Most of our services do not require any form of registration or the provision of personal information, allowing you to visit our site without telling us who you are. However, some services may require you to provide us with personal data so you can benefit from specified features. In these situations, if you choose to withhold any personal data requested by us, it may not be possible for you to gain access to certain parts of the site or for us to respond to your query. You will be informed what information is required and what information is optional. In addition to personal information that you provide to us, we may gather information about you automatically though your use of this Web site via technical tools (e.g., Web server logs, cookies, etc.). The purpose of gathering such information is to improve the user experience with this Web site.
We may collect and use your personal data to provide you with products or services, to market products or services that we think may be of interest to you, or to communicate with you for other purposes, which will be evident from the circumstances or about which we inform you when we collect your personal data. We may also use information collected via this site to improve the content of our site, for our marketing and research purposes, and for any other legitimate business purpose. In addition, we may make full use of all information acquired through this site that is not personal data.
As a general matter, we will not sell, share, or otherwise distribute your personal data to third parties. However, there may be instances in which we contract with third parties/service providers, in which case we will require that those parties with whom we share personal data treat that data with the same degree of confidentiality and protections that we utilize.
To ensure that the personal data you may provide remains accurate, current, and complete, please contact us as explained below as needed, and we will take reasonable steps to update such information in our possession, or to delete your information from our contact list as appropriate.
We take reasonable organizational, administrative, and technical measures to protect personal data as you transmit it to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction.
ANTHIM® (obiltoxaximab) is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs. ANTHIM is indicated for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate.
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity and anaphylaxis 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.
Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough.
Premedication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions (occurred in >1.5% of healthy subjects) were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
No adequate and well-controlled studies in pregnant women were conducted. Because animal reproduction studies are not always predictive of human response, ANTHIM should be used during pregnancy only if clearly needed.
There have been no studies of the safety or PK of ANTHIM in the pediatric population.