Pronunciation: ess-per-rot
Generic name: antihemophilic factor (recombinant) glycopegylated-exei
Dosage form: kit for intravenous use
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Esperoct?

Esperoct (antihemophilic factor [recombinant] glycopegylated-exei) is an injectable, long-lasting, coagulation factor VIII concentrate that may be used to manage active bleeding, bleeding during surgery, and to reduce the frequency of bleeding episodes in adults and children with hemophilia A.

Hemophilia A (also called classical hemorrhagic disorder) is an inherited bleeding disorder characterized by deficient or defective factor VIII, that prevents blood from clotting normally. Esperoct works by temporarily replacing the missing coagulation Factor VIII needed for effective blood clotting (hemostasis). It has been conjugated with a polyethylene glycol molecule which slows down its removal from the blood and extends how long it lasts in the body.

Esperoct was FDA-approved on February 19, 2019.

What are the side effects of Esperoct?

Esperoct can cause serious side effects (see warnings below).

The most common side effects of Esperoct affecting 1% or more people are rash, redness, itching, and injection site reactions. Hypersensitivity and anaphylactic reactions are also frequently reported.

These are not the only side effects possible with Esperoct. To learn more, talk to your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or does not go away. You may report side effects to Novo Nordisk Inc. at 1-877-668-6777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Related/similar drugs

Rebinyn, NovoSeven RT, tranexamic acid, desmopressin, Cyklokapron, DDAVP, Hemlibra

Esperoct warnings and serious effects

Do not receive Esperoct if you

• have had life-threatening hypersensitivity reactions to Esperoct, coagulation factor VIII products, or any of the inactive ingredients in the vial or diluent
• are allergic to hamster proteins.

Allergic and hypersensitivity reactions have been reported with Esperoct. Patients may develop hypersensitivity to hamster (CHO) protein as Esperoct contains trace amounts. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor VIII, which may stop Esperoct from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.

Esperoct has been associated with a temporary low incremental recovery in young children which is reversed with continued treatment.

Before taking

Before receiving Esperoct, you should tell your healthcare provider if you:

• have or had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• have had an allergic reaction to any Factor VIII product before using Esperoct
• have any allergies, including allergies to hamster proteins
• have been told that you have inhibitors to Factor VIII (because Esperoct may not work for you)
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

It is not known if Esperoct can harm your unborn baby. Talk to your healthcare provider about the risks involved with receiving Esperoct if you are pregnant.

Breastfeeding

It is not known if Esperoct passes into your milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Esperoct.

How is Esperoct administered?

Esperoct is administered by an intravenous (into a vein) infusion, directly into the bloodstream. It is usually administered by a healthcare provider initially, but people can be taught how to self-administer it themselves, or a caregiver can be taught how to administer it to a person with hemophilia A.

• Do not attempt to administer Esperoct yourself unless you have been shown how to do so by a healthcare provider.
• Follow the step-by-step instructions provided in the product information.
• Esperoct needs to be diluted before use. Once diluted, it should be administered immediately or within 4 hours of mixing.

Your healthcare provider will tell you how much Esperoct to administer based on your weight, the severity of your hemophilia A, and where you are bleeding.

Call your healthcare provider right away if your bleeding does not stop after administering Esperoct.

It is a good idea to record the lot number from the Esperoct vial label every time you use Esperoct. You can use the peel-off label found on the vial to record the lot number.

Esperoct may be used:

• To control and prevent bleeding episodes
• During surgery
• To reduce the number of bleeding episodes when used regularly (prophylaxis).

The frequency of administration depends on what Esperoct is being used to treat, but for the prevention and control of bleeding episodes in adults and adolescents, it is usually given every 4 days.

Do not use Esperoct for a condition for which it is not prescribed or share it with other people, even if they have the same symptoms that you have.

What are the dosage strengths of Esperoct?

Esperoct comes in five different dosage strengths which are printed on the vial label:

• 500 IU (red)
• 1000 IU (green)
• 1500 IU (grey)
• 2000 IU (yellow)
• 3000 IU (black).

Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.

What happens if I miss a dose?

If you forget a dose, infuse the missed dose when you discover the mistake. Do not infuse a double dose to make up for a forgotten dose. Proceed with the next infusions as scheduled and speak to your healthcare provider if you have any questions or concerns.

Do not stop using Esperoct without consulting your healthcare provider.

What happens if I overdose?

Always take Esperoct exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you infuse more Esperoct than recommended, tell your healthcare provider as soon as possible.

What other drugs will affect Esperoct?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Esperoct may affect the way other medicines work. Especially tell your healthcare provider if you take other medications that:

• affect the way your blood clots, such as carfilzomib
• affect other coagulation factors, such as efgartigimod alfa or rozanolixizumab
• also contain PEG, such as pegloticase or pegvaliase.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store the unmixed vial of Esperoct in its original carton to protect it from light. It can be stored in the refrigerator at 36°F-46°F (2°C-8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label.

It may also be stored at room temperature not to exceed 86°F (30°C) for up to 12 months or up to 104°F (40°C) for up to 3 months. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. Do not return the product to the refrigerator. Do not freeze.

Do not use it after the expiration date printed on the label.

Once the dry product has been mixed with the diluent (reconstituted) it must be used within 4 hours when stored at ≤86°F (30°C) or within 24 hours when stored in the refrigerator.

Discard any unused reconstituted Esperoct.

Esperoct ingredients

Active: recombinant analog of human coagulation FVIII conjugated with a 40-kDa polyethylene glycol molecule.

Inactive: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride.

Contains no preservatives.

Available in the following unit strengths: 500, 1000, 1500, 2000, or 3000 IU

Manufacturer

Novo Nordisk.

Further information

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

Medical Disclaimer