Ansuvimab

Ansuvimab is a prescription medication used for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are reverse-transcriptase polymerase chain reaction-positive for Zaire ebolavirus infection.

• Ansuvimab is available under the following different brand names: Ebanga, ansuvimab-zykl

Common side effects of Ansuvimab include:

• fever
• fast heart rate
• diarrhea
• vomiting
• low blood pressure (hypotension)
• fast, shallow breathing
• chills
• low blood oxygen

Serious side effects of Ansuvimab include:

• severe and life-threatening allergic reactions during and after the infusion

Rare side effects of Ansuvimab 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 and pediatric dosage

Injection, lyophilized powder for reconstitution

• 400 mg/vial

Ebolavirus Infection

Adult and pediatric dosage

• 50 mg/kg IV single infusion

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Ansuvimab has severe interactions with no other drugs.
• Ansuvimab has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Ansuvimab has moderate interactions with the following drugs:
  • efgartigimod alfa
  • isavuconazonium sulfate
  • ublituximab
• Ansuvimab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, 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. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Hypersensitivity reactions
  • Hypersensitivity reactions, including infusion-associated events, have been reported
  • These may include acute, life-threatening reactions during and after infusion
  • Monitor for signs and symptoms (e.g., hypotension, chills, elevation of fever) during and following infusion
  • Infusion rate may be slowed or interrupted if any signs of infusion-associated events or other adverse events develop
  • Discontinue infusion immediately if a severe or life-threatening reaction occurs and administer appropriate emergency care
• Drug interaction overview
  • Avoid coadministration of live vaccine during treatment
  • Potential for monoclonal antibodies to inhibit replication of live vaccine virus indicated for prevention of Zaire ebolavirus infection and possibly reduce vaccine efficacy
  • Follow current immunization guidelines for the interval needed between monoclonal antibodies and administering the live vaccine

Pregnancy and Lactation

• Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld because of pregnancy; many such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death
• Data from clinical trials demonstrate a high rate of maternal and fetal/neonatal morbidity in treated pregnant women with Zaire ebolavirus infection, which is consistent with published literature regarding the risk associated with underlying maternal Zaire ebolavirus infection
• Data are insufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal/fetal outcome
• Animal reproduction studies with ansuvimab have not been conducted
• Human monoclonal antibodies cross the placenta; therefore, monoclonal antibodies are potentially transferred from mother to fetus
• Lactation
  • CDC recommends patients with confirmed Zaire ebolavirus not breastfeed their infants to reduce the risk for postnatal transmission
  • No data are available on the presence of ansuvimab in human or animal milk, its effects on breastfed infants, or on milk production
  • Maternal IgG is known to be present in human milk