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Hemlibra (Subcutaneous)

Generic Name: emicizumab-kxwh (Subcutaneous route)

em-i-SIZ-ue-mab - kxwh

Subcutaneous route(Solution)

Warning: Thrombotic Microangiopathy and ThromboembolismCases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of greater than 100 units/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving emicizumab-kxwh prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of emicizumab-kxwh if symptoms occur .

Medically reviewed on Oct 4, 2018

Commonly used brand name(s)

In the U.S.

  • Hemlibra

Available Dosage Forms:

  • Solution

Therapeutic Class: Antihemophilic Agent

Pharmacologic Class: Emicizumab

Uses For Hemlibra

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

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

Before Using Hemlibra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of emicizumab-kxwh injection in children. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emicizumab-kxwh injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of Hemlibra

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.

Precautions While Using Hemlibra

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

Thrombotic microangiopathy (damage in the smallest blood vessels) may occur while you are using this medicine. Tell your doctor right away if you have the following symptoms: a fever, tiredness, confusion, loss of vision, or seizures.

This medicine may increase your chance of having blood clotting problems. Tell 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 receiving this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Women should use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

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

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days or months before you have surgery or medical tests.

Hemlibra Side Effects

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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