Obiltoximab- Anthim -@-(March 2016)- Antibacterial
Drug Name:Obiltoximab- Anthim -@-(March 2016)- Antibacterial
List Of Brands:
Indication Type Description:
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
3. Anthim Obiltoxaimab 3/18/2016 To treat inhalational anthrax in
combination with appropiate genoytpes 1 and 4 infections antibacterial drugs
Press Release
Drug trials Snapshot
Approved by FDA on 3/18/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ANTHIM safely and effectively. See full prescribing information for ANTHIM.
ANTHIM® (obiltoxaximab) injection, for intravenous use
Initial U.S. Approval: 2016
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning.
• Hypersensitivity reactions, including anaphylaxis, have been
reported during ANTHIM infusion
• ANTHIM should be administered in monitored settings by
personnel trained and equipped to manage anaphylaxis
• Stop ANTHIM infusion immediately and treat appropriately if
hypersensitivity or anaphylaxis occurs
INDICATIONS AND USAGE
ANTHIM® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Limitations of Use
• ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis.
• The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.
• There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach.
• ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs.
• ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis
Adverse Reaction:
ADVERSE REACTIONS
Most frequently reported adverse reactions in healthy adult subjects (=1.5%)
were headache, pruritus, infections of the upper respiratory tract, cough,
vessel puncture site bruise, infusion site swelling, nasal congestion, infusion
transit pain, urticaria and pain in extremity
Contra-Indications:
CONTRAINDICATIONS
None
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
See full prescribing information for complete( boxed warning.)
Hypersensitivity reactions, including anaphylaxis, have been
reported during ANTHIM infusion
ANTHIM should be administered in monitored settings by
personnel trained and equipped to manage anaphylaxis
Stop ANTHIM infusion immediately and treat appropriately if
hypersensitivity or anaphylaxis occurs
Dosages/ Overdosage Etc:
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning.
• Hypersensitivity reactions, including anaphylaxis, have been
reported during ANTHIM infusion
• ANTHIM should be administered in monitored settings by
personnel trained and equipped to manage anaphylaxis
• Stop ANTHIM infusion immediately and treat appropriately if
hypersensitivity or anaphylaxis occurs
INDICATIONS AND USAGE
ANTHIM® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Limitations of Use
• ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis.
• The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax.
• There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach.
• ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs.
• ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis
DOSAGE AND ADMINISTRATION
1 Dosage for Adult Patients
? Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions
? Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion
? 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)
2 Dosage for Pediatric Patients
? Pre-medicate with diphenhydramine prior to administering ANTHIM
? Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion
? The recommended dose for pediatric patients is based on weight as shown below
Recommended Pediatric Dose of ANTHIM (weight-based dosing)
Body Weight Dose Greater than 40 kg 16 mg/kg Greater than 15 kg to 40 kg 24 mg/kg Less than or equal to 15 kg 32 mg/kg
? Administer the recommended dose of ANTHIM intravenously over 90 minutes (1 hour and 30 minutes)
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling
(Patient Information).
Inform patients that:
1.The effectiveness of ANTHIM has been studied only in animals with
inhalational anthrax. ANTHIM has not been tested in people who have
inhalational anthrax.
2. The safety of ANTHIM has been studied in healthy adults, but no safety
data are available in pediatric patients or pregnant women. Limited data
are available in geriatric subjects
3.Hypersensitivity Reactions and Anaphylaxis
Inform patients that hypersensitivity reactions, including anaphylaxis, have
occurred with administration of ANTHIM.
Inform patients of the signs and symptoms of hypersensitivity reactions and
anaphylaxis and instruct patients to seek immediate medical care if they
experience such symptoms during or following administration of ANTHIM.
Manufactured by:
Elusys Therapeutics, Inc.
25 Riverside Drive
Unit 1
Pine Brook, NJ 07058
U.S. License Numb
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Obiltoxaximab is a monoclonal antibody that binds the PA of B. anthracis.
2. Pharmacokinetics
The PK of obiltoxaximab are linear over the dose range of 4 mg/kg
(0.25 times the lowest recommended dose) to 16 mg/kg following
single IV administration in healthy subjects. Following single IV
administration of ANTHIM 16 mg/kg in healthy, male and female human
subjects, the mean Cmax and AUCinf were 400 ± 91.2 mcg/mL and
5170 ± 1360 mcg•day/mL, respectively.
Distribution
Mean obiltoxaximab steady-state volume of distribution was greater than
plasma volume, suggesting some tissue distribution.
Elimination
Clearance values were much smaller than the glomerular filtration rate,
indicating that there is virtually no renal clearance of obiltoxaximab.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category B
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.
2. Nursing Mothers
ANTHIM has not been evaluated in nursing women. Although human
immunoglobulins are excreted in human milk, published data suggest
that neonatal consumption of human milk does not result in substantial
absorption of these maternal immunoglobulins into circulation. Inform
a nursing woman that the effects of local gastrointestinal and systemic
exposure to ANTHIM on nursing infant are unknown.
3.Pediatric Use
As in adults, the effectiveness of ANTHIM in pediatric patients is based
solely on efficacy studies in animal models of inhalational anthrax.
As exposure of healthy children to ANTHIM is not ethical, a population PK
approach was used to derive intravenous dosing regimens that are
predicted to provide pediatric patients with exposure comparable to the
observed exposure in adults receiving 16 mg/kg.
The dose for pediatric patients is based on weight . There have been no
studies of safety or PK of ANTHIM in the pediatric population.
4.Geriatric Use
Clinical studies of ANTHIM did not include sufficient numbers of subjects aged
65 years and over to determine whether they respond differently from younger
subjects.
Of the 320 subjects in clinical studies of ANTHIM, 9.4% (30/320) were 65 years
and over, while 2% (6/320) were 75 years and over. No alteration of dosing is
needed for patients =65 years of age.
5. OVERDOSAGE
There is no clinical experience with overdosage of ANTHIM.
In case of overdosage, monitor patients for any signs or symptoms of
adverse effects.
