of the following:
- Metastatic colorectal cancer.
- Advanced gastric cancer.
- Advanced pancreatic cancer.
- Advanced esophageal cancer.
- Advanced or metastatic breast cancer.
- Inoperable locally advanced squamous cell carcinoma of the head and neck in previously untreated patients.
- Locally recurrent or metastatic squamous cell carcinoma of the head and neck.
Fluoracilex (Fluorouracil) can be administered either as an intravenous bolus or as an intravenous infusion, allowing for flexibility and personalized treatment approaches tailored to each patient's needs.
* Full prescribing information is available upon request
DESCRIPTION
Generic Name:
FLUOROURACIL
Brand Name:
(FLUORACILEX)
Sizes:
________________
Notes:
________________
Preparation:
500 mg / 10 mL (50 mg / mL) glass vial in 10 mL Concentrate Solution for IV Injection/Infusion
Name of Manufacturer
Kemex Laboratory
Place of Manufacturer:
Argentina
Shelf Life
24 months
Storage Condition:
Store at a temperature not exceeding 30 ͦC. Protect from light. Do not freeze.
Packaging:
10 mL USP Type 1 clear and colorless glass vial (box of 5s)
FDA Registration:
DRP-11689
PACLITAXEL
(PACLITEX)
OVERVIEW
DISCLAIMER: The following content is intended for healthcare professionals only. If you are a patient or general mass viewing this site, we advise you to clarify with your doctor any information you read herein.
PACLITEX) Paclitaxel is a chemotherapy medication that destroys fast-dividing cancer cells. It treats several types of cancers including ovarian cancer, breast cancer, and lung cancer. A healthcare provider will give you this medication by infusion into your vein in a hospital or clinic setting.
PACLITEX ( Paclitaxel) is used for the primary treatment of advanced ovarian cancer with cisplatin or carboplatin, and secondary treatment.
In the treatment of node-positive breast cancer, paclitaxel is used for primary adjuvant therapy after anthracycline-containing chemotherapy. In locally advanced or metastatic breast cancer, it is used first-line with an anthracycline, or as a second-line single-agent, usually after failure of anthracycline-based therapy. In patients with metastatic disease who over-express HER2 (human epidermal growth receptor 2), it may be used with trastuzumab as initial therapy. Paclitaxel is used with cisplatin or carboplatin, for the primary treatment of advanced non-small cell lung cancer. It may be used for the second-line treatment of AIDS-related Kaposi’s sarcoma, and has been tried in other neoplasms including cancers of the head and neck, and
relapsed germ-cell tumors.
* Full prescribing information is available upon request
DESCRIPTION
Generic Name:
PACLITAXEL
Brand Name:
(PACLITEX)
Sizes:
100 mg/17 mL Concentrate for Solution for IV Infusion
Notes:
________________
Preparation:
100 mg/17 mL Concentrate for Solution for IV Infusion
Name of Manufacturer
Kemex Laboratory
Place of Manufacturer:
Argentina
Shelf Life
36 months
Storage Condition:
Store at a temperature not exceeding 2 to 8 ͦC
Packaging:
2 mL USP Type 1 Amber-colored Ampoule (Box of 1s)
FDA Registration:
DR-XY41520
DOXORUBICIN
D-XOBIN
OVERVIEW
DISCLAIMER: The following content is intended for healthcare professionals only. If you are a patient or general mass viewing this site, we advise you to clarify with your doctor any information you read herein.
D-XOBIN (Doxorubicin) is the newest addition to our lineup of cutting-edge oncology treatments. It is developed in collaboration with our esteemed partner, Venus Remedies Ltd., India, with a Certificate of Current Good Manufacturing Practice (CGMP) seal.
D-XOBIN (Doxorubicin) is a potent chemotherapy drug belonging to the anthracycline class. Its mechanism of action involves blocking an enzyme called topo isomerase 2, thereby slowing or halting the growth of cancer cells. This innovative therapy has demonstrated significant therapeutic responses across a spectrum of solid tumors and hematologic malignancies.
* Full prescribing information is available upon request
DESCRIPTION
Generic Name:
DOXORUBICIN
Brand Name:
D-XOBIN
Sizes:
2 mg/mL (10 mg/5 mL) Solution for Injection (I.V.)
Notes:
INDICATIONS:
D-XOBIN (Doxorubicin) has shown efficacy in the treatment of various cancers, including but not limited to:
a. Carcinoma of the breast, lung, ovary, and bladder
b. Neuroblastoma and Wilms' tumor
c. Soft tissue sarcomas and osteosarcoma
d. Acute lymphocytic-lymphoblastic leukemia and acute myelogenous leukemia
e. Non-Hodgkin's lymphoma and Hodgkin's disease
Preparation:
D-XOBIN-10: Doxorubicin HCl 2 mg/mL (10 mg/5 mL) Solution for Injection is a red solution, free from visible extraneous particulate matter.
D-XOBIN-50: Doxorubicin HCl 2 mg/mL (50 mg/25 mL) Solution for Injection is a red solution, free from visible extraneous particulate matter
Name of Manufacturer
Venus Remedies Ltd.
Place of Manufacturer:
India
Shelf Life
24 months
Storage Condition:
Store in a refrigerator (2ºC to 8ºC). Do not freeze. Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after two to a maximum of four hours of equilibration at controlled room temperature (15° to 25°C).
Packaging:
USP Type I amber-colored tubular glass vial sealed with 20 mm grey bromo butyl rubber plug, aluminum seal, and 20 mm red flip-off cap x 5 mL (Box of 1's)
FDA Registration:
DRP-9148-01
DOCETAXEL
DOCELEX
OVERVIEW
DISCLAIMER: The following content is intended for healthcare professionals only. If you are a patient or general mass viewing this site, we advise you to clarify with your doctor any information you read herein.
At Delex Pharma, we are committed to advancing healthcare by introducing high-quality pharmaceutical products to meet the evolving needs of patients in the country. In 2023, we proudly launched our Oncology portfolio, offering cutting-edge treatments sourced from reputable partners such as KEMEX LABORATORY of Argentina, renowned internationally for producing excellent quality pharmaceuticals. Complying with the stringent standards of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP), KEMEX LABORATORY ensures that every product meets the highest standards of safety, efficacy, and reliability.
DOCELEX is an antineoplastic agent that belongs to the taxane family. It is indicated for the management of multiple metastatic and non-resectable tumor types.
* Full prescribing information is available upon request
DESCRIPTION
Generic Name:
DOCETAXEL
Brand Name:
DOCELEX
Sizes:
100mg/mL (400mg / 4mL and 800mg/8mL)
Notes:
Indications: Docetaxel is indicated for locally / advanced / metastatic breast cancer, ovarian cancer, head and neck cancer, non-small cell lung cancer
Preparation:
100mg/mL (400mg / 4mL and 800mg/8mL)
Name of Manufacturer
Kemex Laboratory
Place of Manufacturer:
Argentina
Shelf Life
36 months
Storage Condition:
2 ͦC- 8 ͦC (Do not Freeze)
Packaging:
- 80 mg (40 mg / mL) with one single dose of Docetaxel (2mL) and one single dose of Ethanol Diluent (6mL) by Box of 1s
• 20 mg (20 mg / 0.5 mL) with one single dose Vial of Docetaxel (0.5mL) and one single dose vial of Ethanol Diluent (1.5mL) by Box of 1s
FDA Registration:
DRP 10616 (80 mg), DRP 10615 (20 mg)
