Instruction for medical use of 

CISPLACEL

(information for healthcare professionals)

Trade name:

Cisplacel

International nonproprietary name:

Cisplatin

Appearance:

White-yellowish or yellow textile fabric surgical swabs.

Composition:

Active ingredient –Cisplatin (1±0.15 mg/1 cm2 of a swab).

Oxidized cellulose.

Pharmaceutical form:

Swabs

  • 1.5 x 1.5 cm in package No. 10 or No. 20
  • 3.0 x 5.0 cm in package No. 5

Pharmacotherapeutic group:

Alkylating agent

Cisplacel (absorbable swabs) provides local cytostatic antitumor effect and is intended for implantation in the bed of an excised supratentorial neuroepithelial or metastatic brain tumor, in postoperative cavities and/or soft tissues at the site of removal of malignant tumors of the spine and paravertebral soft tissues, as well as in the soft tissues and cavities in the place of an excised tumor of the head and neck organs (maxillary resection, orbital tumor resection, neck lymphadenectomy, soft tissue tumor removal, etc.).

ATC code:

L01AX

Pharmacological effect:

The pharmacological effect of the medicinal product is caused by the cytostatic effect of Cisplatin immobilized on oxidized cellulose (pharmacological group of alkylating agents), which bifunctionally alkylates DNA strands, inhibits the biosynthesis of nucleic acids and causes cell death. Cisplatin has no specificity with respect to the cell cycle, it acts in the G0 phase. It turns into an active form in two steps. At the first stage it inhibits the synthesis of DNA, RNA and protein, and at the second stage it forms metabolic products affecting only DNA synthesis. The platinum complexes with cis-arrangement of halogen atoms can form stable chelates with purine and pyrimidine components of the nucleic acid molecule and in this way form bonds within one strand or parallel strands of a double helix of DNA. Blocking of DNA strands is maintained for several days after the administration of Сisplatin.

Indications:

Cisplacel is used for local chemotherapy after the complete or partial surgical removal of supratentorial neuroepithelial brain tumors regardless of the degree of their malignancy, for local chemotherapy after surgical removal of malignant tumors of the cervical, thoracic, lumbar, sacral spine and paravertebral soft tissues, brain metastases, as well as after surgical removal of malignant head and neck neoplasms (maxillary resection, orbital tumor resection, neck lymphadenectomy, soft tissue tumor removal, etc.).

Administration and Posology:

Local implantation is the only possible way of the Cisplacel administration:

  •  during brain surgeries, after partial or complete removal of the supratentorial tumor, its bed is imbricated with 20 Cisplacel swabs, so that all walls of the wound are completely covered with the medicinal product. The swabs absorb sanious discharge of the brain wound walls and stick to it initially facilitating the final hemostasis. The optimal effective dose of the medicinal product is 45 mg (20 swabs of 1.5 (±0.1) х 1.5 (±0.1) cm in package No. 20). Dose reduction is acceptable when applying to small brain wound surface areas. If the indicated surface area of the swabs is not sufficient to cover the wound, the medicinal product should be put in places of the most probable localization of the residual tumor (on vessels, tumor attachment points, etc.);
  •  during the head and neck malignant tumor removal, the Cisplacel swabs are applied to the postoperative cavity walls or to soft tissues, in areas of not radically removed tumors, placed one upon another or imbricated in the necessary amount, so that the total dose is 60-80 mg, after that the wound shall
  • be stitched.
  •  during the spine and paravertebral soft tissue malignant tumor removal, the Cisplacel swabs are applied to the postoperative cavity walls and/or to soft tissues, in areas of not radically removed tumors, placed one upon another or imbricated in the necessary amount, so that the total dose is 45-80 mg. Dose reduction is acceptable when applying to a small surface area of the postoperative cavity walls. It is necessary to avoid the application of Cisplacel on the thinned pachymeninx, as well as on the site of the pachymeninx suture. If the indicated surface area of the swabs is not sufficient to cover the wound, the medicinal product should be put in places of the most probable localization of the residual tumor.

Adverse reactions:

During clinical trials, no adverse reactions and complications were detected, no toxic effects of the medicinal product to the CNS distant parts were found. However, due to the fact that the medicinal product contains Cisplatin, allergic reactions may occur.

Overdose:

Taking into account the dosage form and the implant application of the medicinal product, the overdose is excluded.

Contraindications:

  •  pregnancy (women of childbearing potential should have a urine pregnancy test);
  •  individual intolerance of the medicinal product (it may be necessary to remove swabs from the brain wound in case of a severe course of the early postoperative period with toxic aseptic meningitis);
  •  presence of polyvalent allergy;
  •  intraoperative complications requiring a reduction in time or interruption of surgical procedures.

Interaction with other medicinal products:

When applied topically, the interaction with other medicinal products is negligible. Compatible in combination with other antitumor medicinal products.

Storage conditions:

At a temperature of 5 °C to 15 °C. Keep out of reach of children.

Shelf life:

2.5 years. Do not use after the expiration date.

Packaging:

10 or 20 swabs of 1.5х1.5 cm, or 5 swabs of 3.0x5.0 cm packed into a polyethylene film bag or a polymer film bag, which is placed into a metallized film bag. The metallized film bag together with the package leaflet is put into a cardboard pack.

Prescription status:

Prescription only medicine.

Manufacturer:

UNITEHPROM BSU Unitary Enterprise

1 Kurchatov str., Minsk,

220045, Republic of Belarus,

Tel./fax: +375 (17) 212 09 26