Empliciti (elotuzumab)

If administration of one drug in the combination regimen is delayed, interrupted, or discontinued, therapy with the other drugs may be continued; however, since dexamethasone also is used to reduce the risk of infusion-related events associated with elotuzumab, clinical judgment should be used in deciding whether elotuzumab should be continued without dexamethasone. Clinicians should consult the respective manufacturers' labelings for information on recommended dosage modifications for lenalidomide and dexamethasone.

Elotuzumab is administered by IV infusion using a sterile, nonpyrogenic, low-protein-binding, 0.2- to 1.2-mcm inline filter. Solutions of the drug should be administered via an infusion pump. Other drugs should not be administered simultaneously through the same IV line with elotuzumab infusion.

Prior to administration, commercially available elotuzumab lyophilized powder for injection must be reconstituted and diluted using proper aseptic technique.

Unreconstituted elotuzumab lyophilized powder for injection should be stored in unopened vials at 2-8degreesC, and should not be frozen or shaken. Unopened vials should be retained in the original package for protection from light.

No dosing information is available for this tab.

No formal drug interactions studies have been performed to date.

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)

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

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

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

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)

The manufacturer states there are no known contraindications to the use of elotuzumab.

• Lactation

• Pregnancy

• Herpes zoster
• Severe infection

Adverse effects reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone for the treatment of previously treated multiple myeloma and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, loss of appetite, pneumonia, extremity pain, headache, vomiting, weight loss, lymphopenia, cataracts, and oropharyngeal pain.

Laboratory abnormalities reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include lymphopenia, leukopenia, thrombocytopenia, hypoalbuminemia, elevated concentrations of alkaline phosphatase, hyperglycemia, hypocalcemia, decreased serum bicarbonate concentrations, and hyperkalemia.

More Frequent

• Bradycardia
• Hyperkalemia
• Hypocalcemia
• Infection
• Leukopenia
• Opportunistic fungal infection
• Peripheral motor neuropathy
• Pneumonia
• Thrombocytopenic disorder

Less Frequent

• Abnormal hepatic function tests
• Acute renal failure
• Anemia
• Cataracts
• Hypertension
• Hypokalemia
• Hyponatremia
• Hypotension
• Lymphopenia
• Pulmonary thromboembolism

Rare or Very Rare

• Hypersensitivity drug reaction
• Hypoesthesia

More Frequent

• Anorexia
• Constipation
• Cough
• Diarrhea
• Fatigue
• Fever
• Hyperglycemia
• Peripheral sensory neuropathy
• Pharyngitis
• Upper respiratory infection

Less Frequent

• Bone pain
• Chills
• Dyspnea
• Headache disorder
• Mouth irritation
• Muscle spasm
• Pain in extremities
• Peripheral edema
• Vomiting
• Weight loss

Rare or Very Rare

• Chest pain
• Mood changes
• Night sweats

No enhanced messaging available.

Safety and efficacy of elotuzumab have not been established in pediatric patients.

There are no adequate and well-controlled studies of elotuzumab in pregnant women. Animal reproduction studies have not been performed to date with the drug.

Because elotuzumab is administered in combination with lenalidomide and dexamethasone, clinicians must consider that lenalidomide is contraindicated in pregnant women. (See Combination Therapy under Cautions: Warnings/Precautions.)

It is not known whether elotuzumab is distributed into milk. Because of the potential for serious adverse reactions in nursing infants, women should be advised to discontinue nursing during combination therapy with elotuzumab, lenalidomide, and dexamethasone. The effects of elotuzumab on nursing infants or on milk production are unknown.

In the phase 3 clinical trial evaluating elotuzumab in combination with lenalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma, 57% of patients were 65 years of age or older. No overall differences in safety or efficacy were observed between geriatric patients and younger adults.