Arranon

DRUG DESCRIPTION

ARRANON (nelarabine) is a pro-drug of the cytotoxic deoxyguanosine analogue, 9-?- D-arabinofuranosylguanine (ara-G).

The chemical name for nelarabine is 2-amino-9-?-D arabinofuranosyl-6-methoxy-9H- purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27. Nelarabine has the following structural formula:

ARRANON (nelarabine) Structural Formula Illustration

Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209 and 217 C.

ARRANON Injection is supplied as a clear, colorless, sterile solution in glass vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP. ARRANON is intended for intravenous infusion.

Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0.

What are the possible side effects of nelarabine (Arranon)?

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 any of these serious side effects:

  • confusion or clumsiness;
  • lack of balance or...

Read All Potential Side Effects and See Pictures of Arranon

What are the precautions when taking nelarabine (Arranon)?

Before using nelarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), kidney problems, liver disease, numbness/tingling in hands/feet (peripheral neuropathy), seizure.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of...

Read All Potential Precautions of Arranon


Arranon Consumer (continued)

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.

PRECAUTIONS: Before using nelarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), kidney problems, liver disease, numbness/tingling in hands/feet (peripheral neuropathy), seizure.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages and other drugs that may cause drowsiness. (See also Drug Interactions.)

Caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially nervous system problems (e.g., numbness/tingling in hands/feet).

This drug is not recommended for use during pregnancy. It may harm the unborn baby. Consult your doctor for details and to discuss the use of reliable forms of birth control while using this medication. If you become pregnant or think you may be pregnant, contact your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Arranon Patient Information Including Side Effects

Brand Names: Arranon

Generic Name: nelarabine (Pronunciation: nel AR a been)

  • What is nelarabine (Arranon)?
  • What are the possible side effects of nelarabine (Arranon)?
  • What is the most important information I should know about nelarabine (Arranon)?
  • What should I discuss with my healthcare provider before receiving nelarabine (Arranon)?
  • How should I receive nelarabine (Arranon)?
  • What happens if I miss a dose (Arranon)?
  • What happens if I overdose (Arranon)?
  • What should I avoid while receiving nelarabine (Arranon)?
  • What other drugs will affect nelarabine (Arranon)?
  • Where can I get more information?

What is nelarabine (Arranon)?

Nelarabine interferes with the growth of cancer cells and slows their growth and spread in the body.

Nelarabine is used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Nelarabine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of nelarabine (Arranon)?

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 any of these serious side effects:

  • confusion or clumsiness;
  • lack 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;
  • easy bruising or bleeding, unusual weakness;
  • seizure (convulsions);
  • black, bloody or tarry stools; or
  • fever, chills, or signs of infection.

Less serious side effects may include:

  • cough;
  • headache;
  • mild stomach pain, nausea, vomiting, diarrhea, constipation;
  • redness, pain, or swelling where the IV needle was placed; or
  • weakness, dizziness, extreme sleepiness.

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 the most important information I should know about nelarabine (Arranon)?

Nelarabine may cause serious side effects of the central nervous system, such as problems with balance, coordination, or fine motor skills. 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.

Do not receive this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Nelarabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Nelarabine is given as an injection into a vein. Your doctor, nurse, or other healthcare provider will give you this injection while you are in a clinic or hospital setting. Nelarabine must be injected slowly through an IV needle. Each injection may take up to 2 hours to complete.

Do not receive a "live" vaccine while you are being treated with nelarabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Nelarabine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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