Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc)

No dosing information is available for this tab.

Efgartigimod alfa-fcab (Vyvgart(R)) is administered by IV infusion only. The injection is available as a 20 mg/mL (400 mg) single-dose vial. Efgartigimod alfa single-dose vials require further dilution prior to administration.

Efgartigimod alfa and hyaluronidase-qvfc (efgartigimod alfa/hyaluronidase-qvfc; Vyvgart(R)Hytrulo) is administered by subcutaneous injection only. The fixed combination injection is available as a single-dose vial that contains 1008 mg of efgartigimod alfa and 11,200 units of hyaluronidase per 5.6 mL (180 mg/2000 units per mL).

If a scheduled dose of an efgartigimod alfa-containing product is missed, the missed dose may be administered for up to 3 days after the scheduled time. Thereafter, the original schedule may be resumed.

Store product vials at 2--8degreesC in their original container to protect from light. Do not freeze or shake. Unopened vials of efgartigimod alfa/hyaluronidase may be stored in the original carton at room temperature (20-25degreesC) for up to 3 days before administration or returned to refrigeration; do not store vials at room temperature more than one time.

No dosing information is available for this tab.

No formal drug interaction studies have been conducted with efgartigimod alfa. Since efgartigimod alfa is not metabolized by cytochrome P-450 (CYP) enzymes, interactions with medications that are substrates, inhibitors, or inducers of CYP enzymes are not expected. Efgartigimod alfa and hyaluronidase are both expected to undergo metabolism by proteolytic enzymes.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

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

Efgartigimod-Alfa/Igg Antibodies And Derivatives

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)

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

Neonatal Fc Receptor Inhibitors/Insulin Efsitora Alfa

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) Insulin efsitora alfa is fused to IgG2. When bound to FcRn, degradation of insulin efsitora alfa is inhibited, reducing its renal clearance and prolonging its action.(3) FcRn inhibitors bind to FcRn and may decrease systemic exposure of other ligands of FcRn, like insulin efsitora alfa.(3)

CLINICAL EFFECTS: The effectiveness of insulin efsitora alfa may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of insulin efsitora alfa states that if an FcRn inhibitor is required, an alternative basal insulin should be considered.(3)

DISCUSSION: FcRn inhibitors may decrease concentrations of insulin efsitora alfa.(3)

*Serious hypersensitivity to efgartigimod alfa products, hyaluronidase, or any product excipients.

There are no contraindication contraindications for this drug.

• Infection

There are no moderate contraindications for this drug.

The most common adverse reactions experienced in 10% or more of patients with generalized myasthenia gravis receiving efgartigimod alfa-fcab include respiratory tract infections, headache, and urinary tract infections. Injection site reactions are also common in patients receiving the fixed combination of efgartigimod alfa/hyaluronidase-qvfc.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Angioedema
• Dyspnea
• Hypotension
• Urticaria

More Frequent

• Headache disorder
• Injection site sequelae
• Upper respiratory infection
• Urinary tract infection

Less Frequent

• Injection site sequelae
• Myalgia
• Nausea
• Paresthesia

Rare or Very Rare

• Edema
• Skin rash
• Syncope

No enhanced messaging available.

Safety and effectiveness have not been established in the pediatric patient population.

No data are available regarding the use of efgartigimod alfa-containing products during pregnancy. In animal studies, no evidence of adverse developmental outcomes were detected following the administration of efgartigimod alfa at daily dosages of up to 100 mg/kg. In animal studies where hyaluronidase was administered subcutaneously, no evidence of adverse developmental outcomes were detected following administration of doses up to 1800 times the recommended human dose. Since monoclonal antibodies increasingly cross the placenta as pregnancy progresses and the largest amount crosses in the third trimester, transmission of efgartigimod alfa from the mother to the developing fetus may occur. Because maternal IgG antibodies are expected to be reduced with efgartigimod alfa administration, a reduction in fetal passive protection is anticipated. Prior to administration, consider the risks and benefits of live or live-attenuated vaccine use in infants who were exposed to efgartigimod alfa in utero.

A pregnancy exposure registry monitors outcomes in pregnant women exposed to efgartigimod alfa products. Clinicians and patients may enroll in the registry by calling 855-272-6524 or visiting https://Vyvgartpregnancy.com.

No data are available on the presence of efgartigimod alfa or hyaluronidase in human milk, although maternal immunoglobulin G (IgG) is known to be present in human milk. The effects on the breastfed infant and the effects on milk production are also not known. Consider the benefits of breastfeeding along with the mother's clinical need for efgartigimod alfa-containing products and any potential adverse effects on the breastfed infant from the drug or the mother's underlying maternal condition.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical studies of efgartigimod alfa-containing products did not include sufficient numbers of patients 65 years of age and older to determine whether there are differences in response from younger adult patients.