Arranon

Arranon is a prescription medication used to treat relapsed or refractory T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma (rare cancer of the immune system's own T-cells). Arranon belongs to a group of drugs called antineoplastic agents. These medications work by interfering with the growth and spread of cancer cells in the body.

Arranon is a prescription anti-cancer medicine used to treat adults and children who have:

• T-cell acute lymphoblastic leukemia
• T-cell lymphoblastic lymphoma

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• GlaxoSmithKline LLC

Arranon may cause serious nervous system problems. See “Arranon Precautions”.

Common side effect of Arranon include:

• decreased blood counts such as low red blood cells, low white blood cells, and low platelets. Blood tests should be done regularly to check blood counts. Call the doctor right away if you or your child:
  • is more tired than usual, pale, or has trouble breathing
  • has a fever or other signs of an infection
  • bruises easy or has any unusual bleeding
• stomach area problems such as nausea, vomiting, diarrhea, and constipation
• headache
• sleepiness
• blurry eyesight

Call your doctor right away if you experience unexplained muscle pain, tenderness, or weakness while taking Arranon. This is because on rare occasions, muscle problems can be serious.

These are not all the side effects associated with Arranon. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take pentostatin (Nipent).

This is not a complete list of Arranon drug interactions. Ask your doctor or pharmacist for more information.

Arranon may cause serious nervous system problems including:

• extreme sleepiness
• seizures
• coma
• numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
• weakness and paralysis

Call the doctor right away if you or your child has the following symptoms:

• seizures
• numbness and tingling in the hands, fingers, feet, or toes
• problems with fine motor skills such as buttoning clothes
• unsteadiness while walking
• increased tripping while walking
• weakness when getting out of a chair or walking up stairs

These symptoms may not go away even when treatment with Arranon is stopped.

• You or your child should not drive or operate dangerous machines. Arranon may cause sleepiness.
• You or your child should not receive vaccines made with live germs during treatment with Arranon.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Arranon there are no specific foods that you must exclude from your diet when receiving this medication.

Tell the doctor about all health conditions you or your child have, including if you or your child:

• have any nervous system problems.
• have kidney problems.
• are breastfeeding or plan to breastfeed. It is not known whether Arranon passes through breast milk. You should not breastfeed during treatment with Arranon.
• are pregnant or plan to become pregnant. Arranon may harm an unborn baby. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.

Tell the doctor about all the medicines you or your child take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Arranon passes through breast milk. You should not breastfeed during treatment with Arranon.

Arranon is an intravenous medicine. This means it is given through a tube in your vein, usually by a doctor or nurse in a medical setting.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Adult dose: 1,500 mg/m² injected over 2 hours on days 1, 3, and 5 repeated every 21 days.

Pediatric dose: 650 mg/m² injected over 1 hour daily for 5 consecutive days repeated every 21 days.

Arranon is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: NEUROLOGIC ADVERSE REACTIONS

Severe neurologic adverse reactions have been reported with the use of Arranon. These adverse reactions 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 adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome.

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