Arranon Side Effects

Generic name: nelarabine

Note: This document contains side effect information about nelarabine. Some of the dosage forms listed on this page may not apply to the brand name Arranon.

Some side effects of Arranon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to nelarabine: intravenous solution

Nelarabine may cause serious side effects of the central nervous system. These symptoms may not go away even after you stop receiving nelarabine (the active ingredient contained in Arranon) 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 while taking nelarabine: 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 coordination;

• problems with walking, breathing, speech, swallowing, or eye movement;

• numbness, weakness, or prickly feeling in your fingers or toes;

• problems with buttoning clothes or picking up small items with your fingers;

• loss of movement in any part of your body;

• seizure (convulsions);

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat; or

• severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Less serious side effects of nelarabine may include:

• cough;

• mild nausea, vomiting, diarrhea, or constipation;

• dizziness, drowsiness, feeling tired;

• joint or muscle pain;

• headache; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to nelarabine: intravenous solution

Hematologic

Hematologic side effects including anemia (99%), thrombocytopenia (86%), neutropenia (81%), and febrile neutropenia (12%) have been reported. A case of biopsy confirmed multifocal leukoencephalopathy has also been reported.

Nervous system

Nervous system side effects (64%) have been reported including somnolence (23%), dizziness (21%), peripheral neurologic disorders (21%), hypoesthesia (17%), headache (15%), paresthesia (15%), ataxia (9%), depressed level of consciousness (6%), tremor (5%), amnesia (3%), dysgeusia (3%), balance disorder (2%), and sensory loss (2%). Neurologic disorders have included peripheral sensory neuropathy (13%), peripheral motor neuropathy (7%), peripheral neuropathy (5%), neuropathy (4%), demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome.

Other

There were four reported additional fatalities unrelated to treatment with nelarabine (the active ingredient contained in Arranon)

Other side effects have included reports of sometimes fatal opportunistic infections in patients receiving nelarabine. A fatal case of cerebral hemorrhage/coma/leukoencephalopathy which was thought to be related to treatment with nelarabine has also been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (41%), diarrhea (22%), vomiting (22%), constipation (21%), abdominal pain (9%), anorexia (9%), stomatitis (8%), and abdominal distention (6%) have been reported.

General

General side effects including fatigue (50%), pyrexia (23%), asthenia (17%), peripheral edema (15%), edema (11%), pain (11%), infection (9%), rigors (8%), dehydration (7%), abnormal gait (6%), chest pain (5%), and noncardiac chest pain (5%) have been reported.

Respiratory

Respiratory side effects including cough (25%), dyspnea (20%), pleural effusion (10%), epistaxis (8%), pneumonia (8%), exertional dyspnea (7%), sinusitis (7%), and wheezing (5%) have been reported.

Hepatic

Hepatic side effects including increased AST (6%) have been reported.

Metabolic

Metabolic side effects including hyperglycemia (6%) and tumor lysis syndrome have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (13%), arthralgia (9%), back pain (8%), muscular weakness (8%), and pain in extremity (7%) have been reported. Postmarketing reports of rhabdomyolysis and increased blood creatine phosphokinase have been received.

Psychiatric

Psychiatric side effects including confusional state (8%), insomnia (7%), and depression (6%) have been reported.

Cardiovascular

Cardiovascular side effects including sinus tachycardia (8%) and hypotension (8%) have been reported.

Dermatologic

Dermatologic side effects including petechiae (12%) have been reported.

Ocular

Ocular side effects including blurred vision (4%) has been reported.

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