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Obiltoxaximab

Medically reviewed by Drugs.com. Last updated on May 29, 2020.

Pronunciation

(oh bil tox AX i mab)

Index Terms

  • Anthim

Pharmacologic Category

  • Antidote
  • Monoclonal Antibody

Pharmacology

Obiltoxaximab is a monoclonal antibody that binds the free protective antigen component of B. anthracis toxin thereby preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin.

Distribution

Greater than plasma volume (eg, some tissue distribution).

Excretion

Minimal renal elimination

Use: Labeled Indications

Anthrax, inhalational:

Treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs

Prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate

Limitations of use: Should only be used for prophylaxis when the benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis.

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Anthrax, inhalational (treatment and prophylaxis): IV: Note: Premedicate with diphenhydramine prior to infusion.

<40 kg: 24 mg/kg/dose as a single dose

>40 kg: 16 mg/kg/dose as a single dose

Dosing: Geriatric

Refer to adult dosing

Dosing: Pediatric

Note: Premedicate with diphenhydramine prior to infusion.

Anthrax, inhalational; treatment and prophylaxis: Infants, Children, and Adolescents: IV:

≤15 kg: 32 mg/kg as a single dose

>15 kg to 40 kg: 24 mg/kg as a single dose

>40 kg: 16 mg/kg as a single dose

Reconstitution

IV bag for infusion: Volume of prepared solution for infusion is based upon patient weight. Select an appropriate size bag of NS (outlined below) and withdraw a volume of solution from the bag equal to the calculated volume of obiltoxaximab needed for the patient dose. Discard the solution that was withdrawn from the bag. Inject obiltoxaximab dose into the bag and gently invert to mix; do not shake.

IV syringe for infusion: Volume of prepared solution for infusion is based upon patient weight. Select an appropriate size syringe for the total volume of infusion (outlined below). Withdraw obiltoxaximab dose into syringe, then withdraw an appropriate volume of NS into syringe to equal the total infusion volume needed. Gently mix the solution; do not shake.

Total obiltoxaximab infusion volume by body weight:

≥31 kg or adult: 250 mL

11 to 30 kg: 100 mL

5 to 10 kg: 50 mL

3.1 to 4.9 kg: 25 mL

2.1 to 3 kg: 20 mL

1.1 to 2 kg: 15 mL

≤1 kg or less: 7 mL

Administration

IV: Premedication with diphenhydramine is recommended. Administer prepared solution (IV infusion bag or syringe) using a 0.22 micron inline filter over 1 hour and 30 minutes. Flush the line with NS at the end of the infusion.

Storage

Store in refrigerator at 2°C to 8°C (36°F to 46°F); protect from light. Do not freeze or shake. Prepared solution in NS in an IV bag for infusion is stable at room temperature or refrigerated for up to 8 hours after admixture. Prepared solution in a syringe for infusion should be administered immediately; do not store.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%: Central nervous system: Headache (8% to 16%)

1% to 10%:

Cardiovascular: Chest discomfort (<2%), chest pain (<2%), palpitations (<2%)

Central nervous system: Dizziness (<2%), fatigue (<2%), voice disorder (<2%)

Dermatologic: Skin rash (7%), pruritus (4%), urticaria (2%)

Gastrointestinal: Vomiting (<2%), xerostomia (<2%)

Hematologic & oncologic: Abnormal lymphocyte count (decreased: <2%), change in neutrophil count (decreased: <2%), decreased white blood cell count (<2%)

Hypersensitivity: Hypersensitivity reaction (11%)

Immunologic: Antibody development (3%; no evidence of therapeutic efficacy not altered)

Local: Infusion site reaction (erythema: 4%), bruising at injection site (3%), local discoloration (at infusion site: <2%)

Neuromuscular & skeletal: Limb pain (2%), increased creatine phosphokinase (<2%), musculoskeletal pain (<2%), myalgia (<2%)

Respiratory: Cough (3% to 8%), upper respiratory tract infection (5%), throat irritation (3%), rhinorrhea (<2% to 3%), nasal congestion (2%), cyanosis (<2%), dyspnea (<2%), oropharyngeal pain (<2%), sinus congestion (<2%)

Miscellaneous: Fever (<2%), infusion related reaction (swelling: <2%)

<1%, postmarketing, and/or case reports: Anaphylaxis

ALERT: U.S. Boxed Warning

Hypersensitivity and anaphylaxis:

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

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: [US Boxed Warning]: Hypersensitivity or anaphylactic reactions (eg, rash/urticaria, cough, dyspnea, cyanosis, postural dizziness, chest discomfort) may occur. Administer in a monitored setting; monitor patients closely for signs and symptoms of hypersensitivity during and after the infusion. If hypersensitivity or anaphylaxis occurs, discontinue the infusion immediately and treat appropriately.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). Refer to manufacturer's labeling.

Monitoring Parameters

Monitor patients closely for signs and symptoms of hypersensitivity during and after the infusion.

Pregnancy Considerations

Obiltoxaximab is a chimeric monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Untreated maternal anthrax infection has a high risk of maternal, fetal, and neonatal death. In general, guidelines for the prophylaxis and treatment of inhalational anthrax following exposure to Bacillus anthracis in pregnant and postpartum women are the same as nonpregnant adults (Meaney-Delman 2014).

Patient Education

What is this drug used for?

• It is used to prevent or treat anthrax.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Cough

• Shortness of breath

• Blue/gray skin discoloration

• Dizziness

• Passing out

• Chest pain

• Sore throat

• Trouble speaking

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about obiltoxaximab

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