Adynovate

Name: Adynovate

Adynovate Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with recombinant antihemophilic factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Manufacturer

  • Shire US Inc.

Adynovate and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Adynovate crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Adynovate.

Other Requirements

  • Store Adynovate in the refrigerator and do not freeze.
  • Adynovate may be stored at room temperature for up to one month. After storage at room temperature, do not return Adynovate back to the refrigerator.
  • Do not use beyond the expiration date printed on the carton or vial.
  • Store vials in their original box and protect them from extreme exposure to light.
  • Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
  • Dispose of all materials, including any leftover reconstituted (after mixing dry product with wet diluent) Adynovate, in an appropriate container.
  • Reconstituted product must be used within 3 hours and cannot be stored or refrigerated.
  • Keep this and all medicines out of reach of children.

Commonly used brand name(s)

In the U.S.

  • Advate
  • Adynovate
  • Afstyla
  • Eloctate
  • Helixate FS
  • Hemofil-M
  • Hyate:C
  • Koate DVI
  • Kogenate FS
  • Monarc-M
  • Monoclate-P
  • Obizur
  • Xyntha

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Adynovate

Antihemophilic factor (AHF) injection is used to treat and prevent serious bleeding episodes in patients with a bleeding problem called hemophilia A. The bleeding episode may be related to an injury (trauma) or a surgical procedure. AHF is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

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

Precautions While Using Adynovate

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, lightheadedness or dizziness, or any swelling of your hands, face, or mouth after you receive this medicine.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Adynovate 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:

More common
  • Fever
Less common or rare
  • Changes in facial skin color
  • chills
  • fast or irregular breathing
  • nausea
  • puffiness or swelling of the eyelids or around the eyes
  • sensation of burning, warmth, heat, numbness, tightness, or tingling
  • skin rash, hives, or itching
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Incidence not known
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • blurred vision
  • chest pain or discomfort
  • confusion
  • cough
  • deep or fast breathing with dizziness
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • noisy breathing
  • numbness of the feet, hands, and around the mouth
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • slow or irregular heartbeat
  • sweating
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness

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
  • Headache
Less common
  • Burning, stinging, or swelling at the injection site
  • diarrhea
  • dizziness or lightheadedness
  • dry mouth or bad taste in the mouth
  • lack or loss of strength
  • nosebleed
  • redness of the face
  • vomiting
Rare
  • Change in taste
  • loss of taste
Incidence not known
  • Abdominal or stomach pain
  • feeling of warmth
  • increased sweating
  • irritability
  • muscle or bone pain
  • redness of the eye
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • trouble seeing

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.

What do I need to tell my doctor BEFORE I take Adynovate?

  • If you have an allergy to Adynovate (antihemophilic factor (recombinant [pegylated])) or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have an allergy to hamster or mouse protein.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Adynovate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Adynovate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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