Efgartigimod alfa and hyaluronidase (human recombinant)
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From MedlinePlus, U.S. National Library of Medicine
Endoglycosidase, Neonatal Fc Receptor Blocker
Dosing in kidney impairment
Renal Impairment No dose adjustment of VYVGART HYTRULO is needed for patients with mild renal impairment. There are insufficient data to evaluate the impact of moderate renal impairment (eGFR 30-59 mL/min/1.73 m 2 ) and severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) on pharmacokinetic parameters of VYVGART HYTRULO [see Clinical Pharmacology ].
Preparation and administration
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Important Dosage and Administration Instructions VYVGART HYTRULO is for subcutaneous use only. Do not administer intravenously. Do not dilute VYVGART HYTRULO. Single-Dose Prefilled Syringe VYVGART HYTRULO prefilled syringe may be administered by patients and/or caregivers after proper instruction in subcutaneous injection technique [see Instructions for Use ] .
Single-Dose Vial VYVGART HYTRULO vial is to be administered with a winged infusion set by a healthcare professional only [see Dosage and Administration ].
Preparation and Administration Instructions Single-Dose Prefilled Syringe Take the VYVGART HYTRULO prefilled syringe out of the refrigerator at least 30 minutes before injecting to allow it to reach room temperature [see How Supplied/Storage and Handling ] . Do not use external heat sources to bring the syringe to room temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Visually inspect that the prefilled syringe solution is yellowish, clear to opalescent and devoid of particulate matter. Do not use if visible particles are present.
Each prefilled syringe is for one-time use only. To administer VYVGART HYTRULO prefilled syringe, use a safety needle that is 25G, 5/8 inches in length, and thin wall type. The safety needle is not included in the carton. Choose an injection site on the abdomen (at least 2 inches away from the navel). Do not inject into areas where the skin is irritated, red, bruised, infected, tender, hard, or into areas where there are moles or scars.
Rotate injection sites for subsequent administrations. Inject VYVGART HYTRULO prefilled syringe subcutaneously into a pinched skin area at an angle of 45 to 90 degrees for approximately 20 seconds to 30 seconds. Discard any unused portions of medicine remaining in the syringe. Localized injection site reactions may occur after VYVGART HYTRULO is administered [see Adverse Reactions ].
Monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the patient should seek medical attention and the healthcare professional should institute appropriate measures, if needed [see Warnings and Precautions ] . For detailed instructions on the preparation and administration of VYVGART HYTRULO prefilled syringe see INSTRUCTIONS FOR USE .
Single-Dose Vial Use aseptic technique when preparing and administering VYVGART HYTRULO vial. Do not shake the vial. Each vial is for one-time use only. Avoid exposure to direct sunlight. Preparation Take the VYVGART HYTRULO vial out of the refrigerator at least 15 minutes before injecting to allow it to reach room temperature [see How Supplied/Storage and Handling ].
Do not use external heat sources. Check that the VYVGART HYTRULO solution is yellowish, clear to opalescent. Parenteral medicine products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Do not use if opaque particles or other foreign particles are present.
Withdraw the entire content of VYVGART HYTRULO from the vial using a polypropylene syringe and an 18G stainless steel transfer needle. Remove large air bubbles, if present. Each vial contains overfill to compensate for liquid loss during preparation and to compensate for the priming volume of the winged infusion set. VYVGART HYTRULO vial does not contain preservatives.
Administer immediately after preparation. Administration To administer VYVGART HYTRULO vial use a winged infusion set made of polyvinyl chloride (PVC), 25G, 12 inches tubing, maximum priming volume of 0.4 mL. Remove the transfer needle from the syringe and connect the syringe to the winged infusion set. Prior to administration, fill the tubing of the winged infusion set by gently pressing the syringe plunger until the plunger is at 5.6 mL.
There should be solution at the end of the winged infusion set needle. Choose an injection site on the abdomen (at least 2 inches to 3 inches away from the navel). Do not inject in areas where the skin is red, bruised, tender, hard, or into areas where there are moles or scars. Rotate injection sites for subsequent administrations.
Inject VYVGART HYTRULO vial subcutaneously into a pinched skin area at an angle of about 45 degrees over 30 seconds to 90 seconds. Localized injection site reactions may occur after VYVGART HYTRULO is administered. [see Adverse Reactions ] . Discard any unused portions of medicine remaining in the vial, the syringe and the winged infusion set.
Healthcare professionals should monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention [see Warnings and Precautions ].
Drug interactions
Check efgartigimod alfa and hyaluronidase (human recombinant) against a medication listLabel text (2 paragraphs)
Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART HYTRULO and using alternative therapies. ( 7 )
7.1 Effect of VYVGART HYTRULO on Other Drugs Concomitant use of VYVGART HYTRULO with medications that bind to the human neonatal Fc receptor (FcRn) (e.g., immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) may lower systemic exposures and reduce effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. When concomitant long-term use of such medications is essential for patient care, consider discontinuing VYVGART HYTRULO and using alternative therapies.
Contraindications
4 CONTRAINDICATIONS VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope [see Warnings and Precautions (5.2) ]. VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.Vyvgartpregnancy.com to enroll in or to obtain information about the registry. Risk Summary There are no available data on the use of VYVGART HYTRULO or efgartigimod alfa containing products during pregnancy. There was no evidence of adverse developmental outcomes following the intravenous administration of efgartigimod alfa at up to 100 mg/kg/day in rats and rabbits (see Data ).
The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Therefore, efgartigimod alfa may be transmitted from the mother to the developing fetus.
As VYVGART HYTRULO is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risk and benefits should be considered prior to administering live vaccines to infants exposed to VYVGART HYTRULO in utero [see Warnings and Precautions (5.1) ]. Data Animal Data VYVGART HYTRULO for subcutaneous injection contains efgartigimod alfa and hyaluronidase [see Description (11) ] . Efgartigimod alfa: - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to pregnant rats and rabbits throughout organogenesis resulted in no adverse effects on embryofetal development in either species.
Maternal efgartigimod alfa exposures at the highest no-effect doses were approximately 8 and 62 times, respectively, that in humans at the recommended human dose (RHD) of 1008 mg. - Intravenous administration of efgartigimod alfa (0, 30, or 100 mg/kg/day) to rats throughout gestation and lactation resulted in no adverse effects on pre- or postnatal development. Maternal exposures at the highest no-effect dose were approximately 13 times that in humans at the RHD.
Hyaluronidase: - In a study in which hyaluronidase (human recombinant) was administered by subcutaneous injection to pregnant mice throughout organogenesis, increased embryofetal mortality and decreased fetal body weights were observed at the highest doses…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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