Adagen

Name: Adagen

Pegademase Bovine Dosage

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pegademase bovine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Pegademase bovine is usually given once every 7 days. Follow your doctor's dosing instructions very carefully.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not use pegademase bovine if it has changed colors or has particles in it. Call your pharmacist for new medication.

While using pegademase bovine, your blood will need to be tested often.

It may take up to 6 months before your immune system improves and you have fewer infections. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Call your doctor if your symptoms do not improve after the first few weeks of treatment.

Store in the refrigerator, do not freeze. Throw away the medicine if it has become frozen.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Call your doctor for instructions if you miss a dose of pegademase bovine.

Descriptions

Pegademase contains an enzyme called adenosine deaminase (ADA). It is used to treat children who do not have a properly developed immune system because of a lack of ADA in the body.

Pegademase is to be given only by or under the supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

How should I use Adagen (pegademase bovine)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Pegademase bovine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Pegademase bovine is usually given once every 7 days. Follow your doctor's dosing instructions very carefully.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Do not use pegademase bovine if it has changed colors or has particles in it. Call your pharmacist for new medication.

While using pegademase bovine, your blood will need to be tested often.

It may take up to 6 months before your immune system improves and you have fewer infections. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Call your doctor if your symptoms do not improve after the first few weeks of treatment.

Store in the refrigerator, do not freeze. Throw away the medicine if it has become frozen.

Precautions While Using Adagen

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important that you or your child should continue to receive treatment with pegademase. Treatment must be continued for life. Do not stop treatment with pegademase without checking with your doctor. If regular treatment is not continued, the immune system will break down and serious infections may occur.

Indications and Usage for Adagen

Adagen® (pegademase bovine) Injection is indicated for enzyme replacement therapy for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) who are not suitable candidates for – or who have failed – bone marrow transplantation. Adagen® (pegademase bovine) Injection is recommended for use in infants from birth or in children of any age at the time of diagnosis. Adagen® (pegademase bovine) Injection is not intended as a replacement for HLA identical bone marrow transplant therapy. Adagen® (pegademase bovine) Injection is also not intended to replace continued close medical supervision and the initiation of appropriate diagnostic tests and therapy (e.g., antibiotics, nutrition, oxygen, gammaglobulin) as indicated for intercurrent illnesses.

How is Adagen Supplied

Adagen® (pegademase bovine) Injection is a clear, colorless, preservative free solution for intramuscular injection. Adagen® is supplied as a sterile solution in single-use vials containing 375 units per 1.5 mL solution, in boxes of 4 vials (NDC-57665-001-01).

Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Refrigerate. Store between +2°C and +8°C (36°F and 46°F). DO NOT FREEZE. Adagen® (pegademase bovine) Injection should not be stored at room temperature. This product should not be used if there are any indications that it may have been frozen.

Manufactured by Sigma-Tau PharmaSource, Inc., Indianapolis, IN 46268.
Distributed by Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegademase in children.

Breastfeeding

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.

Other Interactions

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.

What are pegademase bovine (adagen)?

Pegademase bovine is the enzyme called adenosine deaminase (ADA). Without ADA, certain proteins accumulate that harm white blood cells. White blood cells are important for protecting the body from infection.

Pegademase bovine is used to replenish ADA which allows an increase in white blood cells and decreases the risk of infection in conditions such as severe combined immunodeficiency disease (SCID).

Pegademase bovine may also be used for purposes other than those listed in this medication guide.

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