Ryzneuta (efbemalenograstim alfa-vuxw)

No dosing information is available for this tab.

Efbemalenograstim alfa-vuxw is administered via subcutaneous injection by a healthcare professional.

Efbemalenograstim alfa-vuxw is available in single-dose, prefilled syringes; syringes do not have graduation marks, and are only intended to deliver the full contents of the syringe. The needle cap on the prefilled syringe contains natural rubber, so people with latex allergies should not administer the product.

Store prefilled syringes at 2--8degreesC in the carton to protect from light. Do not shake. Discard syringes if frozen.

Prior to administration, remove the carton containing the prefilled syringe of efbemalenograstim alfa-vuxw from the refrigerator and let stand for at least 30 minutes to allow the product to reach room temperature. Keep the prefilled syringe in the carton during this time. Discard any product left at room temperature for >48 hours.

Visually inspect the solution prior to administration; do not administer if particulate matter or discoloration is observed.

Administer the subcutaneous injection by pinching the skin and holding. Administer the injection into the abdomen, the thighs, or the back or side of the upper arm; rotate injection sites. If injecting into the abdominal area, avoid injecting within a 2-inch diameter circle around the navel. Avoid injecting into scar tissue or areas that are reddened, inflamed, or swollen.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with efbemelanograstim alfa-vuxw. Efbemelanograstim alfa-vuxw is expected to be metabolized into small peptides via catabolic pathways.

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)

*History of serious allergic reactions to granulocyte stimulating factors (e.g., efbemalenograstim alfa-vuxw, pegfilgrastim, filgrastim products).

There are no contraindication contraindications for this drug.

• Acute respiratory distress syndrome
• Capillary leak syndrome
• Glomerulonephritis
• Nontraumatic splenic rupture
• Sickle cell disease with crisis

• Acute myeloid leukemia
• Myelodysplastic syndrome
• Sickle cell disease
• Thrombocytopenic disorder

Adverse effects reported in >=10% of patients receiving efbemelanograstim alfa-vuxw include nausea, anemia, and thrombocytopenia.

There are no severe adverse reactions for this drug.

More Frequent

• Anemia
• Nausea
• Thrombocytopenic disorder

No enhanced messaging available.

Safety and efficacy of efbemalenograstim alfa-vuxw have not been established in pediatric patients.

Data are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Studies examining the use of other human G-CSF products during pregnancy have not established a link between human G-CSF products and major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In studies of pregnant rats and rabbits, no reproductive or developmental toxicity was observed in offspring exposed to cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area).

It is not known whether efbemalenograstim alfa-vuxw or its metabolite are present in either human or animal milk. The effects on the breast-fed child and on milk production are not known. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of efbemalenograstim alfa-vuxw did not include a sufficient number of patients >=65 years of age to assess differences in response compared to younger adults; however, other reported clinical experience has not identified differences in response between geriatric and younger adult patients.