Raxibacumab for Anthrax

• raxibacumab is a prescription medicine used along with antibiotic medicines to treat people with inhalational anthrax. Raxibacumab can also be used to prevent anthrax disease when there are no other treatment options.
• The effectiveness of raxibacumab has been studied only in animals with inhalational anthrax. There have been no studies in people who have inhalational anthrax.
• The safety of raxibacumab was studied in healthy adults. There have been no studies of raxibacumab in pediatric patients.
• raxibacumab is not used for prevention or treatment of anthrax meningitis.

Before you receive raxibacumab, tell your healthcare provider about all of your medical conditions, including if you are:

• allergic to any of the ingredients in raxibacumab.
• allergic to diphenhydramine (Benadryl).

Raxibacumab may cause serious side effects, including:

• infusion reactions. Tell your healthcare provider right away if you have rash, hives, or itching while receiving raxibacumab.

The most common side effects of raxibacumab include rash, pain in your arms or legs, itchiness, and sleepiness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of raxibacumab. For more information, ask your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

• You will be given 1 dose of raxibacumab by a healthcare provider through a vein (intravenous infusion). It takes about 2 hours and 15 minutes to give you the full dose of medicine.
• Your healthcare provider should give you a medicine called diphenhydramine (Benadryl) before you receive raxibacumab to help reduce your chances of developing a skin reaction from raxibacumab. Benadryl may be given to you to take by mouth or through a vein.
• Benadryl may make you sleepy, and you should use caution if you will be driving or operating equipment.

Ciprofloxacin

Co-administration of 40 mg/kg raxibacumab intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or raxibacumab

Before you receive raxibacumab, tell your healthcare provider about all of your medical conditions, including if you are:

• pregnant or planning to become pregnant. It is not known if raxibacumab will harm your unborn baby.
• breastfeeding or plan to breastfeed. It is not known if raxibacumab passes into your breast milk. You and your healthcare provider should decide if you will receive raxibacumab or breastfeed.