H.P. ACTHAR(repository corticotropin)injection(十二)
r Gel should be given intermittently along with careful observation. [see Warnings and Precautions (5.2), (5.12), and (5.13) and Adverse Reactions (6.1.1)].
Patients, their caregivers and families should be informed that H.P. Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder. The patient will need to be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight, and fecal blood loss. [see Warnings and Precautions (5.5)].
In the treatment of Infantile Spasms, other types of seizures may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome). Additionally the spasms sometimes mask other seizures and once the spasms resolve after treatment with H.P. Acthar Gel, the other seizures may become visible. Parents and caregivers should inform their physician of any new onset of seizures so that appropriate management can then be instituted. [see Adverse Reactions (6.1.1)].
H.P. Acthar ® Gel
(repository corticotropin injection)
Manufactured for Questcor Pharmaceuticals, Inc.
Questcor Pharmaceuticals, Inc.
26118 Research Road
Hayward, CA 94545 USA
phone (800) 411-3065
(510) 400-0700
fax(510) 400-0799
PL065/Rev. 03 No. 1350
Issued: 06/2011
MEDICATION GUIDE
H.P. Acthar® Gel (H P AK-thar jel)
(repository corticotropin Injection)
This Medication Guide provides information only about the use of H.P. Acthar Gel for the treatment of Infantile Spasms. If your doctor prescribes H.P. Acthar Gel for you or your child for any other reason, talk to your doctor for information about how this medicine is used to treat your medical condition.
Read this Medication Guide before your child receives H.P Acthar Gel and each time you refill your child’s prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your child’s medical condition or treatment.
What is the most important information I should know about H.P. ACTHAR GEL?
H.P. Acthar Gel can cause serious side effects including:
1. Increased risk of infections. H.P Acthar Gel is a medicine that can affect your child’s immune system. When your child is taking H.P. Acthar Gel, it can lower the ability of your child’s immune system to fight infections. H.P. Acthar Gel may:
make your child more likely to get new infections
worsen an infection that your child already has
cause an inactive infection to become active, such as tuberculosis (TB
Before starting H.P. Acthar Gel, tell your doctor if your child has:
an infection or signs of an infection, such as:
fever
cough
vomiting
diarrhea
other signs of flu or illness
a family member with an infection or signs of an infection
While taking H.P. Acthar Gel, your child should:
stay away from people who are sick or who have infections
tell your doctor right away if your child has any sign of infection such as:
fever (but your child may not have a fever with an infection)
cough
vomiting
diarrhea or
other signs of illness or flu and
any open cuts or sores on his or her body
2. Effects on the adrenal gland after stopping H.P. Acthar Gel.
When your child stops taking H.P. Acthar Gel, his or her body may not produce enough of a hormone called cort |
