Anthim

Anthim is a prescription medication used to treat inhalational anthrax. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Anthim belongs to a group of drugs called monoclonal antibodies. It works to neutralize the toxins produced by B. anthracis. 

Anthim is available as an injection and is administered by a healthcare provider. 

Common side effects of Anthim include headache, itching, and upper respiratory tract infections. 

Anthim is a prescription medication given with other appropriate antibacterial drugs to treat inhalational anthrax. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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

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

Common side effects include:

• headache
• itching (pruritus)
• upper respiratory tract infections
• cough
• nasal congestion
• hives
• bruising, swelling and pain at the infusion site

Your healthcare provider should give you a medicine called diphenhydramine (Benadryl) before you receive Anthim to help reduce your chances of developing a skin reaction from Anthim. Benadryl may make you sleepy, and you should use caution if you will be driving or operating equipment.

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 Anthim. For more information, ask your healthcare provider or pharmacist.

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. Anthim was studied when given with the antibiotic ciprofloxacin (Cipro) in human subjects, and it was determined there was no interaction for this specific medication combination. 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 Anthim including serious allergic reactions. Tell your healthcare provider right away if you have any of the following symptoms of a serious allergic reaction:

• itching
• hives
• rash
• throat irritation
• cough
• dizziness
• shortness of breath
• chest discomfort

Do not take Anthim if you are allergic to Anthim 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 Anthim, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• allergic to obiltoxaximab or any of the ingredients in Anthim. See the end of this leaflet for a list of ingredients in Anthim.
• allergic to diphenhydramine (Benadryl)
• pregnant or planning to become pregnant. It is not known if Anthim will harm your unborn baby.
• breastfeeding or plan to breastfeed. It is not known if Anthim passes into your breast milk. You and your healthcare provider should decide if you will receive Anthim or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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.

Anthim falls into category B.

There are no well-done studies that have been done in humans with Anthim. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

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

Anthim has not been evaluated in nursing women. Because of the possibility for adverse reactions in nursing infants from Anthim, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

You will be given 1 dose of Anthim by a healthcare provider through a vein (IV or intravenous infusion). It takes about 1 hour and 30 minutes to give you the full dose of medicine.

Your healthcare provider should give you a medicine called diphenhydramine (Benadryl) before you receive Anthim to help reduce your chances of developing a skin reaction from Anthim. 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.

The recommended dosage of Anthim in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes).

The recommended dosage of Anthim in pediatric patients greater than 40 kg is 16 mg/kg.

The recommended dosage of Anthim in pediatric patients greater than 15 kg to 40 kg is 24 mg/kg.

The recommended dosage of Anthim in pediatric patients less than or equal to 15 kg is 32 mg/kg.

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

If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Anthim that is written for health professionals.

WARNING: HYPERSENSITIVITY AND ANAPHYLAXIS
Hypersensitivity and anaphylaxis (severe allergic reaction) have been reported during the intravenous infusion of Anthim. Due to the risk of hypersensitivity and anaphylaxis, Anthim should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive Anthim closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop Anthim infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.