Sibeprenlimab

Sibeprenlimab is a prescription medication indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression

• Sibeprenlimab is available under the following different brand names: Voyxact, sibeprenlimab-szsi

Common side effects of Sibeprenlimab include:

• upper respiratory tract infection
• injection site erythema

Serious side effects of Sibeprenlimab include:

• immunosuppression and increased risk of infections

Rare side effects of Sibeprenlimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution for SC

• 400 mg/2 mL single-dose prefilled syringe

Immunoglobulin A Nephropathy

Adult dosage

• 400 mg SC every 4 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Serious hypersensitivity to sibeprenlimab or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sibeprenlimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sibeprenlimab?”

Cautions

• Immunosuppression and increased infection risk
• Suppresses the immune system by reducing antibody production, which may increase the risk of infections
• Patients with chronic or recurring infections may have an increased risk of serious infection
• Before initiating, assess patients for active infections
• During treatment, monitor patients for signs and symptoms of infection
• If a serious infection develops, consider interrupting dosing until the infection resolves
• Data are limited with concomitant use of sibeprenlimab and systemic immunosuppressants
• Consider potential for increased immunosuppression when coadministering Sibeprenlimab and immunosuppressants, or when initiating sibeprenlimab before or after immunosuppressive therapy
• Immunosuppression and immunization risks
  • Sibeprenlimab may interfere with immune responses to vaccines and increase the risk of infection from live vaccines
  • Live vaccines are not recommended within 30 days before initiating treatment or during treatment, as safety has not been established
  • No data are available on secondary transmission of infection from persons receiving live vaccines to patients receiving sibeprenlimab or on the efficacy of immunizations administered while receiving treatment

Pregnancy and Lactation

There are no available data on use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Monoclonal antibodies 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 trimesters

Report exposure during pregnancy 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, sibeprenlimab may be present in infants exposed to utero
• Consider the potential clinical impact of exposure in infants who were exposed in utero

Lactation

• There are no data regarding the presence of sibeprenlimab in human milk, effects on breastfed infants, or effects on milk production
• Endogenous maternal IgG and monoclonal antibodies are transferred into human milk
• The effects of local gastrointestinal exposure on sibeprenlimab in breastfed infants are unknown