Sibeprenlimab
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Prepare this dose
Your numbers for sibeprenlimab. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Preparation and Administration VOYXACT is intended for patient self-administration or for administration by a caregiver. Provide proper training to patients and/or caregivers on the administration of VOYXACT prior to use according to the "Instructions for Use". Visually inspect the prefilled syringe for particulate matter and discoloration.
The solution should be clear to opalescent and colorless to yellow. Do not use the prefilled syringe if the solution contains visible particulate matter, is cloudy or discolored (other than clear to opalescent, colorless to yellow). Allow VOYXACT prefilled syringe to come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection.
Keep VOYXACT prefilled syringe in the original carton to protect it from light. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator. Do not use VOYXACT if it has been at room temperature for 7 days or longer. Administer VOYXACT by subcutaneous injection only. Inject into the front of the thigh or abdomen.
The back of the upper arm can also be used as an injection site if administered subcutaneously by a caregiver. Do not inject into the same site used for the previous injection, or into moles, scars, bruises or areas where the skin is tender, damaged, red, scaly, or hard.
Contraindications
4 CONTRAINDICATIONS VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT. Serious hypersensitivity to sibeprenlimab-szsi or any excipients in VOYXACT. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for sibeprenlimab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy (see Clinical Considerations ) .
In an enhanced prenatal and postnatal development (ePPND) toxicity study, administration of sibeprenlimab-szsi subcutaneously to pregnant monkeys did not result in any adverse effects on embryofetal or postnatal development at exposures approximately 10-times the clinical exposure at the maximum recommended human dose (MRHD) based on area under the curve (AUC) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting www.VOYXACT.com. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk IgA nephropathy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight.
Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, VOYXACT may be present in infants exposed in utero . Consider the potential clinical impact of VOYXACT exposure in infants who were exposed to VOYXACT in utero .
Data Animal Data In an ePPND toxicity study, subcutaneous administration of sibeprenlimab-szsi once every two weeks to pregnant cynomolgus monkeys from gestation Day 20 through delivery (includes the period of organogenesis) did not result in any adverse effect on embryofetal or postnatal development at the single tested dose of 101 mg/kg, which provided an approximately 10-fold margin to the clinical exposure at the MRHD based on AUC.
Breastfeeding (LactMed)
No information is available on the clinical use of sibeprenlimab during breastfeeding. Because sibeprenlimab is a large protein molecule with a molecular weight of 146,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant’s gastrointestinal tract and absorption by the infant is probably minimal. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.