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Arranon (Nelarabine) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions

Nelarabine and ara-G did not significantly inhibit the activities of the human hepatic cytochrome P450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4 in vitro at concentrations of nelarabine and ara-G up to 100 μM.

There is in vitro evidence that pentostatin is a strong inhibitor of adenosine deaminase. This may result in a reduction in the conversion of the pro-drug nelarabine to its active moiety and consequently in a reduction in efficacy of nelarabine and/or change in adverse event profile of either drug. Administration of nelarabine in combination with adenosine deaminase inhibitors, such as pentostatin, is not recommended.

OVERDOSAGE

There is no known antidote for overdoses of ARRANON. It is anticipated that overdosage would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression, and potentially death. In the event of overdose, supportive care consistent with good clinical practice should be provided.

Nelarabine has been administered in clinical trials up to a dose of 2,900 mg/m2 on days 1, 3, and 5 to 2 adult patients. At a dose of 2,200 mg/m2 given on days 1, 3, and 5 every 21 days, 2 patients developed a significant grade 3 ascending sensory neuropathy. MRI evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.

A single IV dose of 4,800 mg/m2 was lethal in monkeys, and was associated with CNS signs including reduced/shallow respiration, reduced reflexes, and flaccid muscle tone.

CONTRAINDICATIONS

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

REFERENCES

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
  2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health and Human Services, 1992, US Dept of Health and Human Services, Public Health Service publication NIH 92-2621.
  3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA.  1985;253:1590-1591.
  4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
  5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
  6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
  7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
  8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.
  9. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.

GlaxoSmithKline

Research Triangle Park, NC 27709

ARRANON is a registered trademark of GlaxoSmithKline.

©2006, GlaxoSmithKline. All rights reserved.

July 2006 RL-2297

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

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PATIENT INFORMATION LEAFLET

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 child’s medical condition or treatment. Talk to your or your child’s 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
  • unsteadiness 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 associated 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.

GlaxoSmithKline

Research Triangle Park, NC 27709

ARRANON is a registered trademark of GlaxoSmithKline.

©2006, GlaxoSmithKline. All rights reserved.

July 2006 RL-2297

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