H.P. ACTHAR(repository corticotropin)injection(十五)
ke certain other medical conditions worse, such as diabetes (may increase blood sugar).
Eye problems.Your child can get cataracts, increased pressure in the eye (glaucoma), and possible damage to the optic nerve if treated with H.P. Acthar Gel for a long time.
Allergic reactions to H.P. Acthar Gel.Your child may have an allergic reaction to H.P. Acthar Gel. Allergic reactions may not happen until your child has received several injections of H.P. Acthar Gel. Tell your doctor right away if your child has any of the following signs of an allergic reaction:
skin rash
swelling of the face, tongue, lips, or throat
trouble breathing
Changes in growth and physical development.H.P. Acthar Gel may affect your child’s growth and physical development and may weaken his or her bones. This is more likely to happen with long term use of H.P. Acthar Gel.
Enlarged heart. H.P. Acthar Gel may cause an increase in the size of your child’s heart. This is more likely to happen with long term use of H.P. Acthar Gel but usually goes away after H.P. Acthar Gel is stopped.
Common side effects of H.P. Acthar Gel may include:
infections
increased blood pressure
irritability and changes in behavior
changes in appetite and weight
diarrhea
vomiting
These are not all the possible side effects of H.P. Acthar Gel. Tell your doctor if your child has any side effect that bothers them or does not go away. For more information ask your child’s doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store H.P. ACTHAR GEL?
Store vials of H.P. Acthar Gel in the refrigerator between 36°F to 46°F (2°C to 8°C).
Throw away any vials after the expiration date printed on the label.
Keep H.P. Acthar Gel and all other medicines out of the reach of children
General information About H.P. Acthar Gel
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use H.P. Acthar Gel for a condition for which it has not been prescribed. Do not give H.P. Acthar Gel to other people, even if they have the same symptoms. It may harm them.
This Medication Guide summarizes the most important information about H.P. Acthar Gel. If you would like more information, talk with your child’s doctor. You can ask your child’s doctor or pharmacist for information about H.P. Acthar Gel that is written for healthcare professionals. For more information, go to www.acthar.com or call 1-800-465-9217.
What are the ingredients in H.P. Acthar Gel?
Active ingredient: Corticotropin
Inactive ingredients: gelatin, phenol, cysteine, sodium hydroxide and/or acetic acid to adjust pH, and water for injection
Manufactured for:
Questcor Pharmaceuticals, Inc.
26118 Research Road
Hayward, CA 94545 USA
PL122/ Rev. 01
Issued: 06/2011
This Medication Guide has been approved by the U.S. Food and Drug Administration.
H.P. Acthar® Gel is a registered trademark of Questcor Pharmaceuticals, Inc.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 5 mL CARTON
H.P.* Acthar®
Gel
(repository corticotropin
injection) in 16% gelatin
5 mL multiple-
dose vial
80 USP UNITS
PER mL
Rx only* HIGHLY PURIFIED
H.P. ACTHAR
repository corticotropin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63004-7731
Route of Adminis |
