Vilobelimab

Vilobelimab injection is an investigational medicine that has received Emergency Use Authorization (EUA) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults when initiated within 48 hr of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

• Vilobelimab is available under the following different brand names: Gohibic

Common side effects of vilobelimab include:

• confusion
• constipation
• rash
• irregular heartbeats
• pain, swelling, or warmth in one leg
• pain and burning while urinating
• chest pain
• breathing problems
• shortness of breath

Serious side effects of vilobelimab include:

• severe headache
• blurred vision
• pounding in the neck or ears
• easy bruising
• unusual bleeding
• purple or red spots under the skin
• cold symptoms such as stuffy nose, sneezing, sore throat
• symptoms of sepsis—confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, and feeling very ill

Rare side effects of vilobelimab 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, light-headedness, 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

Injectable, solution for dilution

• 200 mg/20 mL single-dose vial

COVID-19 disease

Adult dosage

• 800 mg IV for a maximum of 6doses
• Initiate within 48 h of intubation (day 1), followed by the administration on days 2, 4, 8, 15, and 22 if the patient is hospitalized (even if discharged from ICU)

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, health care provider, or pharmacist first.

• Vilobelimab has no noted severe interactions with any other drugs.
• Vilobelimab has no noted serious interactions with any other drugs.
• Vilobelimab has no noted moderate interactions with any other drugs.
• Vilobelimab has no noted minor interactions with any 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 Vilobelimab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Vilobelimab?"

Cautions

• Serious infections
  • Serious infections owing to bacterial, fungal, and viral pathogens were reported
  • Monitor for signs and symptoms of new infections during and after treatment
  • Information is limited regarding use in patients with COVID-19 and concomitant active serious infections
  • Consider the risks and benefits of treatment with vilobelimab in patients with concurrent infections
• Hypersensitivity reactions
  • Hypersensitivity reactions observed
  • If a severe hypersensitivity reaction occurs, discontinue administration and initiate appropriate therapy
• Drug interactions
  • No drug interaction studies have been conducted

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Placental transfer of monoclonal antibodies is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during that time
• Lactation
  • Data are unavailable regarding the presence of vilobelimab in either human or animal milk, its effects on breastfed infants, or its effects on milk production
  • Maternal IgG is known to be present in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed infants are unknown