CYTARINE KABI SOLUTION FOR INJECTION OR INFUSION 100MG/ML [SIN17149P]

Product Info

CYTARINE KABI SOLUTION FOR INJECTION OR INFUSION 100MG/ML

[SIN17149P]

INDICATIONS:

Cytarabine is indicated primarily for:

• Induction and maintenance of remission in acute myelocytic leukemia of both adults and children.

It has also been found to be useful in the treatment of other leukemias such as:

• Acute lymphocytic leukemia.

• Chronic myelocytic leukemia (blast phase).

Cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy. Children with non-Hodgkin’s lymphoma have benefited from a combination drug program (LSA2L2) that includes cytarabine. Remissions induced by cytarabine not followed by maintenance treatment have been brief. Maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.

DOSAGE AND ADMINISTRATION:

Cytarabine may be administered by intravenous injection or infusion, or subcutaneously.

Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. In most instances, however, the drug has been well tolerated.

Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. This phenomenon is related to the drug’s rapid inactivation and brief exposure of susceptible normal and neoplastic cells to significant levels after rapid injection. Normal and neoplastic cells seem to respond in somewhat parallel fashion to these different modes of administration and no clear-cut clinical advantage has been demonstrated for either.

Dose regimens are usually at the discretion of the attending physician. Clinical and haematological responses and tolerance vary between patients and a dose which gives optimal therapeutic effect with minimum toxicity should be used.

Normal Adult Dosage, Single Agent Therapy: Doses of up to 200 mg/m₂ daily as a continuous intravenous infusion for five days (120 hours) repeated at approximately two weekly intervals have been used. Modification must be made based on results of daily haematological monitoring. After each five-day treatment, drug therapy should be withdrawn to allow for bone marrow recovery.

Maintenance of Acute Myelocytic Leukemia in Adults: Maintenance programs are generally modifications of induction programs. Similar schedules of drug therapy to those used for induction are normally employed. Most programs have a greater interval between courses of therapy during remission maintenance.

Induction and Maintenance of Acute Myelocytic Leukaemia (AML) in Children: Childhood AML has been shown to respond better than adult AML given similar regimes. Where the adult dosage is given in terms of body weight or surface area, the paediatric dosage may be calculated on the same basis, being adjusted on the consideration of such factors as age, body weight or body surface area.

Conditions Requiring Dosage Adjustment:
Myelosuppression: The dose of cytarabine should be modified if signs of severe myelosuppression appear, e.g. consideration of discontinuation of the drug if the polymorphonuclear granulocyte count falls below 1 x 10₉ L or the platelet count falls below 50 x 10₉ L.

Combination Therapy: Dosage modifications may have to be made when cytarabine is used in combination with other myelosuppressive drugs. Before instituting a programme of combined therapy, the physician should be familiar with the adverse effects, precautions, contraindications and warnings applicable to all the drugs in the programme.

CONTRAINDICATIONS:

Known hypersensitivity to cytarabine.