Emicizumab-kxwh (Subcutaneous)

Emicizumab-kxwh injection is used to stop or lessen the number of bleeding episodes in patients with hemophilia A (congenital Factor VIII deficiency).

This medicine is available only with your doctor's prescription.

It is very important that your doctor monitors your progress closely at regular visits while you or your child are using this medicine to ensure it is working properly. Blood tests will be required to check for unwanted effects.

Thrombotic microangiopathy (damage in the smallest blood vessels) may happen while you are using this medicine. Inform your doctor immediately if you experience any of the following symptoms: a fever, tiredness, confusion, loss of vision, or seizures.

This medicine may raise your risk of blood clotting issues. Notify your doctor right away if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are using this medicine.

Using this medicine during pregnancy can harm your unborn baby. Women should use an effective form of birth control to prevent pregnancy while being treated with this medicine. If you think you might be pregnant while using this medicine, inform your doctor immediately.

Tell your doctor if this medicine does not prevent or stop bleeding as expected.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. You may need to stop using this medicine several days or months before undergoing surgery or medical tests.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of emicizumab-kxwh injection. Safety and effectiveness have been confirmed.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the use of emicizumab-kxwh injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and do not necessarily include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Anti-Inhibitor Coagulant Complex

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around meal times, or with certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Bleeding problem or
• Blood vessel problem—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blue-green to black skin discoloration
• Changes in skin color, pain, tenderness, or swelling of the foot or leg
• Pain, redness, or sloughing of the skin at the injection site
• Sudden weakness in the arms or legs
• Sudden, severe chest pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Headache
• Diarrhea
• Difficulty in moving
• Fever
• Joint pain or swelling
• Muscle aches, cramps, pain, or stiffness
• Muscle pain or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Hemlibra

Available Dosage Forms:

• Solution

Therapeutic Class: Antihemophilic Agent

Pharmacologic Class: Emicizumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the upper outer arms, thighs, or stomach. You or your caregiver may be trained to prepare and inject this medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, hard, or not intact, or into areas with moles or scars.

Check the liquid in the vial. It should be colorless or slightly yellow. Do not use the medicine if the liquid is discolored, or has particles in it. Do not shake.

You might not use all of the medicine in each vial. Use each vial only one time. Do not save an open vial.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For prevention of bleeding episodes: Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 milligrams (mg) per kilogram (kg) injected under the skin once a week for the first 4 weeks followed by 1.5 mg/kg once a week. Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 milligrams (mg) per kilogram (kg) injected under the skin once weekly for the first 4 weeks followed by 1.5 mg/kg once a week.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store it in its original carton. You may store the unopened vial at room temperature if needed, and then return to the refrigerator. It should not be stored out of the refrigerator for more than 7 days. Throw away any unused medicine left in the vial.