EFGARTIGIMOD/ HYALURONIDASE-QVFC INJ,SOLN
Clinical Criteria Summary
Document 532
Indication
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Exclusion Criteria
- Sensory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Concomitant therapy with other monoclonal antibody therapy
- Immunoglobulin therapy or plasma exchange within 1 month
- Serum IgG level less than 600 mg/dL
- Active, untreated infection
Inclusion Criteria
- Care provided by a VA/VA Community Care neurologist or locally designated expert
- Diagnosis of typical CIDP or any CIDP variant except sensory CIDP
- Inflammatory neuropathy cause and treatment (INCAT) score of 2 or more
- Contraindication, intolerance, or inadequate symptom control after a minimum 3-month trial of each: corticosteroids and immunoglobulins
Additional Requirements
- Plasma exchange may count as one of the two required trials.
Document 341
Exclusion Criteria
- Concomitant therapy with other monoclonal antibody or neonatal Fc receptor antagonist (e.g., rozanolixizumab)
- Thymectomy within 3 months
- Intravenous immunoglobulin (IVIG) or plasma exchange within 1 month
- Untreated hepatitis B, hepatitis C, or HIV with low CD4 count
- Serum IgG level less than 600 mg/dL
- Active, untreated infection
Inclusion Criteria
- Care provided by a VA/VA Community Care neurologist
- Anti-acetylcholine receptor (AChR) antibody positive
- Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV
- Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL) total score ≥ 5
Additional Inclusion Criteria
- One of the following must be met:
- Inadequate symptom control, contraindication, or intolerance to high dose steroid burst, plasma exchange or IVIG and patient requires rapid onset or bridge therapy
- Inadequate symptom control to maximally tolerated pyridostigmine and at least two immunosuppressive agents separately trialed for at least 6 months each (e.g., azathioprine, cyclosporine, mycophenolate, etc.)
- History of intolerance or contraindication preventing trial of immunosuppressive agents (e.g., azathioprine, cyclosporine, mycophenolate, etc.)
Document 709
Indication
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
Dosage & Administration
- 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase in a single-dose vial
- 1,008 mg/11,200 units once weekly via slow subcutaneous injection
- Must be administered by a healthcare professional
Contraindications
- Hypersensitivity to efgartigimod, hyaluronidase, or other excipients included in the injection
Warnings & Precautions
- Infections: Monitor for infections; most common was COVID-19, generally mild to moderate in severity
- Vaccinations: Avoid live or live-attenuated vaccinations while a patient is treated with efgartigimod
- Hypersensitivity and infusion-related reactions: Risk of severe anaphylaxis and hypotension leading to syncope; more common mild reactions include hypertension, chills, and pain
Monitoring Requirements
- Patients should be monitored for 30 minutes after administration
- For mild to moderate infusion-related reactions, rechallenge can be considered with close observation, slower infusion rate, and pre-medication as applicable
Drug Interactions
- May lower the effectiveness of other medications that bind to neonatal Fc receptor, including immunoglobulin products and monoclonal antibodies
Pregnancy & Lactation
- Reduces circulating IgG levels, which may reduce maternal passive immunity to the fetus or infant
- May be transmitted from the mother to the developing fetus, potentially inhibiting the fetus’ own immunoglobulin production
Clinical Context/Notes
- Utilized as maintenance therapy rather than induction therapy
- Subcutaneous formulation with hyaluronidase is specified; intravenous formulation has not been studied in CIDP
- Hyaluronidase alone does not have a clinical effect on CIDP