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ARRANON- nelarabine injection


Patient Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hematologic Adverse Reactions

  • Advise patients that leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, have been associated with ARRANON.
  • Advise patients that complete blood counts, including platelets, will be monitored regularly during treatment[see Warnings and Precautions (5.2), Adverse Reactions (6.1)].

Embryo-Fetal Toxicity

  • Advise pregnant females of reproductive potential and males with female partners of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ARRANON. Instruct females to inform their physician of a known or suspected pregnancy.
  • Advise male patients with partners of reproductive potential to use condoms during treatment with ARRANON and for 3 months after the last dose[see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Tumor Lysis Syndrome

  • Advise patients of the risk of tumor lysis syndrome[see Warnings and Precautions (5.4), Adverse Reactions (6.1)].

Vaccinations

  • Instruct patients not to receive live vaccines during treatment with ARRANON[see Warnings and Precautions (5.5), Adverse Reactions (6.1)].

Effects on Ability to Drive and Use Machines

  • Patients receiving ARRANON may experience somnolence during and for several days after treatment. Instruct patients to not drive or engage in hazardous occupations or activities until somnolence has resolved[see Warnings and Precautions (5.6), Adverse Reactions (6.1)].

Neurologic Adverse Reactions

  • Instruct patients to contact their physician if they experience new or worsening symptoms of peripheral neuropathy[see Boxed Warning, Dosage and Administration (2.3), Warnings and Precautions (5.1), Adverse Reactions (6.1)]. These signs and symptoms include: tingling or numbness in fingers, hands, toes, or feet; difficulty with the fine motor coordination tasks such as buttoning clothing; unsteadiness while walking; weakness arising from a low chair; weakness in climbing stairs; increased tripping while walking over uneven surfaces.
  • Advise patients of the risk of seizures[see Adverse Reactions (6.1)]. If a seizure occurs, instruct patients to promptly notify the physician administering ARRANON.

Infection

  • Instruct patients to promptly notify their physician if they develop fever or signs of infection while on therapy[see Adverse Reactions (6.1, 6.2)].

Lactation

  • Advise women not to breastfeed during treatment with ARRANON[see Use in Specific Populations (8.2)].

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

Novartis

T2019-90



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