Ticelo 250Mg Vial Of 50Ml Injection

• T-cell acute lymphoblastic leukaemia (T-ALL) in adult and paediatric patients age 1 year and older whose disease has relapsed or is refractory following treatment with at least two chemotherapy regimens.
• T-cell lymphoblastic lymphoma (T-LBL) in adult and paediatric patients age 1 year and older whose disease has relapsed or is refractory following treatment with at least two chemotherapy regimens.

• In patients with known hypersensitivity to nelarabine or to any of the excipients in the formulation.

• Low white blood cell count (neutropenia, including febrile neutropenia)
• Low red blood cell count (anaemia), causing tiredness and weakness
• Low platelet count (thrombocytopenia), causing easy bruising or bleeding
• Infections (including sepsis, bloodstream infections, pneumonia, and fungal infections)
• Severe sleepiness (somnolence) and fatigue
• Numbness or reduced sensation in hands and feet (hypoesthesia)
• Tingling, burning, or muscle weakness in hands and feet (peripheral neuropathy)
• Dizziness and headache
• Nausea, vomiting, diarrhoea, and constipation
• Cough and breathlessness (dyspnoea)
• Muscle pain (myalgia)
• Fever (pyrexia) and fluid swelling (oedema/peripheral oedema)

• Low red blood cell count (anaemia)
• Low white blood cell count (neutropenia and leukopenia)
• Low platelet count (thrombocytopenia)
• Infections
• Low blood potassium levels (hypokalemia)
• Increased liver enzymes (transaminases increased)
• Headache
• Numbness, tingling, or weakness in hands and feet (peripheral neuropathy)

• Seizures (including grand mal convulsions and status epilepticus)
• Confusional state and loss of memory (amnesia)
• Unsteadiness or loss of coordination (ataxia), balance disorders, and tremors
• Low blood sugar (hypoglycaemia) and low blood salts (hypocalcaemia, hypomagnesaemia)
• Tumour lysis syndrome
• Stomatitis (mouth sores) and abdominal pain
• Elevated liver bilirubin and blood creatinine
• Joint pain (arthralgia) and muscle weakness

• Severe neurological reactions including coma, severe somnolence, status epilepticus, severe peripheral neuropathy, and other serious neurological disorders, which may not completely reverse even after treatment is discontinued.
• Severe infection or fever during periods of low white blood cell counts (febrile neutropenia)
• Tumour lysis syndrome, caused by the rapid breakdown of cancer cells, which can affect kidney function

Other General Warnings

• You develop confusion, altered mental state, seizures, unsteadiness, numbness, or weakness, as serious neurological toxicity can occur and may require treatment discontinuation.
• You develop fever, chills, sore throat, or other signs of infection, as low blood counts can increase infection risk.
• You have a high tumour burden, as this may increase the risk of tumour lysis syndrome (TLS); your doctor may recommend hydration and preventive treatment.
• You have kidney or liver impairment, as closer monitoring may be required.
• You are 65 years or older, as careful monitoring for neurological and other adverse effects may be needed.
• You have previously received intrathecal chemotherapy or craniospinal irradiation, as this may increase the risk of severe neurological toxicity.
• You are planning to receive vaccines, as live vaccines should be avoided during treatment.
• You are planning a family, as treatment may affect fertility and reproductive health.

• Ticelo injection must be administered only under the supervision of a physician experienced in the use of cytotoxic agents in a hospital or clinic.
• It is given strictly as an intravenous infusion directly into a vein and is administered without dilution.
• Do not miss or postpone your scheduled appointments without speaking to your oncologist.

• Ticelo injection is stored and handled exclusively by qualified hospital pharmacy staff. It is not stored or handled at home.
• Store below 25°C.
• Must be kept in original packaging and handled following standard cytotoxic waste procedures.
• Keep out of reach and sight of children.

• Report new or worsening numbness, tingling, burning, muscle weakness, or difficulty walking immediately, as serious neurological toxicity can occur and may require treatment discontinuation.
• Report fever or other signs of infection promptly, as treatment can significantly reduce blood counts.
• Avoid driving or operating machinery if you experience drowsiness, impaired alertness, or coordination problems.
• Use effective contraception during treatment. Male patients with partners who are or could become pregnant should use condoms during treatment and for at least 3 months after the last dose.
• Attend all scheduled blood tests and medical appointments to monitor blood counts and other relevant laboratory parameters.

Overdose

• No cases of overdose have been reported in clinical trials.
• An overdose would be expected to cause more severe adverse effects, particularly neurological toxicity and bone marrow suppression.
• Because this medicine is prepared and given only by trained staff in a clinical setting, the risk of accidental overdose is extremely low. If an overdose is suspected, appropriate supportive treatment and monitoring should be provided.

Missed a Dose

• Ticelo injection is administered in a hospital or clinic setting; missing a dose means missing a scheduled appointment.
• Contact your oncology team immediately if you cannot attend a scheduled session. Do not attempt to adjust your dosing schedule independently. Your physician will reschedule your infusion safely.

• Ticelo injection is a prodrug that is rapidly converted by adenosine deaminase (ADA) into ara-G. Ara-G is then converted inside cells to its active form, ara-GTP.
• Ara-GTP accumulates in leukaemic T-cells and is incorporated into DNA, disrupting DNA synthesis and preventing cell replication, ultimately causing leukaemic cell death.

Interactions with other medicines

• Tell your doctor about all prescription and OTC medicines, vitamins, supplements, and herbal products you take.
• Pentostatin: Concomitant use with nelarabine is not recommended because it may increase the risk of serious neurological toxicity.
• Intrathecal chemotherapy or craniospinal irradiation: Previous or concurrent treatment may increase the risk of neurological toxicity.
• Live vaccines: Avoid during treatment because immune suppression may increase the risk of infection and reduce vaccine effectiveness.
• Nelarabine does not significantly affect major CYP450 enzymes, so clinically significant CYP-mediated drug interactions are not expected.

Interactions with food items

• No specific food interactions have been reported, as Ticelo injection is administered intravenously.
• Adequate hydration may be recommended to help reduce the risk of hyperuricaemia and tumour lysis syndrome particularly in patients with a high tumour burden.
• Try to avoid alcohol during treatment, as it can worsen drowsiness, somnolence, and central nervous system side effects.