Arzerra

Arzerra is a prescription medication used to treat patients with leukemia. Arzerra belongs to a group of drugs called monoclonal antibodies, which work by killing cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Arzerra include cough, diarrhea, fatigue, and rash.

Arzerra can also cause dizziness. Do not drive or operate heavy machinery until you know how Arzerra affects you.

Arzerra is a prescription medication used to treat:

• previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate
• patients with CLL that have not seen a response to fludarabine and alemtuzumab
• who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL)

CLL is a cancer of the white blood cells. White blood cells help your body fight infection.

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

• Glaxo SmithKline Pharmaceuticals

• GlaxoSmithKline LLC

Serious side effects have been reported with Arzerra. See the "Arzerra Precautions" section.

Common side effects of Arzerra include:

• pneumonia
• fever
• cough
• diarrhea
• anemia
• fatigue
• difficulty breathing
• rash
• nausea
• bronchitis
• upper airway infections
• muscle spasms

This is not a complete list of Arzerra side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Arzerra including the following:

• Infusion reactions. To reduce the risk of a reaction to the infusion of Arzerra, your doctor may prescribe a corticosteroid, acetaminophen (Tylenol), and an antihistamine for you to take before you receive the infusion. Tell your healthcare provider right away if you have some or all of the symptoms of an infusion reaction:
  • shortness of breath
  • flushing
  • irregular heartbeat
  • back pain or abdominal pain
  • fever
  • rash
  • swelling of the face or throat

• Hepatitis B Virus Infection or Reactivation. Tell your doctor if you have or have ever had hepatitis B virus infection.
• Decreased quantities of certain blood cells. Arzerra can cause neutropenia (decreased white blood cells), thrombocytopenia (decreased platelets), and anemia (decreased red blood cells). Complete blood counts should be monitored during therapy with Arzerra. Tell your healthcare provider right away if you have any of the following symptoms:
  • bleeding
  • easy bruising
  • worsening weakness or fatigue
• Neurological symptoms. Tell your healthcare provider right away if you have any oif the following symptoms of new onset neurological symptoms:
  • confusion
  • dizziness
  • loss of balance
  • difficulty talking or walking
  • changes in vision

Arzerra can cause dizziness. Do not drive or operate heavy machinery until you know how Arzerra affects you.

Do not take Arzerra if you:

• are allergic to Arzerra or to any of its ingredients

Medications 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 Arzerra, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Arzerra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Arzerra or to any of its ingredients
• have or have had hepatitis B infection
• have chronic obstructive pulmonary disease (COPD)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription 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.

Arzerra falls into category C. There are no well-controlled studies that have been done in pregnant women. Arzerra should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Arzerra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Arzerra.

Take Arzerra exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

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

The recommended dosage of Arzerra for previously untreated chronic lymphocytic leukemia (CLL) is:

• 300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
• On Day 1 of the following cycles, 1,000 mg will be given for at least 3 cycles until best response or a maximum of 12 cycles

The recommended dosage of Arzerra for CLL that has not responded to previous treatment is:

• 300 mg initial dose, followed 1 week later by
• 2,000 mg weekly for 7 doses, followed 4 weeks later by
• 2,000 mg every 4 weeks for 4 doses

The recommended dosage for patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL) is:

• 300 mg on Day 1 followed by 1,000 mg on day 8 and then 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years.

If Arzerra is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Arzerra in the refrigerator between 2° and 8°C (36° and 46°F). Do not freeze.
• Protect vials from light.
• Do not receive live vaccines while taking Arzerra.

• Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ofatumumab, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
• Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ofatumumab.