WARNING

While Hemlibra (emicizumab) can be an effective treatment for individuals with hemophilia A, it is essential to be aware of the potential risks associated with its use. Here is a brief overview of some of the risks:

• Thrombotic Microangiopathy (TMA): Hemlibra has been associated with an increased risk of developing TMA, a condition characterized by blood clot formation in small blood vessels. Symptoms may include decreased urine output, fatigue, confusion, and unexplained bleeding or bruising. If TMA is suspected, immediate medical attention is necessary.
• Thrombosis: There have been reports of blood clot formation in patients receiving Hemlibra. Signs of thrombosis may include pain, swelling, warmth, or redness in the limbs, sudden difficulty breathing, chest pain, or severe headache. Prompt medical evaluation is essential if these symptoms occur.
• Hypersensitivity Reactions: Allergic reactions, including rash, itching, hives, and swelling, may occur with Hemlibra. If you experience any signs of a hypersensitivity reaction, seek medical assistance right away.
• Laboratory Test Interference: Hemlibra can affect laboratory tests that measure activated clotting time (ACT) or activated partial thromboplastin time (aPTT), potentially leading to inaccurate results.

It is important to discuss any potential risks and concerns with your healthcare provider before starting Hemlibra. They will carefully consider your individual medical history and assess the potential benefits and risks associated with the medication. It’s crucial to promptly report any unusual symptoms or side effects to your healthcare provider for proper evaluation and guidance.

Why is this medication prescribed?

Hemlibra (emicizumab) is prescribed to individuals with hemophilia A, a genetic bleeding disorder. Hemophilia A is characterized by a deficiency or dysfunction of clotting factor VIII in the blood, which impairs the blood’s ability to clot properly.

Hemlibra is used to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. It can be prescribed for individuals who have developed factor VIII inhibitors (antibodies that neutralize factor VIII) or for those without inhibitors.

By mimicking the function of factor VIII, Hemlibra helps facilitate the clotting process and improves blood coagulation in individuals with hemophilia A. It can be an effective prophylactic treatment to reduce the occurrence of spontaneous bleeding episodes and to manage bleeding during certain procedures or surgeries.

It is important to note that Hemlibra is not a replacement for factor VIII replacement therapy and should not be used in individuals with a known hypersensitivity to factor VIII products.

How should this medicine be used?

Hemlibra (emicizumab) is administered as a subcutaneous injection, which means it is injected under the skin. Here are general guidelines for the use of Hemlibra:

• Preparation: Wash your hands thoroughly with soap and water. Gather the necessary supplies, including the Hemlibra vial, a syringe, and a needle. Check the expiration date and visually inspect the vial. Do not use if the liquid is discolored or contains particles. Allow the vial to reach room temperature if it has been stored in the refrigerator. Do not warm it using external heat sources.
• Reconstitution: Clean the rubber stopper on the Hemlibra vial with an alcohol swab. Using a syringe and needle, withdraw the appropriate amount of sterile water for injection provided by your healthcare professional. The specific amount will be determined based on your prescribed dose. Slowly inject the sterile water into the vial, aiming the stream of liquid against the inside wall of the vial. Gently swirl the vial to mix the solution. Do not shake vigorously to avoid foaming.
• Preparation of the Injection: Clean a suitable injection site (such as the thigh or abdomen) with an alcohol swab and let it dry. Attach a new needle to the syringe, and then withdraw the required dose of the reconstituted Hemlibra solution.
• Injection: Pinch the cleaned skin at the injection site to create a firm surface. Insert the needle into the skin at a 45- to 90-degree angle, as instructed by your healthcare professional. Slowly inject the Hemlibra solution under the skin. Once the full dose is injected, remove the needle and apply gentle pressure to the injection site with a sterile cotton ball or gauze.

It’s important to note that the above instructions provide a general overview and should not replace the specific instructions provided by your healthcare provider. They will provide you with detailed instructions tailored to your individual needs. If you have any questions or concerns about the administration of Hemlibra, it’s always best to consult your healthcare professional for guidance.

Other uses for this medicine

Hemlibra is primarily used for the treatment and prevention of bleeding episodes in individuals with hemophilia A, with or without factor VIII inhibitors. It is not approved for other uses, and its safety and efficacy in other conditions have not been established.

What special precautions should I follow?

When using Hemlibra, it is important to consider the following precautions:

• Inform your healthcare provider about all your medical conditions, including any history of blood clotting disorders or inhibitors to factor VIII.
• Inform your healthcare provider about all the medications, including over-the-counter drugs and supplements, that you are taking, as they may interact with Hemlibra.
• Hemlibra may interfere with laboratory tests that measure activated clotting time (ACT) or activated partial thromboplastin time (aPTT), leading to inaccurate results. Inform healthcare professionals conducting these tests that you are taking Hemlibra.
• Seek immediate medical attention if you experience signs of thrombosis (blood clot formation), such as pain, swelling, warmth, redness in the limbs, sudden difficulty breathing, chest pain, or severe headache.
• Report any signs of allergic reactions or hypersensitivity, such as rash, itching, hives, or swelling, to your healthcare provider.
• If you are pregnant or planning to become pregnant, discuss the risks and benefits of using Hemlibra with your healthcare provider.
• It is not known if Hemlibra passes into breast milk, so talk to your healthcare provider about the potential risks and benefits if you are breastfeeding or planning to breastfeed.

These are general precautions, and it’s important to consult your healthcare provider for personalized advice and to discuss any specific concerns or considerations related to your individual situation.

What special dietary instructions should I follow?

Hemlibra does not have any specific dietary restrictions. However, it is always a good idea to maintain a balanced and healthy diet to support overall well-being.

What should I do if I forget a dose?

If you forget to take a dose of Hemlibra, it is important to contact your healthcare provider for guidance. They can provide specific instructions based on your individual circumstances. It is generally recommended to take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, it is usually best to skip the missed dose and resume your regular dosing schedule.

What side effects can this medication cause?

Hemlibra (emicizumab) may cause some side effects. It’s important to note that not everyone experiences these side effects, and their severity can vary. If you are prescribed Hemlibra, your healthcare provider will discuss the potential risks and benefits with you. Here are some commonly reported side effects associated with Hemlibra:

• Injection site reactions: This includes redness, swelling, itching, pain, or irritation at the site of injection.
• Headache: Some individuals may experience headaches while receiving Hemlibra treatment.
• Joint pain: Joint pain has been reported as a side effect of Hemlibra.
• Cold-like symptoms: Symptoms such as a runny or stuffy nose, sore throat, or cough have been reported.
• Injection site bleeding: Hemlibra can increase the risk of bleeding at the injection site. It is important to follow proper injection techniques and seek medical attention if bleeding is persistent or severe.
• Antibody development: Some individuals may develop antibodies against Hemlibra, which could potentially reduce its effectiveness.

It’s crucial to promptly report any side effects or concerns to your healthcare provider. They can evaluate your specific situation and provide guidance on managing side effects or adjusting your treatment if necessary.

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

• Storage: Hemlibra should be stored in the refrigerator at a temperature between 36°F and 46°F (2°C and 8°C). It should be kept in its original carton to protect it from light. Do not freeze Hemlibra. If accidentally frozen, allow it to thaw in the refrigerator before use. Once removed from the refrigerator, Hemlibra can be kept at room temperature (up to 77°F or 25°C) for up to 3 months. Discard any unused portion after 3 months.
• Disposal: Proper disposal of Hemlibra and its packaging is important to prevent accidental ingestion or misuse. Follow your local regulations and guidelines for the disposal of medical waste or unused medications. If you have any specific questions about the disposal process, consult your healthcare provider or pharmacist.

In case of emergency/overdose

In case of an emergency or overdose situation, it is essential to take appropriate actions. Here’s what you should do:

• Emergency: If you experience a severe allergic reaction or any other life-threatening emergency while using Hemlibra, such as difficulty breathing, swelling of the face or throat, or severe dizziness, seek immediate medical assistance by calling emergency services (e.g., 911) or going to the nearest emergency room.
• Overdose: It is important to use Hemlibra as prescribed by your healthcare provider and not exceed the recommended dose. However, if you accidentally receive more Hemlibra than prescribed or suspect an overdose, contact your healthcare provider or your local poison control center immediately. They will provide guidance on the necessary steps to take.

What other information should I know?

• Administration: Hemlibra is typically administered by subcutaneous (under the skin) injection once weekly, every two weeks, or every four weeks, depending on the prescribed dose and your treatment plan. Your healthcare provider will guide you on the correct administration technique.
• Side Effects: Like any medication, Hemlibra can cause side effects. Common side effects may include injection site reactions, headache, and joint pain. However, everyone may not experience these side effects. It is important to discuss any concerns or unexpected reactions with your healthcare provider.
• Drug Interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are currently taking or plan to take, as some drugs may interact with Hemlibra. This includes both prescription and over-the-counter medications.
• Regular Check-ups: Regularly attend follow-up appointments with your healthcare provider to monitor your condition and response to Hemlibra. They may conduct blood tests to assess your progress and adjust the treatment plan if necessary.

Remember, this information is not exhaustive, and it is important to consult your healthcare provider or pharmacist for specific instructions, guidelines, and any concerns you may have regarding the storage, disposal, emergency procedures, or general use of Hemlibra.

Please note that the information provided here is for general knowledge and should not replace the specific instructions and advice given by your healthcare provider.