Atoltivimab-Maftivimab-Odesivimab

Atoltivimab-Maftivimab-Odesivimab is a prescription medication used to treat infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

• Atoltivimab-Maftivimab-Odesivimab is available under the following different brand names: Inmazeb, Ebola monoclonal antibodies

Common side effects of Atoltivimab-Maftivimab-Odesivimab include:

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

Serious side effects of Atoltivimab-Maftivimab-Odesivimab include:

• fever or chills
• fast heartbeat
• fast breathing
• trouble breathing
• diarrhea or throwing up
• signs of low blood pressure, such as severe dizziness, passing out, or any other bad effects during or after the infusion

Rare side effects of Atoltivimab-Maftivimab-Odesivimab 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, solution

• 241.7 mg/241.7 mg/241.7 mg per 14.5 mL (16.67 mg/16.67 mg/16.67 mg per mL)
• 483.3 mg/483.3 mg/483.3 mg per 14.5 mL (33.33 mg/33.33 mg/33.33 mg per mL)

Ebola virus infection

Adult and pediatric dosage

• 50 mg atoltivimab/50 mg maftivimab/50 mg odesivimab per kg IV as a 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.

• Atoltivimab-Maftivimab-Odesivimab has severe interactions with no other drugs.
• Atoltivimab-Maftivimab-Odesivimab has serious interactions with at least 26 other drugs
• Atoltivimab-Maftivimab-Odesivimab has moderate interactions with the following drugs:
  • efgartigimod alfa
  • efgartigimod/hyaluronidase SC
  • isavuconazonium sulfate
  • rozanolixizumab
  • ublituximab
• Atoltivimab-Maftivimab-Odesivimab 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 Atoltivimab-Maftivimab-Odesivimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Atoltivimab-Maftivimab-Odesivimab?”

Cautions

• Hypersensitivity reactions reported, including infusion-associated events during and after infusion
• Monitor for signs and symptoms including but not limited to hypotension, chills, and elevation of fever, during and after infusion
• If a severe or life-threatening hypersensitivity reaction occurs, discontinue monoclonal antibodies immediately 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 its treatment should not be withheld during pregnancy; the majority of such pregnancies result in maternal death with miscarriage, stillbirth, or neonatal death
• Data from clinical trials and an expanded access program demonstrate a high rate of maternal and fetal/neonatal morbidity consistent with published literature regarding the risk associated with underlying maternal Zaire ebolavirus infection
• Data are insufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal/fetal outcome
• Animal reproduction studies have not been conducted
• Human monoclonal antibodies cross the placenta; therefore, monoclonal antibodies can potentially be transferred from mother to fetus
• Lactation
  • The CDC recommends patients with confirmed Zaire ebolavirus not to breastfeed their infants to reduce the risk for postnatal transmission
  • Data are not available on the presence of the drug in human or animal milk or its effects on breastfed infants and milk production
  • Maternal IgG is known to be present in human milk