ARRANON (nelarabine) injection

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T-Cell Acute Lymphoblastic Lymphoma (T-LBL) T-Cell Lymphoblastic Lymphoma (T-LBL)

Diagnosis [14]

Because lymphoblastic lymphoma (LBL) can spread rapidly and affect breathing, it needs to be diagnosed and treated quickly. Since most of the symptoms of non-Hodgkin's lymphoma (NHL), including LBL, are not specific and may indicate other types of cancer or noncancerous problems, such as infections, an accurate diagnosis is needed.

There are several different biopsy procedures that may be used to accurately diagnose the lymphoma, including a fine needle biopsy and excisional or incisional biopsy. A bone marrow aspiration followed by biopsy, a lumbar puncture, or a pleural or peritoneal examination may also be used to initially diagnose the lymphoma, but are more commonly used for staging.

If a biopsy does not provide a definitive answer, other laboratory tests may be performed.
  • Flow cytometry and immunohistochemistry (IHC)—used to distinguish different types of NHL from one another as well as determine if the lymph node is enlarged due to other cancers or a benign growth
  • Cytogenics and molecular genetic studies (eg, polymerase chain reaction, fluorescent in situ hybridization)—may help differentiate certain types of NHL by identifying DNA translocations
  • Blood counts and LDH—used to determine how advanced the lymphoma is

Imaging tests such as a chest X-ray, CT scan, MRI scan, PET scan, gallium scan, bone scan, and ultrasound are useful in the diagnosis as well as the staging of cancers.

For more information regarding these diagnostic tests, please refer to the American Cancer Society (www.cancer.org).

Indication

ARRANON is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted.

Important Safety Information

ARRANON® (nelarabine) injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous use only.

Neurologic Events: Severe neurologic events have been reported with the use of ARRANON. These events 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 events associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.

Full recovery from these events has not always occurred with cessation of therapy with ARRANON. Close monitoring for neurologic events is strongly recommended, and ARRANON should be discontinued for neurologic events of NCI Common Toxicity Criteria grade 2 or greater.

In clinical studies of ARRANON, hematologic toxicity was the most common grade 3 (moderate) or 4 (severe) adverse event. For a complete list and incidence of adverse events: pediatric patients; adult patients. Hematologic toxicity included neutropenia, thrombocytopenia, anemia, febrile neutropenia, or neutropenia with infection.

Other common toxicities included laboratory abnormalities including increased transaminases, gastrointestinal toxicity, fatigue, and asthenia.

Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events.

Women of child-bearing potential should be advised to avoid becoming pregnant while receiving treatment with ARRANON.

Appropriate measures (e.g., hydration, urine alkalinization, and prophylaxis with allopurinol) must be taken to prevent hyperuricemia of tumor lysis syndrome.

Nursing should be discontinued in women who are receiving therapy with ARRANON.

Because the risk of adverse reactions to this drug may be greater in patients with severe renal impairment (CLcr <30 mL/min), these patients should be closely monitored for toxicities when treated with ARRANON.

Because the risk of adverse reactions to this drug may be greater in patients with severe hepatic impairment (bilirubin >3.0 mg/dL), these patients should be closely monitored for toxicities when treated with ARRANON.

Prescribing Information for ARRANON  |  Important Safety Information | Patient Information Leaflet

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