Oncology Division
HENPLATIN (Oxaliplatin) HENTAXEL (Docetaxel) TPIAO (Thrombopoietin) ZEFEI (Gemcitabine) ZILONGJIN (Astragalus) HENSETRON (Tropisetron HCl)
Hematology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose) TPIAO (Thrombopoietin) WHITE-C (Filgrastim)
Nephrology Division
EPOSINO (Epoetin Alfa) FERROFER (Iron Sucrose)
GoodFellow Pharma Corporation

HENPLATIN (Oxaliplatin)

Henplatin for Injection 50mg
Formula
Each vial contains Oxaliplatin
(Lyophilized powder) - 50mg

Molecular Formula
C8H14N2O4Pt


Indication
It is used for the treatment of metastatic colorectal cancer in patients who were previously on fluorouracil. It may be used singly or in combination with fluorouracil.

Dosage and Administration
In monotherapy or combination therapy, the suggested dosage is 130mg/? of body surface area, add into 250 to 500 ml 5% of glucose solution and infuse 2 to 6 hours. If no major toxicity appears, repeat every 3 weeks. Adjust dosage according to safety, particularly safety of neurology.

Pharmacology and Toxicology
It has toxicities commonly seen platinum compounds, and exhibits category-specific cardiac toxicity. No renal toxicity of cisplatin or bone marrow toxicity was observed. A relatively new platinum compound, it acts on DNA by producing alkylation conjugate, and forms inter- and intra-strand Pt-DNA crosslinks, consequently, inhibits synthesis and replication of DNA. It rapidly combines with DNA, at most 15 minutes. Combination of cisplatin and DNA is divided into phases, which includes a delay phase after 48 hours [In vivo, an hour after administration, determine presence of conjugate of adduct of leukocyte. DNA synthesis during replication, DNA separation after replication, synthesis of RNA and cell protein is inhibited]. It is effective for some cell lines resistant to cisplatin.

Pharmacokinetics
After 2 hours of continuous infusion at a dose of 130mg/m2, the total plasma platinum reaches peak value of 5.10.8mg/ml/h, the stimulant AUC is 18945mg/ml/h. After infusion, 50% of platinum combine with erythrocyte; and the other 50% of platinum is present in plasma. 25% of plasma platinum is in free form; the other 75% plasma platinum combine with protein. Protein-combined platinum increases gradually and reaches stable level of 95%, 5 days after administration. The clearance is divided into tow phases; the half-life of clearance phase is about 40 hours. Up to 50% of platinum is eliminated via urine within 48 hours (55% of platinum is cleared in 6 days). Fecal excretion is limited (only 5% of platinum is eliminated through feces in 11 days). In patients with renal failure, only clearance of filterable platinum decreases, and thus no dosage adjustment is necessary.

At 22nd day after administration, the level of erythrocyte-bonded platinum is 56% of plasma peak value, while at same time, most plasma platinum have been eliminated. During latter administration periods, no significant increase in the levels of total or plasma platinum was observed while erythrocyte-bonded platinum cumulative evidence.

Contraindications
  1. It should not be administrated to patients with a history of known allergy to platinum derivatives.
  2. It should be administrated cautiously to women during pregnancy and lactation.
Overdosage
No antidote is available. When overdosage occurs, adverse reactions will aggravate, hematologic monitoring should be performed, and take expectant treatment according to its toxicity.

Storage
Store at room temperature not exceeding 25oC

Caution
Foods, Drugs and Cosmetics Act prohibits dispensing without prescription.

Adverse Reactions
  1. Hemopoietic system: It exhibits a certain extent of hematologic toxicity. Monotherapy may cause the following adverse reactions: anemia, aleukocytosis, granulocytopenia, thrombopenia, sometimes grade 3 and 4. In combination with 5-fluorouracil, the incidence of hematology toxicity events increases, including neutrophilic granulocytopenia and thrombocytopenia, etc.
  2. Digestive system: Single administration of the agent may cause nausea, vomiting and diarrhea, which is sometimes very severe. When in combination with 5-fluorouracil, the adverse reactions increase significantly. Preventative or therapeutic antiemetic is recommended.
  3. Nervous system: Peripheral and sensory neuropathy that is characterized by peripheral neuritis. These symptoms may be accompanied by convulsion and sensory disturbance around mouth, at upper respiratory tract and upper digestive tract; even clinical conditions similar to laryngeal spasm, which may recover and without sequela. These symptoms may often be severe. Abnormal sensation may relieve during resting period of treatment, and when cumulative dose is over 800mg/m2 (6 cycles), permanent abnormal sensation or dysfunction may be caused. Several months after termination of treatment, neurotoxicity of over 3/4 patients is relieved and disappears. When reversible abnormal sensation occurs, it is not necessary to adjust the dosage of next administration. Dosage adjustment should be based on the duration and severity of observed neurotoxicity. If abnormal sensation occurs and continues during two periods of treatment, and aching abnormal sensation and/or dysfunction begins to occur, the dose should be decreased by 25% (or 100mg/m2). After symptoms partly or completely disappear, there is still possibility of administering the drug (full or decreased dose) depending on the physician's judgment.
Precautions
  • It should be administered under the supervision of a qualified physician with experience in the use of cancer chemotherapeutic agents. Caution should be taken especially in combination therapy with potential neurotoxicity. CNS symptoms should be monitored strictly;
  • It is associated with digestive system toxicity, such as nausea, vomiting, preventive and therapeutic anti-vomit medicine should be used;
  • When blood toxicity occurs (leukocyte < 2000/mm3 or blood platelet < 50000/mm3), the next cycle should be delayed until recovery.
  • The blood amount and classification should be finished before each period of treatment, and the neurologic symptoms should be checked before and after the treatment.

Pregnancy And Lactation
It may cause harm and damage to the fetus and should not therefore be given to pregnant women. No study is performed about whether the product is excreted in human milk; it should not be administrated during lactation.



Manufactured By
Jiangsu-Hengrui Medicine Co., Ltd. No.
145 East Renmin Road, Xinpu District,
Lianyungang, Jiangsu Province, China

Exclusively Imported By
Goodfellow-Hengrui Pharma, Inc
Unit 3009 Jollibee Plaza Bldg., Emerald Ave.,
Ortigas Center, Pasig City
Tel. Nos.: (632) 632-7031
Fax: (632) 635-3957
E-mail: good_fellow88@yahoo.com
Copyright © 2008 Goodfellow Pharma Corporation
Unit 3009 Jollibee Plaza Bldg.,
Emerald Ave., Ortigas Center 1605 Pasig City

Telephone: (+632) 635-3957 / 632-7031
Mobile No.: (0917) 831-1338

e-mail: good_fellow88@yahoo.com