Raxibacumab (Nat'l Stockpile) (raxibacumab)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*Premedicate with diphenhydramine.

*Dilute and administer as an IV infusion over 2 hours and 15 minutes.

*Administer raxibacumab in monitored settings appropriately equipped to manage hypersensitivity, anaphylaxis, and shock.

*The recommended dose of raxibacumab is weight-based, given as an IV infusion after dilution in a compatible solution to a final volume of 250 mL in adults or to a volume indicated based on the child's weight.

*Recommended Dosage in Adults: 40 mg/kg.

*Recommended Dosage in Pediatric Patients Weighing Greater than 40 kg: 40 mg/kg.

*Recommended Dosage in Pediatric Patients Weighing Greater than 10 kg to 40 kg: 60 mg/kg.

*Recommended Dosage in Pediatric Patients Weighing 10 kg or Less: 80 mg/kg.

*See Full Prescribing Information for additional details on preparation and administration of raxibacumab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

Common adverse reactions in healthy adult subjects (>=1.5%) were injection site reaction, erythema and pain, headache, rash, pain in extremity, pruritus, and somnolence.

Rare or Very Rare

• Anaphylaxis
• Anemia
• Chest tightness
• Dyspnea
• Elevated serum amylase
• Hypersensitivity drug reaction
• Hypertension
• Hypotension
• Increased creatine kinase level
• Leukopenia
• Myoclonus
• Throat constriction
• Urticaria

More Frequent

• Drowsy
• Headache disorder
• Injection site erythema
• Injection site pain
• Pain in extremities
• Pruritus of skin
• Skin rash

Rare or Very Rare

• Back pain
• Erythema
• Fatigue
• Flushing
• Insomnia
• Lymphadenopathy
• Muscle spasm
• Palpitations
• Peripheral edema
• Syncope
• Vertigo

No enhanced messaging available.

As in adults, the effectiveness of raxibacumab in pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. As exposure of healthy children to raxibacumab is not ethical, an extrapolation approach was used to derive dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 40 mg/kg. The dose for pediatric patients is based on weight.

Safety or pharmacokinetics of raxibacumab have not been studied in the pediatric population.

There are no data on the use of raxibacumab in pregnant women to inform on drug-associated risk. In pregnant rabbits, IV administration of raxibacumab was not associated with teratogenicity or other adverse developmental outcomes at 3 times the human maximum plasma concentrations at the maximum recommended adult dose.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background rate of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment.

There is no information available on the presence of raxibacumab in human milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk.

Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for raxibacumab and any potential adverse effects on the breastfed child from raxibacumab or from the underlying maternal condition.

Clinical trials of raxibacumab did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Of the total number of subjects in clinical trials of raxibacumab, 6.4% (21/326) were 65 years of age and older, while 1.5% (5/326) were 75 years of age and older. However, no alteration of dosing is needed for patients 65 years of age and older.