Pegademase bovine (Intramuscular route)
Uses of This Medicine:
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.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegademase in children.
No information is available on the relationship of age to the effects of pegademase in geriatric patients.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems (e.g., thrombocytopenia) or
- Infections Use with caution. May make these conditions worse.
- Thrombocytopenia, severe Should not be used in patients with this condition.
Proper Use of This Medicine:
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.
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.
- For treatment of lack of ADA:
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.
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.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- dark urine
- difficulty breathing
- general body swelling
- loss of appetite
- nausea or vomiting
- 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
- Incidence not known
- Hives or welts
- redness of skin
- redness or pain at the site of injection
- skin rash
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:
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:
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.
Last Updated: 10/12/2016