LITAK Solution for injection Ref.[8315] Active ingredients: Cladribine

Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy.

Posology

The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous bolus injection at a daily dose of 0.14 mg/kg body weight for 5 consecutive days.

Deviations from the posology indicated above are not advised.

Elderly

Experience with patients older than 65 years is limited. Elderly patients should be treated by individual assessment and careful monitoring of the blood counts and of the renal and hepatic function. The risk requires assessment on a case-by-case basis (see section 4.4).

Renal and hepatic impairment

There are no data on the use of LITAK in patients with renal or hepatic impairment. LITAK is contraindicated in patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min) or with moderate to severe hepatic impairment (Child-Pugh score >6) (see sections 4.3, 4.4 and 5.2).

Paediatric population

LITAK is contraindicated in patients less than 18 years of age (see section 4.3).

Method of administration

LITAK is supplied as a ready-to-use solution for injection. The recommended dose is directly withdrawn by a syringe and injected as a subcutaneous bolus injection without dilution. LITAK should be inspected visually for particulate matter and discoloration prior to administration. LITAK should warm up to room temperature prior to administration.

Self-administration by the patient

LITAK can be self-administered by the patient. Patients should be instructed and trained appropriately. Detailed instructions are contained in the Package Leaflet.

Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, as well as irreversible neurologic toxicity (paraparesis/quadriparesis), Guillain-Barré syndrome, and Brown-Séquard syndrome. Acute, irreversible neuro- and nephrotoxicity have been described in individual patients treated at a dose which was ≥4 times higher than the recommended regimen for hairy cell leukaemia.

No specific antidote exists. Immediate discontinuation of therapy, careful observation, and initiation of appropriate supportive measures (blood transfusions, dialysis, haemofiltration, anti-infectious therapy, etc.) are the indicated treatment of overdose of cladribine. Patients who have received an overdose of cladribine should be monitored haematologically for at least four weeks.

Shelf life: 4 years.

From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Store in a refrigerator (2°C-8°C).

Do not freeze.

10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap.

Packs contain 1 or 5 vials, each with 5 ml of solution. Not all pack-sizes may be marketed.

Procedures for proper handling and disposal of antineoplastic medicinal products should be used. Cytotoxic medicinal products should be handled with caution. Avoid contact by pregnant women.

The use of disposable gloves and protective garments is recommended when handling and administering LITAK. If LITAK contacts the skin or mucous membranes, rinse the area immediately with copious amounts of water.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.

The vials are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.