Adynovate

Name: Adynovate

Adynovate Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using recombinant antihemophilic factor and call your doctor at once if you have:

  • chest pain;
  • easy bruising, increased bleeding episodes; or
  • bleeding from a wound or where the medicine was injected.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • headache;
  • joint pain;
  • sore throat, cough, stuffy nose;
  • weakness, feeling tired;
  • fever; or
  • pain, swelling, itching, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Description

ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-use vials containing nominal (approximate) potencies of 250, 500, 1000, or 2000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.

When reconstituted with 5 mL sterile water for injection, the final solution contains the following excipients and stabilizer in targeted amounts per vial:

Stabilizer and Excipient 5 mL Reconstitution Target
Tris (hydroxymethyl) aminomethane 6.1 mg
Calcium Chloride 1.2 mg
Mannitol 160 mg
Sodium Chloride 26.3 mg
Trehalose Dihydrate 40 mg
Glutathione .04 mg
Histidine 7.8 mg
Polysorbate 80 0.5 mg

ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700 - 8000 IU/mg protein.

ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa). [see CLINICAL PHARMACOLOGY]. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues.

The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.

Adynovate Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

  • the condition being treated
  • other medical conditions you have
  • other medications you are taking
  • how you respond to this medication
  • your weight
  • your height
  • your age

Your healthcare provider will tell you how much Adynovate to use based on your weight, level of physical activity, the severity of your hemophilia A, and where you are bleeding.

Proper Use of antihemophilic factor

This section provides information on the proper use of a number of products that contain antihemophilic factor. It may not be specific to Adynovate. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child is using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Use only the brand of this medicine that your doctor prescribed. Not all brands are prepared in the same way and the dose may be different.

Every package of medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 2 bottles (vials) or containers:

  • Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.
  • Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.
  • Follow the specific directions for your brand of medicine when you prepare the injection.
  • Add the liquid to the powder using the special transfer needle or transfer device that comes with the package.
  • When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming.
  • Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.
  • Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.
  • Use a plastic disposable syringe to remove the mixture from the bottle. Use a special filter needle if your brand of medicine provides one.
  • Give the injection as directed by your doctor.
  • If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.

To prepare the medicine using a prefilled dual-chamber syringe (Xyntha®):

  • Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.
  • The dual-chamber syringe has the powder medicine in one part and the liquid (diluent) in the second part of the syringe.
  • Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking of the liquid.
  • Remove the white seal and the grey rubber tip cap. Put the blue vented cap on the syringe. Do not touch the open ends of the syringe and the blue cap.
  • Slowly push the plunger until the 2 stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder medicine.
  • Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.
  • Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.
  • Keep the syringe pointed up and push the plunger until most of the air is removed.
  • A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.
  • Give the injection as directed by your doctor.
  • If you are using more than one syringe of medicine for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3 or 4 hours after it is prepared. It must not be stored and used later. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.

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 (injection):
    • For bleeding episodes in patients with hemophilia A:
      • Adults and teenagers—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
      • Children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your child's doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

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.

The AHF products should be stored in the original container in the refrigerator. Do not let the packages freeze. They can also be kept at room temperature for short periods of time, such as 3 to 12 months. Store the medicine as directed by your doctor or by the manufacturer of the brand you are using. Protect the container from heat and direct light.

If you move the medicine from the refrigerator to room temperature, write the date you take it from the refrigerator on the container. The length of time the medicine can remain at room temperature will depend on the brand you use. If you have already stored the medicine at room temperature, do not return it to the refrigerator. If you do not use the medicine within the time recommended by the manufacturer, you must destroy the medicine.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Wheezing.
  • Chest pain.
  • Dizziness or passing out.
  • Very upset stomach or throwing up.
  • Hemophilia
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