Pemgarda 500mg/4ml Inj, 4ml
WARNING: Allergic reactions have happened with this drug. Rarely, severe and sometimes life-threatening allergic reactions have happened. You will be watched closely while getting this drug and for at least 2 hours after your dose. @ COMMON USES: It is used in certain people to prevent COVID-19.
Drug Class
Respiratory Syncytial Virus (RSV) Prophylaxis
Pharmacologic Class
Monoclonal Antibody; RSV F Protein Inhibitor
Pregnancy Category
Not available
FDA Approved
Apr 2024
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pemgarda is a medicine given as a single shot to help protect certain infants and young children from severe lung infections caused by Respiratory Syncytial Virus (RSV). It works by providing antibodies that fight off the virus.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. This medication is administered as an intravenous infusion, which means it is slowly injected into a vein over a specified period of time.
Storage and disposal of this medication are not applicable to you, as it will be administered in a healthcare setting and you will not be required to store it at home.
If you miss a scheduled dose, contact your doctor promptly to determine the best course of action.
Storage and disposal of this medication are not applicable to you, as it will be administered in a healthcare setting and you will not be required to store it at home.
If you miss a scheduled dose, contact your doctor promptly to determine the best course of action.
Lifestyle & Tips
- Continue to follow all recommended hygiene practices (e.g., hand washing, avoiding sick contacts) to prevent RSV and other infections.
- Ensure all routine childhood vaccinations are up-to-date, but discuss timing with your healthcare provider regarding live vaccines.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for routine adult use.
Pediatric Dosing
Neonatal:
Not established for neonates under 28 days of age.
Infant:
75 mg (1.5 mL) per dose for infants and young children weighing less than 5 kg. 150 mg (3 mL) per dose for infants and young children weighing 5 kg or more. Administer as a single intramuscular injection.
Child:
75 mg (1.5 mL) per dose for infants and young children weighing less than 5 kg. 150 mg (3 mL) per dose for infants and young children weighing 5 kg or more. Administer as a single intramuscular injection.
Adolescent:
Not indicated for routine adolescent use.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No dose adjustment necessary; not expected to be removed by dialysis.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Pemivibart is a recombinant human IgG1 kappa monoclonal antibody that provides prophylaxis against Respiratory Syncytial Virus (RSV) disease. It binds to a highly conserved epitope on the prefusion conformation of the RSV F protein, blocking viral entry into host cells and inhibiting cell-to-cell fusion.
Pharmacokinetics
Absorption:
Bioavailability:
100% (intramuscular administration)
Tmax:
Approximately 6 days (intramuscular)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 2.4 L
ProteinBinding:
Not specifically studied, but typical for monoclonal antibodies (low non-specific binding)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 60 days
Clearance:
Approximately 0.02 L/day
ExcretionRoute:
Not a primary route of excretion; catabolized.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Rapid (within hours of administration)
PeakEffect:
Approximately 6 days (based on Tmax)
DurationOfAction:
At least 5 months (due to long half-life, providing protection throughout the RSV season)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs that may occur during or after infusion, including:
+ Abnormal heartbeat (fast, slow, or irregular)
+ Dizziness or fainting
+ Headache
+ Upset stomach
+ Fever or chills
+ Chest pain
+ Sweating
+ Flushing
+ Muscle pain
+ Feeling confused, tired, or weak
+ Swelling of the hands or feet
+ Throat irritation
+ Ringing in the ears
These symptoms may indicate a severe allergic reaction or infusion reaction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Signs of a common cold
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs that may occur during or after infusion, including:
+ Abnormal heartbeat (fast, slow, or irregular)
+ Dizziness or fainting
+ Headache
+ Upset stomach
+ Fever or chills
+ Chest pain
+ Sweating
+ Flushing
+ Muscle pain
+ Feeling confused, tired, or weak
+ Swelling of the hands or feet
+ Throat irritation
+ Ringing in the ears
These symptoms may indicate a severe allergic reaction or infusion reaction.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Signs of a common cold
Flu-like symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of an allergic reaction: difficulty breathing, swelling of the face or throat, hives, rash, dizziness, or weakness.
- Signs of an injection site reaction: severe pain, redness, or swelling at the injection site that worsens.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including:
+ An allergy to this medication or any of its components, such as polysorbate
+ An allergy to other medications, foods, or substances, including COVID-19 vaccines or polyethylene glycol
+ The specific symptoms you experienced due to the allergy
If you currently have COVID-19 or have been in close contact with someone who has COVID-19, as this medication is not intended for use in these situations
If you have received a COVID-19 vaccine within the past 2 weeks
Additionally, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any health problems you have
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including:
+ An allergy to this medication or any of its components, such as polysorbate
+ An allergy to other medications, foods, or substances, including COVID-19 vaccines or polyethylene glycol
+ The specific symptoms you experienced due to the allergy
If you currently have COVID-19 or have been in close contact with someone who has COVID-19, as this medication is not intended for use in these situations
If you have received a COVID-19 vaccine within the past 2 weeks
Additionally, this is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are taking, including:
+ Prescription and over-the-counter (OTC) medications
+ Natural products
+ Vitamins
* Any health problems you have
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Be aware that allergic reactions and infusion reactions can occur more than 24 hours after receiving this drug.
This medication is not a substitute for a COVID-19 vaccine. It is crucial to follow your doctor's instructions and recommendations regarding vaccination and COVID-19 prevention measures.
Even after receiving the COVID-19 vaccine, it is vital to continue practicing preventive measures against COVID-19 as advised by local public health officials. These measures include frequent handwashing, wearing a mask, maintaining a distance of at least 6 feet from others, and avoiding crowded areas.
Keep in mind that the COVID-19 virus can mutate over time, and this medication may not provide protection against all forms of the virus. If you experience symptoms of COVID-19, such as fever, chills, cough, shortness of breath, breathing difficulties, fatigue, weakness, muscle or body aches, headache, changes in taste or smell, sore throat, runny or stuffy nose, or gastrointestinal symptoms like diarrhea, upset stomach, or vomiting, notify your doctor immediately.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Be aware that allergic reactions and infusion reactions can occur more than 24 hours after receiving this drug.
This medication is not a substitute for a COVID-19 vaccine. It is crucial to follow your doctor's instructions and recommendations regarding vaccination and COVID-19 prevention measures.
Even after receiving the COVID-19 vaccine, it is vital to continue practicing preventive measures against COVID-19 as advised by local public health officials. These measures include frequent handwashing, wearing a mask, maintaining a distance of at least 6 feet from others, and avoiding crowded areas.
Keep in mind that the COVID-19 virus can mutate over time, and this medication may not provide protection against all forms of the virus. If you experience symptoms of COVID-19, such as fever, chills, cough, shortness of breath, breathing difficulties, fatigue, weakness, muscle or body aches, headache, changes in taste or smell, sore throat, runny or stuffy nose, or gastrointestinal symptoms like diarrhea, upset stomach, or vomiting, notify your doctor immediately.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established, but may include exaggerated adverse effects.
What to Do:
There is no specific antidote. Management should be supportive and directed at treating clinical symptoms. Contact a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
History of hypersensitivity reactions
Rationale: To identify patients at increased risk for allergic or infusion-related reactions.
Timing: Prior to administration
Routine Monitoring
Signs and symptoms of hypersensitivity/infusion-related reactions
Frequency: During and for at least 60 minutes after injection
Target: Absence of symptoms
Action Threshold: Any signs of rash, urticaria, angioedema, dyspnea, hypotension, or other systemic reactions require immediate intervention.
Symptom Monitoring
- Rash
- Urticaria
- Angioedema
- Dyspnea
- Hypotension
- Anaphylaxis
- Injection site reactions (pain, swelling, erythema)
Special Patient Groups
Pregnancy
There are no available human data on Pemivibart use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted. As a human IgG1 monoclonal antibody, Pemivibart is expected to cross the placenta. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown, but generally low for mAbs.
Second Trimester:
Risk unknown, but generally low for mAbs.
Third Trimester:
Expected to cross the placenta, potentially providing passive immunity to the infant, but risk to fetus unknown.
Lactation
There are no data on the presence of Pemivibart in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Pemivibart and any potential adverse effects on the breastfed infant from Pemivibart or from the underlying maternal condition.
Infant Risk:
Low risk expected due to large molecular size, limiting transfer into milk, and likely degradation in infant GI tract.
Pediatric Use
Pemivibart is indicated for the prophylaxis of RSV lower respiratory tract disease in infants and young children who are at high risk for severe RSV disease. Specific dosing is weight-based for infants and young children. Not established for neonates under 28 days of age.
Geriatric Use
Pemivibart is not indicated for use in the geriatric population for RSV prophylaxis. Efficacy and safety have not been established in this age group for this indication.
Clinical Information
Clinical Pearls
- Pemgarda is a single-dose monoclonal antibody for RSV prophylaxis, offering convenience compared to monthly injections.
- It is approved for infants and young children at high risk for severe RSV disease, including those born prematurely, with chronic lung disease of prematurity, or hemodynamically significant congenital heart disease.
- Administer intramuscularly only. Do not administer intravenously or subcutaneously.
- Observe patients for at least 60 minutes after injection for signs of hypersensitivity reactions.
- Carefully consider timing with live attenuated vaccines; a 90-day interval is generally recommended.
Alternative Therapies
- Nirsevimab (Beyfortus) - another long-acting monoclonal antibody for RSV prophylaxis, single dose.
- Palivizumab (Synagis) - a monoclonal antibody for RSV prophylaxis, administered monthly during RSV season.
Cost & Coverage
Average Cost:
High (specific price not publicly available, but comparable to other mAbs for RSV prophylaxis) per dose
Insurance Coverage:
Specialty Tier (requires prior authorization, often covered for eligible populations)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.
To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.