KAVIGALE (Sipavibart)
Monoclonal Antibody for COVID-19 Pre-Exposure Prophylaxis
Quick Facts About KAVIGALE
Key Takeaways About KAVIGALE
- Passive immunity for the immunocompromised: KAVIGALE provides antibody-based protection against COVID-19 for patients who cannot generate an adequate immune response to vaccination
- Single-dose convenience: It is administered as a single 300 mg dose, either as an intramuscular injection or an intravenous infusion
- Not a vaccine replacement: KAVIGALE is a complement to, not a substitute for, COVID-19 vaccination; it provides passive rather than active immunity
- Variant coverage may vary: As SARS-CoV-2 evolves, KAVIGALE may not provide protection against all circulating variants of the virus
- Monitor for allergic reactions: Patients should be observed after administration for signs of hypersensitivity or infusion-related reactions
What Is KAVIGALE and What Is It Used For?
KAVIGALE (sipavibart) is a monoclonal antibody used for pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older, weighing at least 40 kg, who have an increased risk of SARS-CoV-2 infection due to immunocompromise caused by disease or immunosuppressive treatment.
KAVIGALE belongs to a class of medicines known as monoclonal antibodies. These are laboratory-engineered proteins designed to mimic the immune system's ability to fight off specific pathogens. The active substance in KAVIGALE, sipavibart, has been specifically designed to recognise and bind to a protein on the surface of the SARS-CoV-2 virus – the virus responsible for COVID-19.
The SARS-CoV-2 virus uses its spike protein to attach to and enter human cells. Sipavibart binds to a critical region of this spike protein called the receptor-binding domain (RBD), effectively blocking the virus from latching onto human cell receptors. This prevents the virus from entering cells and replicating, helping the body resist infection before it can take hold.
Unlike COVID-19 vaccines, which stimulate the body's own immune system to produce antibodies (active immunity), KAVIGALE provides ready-made antibodies (passive immunity). This distinction is particularly important for immunocompromised patients – individuals whose immune systems have been weakened by conditions such as organ transplantation, haematological malignancies, primary immunodeficiency disorders, or immunosuppressive therapies. These patients often fail to mount a sufficient antibody response to vaccination, leaving them vulnerable to severe COVID-19 despite being fully vaccinated.
The development of monoclonal antibodies for COVID-19 prophylaxis represents a significant advancement in protecting the most vulnerable patient populations. Previous anti-SARS-CoV-2 monoclonal antibodies, including tixagevimab/cilgavimab (Evusheld), lost efficacy as the virus evolved. KAVIGALE has been designed with a broader neutralisation profile to maintain activity against currently circulating variants, although ongoing surveillance is essential to ensure continued efficacy as the virus continues to mutate.
What Should You Know Before Receiving KAVIGALE?
Before receiving KAVIGALE, inform your doctor about any allergies, bleeding disorders, or medications you are taking. KAVIGALE should not be given if you are allergic to sipavibart or any of its excipients, including polysorbate 80.
Contraindications
KAVIGALE must not be administered to anyone who has a known allergy (hypersensitivity) to sipavibart or to any of the other ingredients in the formulation. The excipients include histidine, histidine monohydrochloride, arginine hydrochloride, polysorbate 80 (E433), and water for injections. Polysorbate 80 is known to cause allergic reactions in some individuals, so it is important to inform your healthcare provider if you have any known allergies to this substance.
If you have experienced a severe allergic reaction (anaphylaxis) to a previous dose of any monoclonal antibody therapy, this should be discussed with your doctor before receiving KAVIGALE, as cross-reactivity may be possible in rare cases.
Warnings and Precautions
Before receiving KAVIGALE, tell your doctor or nurse if you have any of the following conditions:
- Low platelet count (thrombocytopenia) – as intramuscular injection may cause bleeding at the injection site
- Bleeding disorders – any condition that affects blood clotting may increase the risk of bleeding complications
- Anticoagulant therapy – if you are taking blood-thinning medications such as warfarin, heparin, or direct oral anticoagulants (DOACs), your doctor may need to take additional precautions or choose intravenous administration instead
KAVIGALE may also cause infusion-related reactions, which can occur immediately or within several hours after administration. Symptoms may include nausea, joint pain, headache, fever and chills, stomach discomfort, pain, dizziness or feeling faint, flushing and warmth in the face, cough, chest discomfort, vertigo, and shortness of breath. Your healthcare provider will monitor you for an appropriate period after receiving KAVIGALE and will determine the observation time based on your individual risk factors.
It is important to understand that KAVIGALE does not guarantee complete protection against COVID-19. SARS-CoV-2 is a rapidly evolving virus, and new variants may emerge that are partially or fully resistant to the neutralising activity of sipavibart. Continue to follow public health recommendations regarding infection prevention measures as advised by your healthcare provider.
Children and Adolescents
KAVIGALE should not be given to children under 12 years of age or to adolescents aged 12 years and older who weigh less than 40 kg. The safety and efficacy of KAVIGALE have not been established in these populations, and insufficient data are available to support dosing recommendations. Clinical trials in younger paediatric populations are ongoing, and recommendations may be updated as new data become available.
Pregnancy and Breastfeeding
KAVIGALE has not been studied in pregnant women, and it is not known whether sipavibart can cross the placental barrier or cause harm to an unborn child. As with other IgG1 monoclonal antibodies, placental transfer is biologically plausible, particularly during the second and third trimesters. Your doctor will only prescribe KAVIGALE during pregnancy if the expected benefit to you outweighs the potential risk to the foetus.
It is not known whether sipavibart is excreted in human breast milk or what effects it may have on a breastfed infant or on milk production. Human IgG antibodies are generally present in breast milk, so transfer of sipavibart into breast milk is considered possible. Your doctor will help you weigh the benefits of breastfeeding against the potential risks and will advise you accordingly.
If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor or nurse before receiving KAVIGALE.
Driving and Using Machines
KAVIGALE is not expected to affect your ability to drive or operate machinery. However, as with any medicine administered in a healthcare setting, you should ensure you feel well before driving or operating heavy equipment, particularly if you experience any infusion-related reactions such as dizziness or fatigue.
How Does KAVIGALE Interact with Other Drugs?
No formal drug interaction studies have been conducted with KAVIGALE. As a monoclonal antibody, sipavibart is not expected to be metabolised by cytochrome P450 enzymes and is unlikely to interact with most conventional medications. However, always inform your doctor about all medicines you are taking.
Monoclonal antibodies like sipavibart are large protein molecules that are catabolised (broken down) by general proteolytic pathways rather than by the cytochrome P450 (CYP) enzyme system in the liver. This means that traditional drug-drug interactions mediated by CYP enzymes – the most common mechanism for interactions between small-molecule drugs – are not expected with KAVIGALE.
However, the potential for pharmacodynamic interactions should be considered. Because KAVIGALE works by binding to the SARS-CoV-2 spike protein, there is a theoretical possibility of interaction with COVID-19 vaccines that also target the spike protein. Although no clinical evidence of interference has been established, your doctor may consider the timing of KAVIGALE administration relative to COVID-19 vaccination schedules.
Tell your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or might take, including over-the-counter medications, supplements, and herbal products. While significant interactions are not anticipated, complete disclosure of your medication list ensures the safest possible care.
| Drug/Category | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Anticoagulants (warfarin, heparin, DOACs) | Increased bleeding risk at injection site | Moderate | Consider IV route; monitor for bleeding |
| COVID-19 vaccines (mRNA, viral vector) | Theoretical pharmacodynamic | Unknown | Discuss timing with your doctor |
| Other monoclonal antibodies | Theoretical overlapping activity | Low | Inform healthcare provider |
| Immunosuppressants (tacrolimus, mycophenolate, ciclosporin) | May reduce immune-mediated clearance of sipavibart | Low | No dose adjustment needed |
| Anti-platelet agents (aspirin, clopidogrel) | Increased bruising/bleeding at injection site | Low | Monitor injection site; consider IV route |
What Is the Correct Dosage of KAVIGALE?
The recommended dose of KAVIGALE is 300 mg administered as a single dose. It can be given either as an intramuscular injection into the thigh muscle or as an intravenous infusion. KAVIGALE is always administered by a healthcare professional.
KAVIGALE is supplied as a clear to opalescent, colourless to slightly yellow solution in a single-use glass vial containing 300 mg of sipavibart in 2 mL of solution. It is not intended for self-administration and must be prepared and given by trained healthcare personnel using aseptic technique.
Adults and Adolescents (12 years and older, weighing ≥40 kg)
Standard Dose
300 mg (2 mL) as a single dose, administered via one of the following routes:
- Intramuscular (IM) injection: Administered into the anterolateral aspect of the thigh. The injection is drawn up into a syringe directly from the vial and given as a single injection.
- Intravenous (IV) infusion via IV bag: The 2 mL of solution is diluted in a 50 mL or 100 mL bag of 0.9% sodium chloride or 5% glucose solution and infused over approximately 20 minutes using an in-line 0.2 or 0.22 micrometre low-protein-binding filter.
- Intravenous (IV) infusion via syringe pump: The undiluted 2 mL (300 mg) is administered intravenously using a syringe pump over a minimum of 6 minutes.
The choice between intramuscular and intravenous administration is made by your healthcare provider based on individual clinical circumstances. Patients with bleeding disorders or those receiving anticoagulant therapy may be more suitable candidates for intravenous administration to avoid potential bleeding complications at the injection site.
Children Under 12 Years
KAVIGALE is not authorised for use in children under 12 years of age or in adolescents weighing less than 40 kg. The safety, efficacy, and pharmacokinetics of sipavibart have not been established in these populations.
Elderly Patients
No dose adjustment is required for elderly patients. The 300 mg single dose applies regardless of age. Clinical trials included patients aged 65 years and older, and no clinically significant differences in safety or efficacy were observed compared with younger adults.
Renal and Hepatic Impairment
As a monoclonal antibody, sipavibart is not eliminated via renal or hepatic metabolic pathways. No dose adjustment is considered necessary in patients with renal or hepatic impairment. Monoclonal antibodies are primarily cleared through intracellular catabolism following pinocytosis or receptor-mediated endocytosis.
Missed Dose
KAVIGALE is administered as a single dose in a healthcare setting, so the concept of a missed dose does not typically apply. If your scheduled appointment is delayed, contact your healthcare provider to reschedule as soon as possible to ensure continued protection.
Overdose
No cases of overdose with KAVIGALE have been reported. There is no specific antidote for sipavibart. In the event of overdose, the patient should be monitored for any signs or symptoms of adverse effects, and appropriate supportive treatment should be administered as necessary. Given the pharmacological profile of monoclonal antibodies, an overdose is unlikely to produce significantly different effects from the standard dose, though the risk and severity of infusion-related reactions may be increased.
| Patient Group | Dose | Route | Duration |
|---|---|---|---|
| Adults (≥18 years) | 300 mg (single dose) | IM or IV | IM: immediate; IV bag: ~20 min; IV pump: ≥6 min |
| Adolescents (12–17 years, ≥40 kg) | 300 mg (single dose) | IM or IV | IM: immediate; IV bag: ~20 min; IV pump: ≥6 min |
| Elderly (≥65 years) | 300 mg (single dose) | IM or IV | No dose adjustment needed |
| Children (<12 years or <40 kg) | Not recommended | N/A | Insufficient data |
What Are the Side Effects of KAVIGALE?
Like all medicines, KAVIGALE can cause side effects, although not everybody gets them. The most common side effects are reactions at the injection or infusion site. Serious allergic reactions are possible but uncommon.
The safety profile of KAVIGALE has been evaluated in clinical trials involving immunocompromised patients. Side effects are categorised below by their frequency of occurrence according to international pharmacovigilance conventions. Most side effects observed with KAVIGALE are mild to moderate in severity and resolve spontaneously without the need for specific treatment.
Before examining the frequency-based breakdown, it is important to note that patients receiving similar monoclonal antibody products have experienced serious allergic reactions (anaphylaxis). Although rare, anaphylaxis is a medical emergency that requires immediate intervention. Healthcare settings administering KAVIGALE should be equipped to manage anaphylaxis.
Common Side Effects
- Injection site reactions (pain, bruising, redness, bleeding, swelling, haematoma, itching, numbness, tingling, rash, discolouration, warmth)
- Infusion site reactions (bruising, pain, itching, redness, swelling)
- Infusion-related reactions (nausea, joint pain, headache, fever)
Uncommon Side Effects
- Allergic reactions (hypersensitivity) including itching, skin redness, hives (urticaria), rash
Rare / Not Yet Fully Characterised
- Severe allergic reactions (anaphylaxis) – reported with similar monoclonal antibody products
- Severe infusion-related reactions with significant cardiovascular or respiratory symptoms
Injection site reactions are the most frequently reported side effects and typically manifest as localised pain, redness, or swelling at the site where the intramuscular injection was given. These reactions usually resolve within a few days without treatment. Applying a cold compress to the area may help reduce discomfort and swelling.
Infusion-related reactions tend to occur during or within several hours of intravenous administration. Symptoms can range from mild (nausea, headache) to more significant (chest discomfort, shortness of breath, dizziness). Your healthcare provider will monitor you after administration and can manage these reactions with supportive care if needed.
If you experience any side effects not listed above, or if any side effects become severe, tell your doctor, pharmacist, or nurse. You can also report suspected side effects directly to your national medicines regulatory authority. Reporting helps to continuously monitor the benefit-risk balance of medicines.
How Should KAVIGALE Be Stored?
KAVIGALE must be stored in a refrigerator at 2°C to 8°C and must not be frozen or shaken. It should be kept in the original carton to protect from light. Storage and handling are the responsibility of your healthcare provider.
As KAVIGALE is administered exclusively in healthcare settings, patients do not need to store this medicine at home. The following storage information is relevant for healthcare professionals responsible for handling the product:
- Unopened vials: Store in a refrigerator at 2°C to 8°C. Do not freeze. Do not shake. Keep the vial in the outer carton to protect from light.
- Prepared syringes or infusion bags: Should be used immediately after preparation. If immediate use is not possible, they may be stored for up to 24 hours at 2°C to 8°C, or up to 4 hours at room temperature (up to 25°C).
- Shelf life: Do not use after the expiry date stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children. Your doctor, pharmacist, or nurse is responsible for the correct storage and disposal of any unused medicine or waste material in accordance with local requirements.
Before administration, the healthcare professional will visually inspect the solution. KAVIGALE should be a clear to opalescent, colourless to slightly yellow solution. The vial should be discarded if the solution appears cloudy, discoloured, or contains visible particles.
What Does KAVIGALE Contain?
Each vial of KAVIGALE contains 300 mg of sipavibart in 2 mL of solution. The other ingredients include histidine, histidine monohydrochloride, arginine hydrochloride, polysorbate 80 (E433), and water for injections.
The active substance in KAVIGALE is sipavibart, a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody produced using recombinant DNA technology. Each single-use vial contains 300 mg of sipavibart in 2 mL, corresponding to a concentration of 150 mg/mL.
The excipients (inactive ingredients) serve important roles in maintaining the stability and integrity of the antibody:
- Histidine and histidine monohydrochloride: Act as buffering agents to maintain the pH of the solution within the optimal range for antibody stability
- Arginine hydrochloride: Functions as a stabiliser, preventing aggregation of the antibody molecules during storage
- Polysorbate 80 (E433): A non-ionic surfactant that protects the antibody from surface-induced denaturation. Note: this excipient may cause allergic reactions in some individuals. Each vial contains 0.8 mg of polysorbate 80
- Water for injections: The solvent component of the formulation
KAVIGALE is presented as a clear to opalescent, colourless to slightly yellow solution for injection or infusion in a clear glass vial with a light green cap. Each carton contains 1 vial. The product does not contain preservatives and is for single use only – any unused solution remaining after administration must be discarded.
KAVIGALE does not contain latex in the vial stopper, making it suitable for patients with latex allergy. It does not contain any components derived from animal sources other than the recombinant human antibody itself.
Frequently Asked Questions About KAVIGALE
COVID-19 vaccines work by stimulating your own immune system to produce antibodies against the SARS-CoV-2 virus (active immunity). KAVIGALE, on the other hand, provides pre-made antibodies (passive immunity) that work immediately without relying on your immune system to generate a response. This is particularly important for immunocompromised patients who may not respond adequately to vaccination. KAVIGALE is not a replacement for vaccination but is used as an additional protective measure for high-risk individuals.
The duration of protection provided by KAVIGALE depends on the half-life of the antibody in your body and the circulating SARS-CoV-2 variants. Monoclonal antibodies of the IgG1 class typically have a half-life of approximately 21 days, meaning the antibody concentration in your blood gradually decreases over time. Your doctor will advise you on whether and when repeat dosing may be necessary based on your individual risk profile and the latest clinical guidance.
Yes, it is still possible to get COVID-19 after receiving KAVIGALE. The SARS-CoV-2 virus continually mutates, and KAVIGALE may not provide protection against all circulating variants. If you develop symptoms of COVID-19 – such as fever, cough, sore throat, loss of taste or smell, fatigue, or difficulty breathing – contact your doctor immediately. Continue to follow recommended infection prevention measures even after receiving KAVIGALE.
KAVIGALE is indicated for adults and adolescents aged 12 years and older who weigh at least 40 kg and have an increased risk of SARS-CoV-2 infection due to immunocompromise. This includes patients with conditions such as organ transplantation, haematological malignancies, primary immunodeficiency disorders, or those receiving immunosuppressive therapies that prevent an adequate response to COVID-19 vaccination. Your doctor will assess whether you are a suitable candidate based on your medical history and immune status.
KAVIGALE can be given either way. The intramuscular injection is given into the thigh muscle and takes just a few minutes. The intravenous infusion can be given via an IV bag (approximately 20 minutes) or via a syringe pump (minimum 6 minutes). Your healthcare provider will choose the most appropriate method based on your clinical situation, including factors such as bleeding risk and venous access availability.
Mild side effects such as injection site pain, redness, or slight swelling are normal and usually resolve within a few days. You can apply a cold compress to reduce discomfort. However, if you experience symptoms of a severe allergic reaction – such as difficulty breathing, swelling of the face or throat, or widespread hives – seek emergency medical attention immediately. For any other concerning symptoms, contact your healthcare provider for guidance.
References
- European Medicines Agency (EMA). KAVIGALE (sipavibart) – Summary of Product Characteristics. European Medicines Agency. Available at: www.ema.europa.eu.
- World Health Organization (WHO). COVID-19 therapeutics and prophylaxis – Living guideline. WHO. 2025. Available at: www.who.int.
- Levin MJ, Ustianowski A, De Wit S, et al. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188–2200. doi:10.1056/NEJMoa2116620.
- European Centre for Disease Prevention and Control (ECDC). Guidance on the use of monoclonal antibodies for COVID-19 in immunocompromised patients. ECDC Technical Report. 2024.
- AstraZeneca. KAVIGALE (sipavibart) – European Public Assessment Report (EPAR). 2025.
- National Institute for Health and Care Excellence (NICE). COVID-19 rapid guideline: managing COVID-19. NICE Guideline [NG191]. Updated 2025.
- Infectious Diseases Society of America (IDSA). Guidelines on the Treatment and Management of Patients with COVID-19. Updated 2025. Available at: www.idsociety.org.
- British National Formulary (BNF). Sipavibart – Monograph. Available at: bnf.nice.org.uk.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in infectious disease, clinical immunology, and clinical pharmacology. All content follows international medical guidelines and is based on peer-reviewed evidence.
Conflicts of interest: The iMedic editorial team has no financial relationships with pharmaceutical companies. All content is independently produced without commercial funding or advertising sponsorship.