Arranon Side Effects

Generic Name: Nelarabine

Please note - some side effects for Arranon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Arranon - for the consumer

Arranon

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Arranon:

Blurred vision; constipation; cough; diarrhea; dizziness; drowsiness; headache; loss of appetite; muscle, joint, or back pain; nausea; stomach pain; stuffy nose; tiredness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; coma; confusion; depression; fast heartbeat; fever, chills, or sore throat; loss of coordination; memory loss; mental or mood changes; numbness, burning, prickling, or tingling of the skin, hands, or feet; paralysis; seizures; severe drowsiness; shortness of breath; stomach swelling; swelling or the hands, feet, or legs; unusual bruising or bleeding; weakness; wheezing.

For the professional

Arranon

Arranon was studied in 459 patients in Phase I and Phase II clinical trials. The safety profile for the recommended dosages of Arranon is based on data from 103 adult patients enrolled and treated in the CALGB 19801 and an adult chronic lymphocytic leukemia study (PGAA2003) who were treated with the recommended dose and schedule. The safety profile for children is based on data from 84 pediatric patients enrolled and treated in the COG P9673 study who were treated with the recommended dose and schedule.

The most common adverse events in pediatric patients, regardless of causality, were hematologic disorders (anemia, leukopenia, neutropenia, and thrombocytopenia). Of the non-hematologic adverse events in pediatric patients, the most frequent events reported were headache, increased transaminase levels, decreased blood potassium, decreased blood albumin, increased blood bilirubin, and vomiting.

The most common adverse events in adults, regardless of causality, were fatigue; gastrointestinal (GI) disorders (nausea, diarrhea, vomiting, and constipation); hematologic disorders ( anemia, neutropenia, and thrombocytopenia); respiratory disorders (cough and dyspnea); nervous system disorders (somnolence and dizziness); and pyrexia.

The most common adverse events by System Organ Class, regardless of causality, including severe or life threatening events (NCI Common Toxicity Criteria grade 3 or grade 4) and fatal events (grade 5) are shown in Table 4 for pediatric patients and Table 5 for adult patients.

Grade 4+ = Grade 4 and Grade 5

Three (3) patients had a fatal event. Fatal events included neutropenia and pyrexia (n = 1), status epilepticus/seizure (n = 1), and fungal pneumonia (n = 1). The status epilepticus was thought to be related to treatment with Arranon. All other fatal events were unrelated to treatment with Arranon.

Grade 4+ = Grade 4 and Grade 5

Five (5) patients had a fatal event. Fatal events included hypotension (n=1), respiratory arrest (n=1), pleural effusion/pneumothorax (n = 1), pneumonia (n = 1), and cerebral hemorrhage/coma/leukoencephalopathy (n = 1). The cerebral hemorrhage/coma/leukoencephalopathy was thought to be related to treatment with Arranon. All other fatal events were unrelated to treatment with Arranon.

Other Adverse Events

Blurred vision was also reported in 4% of adult patients.

There was a single report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult patient population.

There have been reports of sometimes fatal opportunistic infections in patients receiving Arranon.

Neurologic Adverse Events

Nervous system events, regardless of drug relationship, were reported for 64% of patients across the Phase I and Phase II studies.

The most common neurologic adverse events (≥2%), regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 6 for pediatric patients.

Grade 4+ = Grade 4 and Grade 5

One (1) patient had a fatal neurologic event, status epilepticus. This event was thought to be related to treatment with Arranon.

The other grade 3 event in pediatric patients, regardless of causality, was hypertonia reported in 1 patient (1%). The additional grade 4+ events, regardless of causality, were 3rd nerve paralysis, and 6th nerve paralysis, each reported in 1 patient (1%).

The other neurologic adverse events, regardless of causality, reported as grade 1, 2, or unknown in pediatric patients were dysarthria, encephalopathy, hydrocephalus, hyporeflexia, lethargy, mental impairment, paralysis, and sensory loss, each reported in 1 patient (1%).

The most common neurologic adverse events (≥2%), regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 7 for adult patients.

One (1) patient had a fatal neurologic event, cerebral hemorrhage/coma/leukoencephalopathy. This event was thought to be related to treatment with Arranon.

Most nervous system events in the adult patients were evaluated as grade 1 or 2. The additional grade 3 events in adult patients, regardless of causality, were aphasia, convulsion, hemiparesis, and loss of consciousness, each reported in 1 patient (1%). The additional grade 4 events, regardless of causality, were cerebral hemorrhage, coma, intracranial hemorrhage, leukoencephalopathy, and metabolic encephalopathy, each reported in one patient (1%).

The other neurologic adverse events, regardless of causality, reported as grade 1, 2, or unknown in adult patients were abnormal coordination, burning sensation, disturbance in attention, dysarthria, hyporeflexia, neuropathic pain, nystagmus, peroneal nerve palsy, sciatica, sensory disturbance, sinus headache, and speech disorder, each reported in one patient (1%).

Other Neurologic Events

There have also been reports of events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.

Adverse Reactions from Other Clinical Programs

In addition to the safety data from the pivotal clinical trials, tumor lysis syndrome has been observed.

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