HEMLIBRA Preparation & Administration

Resources & Supplies 

Watch the patient injection demonstration video

A step-by-step video to help your patients or their caregivers inject HEMLIBRA

To view this in Spanish, click here.

On screen:
How to Inject HEMLIBRA (emicizumab-kxwh)

Hi! I’m Michael, and today I’m going to demonstrate how to inject HEMLIBRA. Be sure to allow yourself enough time so your medication can reach room temperature and you can inject without interruption. Whether you’re injecting yourself or a person you care for, this video is a refresher of what you learned at your healthcare provider’s office or hemophilia treatment center.

You should not inject yourself unless you have been shown how to by your healthcare provider. I hope the video is helpful, but of course if you have any questions about your treatment, always ask your healthcare provider and be sure you read and understand the Instructions for Use that came with your HEMLIBRA before you inject it.

Alright, let’s get started. First, you’ll need to collect all the necessary injection supplies. Some may be different than what you’re used to, and you may need two of some items, depending on the dose that your healthcare provider prescribed.

Be sure to follow your healthcare provider’s instructions for your dose and only use the syringes and needles that he or she prescribes, being careful to only use them once and to discard everything in a sharps container right after you use it. It’s also good to mention that if your healthcare provider prescribes a dose that is more than 2 mL, you’ll need to administer more than one subcutaneous injection, so check with your healthcare provider for instructions.

On screen:
You will need:

  • Vial containing the medicine
  • Alcohol wipes
  • Gauze
  • A cotton ball
  • A syringe
  • An 18 gauge transfer needle with 5 micron filter
  • A 25, 26, or 27 gauge injection needle with a safety shield
  • Sharps disposal container

Please refer to the Instructions for Use for proper storage instructions.

If you’re not sure if you have everything you need, be sure to always check out the Instructions for Use pamphlet that came in the box with HEMLIBRA and is available at HEMLIBRA.com.

On screen:
Connects Patient Resource Center logo
1-866-HEMLIBRA
(1-866-436-5427)

You also can speak with a Connect coordinator at 1-866-HEMLIBRA.

Remember to inspect all supplies before you start, including the box and vial label. If they are damaged, have dropped or expired, don’t use them and get another set of supplies.

Also, check your medication to be sure it is the right strength, isn’t damaged and hasn’t expired. Double check to make sure the name HEMLIBRA appears on the box and vial label too.

On screen:
Vial for illustrative purposes only

You’ll also want to check the appearance of your medication. HEMLIBRA is a colorless to slightly yellow liquid. Don’t use it if it is damaged, looks cloudy, hazy or colored, is missing the cap covering the stopper or has particles.

On screen:

  • Place supplies on a clean, well-lit surface away from direct sunlight.
  • Do not try to warm up the vial by any other way.

Okay, I have everything I need. I have inspected the vial and, since I took my vial out of the refrigerator 15 minutes ago in order to bring it to room temperature, the vial is ready to use.

I’ll grab my injection log so I can track the date of my dose, how much I injected and the injection site. And now I just need to wash my hands (with soap and water of course) and dry them thoroughly.

Let’s start by getting the HEMLIBRA vial ready.

First, take off the cap. Clean the vial stopper with an alcohol wipe and throw it away.

On screen:

  • Attach syringe to transfer needle with filter.

Next, we need to prepare the syringe by attaching it to the transfer needle. To do this, push and twist the transfer needle clockwise until it’s fully attached.

Now, I’m going to slowly pull back the plunger to draw air into the syringe. Take your time here as you’ll want to pull back to the same amount as your prescribed dose.

As you know, your healthcare provider prescribed your dose based on your weight, and will tell you your specific dose. For me, I have a 105 mg vial and there will be a little left over, which I have to discard in a puncture-proof container.

On screen:

  • Do not save unused medicine in the vial for later use.
  • The medicine in the syringe must be injected immediately.
  • If your prescribed dose is more than 2 mL, you will need to administer more than one subcutaneous injection; contact your healthcare provider for the appropriate injection instructions.

Do not save unused medicine in the vial for later use, as the medicine in the syringe must be injected immediately. If your prescribed dose is more than 2 milliliters, you will need to administer more than one subcutaneous injection. Instructions on how to administer a second vial will be shown later in this video.

Once that’s done, uncap the transfer needle by holding the syringe at the bottom with the needle pointing up and pull the cap straight off.

On screen:

  • Place the transfer needle cap down on a flat surface.
  • Do not touch the needle or place it on a surface after the cap has been removed.

When you’re doing this be careful not to touch the needle or place it on a surface after the cap has been removed. And don’t throw the cap away, because you’ll need it again. If you do touch the needle by accident, or it touches anything else, just throw it away and start with another one.

Next, you’ll need to inject air into the vial. With the vial on a flat surface, insert the needle and syringe straight down into the center of the vial stopper. Then, once the needle’s in the vial, turn it upside down.

With the needle above the medicine, now push that plunger to inject air out of the syringe and above the medicine.

On screen:

  • Do not inject air into the medicine as this could create air bubbles in the medicine.

Make sure to keep your finger pressed down on the plunger.

Next, slide the tip of the needle down so that it’s in the medicine and slowly pull back the plunger to fill the syringe.

You’ll want to fill it with more than your prescribed dose to make sure that you get the correct amount.

On screen:

  • Be careful not to pull the plunger out of the syringe.
  • If your prescribed dose is more than is in the vial, withdraw all of the medicine and refer to the Instructions for Use on how to combine vials.
  • HEMLIBRA comes in four strengths. Depending on your dose, you may need to use more than one vial to give your total prescribed dose. Your healthcare provider will determine your dose in milliliters (mL) that you will need to give based on your body weight. Do not combine HEMLIBRA vials of different concentrations in one injection to give the prescribed dose.

Be careful not to pull the plunger out of the syringe. If your prescribed dose is more than is in the vial, withdraw all of the medicine and refer to the Instructions for Use on how to combine vials. HEMLIBRA comes in four strengths. Depending on your dose, you may need to use more than one vial to give your total prescribed dose. Your healthcare provider will determine your dose in milliliters that you will need to give based on your body weight. Do not combine HEMLIBRA vials of different concentrations in one injection to give the prescribed dose.

Before we move on, we’ll also need to remove any large air bubbles in the medicine.

Just gently tap the syringe with your fingers – like this – until the air bubbles rise to the top.

Next, move the tip of the needle above the medicine and slowly push the plunger to get the air bubbles out of the syringe.

If the medicine is now at or below your prescribed dose, move that needle back into the medication and slowly pull the plunger until you have more than you need.

On screen:

  • Repeat these steps until you have removed all larger air bubbles.
  • Ensure you have enough medicine in the syringe to complete your dose before moving on.
  • If you can’t remove all medicine, turn the vial upright to reach the remaining amount.

Repeat these steps until you have removed all larger air bubbles. Ensure you have enough medicine in the syringe to complete your dose before moving on. If you can’t remove all medicine, turn the vial upright to reach the remaining amount.

When the air bubbles are gone, it’s time to recap the needle. First, remove the syringe and transfer needle from the vial.

Then, using only one hand, slide the needle into the cap in an upward scooping motion. You may want to use a clean, hard surface to help you – like your injection mat. Push the cap down to fully attach it.

Using one hand may feel awkward at first, but it helps to make sure you don’t accidentally stick yourself with the needle.

If you need to use more than one vial to get your total prescribed dose, follow these steps after you have prepared the vials:

  • Remove the previous transfer needle
  • Attach a new transfer needle
  • Uncap new transfer needle
  • With the new vial on a flat surface, insert the needle straight down into the center of the vial
  • Turn the vial and needle upside down
  • Slide the tip of the needle down so it is within the medicine, then pull the plunger back to your dose
  • Recap the transfer needle

For further instructions on combining vials, please reach out to your healthcare provider.

Now it’s time to choose your injection site. You can use the front or middle of your thigh, your stomach area (abdomen), except for a 2-inch section around your belly button, or, if you are injecting someone else, you can use the outer area of the upper arm.

Today, I’ve chosen my stomach, but it’s important to choose a different location each time you take your medication. As long as the site is at least 1 inch away from the area you used last time, you’re good.

Then you’ll need to clean the injection site with an alcohol wipe and wait for about 10 seconds while it dries.

On screen:

  • Do not inject into areas that could be irritated by a belt or waistband.
  • Do not inject into moles, scars, bruises or areas where the skin is tender, red, hard or the skin is broken.
  • Do not touch, fan or blow on the cleaned area before your injection.

Do not inject into areas that could be irritated by a belt or waistband. Do not inject into moles, scars, bruises or areas where the skin is tender, red, hard or the skin is broken. Do not touch, fan or blow on the cleaned area before your injection.

Now, I’m ready to inject HEMLIBRA.

On screen:

  • Remove the transfer needle with filter.

First, remove the transfer needle from the syringe by twisting it counter-clockwise and gently pulling. Then throw away the transfer needle in a sharps container.

Don’t use the transfer needle to inject medicine as this may cause harm such as pain and bleeding.

Next, you’ll need to attach the injection needle to the syringe by pushing the needle clockwise until it is fully attached and moving the safety shield away toward the syringe barrel.

On screen:

  • Do not touch the needle or allow it to touch any surface.
  • After the injection needle cap has been removed, the medicine must be injected immediately.

And finally, carefully pull the injection needle cap away from the syringe and throw away the cap into your sharps disposal container.

Now you’ll want to slowly push the plunger to your prescribed dose.

Next, pinch the skin on the spot you chose for your injection. You don’t need a lot of skin – just enough to hold with two fingers.

On screen:

  • Do not hold or push on the plunger while inserting the needle.
  • Do not rub the injection site after injection.

Then fully insert the needle quickly and firmly at a 45- to 90-degree angle to your skin. Hold the syringe and let go of the pinched skin.

Now slowly push the plunger all the way down to inject the medication, then remove the needle and syringe at the same angle. Remember, do not inject the medicine intravenously – the injection goes just under the skin, not into your veins.

For safety, cover the needle with the safety shield. To do this, move the safety shield forward 90 degrees and then press down firmly against a flat surface until you hear a click.

On screen:

  • Keep your fingers behind the safety shield and away from the needle.

Ok, that’s it – we’re done.

On screen:

  • If bleeding does not stop, contact your healthcare provider.

After the injection, you may see a few drops of blood. If you do, just press a cotton ball or gauze on it to stop the bleeding. If you experience any bruising, you can also use an ice pack.

Since you can only use your needles and syringes one time, you can now throw them away in a sharps container. Just remember to not throw away any loose needles or syringes in your trash can.

On screen:

  • Only use the vial one time.
  • Throw away any unused medicine in the vial.
  • Do not save unused medicine for later use.
  • Always keep the sharps disposal container out of reach of children.

Only use the vial one time. Throw away any unused medicine in the vial. Do not save unused medicine for later use. Always keep the sharps disposal container out of reach of children.

When I’m done, I like to write down the spot I just used in my injection log so I don’t forget. I also write down the date, time and vial lot information in case I need it for my healthcare provider at some point in the future.

On screen:

  • Set a calendar reminder to help remember the next injection.

That’s it! I’ve set a calendar reminder in my phone to help me remember my next injection. You may use your phone or a paper calendar – whatever works best for you.

I know that a new routine can sometimes take a little bit of time to get used to, but keep it up and refer back to this video anytime you need a refresher.

Remember, if you have any questions, always talk to your healthcare provider.

On screen:

  • For a copy of the full Instructions for Use and Medication Guide, visit HEMLIBRA.com and the link to the full Prescribing Information.

Summary of injection tips for people with hemophilia A

Here are important injection tips to remember when taking HEMLIBRA:

  • Leave your HEMLIBRA out for at least 15 minutes to bring it to room temperature before injecting
  • If you are nervous about your first injection, it may be helpful to use some relaxation techniques or video chat with a friend for support
  • Make sure to rotate injection sites each time you treat. They should be at least 1 inch from the previous injection site
  • After using an alcohol swab to clean the injection site, let the skin dry for at least 10 seconds before injecting
  • Pinch the skin to avoid muscle when injecting
  • The medication should be injected slowly after the needle has penetrated the skin
  • After the injection, do not rub the injection site
  • If there is bruising, an ice pack can be applied with gentle pressure
  • Always talk to your doctor if you have questions about how to administer HEMLIBRA, including any other injection tips

What is HEMLIBRA?

HEMLIBRA is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

What is the most important information I should know about HEMLIBRA?

HEMLIBRA increases the potential for your blood to clot. People who use activated prothrombin complex concentrate (aPCC; Feiba®) to treat breakthrough bleeds while taking HEMLIBRA may be at risk of serious side effects related to blood clots.

These serious side effects include:

  • Thrombotic microangiopathy (TMA), a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs
  • Blood clots (thrombotic events), which may form in blood vessels in your arm, leg, lung, or head

Talk to your doctor about the signs and symptoms of these serious side effects, which can include:

  • Confusion
  • Stomach, chest, or back pain
  • Weakness
  • Nausea or vomiting
  • Swelling, pain, or redness
  • Feeling sick or faint
  • Decreased urination
  • Swelling of arms and legs
  • Yellowing of skin and eyes
  • Eye pain, swelling, or trouble seeing
  • Fast heart rate
  • Numbness in your face
  • Headache
  • Shortness of breath
  • Coughing up blood

If you experience any of these symptoms during or after treatment with HEMLIBRA, get medical help right away.

Carefully follow your healthcare provider’s instructions regarding when to use an on-demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. If aPCC (Feiba®) is needed, talk to your healthcare provider in case you feel you need more than 100 U/kg of aPCC (Feiba®) total.

The most common side effects of HEMLIBRA include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of HEMLIBRA. You can speak with your healthcare provider for more information.

What else should I know about HEMLIBRA?

See the detailed “Instructions for Use” that comes with your HEMLIBRA for information on how to prepare and inject a dose of HEMLIBRA, and how to properly throw away (dispose of) used needles and syringes.

  • Stop taking your prophylactic bypassing therapy the day before you start HEMLIBRA
  • You may continue taking your prophylactic factor VIII for the first week of HEMLIBRA

HEMLIBRA may interfere with laboratory tests that measure how well your blood is clotting and create an inaccurate result. Speak with your healthcare provider about how this may affect your care.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Only use HEMLIBRA for the condition it was prescribed. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Keep a list of them to show your healthcare provider and pharmacist.

Before using HEMLIBRA, tell your healthcare provider about all of your medical conditions, including if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Since HEMLIBRA was tested in males, there is no information on whether HEMLIBRA may impact your unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.

Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the HEMLIBRA full Prescribing Information and Medication Guide.

Tips and resources5

  • Per the HEMLIBRA Instructions for Use, some administration recommendations for your patients are: 
    • Bring the vials to room temperature before injection 
    • Rotate injection sites when treating
    • Pinch skin and avoid muscle when injecting 
    • Push injection slowly 
    • After the injection, do not rub the injection site 
    • If there is bruising, an ice pack can also be applied with gentle pressure
  • A dosing calculator is available as a guide to help determine your patient’s weight-based dose 
  • Download the Starting HEMLIBRA Quick Reference Guide to help your patients get started 

A subcutaneous injection that can be done at home or on the go5

Once individuals are trained and confident with HEMLIBRA administration, administration-related follow-up is minimal.

A simple subcutaneous administration

Ready-to-use-solution that can be taken in less than a minute once prepared

Vial information for HEMLIBRA® (emicizumab-kxwh)
Vial information for HEMLIBRA® (emicizumab-kxwh)

HEMLIBRA supplies

Ready-to-use-solution that can be taken in less than a minute once prepared

Download the Learning to Inject HEMLIBRA brochure  to help your patients get started.

Once trained by a healthcare provider, a patient may self-inject or receive help from a caregiver if a healthcare provider determines that it is appropriate.

  • Do not combine HEMLIBRA vials of different concentrations in a single injection*
  • Patients should follow recommendations in the Instructions for Use regarding proper sharps disposal
  • Self-administration is not recommended for children aged less than 7 years old
  • HEMLIBRA supplies may not look exactly as pictured above

Refer to the HEMLIBRA Instructions for Use for handling instructions when combining vials. 

*HEMLIBRA is available in 2 concentrations: 30 mg/mL (30-mg vial) and 150 mg/mL (60-mg, 105-mg, and 150-mg vials).

Download the My HEMLIBRA Injection Log to help keep your patients on track with their injections

Indication & Important Safety Information

Indication
HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety Information
Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. 

Warnings and Precautions
Thrombotic Microangiopathy (TMA) and Thromboembolism Associated With HEMLIBRA and aPCC
In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.

Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Due to the long half-life of HEMLIBRA, the potential for an interaction with aPCC may persist for up to 6 months after the last dose. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.

Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with HEMLIBRA prophylaxis should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.

Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.

Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (eg, Factor V Leiden, Prothrombin 20210).

Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.

Adverse Reactions
Characterization of aPCC Treatment in Pooled Clinical Trials
There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.

Injection Site Reactions
In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).

Other Less Common (<1%) Reactions
Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations in serum creatine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.

Drug Interactions
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.

Pregnancy, Lactation, Females and Males of Reproductive Potential
Women of childbearing potential should use contraception while receiving HEMLIBRA. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEMLIBRA and any potential adverse effects on the breastfed child from HEMLIBRA or from the underlying maternal condition.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

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      Our commitment to provide transparent and timely safety information about emicizumab-kxwh. Genentech, Inc. https://www.emicizumabinfo.com/content/emicizumabinfo/en_us/patient.html#. Accessed August 25, 2020.

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