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Arranon

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Arranon

Arranon

Arranon Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Arranon (nelarabine) is used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. It is a chemotherapy drug. Common side effects include headache, nausea, vomiting, loss of appetite, constipation, diarrhea, cough, shortness of breath, dizziness, drowsiness, and tiredness.

The recommended adult dose of Arranon is 1,500 mg/mē administered intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days. Arranon may interact with pentostatin. Tell your doctor all medications and supplements you use. Arranon is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor about use of birth control while using this medication. If you become pregnant or think you may be pregnant, contact your doctor. It is unknown if this drug passes into breast milk. Because of possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Arranon (nelarabine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Arranon in Detail - Patient Information: Side Effects

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;
  • loss of balance or coordination;
  • weakness or trouble walking;
  • numbness and tingling in the hands, fingers, feet, or toes;
  • problems with buttoning clothes or picking up small items with your fingers;
  • blurred vision;
  • seizure (convulsions);
  • black, bloody or tarry stools; or
  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds or bleeding gums), loss of appetite, or mouth sores.

Less serious side effects may include:

  • cough;
  • headache;
  • mild stomach pain, nausea, vomiting, diarrhea, constipation;
  • redness, pain, or swelling around the IV needle; or
  • dizziness, extreme drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Arranon (Nelarabine) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Arranon Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Headache, nausea, vomiting, loss of appetite, constipation, diarrhea, cough, shortness of breath, dizziness, drowsiness, and tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, swelling ankles/feet.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

This medication may infrequently cause side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Tell your doctor immediately if you experience symptoms such as low back/side pain (flank pain), red/pinkish urine, painful urination, or muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Arranon (Nelarabine)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Arranon FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

ARRANON was studied in 459 patients in Phase I and Phase II clinical trials.

Adults

The safety profile of ARRANON is based on data from 103 adult patients treated with the recommended dose and schedule in 2 studies: an adult T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL) study and an adult chronic lymphocytic leukemia study.

The most common adverse reactions 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 reactions in adults, by System Organ Class, regardless of causality, including severe or life threatening adverse reactions (NCI Common Toxicity Criteria grade 3 or grade 4) and fatal adverse reactions (grade 5) are shown in Table 1.

Table 1: Most Commonly Reported ( > 5% Overall) Adverse Reactions Regardless of Causality in Adult Patients Treated with 1,500 mg/m² of ARRANON Administered Intravenously Over 2 Hours on Days 1, 3, and 5 Repeated Every 21 Days

System Organ Class
Preferred Term
Percentage of Patients (N = 103)
Toxicity Grade
Grade 3
%
Grade 4 and 5a
%
All Grades
%
Blood and Lymphatic System Disorders
  Anemia 20 14 99
  Thrombocytopenia 37 22 86
  Neutropenia 14 49 81
  Febrile neutropenia 9 1 12
Cardiac Disorders
  Sinus tachycardia 1 0 8
Gastrointestinal Disorders
  Nausea 0 0 41
  Diarrhea 1 0 22
  Vomiting 1 0 22
  Constipation 1 0 21
  Abdominal pain 1 0 9
  Stomatitis 1 0 8
  Abdominal distension 0 0 6
General Disorders and Administration Site Conditions
  Fatigue 10 2 50
  Pyrexia 5 0 23
  Asthenia 0 1 17
  Edema, peripheral 0 0 15
  Edema 0 0 11
  Pain 3 0 11
  Rigors 0 0 8
  Gait, abnormal 0 0 6
  Chest pain 0 0 5
  Non-cardiac chest pain 0 1 5
Infections
  Infection 2 1 9
  Pneumonia 4 1 8
  Sinusitis 1 0 7
Hepatobiliary Disorders
  AST increased 1 1 6
Metabolism and Nutrition Disorders
  Anorexia 0 0 9
  Dehydration 3 1 7
  Hyperglycemia 1 0 6
Musculoskeletal and Connective Tissue Disorders
  Myalgia 1 0 13
  Arthralgia 1 0 9
  Back pain 0 0 8
  Muscular weakness 5 0 8
  Pain in extremity 1 0 7
Nervous System Disorders (see Table 2)
Psychiatric Disorders
  Confusional state 2 0 8
  Insomnia 0 0 7
  Depression 1 0 6
Respiratory, Thoracic, and Mediastinal Disorders
  Cough 0 0 25
  Dyspnea 4 2 20
  Pleural effusion 5 1 10
  Epistaxis 0 0 8
  Dyspnea, exertional 0 0 7
  Wheezing 0 0 5
Vascular Disorders
  Petechiae 2 0 12
  Hypotension 1 1 8
a Five patients had a fatal adverse reaction. Fatal adverse reactions included hypotension (n = 1), respiratory arrest (n = 1), pleural effusion/pneumothorax (n = 1), pneumonia (n = 1), and cerebral hemorrhage/coma/leukoencephalopathy (n = 1).

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.

Neurologic Adverse Reactions: Nervous system adverse reactions, regardless of drug relationship, were reported for 76% of adult patients across the Phase I and Phase II studies. The most common neurologic adverse reactions ( > 2%) in adult patients, regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 2.

Table 2: Neurologic Adverse Reactions ( > 2%) Regardless of Causality in Adult Patients Treated with 1,500 mg/m² of ARRANON Administered Intravenously Over 2 Hours on Days 1, 3, and 5 Repeated Every 21 Days

Nervous System Disorders
Preferred Term
Percentage of Patients (N =103)
Grade 1
%
Grade 2
%
Grade 3
%
Grade 4
%
All Grades
%
Somnolence 20 3 0 0 23
Dizziness 14 8 0 0 21
Peripheral neurologic disorders, any adverse reaction 8 12 2 0 21
  Neuropathy 0 4 0 0 4
  Peripheral neuropathy 2 2 1 0 5
  Peripheral motor neuropathy 3 3 1 0 7
  Peripheral sensory neuropathy 7 6 0 0 13
Hypoesthesia 5 10 2 0 17
Headache 11 3 1 0 15
Paresthesia 11 4 0 0 15
Ataxia 1 6 2 0 9
Depressed level of consciousness 4 1 0 1 6
Tremor 2 3 0 0 5
Amnesia 2 1 0 0 3
Dysgeusia 2 1 0 0 3
Balance disorder 1 1 0 0 2
Sensory loss 0 2 0 0 2

One patient had a fatal neurologic adverse reaction, cerebral hemorrhage/coma/leukoencephalopathy.

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

The other neurologic adverse reactions, 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%).

Pediatrics

The safety profile for children is based on data from 84 pediatric patients treated with the recommended dose and schedule in a T-cell acute lymphoblastic leukemia (T- ALL)/T-cell lymphoblastic lymphoma (T-LBL) treatment study.

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

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

Table 3: Most Commonly Reported ( > 5% Overall) Adverse Reactions Regardless of Causality in Pediatric Patients Treated with 650 mg/m² of ARRANON Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days

System Organ Class
Preferred Term
Percentage of Patients (N = 84)
Toxicity Grade
Grade 3
%
Grade 4 and 5a
%
All Grades
%
Blood and Lymphatic System Disorders
  Anemia 45 10 95
  Neutropenia 17 62 94
  Thrombocytopenia 27 32 88
  Leukopenia 14 7 38
Hepatobiliary Disorders
  Transaminases increased 4 0 12
  Blood albumin decreased 5 1 10
  Blood bilirubin increased 7 2 10
Metabolic/Laboratory
  Blood potassium decreased 4 2 11
  Blood calcium decreased 1 1 8
  Blood creatinine increased 0 0 6
  Blood glucose decreased 4 0 6
  Blood magnesium decreased 2 0 6
Nervous System Disorders (see Table 4)
Gastrointestinal Disorders
  Vomiting 0 0 10
General Disorders & Administration Site Conditions
  Asthenia 1 0 6
Infections & Infestations
  Infection 2 1 5
a Three patients had a fatal adverse reaction. Fatal adverse reactions included neutropenia and pyrexia (n = 1), status epilepticus/seizure (n = 1), and fungal pneumonia (n = 1).

Neurologic Adverse Reactions: Nervous system adverse reactions, regardless of drug relationship, were reported for 42% of pediatric patients across the Phase I and Phase II studies. The most common neurologic adverse reactions ( > 2%) in pediatric patients, regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 4.

Table 4: Neurologic Adverse Reactions ( > 2%) Regardless of Causality in Pediatric Patients Treated with 650 mg/m² of ARRANON Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days

Nervous System Disorders
Preferred Term
Percentage of Patients
(N = 84)
Grade 1
%
Grade 2
%
Grade 3
%
Grade 4 and 5a
%
All Grades
%
Headache 8 2 4 2 17
Peripheral neurologic disorders, any adverse reaction 1 4 7 0 12
  Peripheral neuropathy 0 4 2 0 6
  Peripheral motor neuropathy 1 0 2 0 4
  Peripheral sensory neuropathy 0 0 6 0 6
Somnolence 1 4 1 1 7
Hypoesthesia 1 1 4 0 6
Seizures 0 0 0 6 6
  Convulsions 0 0 0 3 4
  Grand mal convulsions 0 0 0 1 1
  Status epilepticus 0 0 0 1 1
Motor dysfunction 1 1 1 0 4
Nervous system disorder 1 2 0 0 4
Paresthesia 0 2 1 0 4
Tremor 1 2 0 0 4
Ataxia 1 0 1 0 2
a One (1) patient had a fatal neurologic adverse reaction, status epilepticus.

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

The other neurologic adverse reactions, 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%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ARRANON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and Infestations: Fatal opportunistic infections.

Metabolism and Nutrition Disorders: Tumor lysis syndrome.

Nervous System Disorders: Demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome.

Musculoskeletal and Connective Disorders: Rhabdomyolysis, blood creatine phosphokinase increased.

Read the entire FDA prescribing information for Arranon (Nelarabine) »

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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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