WARNING

Casirivimab and Imdevimab are monoclonal antibody drugs used together to treat COVID-19. Like any medication, they come with potential risks and side effects. Here are some of the risks associated with Casirivimab and Imdevimab injection:

• Allergic reactions: Some people may experience allergic reactions to Casirivimab and Imdevimab, which can range from mild to severe. Signs of an allergic reaction may include rash, itching, swelling, dizziness, or difficulty breathing.
• Infusion-related reactions: During or shortly after receiving the injection, patients may experience infusion-related reactions such as fever, chills, nausea, headache, or rapid heartbeat.
• Interference with lab tests: Casirivimab and Imdevimab can interfere with certain laboratory tests, particularly those that assess for the presence of SARS-CoV-2 antibodies. This interference can lead to inaccurate test results.
• Effectiveness concerns: The effectiveness of Casirivimab and Imdevimab may vary depending on the viral variants circulating at the time of treatment. Some variants may be less responsive to this treatment.
• Unknown long-term risks: As these drugs are relatively new, there may be unknown long-term risks associated with their use.

It’s essential for patients to discuss these risks with their healthcare provider before starting treatment with Casirivimab and Imdevimab. Healthcare providers can help assess the potential benefits and risks based on an individual’s specific health situation.

Why is this medication prescribed?

Casirivimab and Imdevimab Injection is prescribed for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to severe COVID-19 and/or hospitalization. It is specifically used in individuals who have tested positive for SARS-CoV-2 and are at high risk due to factors such as age, obesity, diabetes, chronic kidney disease, or immunosuppressive disease or treatment.

How should this medicine be used?

Casirivimab and Imdevimab are administered together as a single intravenous infusion. Here are the general guidelines for their use:

• Timing: Casirivimab and Imdevimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
• Dosage: The recommended dose is 1200 mg of casirivimab and 1200 mg of imdevimab (total dose of 2400 mg) administered together as a single infusion.
• Administration: The infusion should be given over a period of approximately 60 minutes by a healthcare provider in a healthcare setting equipped to manage potential infusion-related reactions.
• Monitoring: Patients should be monitored during and after the infusion for any signs of allergic reactions or infusion-related adverse events.
• Post-infusion observation: After the infusion, patients should be observed for at least 1 hour to ensure there are no immediate adverse reactions.
• Follow-up: Healthcare providers should continue to monitor patients for any adverse effects and to assess clinical improvement post-treatment.

It’s important for healthcare providers to follow specific guidelines and protocols provided by the drug manufacturer and health authorities when administering Casirivimab and Imdevimab to ensure safe and effective use in eligible patients.

Other uses for this medicine

Casirivimab and Imdevimab Injection is primarily used for the treatment of mild to moderate COVID-19 in high-risk individuals as described earlier. Currently, its use is not approved or recommended for other purposes beyond treating COVID-19 caused by SARS-CoV-2.

What special precautions should I follow?

Special Precautions for Casirivimab and Imdevimab Injection:

• Allergic Reactions: Patients should be monitored closely for allergic reactions during and after the infusion. Providers should be prepared to manage anaphylaxis or other severe reactions promptly.
• Infusion-Related Reactions: Infusion-related reactions such as fever, chills, nausea, headache, or rapid heartbeat can occur. Healthcare providers should monitor patients closely during the infusion and for at least 1 hour afterward.
• Interference with Lab Tests: Casirivimab and Imdevimab can interfere with certain laboratory tests that detect antibodies against SARS-CoV-2. This interference may result in false-positive results in antibody tests conducted after treatment.
• Pregnancy and Breastfeeding: The safety of Casirivimab and Imdevimab during pregnancy and breastfeeding has not been established. Healthcare providers should weigh the potential benefits and risks before administering this treatment to pregnant or breastfeeding individuals.
• Immunogenicity: There is a potential risk of developing antibodies against Casirivimab and Imdevimab, which could affect future treatment options if the patient is reinfected with SARS-CoV-2.
• Viral Variants: The effectiveness of Casirivimab and Imdevimab may vary depending on the circulating variants of SARS-CoV-2. Healthcare providers should consider local epidemiology and viral variants when selecting treatment.
• Drug Interactions: There are no known clinically significant drug interactions with Casirivimab and Imdevimab. However, healthcare providers should consider potential interactions with other medications on a case-by-case basis.
• Use in Children: Casirivimab and Imdevimab are approved for use in pediatric patients (12 years of age and older weighing at least 40 kg) based on clinical trials. Safety and efficacy in younger children have not been established.

Patients and healthcare providers should carefully consider these precautions and discuss any specific concerns before initiating treatment with Casirivimab and Imdevimab Injection. Close monitoring and adherence to guidelines are essential to maximize the benefits and minimize the risks associated with this therapy.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Casirivimab and Imdevimab Injection. However, maintaining a balanced diet and staying hydrated can support overall health and recovery from COVID-19.

What side effects can this medication cause?

Casirivimab and Imdevimab Injection, like any medication, can cause side effects. Some of the common side effects reported with Casirivimab and Imdevimab include:

• Allergic Reactions: These can range from mild reactions such as rash and itching to more severe reactions like difficulty breathing, swelling of the face or throat, and anaphylaxis.
• Infusion-Related Reactions: These may include fever, chills, nausea, headache, flushing, dizziness, and rapid heartbeat.
• Nausea and Vomiting: Some patients may experience gastrointestinal symptoms such as nausea and vomiting.
• Fatigue: Feeling tired or fatigued is another potential side effect.
• Muscle Pain: Muscle pain or myalgia can occur.
• Joint Pain: Some patients may experience joint pain or arthralgia.
• Headache: Headaches are a commonly reported side effect.
• Dizziness: Feeling dizzy or lightheaded may occur.
• Decreased Blood Pressure: In some cases, Casirivimab and Imdevimab may cause a decrease in blood pressure.
• Increased Liver Enzymes: Elevated liver enzymes have been reported in some patients.
• Hypersensitivity Reactions: Besides allergic reactions, hypersensitivity reactions including anaphylaxis have been reported.
• Other Reactions: Additional side effects may include diarrhea, rash, itching, and infusion site reactions.

It’s essential to discuss any concerns about potential side effects with your healthcare provider before starting treatment with Casirivimab and Imdevimab. They can provide guidance on managing side effects and monitoring for any adverse reactions during and after the infusion. Promptly reporting any unusual symptoms or reactions is crucial for ensuring safe and effective treatment.

What should I know about storage and disposal of this medication?

Storage and Disposal:

• Storage: Casirivimab and Imdevimab Injection should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Once removed from refrigeration, the infusion should be started within 1 hour. If not used within this time, it should be discarded.
• Handling: Healthcare providers should follow appropriate procedures for handling and preparing the infusion to minimize contamination and ensure proper administration.
• Disposal: Any unused portion of the medication or materials used in the administration should be disposed of according to local regulations for biohazardous waste.

In case of emergency/overdose

• Emergency: In case of a severe allergic reaction (anaphylaxis) or other medical emergency during or shortly after the infusion, seek immediate medical attention. Anaphylaxis may present with symptoms such as difficulty breathing, swelling of the face or throat, rapid heartbeat, or severe rash.
• Overdose: There is limited information regarding potential effects of overdose with Casirivimab and Imdevimab. In clinical trials, doses higher than recommended were not associated with increased adverse effects. However, if overdose is suspected, symptomatic treatment and supportive care should be provided as necessary.

What other information should I know?

• Effectiveness: Casirivimab and Imdevimab are specifically designed to neutralize the SARS-CoV-2 virus and reduce the severity of COVID-19 symptoms in high-risk individuals. It is not a substitute for vaccination against COVID-19.
• Monitoring: After receiving Casirivimab and Imdevimab, healthcare providers may continue to monitor your health to assess for any improvements in symptoms and watch for potential side effects.
• Follow-Up: Follow any instructions provided by your healthcare provider regarding follow-up appointments or additional treatments that may be necessary based on your response to Casirivimab and Imdevimab.
• Vaccination: Casirivimab and Imdevimab treatment does not prevent future infections with SARS-CoV-2. Vaccination against COVID-19 is recommended according to current guidelines to reduce the risk of infection and its complications.
• Patient Education: Be informed about the signs and symptoms of allergic reactions or infusion-related reactions, and know when to seek medical attention if these occur.

Always consult with your healthcare provider for specific guidance on the use, storage, and disposal of Casirivimab and Imdevimab Injection, and to address any concerns or questions you may have regarding your treatment plan.