"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease"...
NEUROLOGIC ADVERSE REACTIONS
Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome [see WARNINGS AND PRECAUTIONS].
Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic adverse reactions is strongly recommended, and ARRANON should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria grade 2 or greater [see WARNINGS AND PRECAUTIONS].
ARRANON (nelarabine) is a pro-drug of the cytotoxic deoxyguanosine analogue, 9-β- D-arabinofuranosylguanine (ara-G).
The chemical name for nelarabine
is 2-amino-9-β-D arabinofuranosyl-6-methoxy-9H- purine. It has the
molecular formula C11H15N5O5 and a molecular weight of 297.27. Nelarabine has
the following structural formula:
Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209° and 217° C.
ARRANON Injection is supplied as a clear, colorless, sterile solution in glass vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. ARRANON is intended for intravenous infusion.
Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.
What are the possible side effects of nelarabine (Arranon)?
Nelarabine may cause serious side effects of the central nervous system. These symptoms may not go away even after you stop receiving nelarabine. Talk with your doctor if you have concerns about any possible long-term side effects.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- confusion or clumsiness, extreme drowsiness, fainting;
- loss of balance or...
What are the precautions when taking nelarabine (Arranon)?
Before using nelarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), kidney problems, liver disease, numbness/tingling in hands/feet (peripheral neuropathy), seizure.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of...
Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Arranon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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