Niktimvo (axatilimab-csfr)

Table 1: Recommended Dosage Modification for Axatilimab-csfr Adverse Reactions

Adverse Reaction Dosage Modification Based on Severity Infusion-related reactions Grade 1 or 2: Temporarily interrupt infusion until resolution or decrease infusion rate by 50%. Initiate symptomatic treatment (e.g., antihistamines or antipyretics). For subsequent infusions, premedicate and resume infusion at 50% of prior infusion rate. Grade 3 or 4: Permanently discontinue. Elevation of AST or ALT (on day of Grade 3 with total bilirubin <=Grade dosing) 1: Withhold until recovery to Grade 2, then resume at 0.2 mg/kg (maximum 23 mg) every 2 weeks. Elevation of AST or ALT (regardless ALT or AST >=3 times ULN with total of time of reaction) bilirubin >=2 times ULN and ALP <2 times ULN: Withhold and investigate for drug-induced liver injury. If confirmed, permanently discontinue. Grade 4: Permanently discontinue. Elevation of CPK, amylase, or lipase Grade 3 or higher: If diagnostic evaluation results show no evidence of end-organ damage, continue without dose reduction. If diagnostic evaluation shows evidence of end-organ damage, permanently discontinue. Symptomatic Grade 3 or higher: Permanently dis continue. Other nonhematologic adverse Grade 3: Withhold until recovery to reactions Grade 2. If delayed by <=4 weeks from planned infusion, resume at 0.2 mg/kg (maximum 23 mg) every 2 weeks. If delayed >4 weeks from planned infusion, permanently discontinue. Grade 4: Permanently discontinue.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed to date. Due to its mechanism of action, there is a low likelihood of drug interactions with axatilimab-csfr.

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.

• Lactation

• Pregnancy

There are no moderate contraindications for this drug.

The most common adverse reactions (>=15%), including laboratory abnormalities, reported with axatilimab-csfr in clinical studies were, increased aspartate aminotransferase (AST), infection (pathogen unspecified), increased alanine aminotransferase (ALT), decreased phosphate, decreased hemoglobin, viral infection, increased gamma-glutamyl transferase (GGT), musculoskeletal pain, increased lipase, fatigue, increased amylase, increased calcium, increased creatine phosphokinase (CPK), increased alkaline phosphatase (ALP), nausea, headache, diarrhea, cough, bacterial infection, pyrexia, and dyspnea.

More Frequent

• Bacterial infection
• Infection
• Viral infection

More Frequent

• Abnormal hepatic function tests
• Anemia
• Anorexia
• Cough
• Diarrhea
• Dizziness
• Dyspnea
• Edema
• Elevated serum amylase
• Elevated serum lipase
• Fatigue
• Fever
• Headache disorder
• Hemorrhage
• Hypercalcemia
• Hypersensitivity drug reaction
• Hypophosphatemia
• Increased creatine kinase level
• Musculoskeletal pain
• Nausea

Less Frequent

• Hypertension
• Periorbital edema
• Pruritus of skin

No enhanced messaging available.

The safety and effectiveness of axatilimab-csfr have been established in pediatric patients weighing >=40 kg. Patients weighing <40 kg had lower maximum concentrations, trough concentration, and average concentration at the same weight-based dosage compared to patients weighing >=40 kg. Based on findings of thickness of the growth plate and metaphysis and/or degeneration of the growth plate in the femur of animals, monitor bone growth and development in pediatric patients.

There are no adequate data regarding the use of axatilimab-csfr in pregnant women. Based on its mechanism of action, axatilimab-csfr may cause fetal harm when administered to pregnant females. (See Fetal/Neonatal Morbidity and Mortality under Cautions)

It is not known whether axatilimab-csfr is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Maternal immunoglobulin G (IgG) is known to be distributed into human milk. Because of the potential for serious adverse reactions in breastfed infants, advise women to not breastfeed during treatment and for 30 days after the last dose of axatilimab-csfr.

No differences in the safety and effectiveness of axatilimab-csfr have been observed between patients 65 years of age and older and younger patients.