DBL CARBOPLATIN INJECTION 10 MG/ML [SIN02301P]

Product Info

DBL CARBOPLATIN INJECTION 10 MG/ML

[SIN02301P]

4.1 Therapeutic indications

Carboplatin is indicated in the treatment of:

• advanced stage ovarian cancer of epithelial origin

• small cell lung carcinoma

• carcinoma of the head and neck

• paediatric cerebral tumours

• neuroblastoma.

4.2 Dose and method of administration

Dosage

Adult: The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 milligrams/m² given as a single intravenous infusion over 15 to 60 minutes. Therapy should not be repeated until four weeks after the previous carboplatin course.

It is recommended that according to clinical circumstances the initial dosage may require reduction by 20 to 25% in patients with risk factors such as increasing age, previous myelosuppressive therapy and poor performance status.

Dosage modification may be required when carboplatin is used in combination with other myelosuppressive drugs or radiation therapy, to minimise additive myelosuppressive effects.

Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin.

Dosage Adjustment

Renal impairment

In patients with initial impaired renal function reduction of dosage of carboplatin may be required. Haematological nadirs and renal function should be monitored in these circumstances.

A suggested dosage schedule in patients with impaired renal function based on creatinine clearance is as follows:

Children

Sufficient usage of carboplatin in paediatrics has not occurred to allow specific dosage recommendations to be made. Physicians are advised to refer to recently published literature for information on the current dosing regimens for particular tumours.

Method of Administration

Preparation of carboplatin solution

Equipment containing aluminium components should be avoided (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

DBL Carboplatin Injection is a ready to use solution containing 10 milligrams/mL carboplatin in Water for Injections.

The injections may be further diluted in 5% glucose intravenous infusion. To reduce microbiological hazard, use as soon as practicable after preparation. If storage is necessary, hold at 2–8°C for not more than 24 hours.

Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.

These products contain no antimicrobial agent. In order to reduce microbiological contamination hazard, infusion should be commenced as soon as practicable after preparation. Infusion should be completed within 24 hours of preparation and any residue discarded.

Compatibilities

Carboplatin has been found to be stable for 24 hours when admixed with 5% glucose in water.

Handling Guidelines

1. Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of the preparation.

2. Operations such as transfer to syringes should be carried out only in the designated area.

3. The personnel carrying out these procedures should be adequately protected with clothing, gloves and eye shield.

4. Pregnant personnel are advised not to handle chemotherapeutic agents.

Contamination

1. In the event of contact with the skin or eyes, the affected area should be washed with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of the skin. Medical advice should be sought if the eyes are affected.

2. In the event of spillage, operators should put on gloves and mop up the spilled material with a sponge kept in the area for that purpose. Rinse the area twice with water. Put all solutions and sponges into a plastic bag and then seal it. The bag should be prominently labelled with the words “Cytotoxic Waste” or similar.

Disposal

Syringes, containers, absorbent materials, solution and any other material which has come into contact with carboplatin should be placed in a thick plastic bag or other impervious container and incinerated at 1000°C or more.

4.3 Contraindications

Carboplatin is contraindicated in patients with the following conditions:

• severe myelosuppression.

• pre-existing severe renal impairment; dose adjustment may allow use in the presence of mild renal impairment (see section 4.2 Dose and method of administration).

• history of severe allergic reactions to carboplatin, other platinum-containing compounds (e.g., cisplatin) or mannitol.

• severe bleeding.

• pregnancy or lactation.