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Arranon (GlaxoSmithKline)

Arranon (GlaxoSmithKline) - General Information

Arranon (GlaxoSmithKline) is a chemotherapy drug used in T-cell acute lymphoblastic leukemia. Arranon (GlaxoSmithKline) is a purine nucleoside analog converted to its corresponding arabinosylguanine nucleotide triphosphate (araGTP), resulting in inhibition of DNA synthesis and cytotoxicity.

 

Pharmacology of Arranon (GlaxoSmithKline)

Arranon (GlaxoSmithKline) is a purine nucleoside analog converted to its corresponding arabinosylguanine nucleotide triphosphate (araGTP), resulting in inhibition of DNA synthesis and cytotoxicity. Pre-clinical studies suggest that T-cells are particularly sensitive to nelarabine.

 

Arranon (GlaxoSmithKline) for patients

ARRANON (AIR-ra-non)
Nelarabine Injection

Read the Patient Information that comes with ARRANON before you or your child start treatment with ARRANON. Read the information you get each time before each treatment with ARRANON. There may be new information. This information does not take the place of talking with the doctor about your or your childs medical condition or treatment. Talk to your or your childs doctor, if you have any questions.

What is the most important information I should know about ARRANON?

ARRANON may cause serious nervous system problems including:

- extreme sleepiness
- seizures
- coma
- numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
- weakness and paralysis

Call the doctor right away if you or your child has the following symptoms:

- seizures
- numbness and tingling in the hands, fingers, feet, or toes
- problems with fine motor skills such as buttoning clothes
- unsteady while walking
- increased tripping while walking
- weakness when getting out of a chair or walking up stairs

These symptoms may not go away even when treatment with ARRANON is stopped.

What is ARRANON?

ARRANON is an anti-cancer medicine used to treat adults and children who have:

- T-cell acute lymphoblastic leukemia
- T-cell lymphoblastic lymphoma

Who should not take ARRANON?

You or your child should not take ARRANON if you or your child are allergic to nelarabine, or to anything else in ARRANON.

What should I tell the doctor before I or my child starts ARRANON?

Tell the doctor about all health conditions you or your child have, including if you or your child:

- have any nervous system problems.
- have kidney problems.
-are pregnant or plan to become pregnant. ARRANON may harm an unborn baby. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.
- are breast feeding. It is not known whether ARRANON passes through breast milk. You should not breast feed during treatment with ARRANON.

Tell the doctor about all the medicines you or your child take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

How is ARRANON given?

- ARRANON is an IV medicine. This means it is given through a tube in your vein.

What should I or my child avoid during treatment with ARRANON?

- You or your child should not drive or operate dangerous machines. ARRANON may cause sleepiness.
- You or your child should not receive vaccines made with live germs during treatment with ARRANON.

What are the possible side effects of ARRANON?

ARRANON may cause serious nervous system problems. See "What is the most important information I should know about ARRANON?"

ARRANON may also cause:

- decreased blood counts such as low red blood cells, low white blood cells, and low platelets. Call the doctor right away if you or your child:
- is more tired than usual, pale, or has trouble breathing
- has a fever or other signs of an infection
- bruises easy or has any unusual bleeding
Blood tests should be done regularly to check blood counts.
- stomach area problems such as nausea, vomiting, diarrhea, and constipation
- headache
- sleepiness
- blurry eyesight

These are not all the side effects with ARRANON. Ask your doctor or pharmacist for more information.

General Advice about ARRANON

This leaflet summarizes important information about ARRANON. If you have questions or problems, talk with your or your child's doctor. You can ask your doctor or pharmacist for information about ARRANON that is written for healthcare providers or it is available at www.GSK.com.

 

Arranon (GlaxoSmithKline) Interactions

 

Arranon (GlaxoSmithKline) Contraindications

ARRANON is contraindicated in patients who have a history of hypersensitivity to nelarabine or any other components of ARRANON.

 

Additional information about Arranon (GlaxoSmithKline)

Arranon (GlaxoSmithKline) Indication: For the treatment of pediatric and adult patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Mechanism Of Action: Arranon (GlaxoSmithKline) is a prodrug of the cytotoxic deoxyguanosine analogue 9-ß-D-arabinofuranosylguanine (ara-G). The drug is ultimately metabolized into the active 5'-triphosphate ara-GTP, which disrupts DNA synthesis and induces apoptosis. Additional cytotoxic activities may exist, but these are not fully understood.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Nelarabine
Synonyms: Nelzarabine
Drug Category: Antineoplastic Agents
Drug Type: Small Molecule; Approved
Other Brand Names containing Nelarabine: Arranon (GlaxoSmithKline);
Absorption: Not Available
Toxicity (Overdose): A single IV dose of 4,800 mg/m^2 was lethal in monkeys, and was associated with CNS signs including reduced/shallow respiration, reduced reflexes, and flaccid muscle tone. It is anticipated that overdosage would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression, and potentially death.
Protein Binding: Nelarabine and ara-G are not substantially bound to human plasma proteins (<25%) in vitro, and binding is independent of nelarabine or ara-G concentrations up to 600 mM.
Biotransformation: The principal route of metabolism for nelarabine is O-demethylation by adenosine deaminase to form ara-G, which undergoes hydrolysis to form guanine. In addition, some nelarabine is hydrolyzed to form methylguanine, which is O-demethylated to form guanine. Guanine is N-deaminated to form xanthine, which is further oxidized to yield uric acid. Ring opening of uric acid followed by further oxidation results in the formation of allantoin.
Half Life: Nelarabine and ara-G are rapidly eliminated from plasma with a half-life of approximately 30 minutes and 3 hours.
Dosage Forms of Arranon (GlaxoSmithKline): Injection, solution Intravenous
Chemical IUPAC Name: (2R,3S,4S,5R)-2-(2-amino-6-methoxypurin-9-yl)-5-(hydroxymethyl)oxolane-3,4-diol
Chemical Formula: C11H15N5O5
Nelarabine on Wikipedia: http://en.wikipedia.org/wiki/Nelarabine
Organisms Affected: Humans and other mammals