Nelarabine

What is Nelarabine?

• Nelarabine (Arranon) is a nucleoside metabolic inhibitor used for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

Nelarabine

Nelarabine ball-and-stick

What are the uses of this medicine?

Arranon is an anti-cancer medicine used to treat in adult and pediatric patients age 1 year and older who have:

• T-cell acute lymphoblastic leukemia (T-ALL)
• T-cell lymphoblastic lymphoma (T-LBL)

How does this medicine work?

• Nelarabine is a prodrug of arabinosylguanine nucleotide triphosphate (araGTP), a type of purine nucleoside analog, which causes inhibition of DNA synthesis and cytotoxicity.
• Nelarabine is demethylated by ADA to ara-G, mono-phosphorylated by deoxyguanosine kinase and deoxycytidine kinase, and subsequently converted to the active 5’-triphosphate, ara-GTP.
• Accumulation of ara-GTP in leukemic blasts allows for incorporation into deoxyribonucleic acid (DNA), leading to inhibition of DNA synthesis and cell death.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended.

Is this medicine FDA approved?

• In October 2005, it was approved by the FDA for acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma that has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
• It was later approved in the European Union in October 2005.

How should this medicine be used?

Recommended dosage:

• Adult Dose: 1500 mg/m2 administered intravenously over 2 hours on Days 1, 3, and 5 repeated every 21 days.
• Pediatric Dose: 650 mg/m2 administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days.

Administration:

• Administer Arranon undiluted.
• Transfer the appropriate dose of Arranon into polyvinylchloride (PVC) infusion bags or glass containers and administer as a 2-hour infusion in adult patients and as a 1-hour infusion in pediatric patients.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 250 mg/50 mL (5 mg/mL) single-dose vial.

This medicine is available in fallowing brand namesː

• Arranon

What side effects can this medication cause?

The most common side effects of this medicine include:

• Adult: anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea.
• Pediatric: anemia, neutropenia, thrombocytopenia, and leukopenia.

The most common neurological adverse reactions were: Adult: somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia. Pediatric: headache and peripheral neurologic disorders.

What special precautions should I follow?

• Severe neurologic reactions have been reported. Monitor for signs and symptoms of neurologic toxicity.
• Leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, have been associated with Arranon therapy. Complete blood counts including platelets should be monitored regularly.
• Based on its mechanism of action and findings in animal studies, Arranon can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with Arranon. Advise males with female partners of reproductive potential to use condoms during treatment with Arranon and for 3 months after the last dose.
• Patients receiving Arranon should receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumor lysis syndrome.
• Avoid the administration of live vaccines to immunocompromised patients.
• Patients treated with Arranon may experience somnolence during and for several days after treatment.
• Advise patients to refrain from driving or engaging in hazardous occupations or activities until somnolence has resolved.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• neurotoxicity (possibly including paralysis, coma), myelosuppression, and potentially death

Management of overdosage:

• There is no known antidote for overdoses of Arranon.
• In the event of overdose, supportive care consistent with good clinical practice should be provided.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animal studies, Arranon can cause fetal harm when administered to a pregnant woman.
• Limited available data with Arranon use in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal, or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Arranon for relapsed or refractory T-ALL and T-LBL has been established in pediatric patients age 1 year and older.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• NELARABINE

Inactive ingredients:

• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store Arranon (nelarabine) Injection between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Nelarabine
• FDA Nelarabine

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