Pemivibart (Investigational)

Pemivibart is a monoclonal antibody indicated for emergency use for preexposure prophylaxis of individuals aged greater than 12 years (weighing at least 40 kg) who are moderately to severely immunocompromised owing to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination.

• Pemivibart is available under the following different brand names: Pemgarda.

Common side effects of Pemivibart include:

• allergic and infusion-related reactions
• infusion site reactions
• common cold 
• viral infection
• flu-like illness 
• tiredness
• headache
• nausea

Serious side effects of Pemivibart include:

• A serious allergic reaction called anaphylaxis includes dizziness, flushing, ringing in the ears, hives, wheezing, skin redness, trouble breathing, swelling of the face, lips, mouth, tongue, throat, hands, or feet, chest discomfort, sweating, fast heartbeat

Rare side effects of Pemivibart 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

• 500 mg/4 mL (125 mg/mL) single-dose vial

COVID-19 (EUA)

Adult and pediatric dosage

• Eligible patients must not be currently infected with COVID-19 and not had a known recent exposure to an infected individual
• Initial dose: 4,500 mg IV as a single infusion
• Repeat dose: 4,500 mg IV as a single infusion every 3 months; repeat dosing should be timed from the date of the most recent dose

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.

• Pemivibart has no noted severe interactions with any other drugs
• Pemivibart has no noted serious interactions with any other drugs
• Pemivibart has no noted moderate interactions with any other drugs
• Pemivibart 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

• Previous severe hypersensitivity reactions, including anaphylaxis, to any component of Pemivibart

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Anaphylaxis
  • Anaphylaxis observed, including life-threatening cases
  • Manifestations included pruritus, flushing, urticaria, erythema, angioedema, diaphoresis, dizziness, tinnitus, wheezing, dyspnea, chest discomfort, and tachycardia
  • Clinically monitor during 60 min infusion and observe for at least 2 hours after completion of infusion
  • Discontinue permanently in individuals who experience signs or symptoms of anaphylaxis
• Hypersensitivity and infusion-related reactions
  • Hypersensitivity and infusion-related reactions occurring during infusion, up to 24 hours after administration, and beyond 24 hours observed
  • Hypersensitivity or infusion-related reactions may be severe or life-threatening
  • If signs or symptoms of a clinically significant hypersensitivity or infusion-related reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy
  • Signs and symptoms may include
    • Fever, difficulty breathing, reduced oxygen saturation, bronchospasm, chills, myalgia, diaphoresis, or fatigue
    • Arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, hypotension, hypertension
    • Weakness, altered mental status, nausea, or headache
    • Angioedema, throat irritation, rash including urticaria, pruritus, vasovagal reactions (eg, presyncope, syncope), or dizziness
• Risk of cross-hypersensitivity with COVID-19 vaccines
  • Contains polysorbate 80, which is in some COVID-19 vaccines and is structurally like polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines
  • Consider consulting an allergist/immunologist before administering to individuals with a history of severe hypersensitivity reactions to a COVID-19 vaccine
  • Administer under the supervision of a healthcare provider with appropriate medical support to manage severe hypersensitivity reactions
  • Immediately discontinue administration if signs and symptoms of clinically significant hypersensitivity reaction or anaphylaxis occur and initiate appropriate medications and/or supportive care
  • Clinically monitor and observe for at least 2 hours
  • Risk for COVID-19 due to SARS-CoV-2 viral variants not neutralized
  • Certain SARS-CoV-2 viral variants may emerge that are not neutralized by monoclonal antibodies
  • Prescribing clinicians should consider the prevalence of resistant variants in their area
  • Health care providers should review antiviral resistance information provided by state and local health departments
  • If signs or symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate
• Drug interaction overview
  • Drug-drug interaction studies have not been performed
  • Not renally excreted or metabolized by CYP450 enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of CYP450 enzymes are unlikely

Pregnancy and Lactation

• Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Nonclinical reproductive toxicity studies have not been performed
• In tissue cross-reactivity studies using human fetal tissues, no off-target binding was detected for Pemivibart.
• Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, Pemivibart has the potential to be transferred from the mother to the developing fetus
• Lactation
  • Data are unavailable regarding the presence of Pemivibart in 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