Pegademase bovine (Intramuscular)

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

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

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 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.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits of the medicine. Here are some important things to consider for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Studies conducted so far have not shown any specific problems in children that would limit the use of pegademase in pediatric patients.

Geriatric

There is no information available on how age affects the effects of pegademase in older patients.

Breast Feeding

There are no adequate studies in women to determine the risks to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even with potential interactions. In these cases, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important that your healthcare professional knows if you are using any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following is generally not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Pentostatin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken near mealtime or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Bleeding problems (e.g., thrombocytopenia) or
• Infections—Use with caution. May worsen these conditions.

• Thrombocytopenia, severe—Should not be used in patients with this condition.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

Incidence not known

• Back, leg, or stomach pains
• Bleeding gums
• Chills
• Dark urine
• Difficulty breathing
• Dizziness
• Fever
• General body swelling
• Headache
• Loss of appetite
• Nausea or vomiting
• Nosebleeds
• Pain, warmth, or burning in the fingers, toes, and legs
• Pale skin
• Problems with vision or hearing
• Sore throat
• Unusual tiredness or weakness
• Yellowing of the eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Hives or welts
• Itching
• Redness of skin
• Redness or pain at the injection site
• Skin rash

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Adagen

Pharmacologic Class: Enzyme

A nurse or other trained health professional will give you or your child this medicine. This medicine is given as a shot into one of your or your child's muscles.

You may be taught how to give this medicine at home. Make sure you understand all instructions before giving yourself or your child an injection. Do not use more medicine or use it more often than your doctor tells you to.

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:For treatment of lack of ADA:Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 20 Units per kilogram (kg) (4.55 to 9.09 Units per pound) of body weight, injected into a muscle once a week. If you are receiving pegademase at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of pegademase, ask your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

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.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.