Oncology

GENERIC:
METHOTREXATE

CLASSIFICATION:
Antimetabolite

MECHANISM OF ACTION:
Cell cycle-specific antifolate analog, active in S-phase of the cell cycle. Enters cells through specific transport systems mediated by the reduced folate carrier and the folate receptor protein. Inhibition of dihydrofolate reductase (DHFR) resulting in depletion of critical reduced folates. Inhibition of de novo thymidylate synthesis.

Composition
HITREX Injection - 15mg/3ml
Each ml contains Methotrexate U.S.P........................5mg
Water for injection U.S.P..............................................q.s.
HITREX 50mg/2ml
Each ml contains Methotrexate U.S.P..........................................25mg
Water for injection U.S.P...................................…………...............q.s.
HITREX 500mg/5ml
Each ml contains Methotrexate U.S.P. ...................................100mg
Water for injection U.S.P..................................................q.s.

INDICATION:
Breast Cancer.
Head and neck Cancer.
Osteogenic Sarcoma.
Acute Lymphoblastic Leukemia.
Non-Hodgkin's Lymphoma.
Meningeal leukemia
Bladder Cancer.
Colorectal Cancer

STORAGE:
Store vials between 36° and 77°F in original package to protect from bright light.

STRENGTHS:
2.5 MG TAB, 15 MG INJ. & 50MG INJ.

GENERIC:
L- ASPARAGINASE

CLASSIFICATION:
Antitumour antibiotic, cytotoxic

MECHANISM OF ACTION:
Asparaginase hydrolyzes the amino acid L-asparagine to L-aspartic acid and ammonia. Asparagine is required for DNA synthesis and cell survival; however, most cells are capable of synthesizing asparagine from glutamine. Acute lymphoblastic leukemia (ALL) cells lack adequate levels of the required enzyme, asparagine synthetase, and cannot survive asparagine depletion. Asparaginase is cycle-specific for the G1 phase.

COMPOSITION:
Each Vial Contains
L-asparginase ……5000 I.U.
Glycine……….q.s.

Each vial contains]
L-asparginase ……10000 I.U.
Glycine……….q.s.

INDICATION:

• Acute lymphoblastic leukemia
• Chronic lymphocytic leukemia
• Hodgkin's lymphoma
• Non-Hodgkin's lymphoma

STRENGTHS:

• 5000 I.U
• 10000 I.U

STORAGE:

• Store between 2º to 8ºC. Do not freeze

GENERIC:
BUSULFAN

CLASSIFICATION:
Alkylating agents

MECHANISM OF ACTION:
Interferes with DNA replication and transcription of RNA and ultimately results in the disruption of nucleic acid function. Contains 2 labile methanesulfonate groups attached to opposite ends of a 4-carbon alkyl chain; in aqueous media, Busulfan is hydrolyzed, releasing the methane- sulfonate groups and producing reactive carbonium ions capable of alkylating DNA. Cytotoxic activity largely results from damage to DNA. Exhibits little immunosuppressive activity.

COMPOSITION:
Each Film Coated Tablets:
Busulphan I.P …………2mg

INDICATIONS:

• Chronic myelogenous leukemia
• Bone marrow transplantation

STORAGE:
Tablets Store at 25ºC (may be exposed to 15-30ºC). Store in a dry place.

STRENGTHS:

• BUSULFAN TAB 2MG

GENERIC:
DACARBAZINE

CLASSIFICATION:
Alkylating agent

COMPOSITION:
Oncodac 100mg
Each Vial contains Dacrbazine USP………100mg
Citric acid I.P. ……..q.s.
Mannitol I.P. q.s.

Oncodac 200 mg
Each Vial contains Dacrbazine USP………200mg
Citric acid I.P. ……..q.s.
Mannitol I.P. q.s.

Oncodac 500 mg
Each Vial contains Dacrbazine USP………500mg
Citric acid I.P. ……..q.s.
Mannitol I.P. q.s.

MECHANISM OF ACTION:
Dacarbazine is a structural analogue of imidazole carboxamide, a purine precursor. Dacarbazine undergoes activation via cytochrome P450 in the liver to the reactive compound, methyltriazenoimidazole carboxamide (MTIC). The cytotoxicity of MTIC is thought to be due primarily to the formation of methylcarbonium ions that attack nucleophilic groups in DNA.Dacarbazine may also inhibit DNA and RNA synthesis by acting as a purine analogue and by interacting with sulfhydryl groups. Dacarbazine is cell cycle phase-nonspecific and is mildly immuno-suppressive

INDICATIONS:

• Hodgkin's lymphoma
• Malignant melanoma

STORAGE:

• Store in a refrigerator 2°C to 8°C (36°F to 46°F). Use within 8 hours of reconstitution. Protect from light.

STRENGTHS:

• ONCODAC INJ 100 MG
• ONCODAC INJ 200 MG
• ONCODAC INJ 500 MG

GENERIC:
6-MERCAPTOPURINE

CLASSIFICATION:
Antimetabolite

MECHANISM OF ACTION:
Cell cycle-specific purine analog with activity in the S phase. Parent drug is inactive. Requires intracellular phosphorylation by the enzyme hypoxanthine-guanine phosphoribosyl transferase (HGPRT) to the cytotoxic monophosphate form, which is then metabolized to the eventual triphosphate metabolite. Inhibits de novo purine synthesis by inhibiting 5-phosphoribosyl-1 pyrophosphate (PRPP) amidotransferase. Incorporation of thiopurine triphosphate nucleotides into DNA resulting in inhibition of DNA synthesis and function. Incorporation of thiopurine triphosphate nucleotides into RNA resulting in alterations in RNA processing and/or translation

INDICATIONS:
Acute lymphoblastic leukemia

STORAGE:
Stable at room temperature. Keep protected from light.

STRENGTHS:
PURENITONE 50 mg Tab

GENERIC:
OXALIPLATIN

CLASSIFICATION:
Platinum analog

• MECHANISM OF ACTION: Third-generation platinum compound.
• Cell cycle-nonspecific with activity in all phases of the cell cycle.
• Covalently binds to DNA with preferential binding to the N-7 position of guanine and adenine.
• Reacts with two different sites on DNA to produce cross-links, either intrastrand (>90%) or interstrand (<5%). Formation of DNA adducts results in inhibition of DNA synthesis and function as well as inhibition of transcription.
• DNA mismatch repair enzymes are unable to recognize oxaliplatin-DNA adducts in contrast with other platinum-DNA adducts as a result of their bulkier size.
• Binding to nuclear and cytoplasmic proteins may result in additional cytotoxic effects.

COMPOSITION:
Xplatin 50mg/100mg
Oxaliplatin……..2mg
Water for injection I.P. …….q.s.

INDICATIONS:

1. Metastatic colorectal cancer-FDA approved as second-line therapy in combination with 5-FU/LV (FOLFOX4) in patients whose disease has recurred or progressed during or within six months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan
2. Metastatic colorectal cancer-FDA-approved as first-line therapy in combination with 5-FU/LV (FOLFOX4).
3. Early-stage colon cancer-FDA-approved as adjuvant therapy in combination with 5-FU/LV (FOLFOX4) in patients with stage III colon cancer and in those with high-risk stage II disease.
4. Pancreatic cancer.
5. Gastric cancer

STORAGE:
Store under normal lighting conditions at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled roomtemperature].

STRENGTHS:
50MG/25ML, 100MG/50ML

GENERIC:
AMIFOSTINE

CLASSIFICATION:
Chemo-radio protectant

COMPOSITION:
Each vial contains:
Amifostine USP eqvivalent to
Amifostine anhydrous ……500mg

MECHANISM OF ACTION:
Amifostine is a pro-drug, which is activated to the free thiol metabolite at the tissue site. The thiol metabolite is responsible for most of the cytoprotective and radioprotective properties of amifostine. It is readily taken up by cells where it binds to and detoxifies reactive metabolites of platinum and alkylating agents as well as scavenges free radicals. Other possible effects include inhibition of apoptosis, alteration of gene expression and modification of enzyme activity. Healthy cells are preferentially protected because amifostine and metabolites are present in healthy cells at 100-fold greater concentrations than in tumour cells.

INDICATIONS:

• Chemoprotector
• Radioprotector

STORAGE:
ParenteraL
Powder for Injection
20-25ºC. Reconstituted solution is stable for 5 hours at room temperature (approximately 25ºC) or 24 hours under refrigeration (2-8ºC).

STRENGTHS:

• AMFOS 500 MG

GENERIC:
LEUCOVORIN CALCIUM

CLASSIFICATION:
Miscellaneous

COMPOSITION:
Each ml contains
Leucovorin Calcium eqivalenr to Leucovorin..7.5mg
Water for Injection I.P. ………..q.s.

Each ml contains
Leucovorin Calcium eqivalenr to Leucovorin….mg
Water for Injection I.P. ………..q.s.

Each uncoated tablets contains:
Leucovorin Calcium ……….15 mg

MECHANISM OF ACTION:
Leucovorin is an active metabolite of folic acid and an essential coenzyme for nucleic acid synthesis. Leucovorin can be used to selectively "rescue" cells from the adverse effects of methotrexate or to increase the efficacy of fluorouracil.

INDICATIONS:

• Leucovorin rescue after methotrexate in Osteosarcoma
• Enhance cytotoxicity of fluorouracil in colorectal cancer.

STORAGE:

• Store in refrigerated conditions (2 to 8°C)
• Protect from direct light and heat.

STRENGTHS:

• CALCIVORIN INJ 50MG/5 mL
• CALCIVORIN INJ 15 MG/2 mL
• CALCIVORIN TAB. 15MG