Download Treatment Journal - Proteinuria in Nephrotic Syndrome Treatment

TREATMENT JOURNAL
To help you get the most from
Acthar and guide your
treatment journey
H.P. Acthar® Gel (repository corticotropin injection) is indicated for the reduction of proteinuria in people
with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in
the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus).
Please see Important Safety Information on pages 40–41, and the accompanying full Prescribing Information.
Introduction
It is important to keep a record of your treatment schedule
and progress. You can use the calendar inside to help keep
track of your injections and how you are feeling over the
course of your treatment. Each month also has tips for
staying on track and managing your health.
If you have any questions for your doctor
or nurse, feel free to write them down and
consult the Doctor Discussion Guide.
Bring this journal to all of your doctor
visits to review your progress and discuss any
side effects or questions you may have.
2
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
Table of Contents
My Acthar routine
4
Building your Acthar team
6
Other resources for support and information
9
Making your doctor’s appointment more productive
10
Appointment tracker
11
Sample calendar
12
My calendar
14
Notes from my office visit
38
Important Safety Information
My phone numbers
40–41
Back Cover
My Acthar routine
Writing down your dosing instructions can help you manage your treatment. It
can also help you determine any questions or concerns you may want to discuss
with your doctor or nurse. Use the table on the following page to keep track of
your dosing instructions.
Converting your Acthar dose
Before you fill out the table, you may need to convert the amount of Acthar your
doctor prescribed, usually given as units (IU) to milliliters (mL). This is because the
amount of medication you will draw up into the syringe for injection is given as mL.
The table below can help with the conversion. You can also consult your Injection
Guide or speak to your doctor if you have any questions about converting your
prescribed dose of Acthar.
Prescribed Units (IU)
Injection Amount (mL)
80 IU
1 mL
60 IU
0.75 mL
40 IU
0.5 mL
20 IU
0.25 mL
The values shown are provided as examples only. This is not a list of all
the possible dosing amounts.
Remember to administer the exact dosage of Acthar that your doctor has
prescribed. Keep in mind that the values above are not all of the possible dosages
of Acthar. Your doctor has determined the best dose for you based on your
medical history and condition.
4
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
Make a plan for your Acthar treatment
Use the table below to plan your Acthar injections. Since schedules can change and things can come up unexpectedly,
it’s a good idea to think in advance about how you would keep up with your injections if your weekly routine changed.
My injections are (check one):
❑ Subcutaneous (under the skin)
❑ Intramuscular (into the muscle)
# of IU of Acthar I was
prescribed:
IU
# of mL of Acthar
I inject:
mL
Days of the week that
I take Acthar:
Time of day/existing
routine to link it to:
My supply container
should include:
❑ Syringe(s)/Needles
❑ Alcohol swabs
❑ Sharps container
❑ Acthar Injection Guide
❑ Adhesive bandage/Gauze (if needed)
Reminders I will use to
remember to take Acthar:
Reminders I will use
to refill Acthar:
Take some time right now to note on your calendar your Acthar start date, the days of your injections, your next
doctor’s appointment, when to order refills, and any events (such as vacations, holidays, special events, etc) that
you may need to plan around during your treatment.
Managing your condition and health can take time and energy. Try to find time
to reward yourself for staying on track and following your doctor’s recommendation
for your treatment. Treat yourself to something meaningful that you will enjoy as a way
to recognize and encourage how well you are following your routine.
Building your Acthar team
Getting support to cope with and manage any health condition is an important part of medical care. It’s important to
identify who can provide support, what kind of support they can provide, and when they can help. The more specific
you can be in your requests, the easier it is for someone to help you. The steps below will help you to plan how to ask
for support.
What
First, check off types of support you would like to have during treatment. You can also write in your own:
❑ Listen to me when I need to talk
❑ Help me cook a new recipe
❑ Attend a kidney support group with me
❑
❑
❑
❑
❑
Examples of support:
Learn about injections with me
Give me a ride to my nephrologist
appointment
Try a new healthy recipe with me
Who
Then, write down the names of people you could ask for help and match each person with a kind of support you need.
Type of support
Name
Phone number
Emergency contact
Someone to learn about
_______________ with me
Someone to listen
Examples of sources of support:
Family/friends (eg, spouse,
child, sibling, neighbor)
Nephrology office staff and
other patients
6
ActharPACT nurse coach
Senior center/YMCA
Kidney support groups
Area office on aging
Civic organizations
Spiritual community
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
What and where
Last, imagining the specific time and place you plan to talk with a person about support can help you feel
more comfortable. Choose a time to talk to this person about support. Use the blank lines to write in your
own dates and times.
✔ Meet for lunch on
✔
✔ When we have dinner on
✔
✔ Call after work on
✔
✔
✔
✔
✔
If you feel uncomfortable about asking for help, think about how you would feel if someone
you cared about was trying to cope with and manage a health condition. You would probably
want to help that person. Other people are likely to feel the same way about helping you.
Building your Acthar team, continued
In addition to the resources you currently have, the distributor of Acthar has developed a no-cost personalized
nurse support service to help guide you through your treatment.
ActharPACT (Patient & Acthar Coaching Team)
1-888-419-8482 • ActharPACT.com
As part of the program, you can choose to schedule regular calls with a registered nurse who is trained
to answer questions about proteinuria management and Acthar treatment. If you choose, your nurse can
also send you personalized emails and/or text messages or direct you to an interactive website designed
specifically for people using Acthar. There is no cost to you, and you can cancel this service at any time.
What can the nurse coach do for me?
A nurse coach can provide:
information about kidney disease, proteinuria, and Acthar therapy
assistance with setting up routines to stay on track
help coping with treatment
information on reimbursement issues
support for other aspects of managing treatment
Specific questions about your symptoms or your care should be directed to your individual healthcare provider.
For example, your nurse coach can talk about general side effects, but your doctor’s office will offer specific
advice on treatment for any side effect you might experience because they know your medical history and
your individual situation.
There is no cost to you, and you can cancel this service at any time. You can sign up by:
Mailing the card enclosed in your Starter Kit
Visiting the website: ActharPACT.com
Calling toll-free at: 1-888-419-8482
8
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
Other resources for support and information
Nephrotic Syndrome in Adults, NKUDIC
kidney.niddk.nih.gov/kudiseases/pubs/nephrotic/
Nephrotic Syndrome, PubMed Health
ncbi.nlm.nih.gov/pubmedhealth/PMH0001520/
Nephrotic Syndrome, Mayo Clinic
mayoclinic.com/health/nephrotic-syndrome/DS01047/DSECTION=causes
NephCure Kidney International
nephcure.org
The National Kidney Foundation
kidney.org
This Treatment Journal may identify third party organizations and provide links
to third party websites or other third party information (“Third Party Content”).
Third Party Content is meant for informational purposes only, is not endorsed by
or under the control of the distributor of Acthar, and is not meant to replace a
physician’s medical advice. The distributor of Acthar has no responsibility or liability
for and makes no representations whatsoever about any Third Party Content.
Making your doctor’s appointment more productive
Getting ready for your appointments ahead of time can help make them more productive. It will also make it easier to
talk with your doctor and help you better understand how to care for your condition. Below are some tips to help you
become better prepared.
✔ READ up on your condition and your treatment options.
✔ RECORD your medications, Acthar doses, and any side effects you may experience
in a log or this Treatment Journal to bring to your appointment.
✔ ASK a family member or friend to go with you to help you remember what your
doctor says and make sure important questions are addressed.
✔ WRITE down any questions or concerns you want to talk about with your doctor.
You might have a lot of questions about Acthar—particularly as you begin treatment. It’s important to have an
open and honest conversation with your healthcare team throughout your Acthar journey. Most people find that
having questions prepared and bringing them to their doctor’s office is helpful—especially if they feel rushed or
overwhelmed at appointments. Below is a list of suggested questions for you to bring to your next appointment.
Is there a specific name for my condition that causes proteinuria?
❑ Membranous nephropathy (MN)
❑ Lupus nephritis (LN)
❑ Minimal change disease (MCD)
❑ IgA nephropathy (IgAN)
❑ Focal segmental
glomerulosclerosis (FSGS)
❑ Membranoproliferative
glomerulonephritis (MPGN)
How and when should I take my Acthar prescription?
Will there be any tests during my Acthar treatment?
How often?
How long will I have to take Acthar?
How will I know Acthar is working?
Are there changes I can make to my diet or exercise
regimen to help me feel better?
Add your own.
What do I do if I miss an injection?
10
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
Appointment tracker
Throughout your treatment journey, your doctor will monitor how your kidneys and your treatments are working. You
can also monitor changes in your health by making notes from your appointment. Use the space below to write down
how you are doing and what your doctor tells you.
Appointment Date
Notes
Medical care is individualized, so which tests are scheduled are based on your own medical situation and what
your healthcare provider recommends.
Here is a sample calendar.
Month: October
Sunday
4
Monday
Tuesday
5
6
Wednesday
7
HITS training
9:00 am
11
12
13
14
Injection
(left arm)
18
19
20
Out of town trip
21
Out of town trip
Injection
(left thigh)
25
26
27
28
Injection
(left arm)
Symptom
Swelling in legs
Start
date
End
date
October 5th Still have it
Comments
My doctor’s
instructions
Gets worse on
work days
Ask doctor about taking Acthar at a different time of the day on the next trip.
Notes:
Talk with ActharPACT nurse about suggestions for traveling with Acthar.
Ask doctor to help alleviate swelling of legs.
12
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
1
Friday
Saturday
2
3
9
10
Neph MD appt.
10:00 am
8
Injection
(right arm)
15
16
17
ActharPACT
11:30 am
22
Injection
(right thigh)
23
24
Injection
(right arm)
29
30
ActharPACT
11:30 am
31
Call pharmacy to
order refill of Acthar
Tips for building a routine:
Write down when and where you plan to take Acthar
Schedule your injections/set an alarm
Link Acthar to part of an existing plan or routine
Use visual cues to remind yourself
Have a partner or friend present for moral support
When you first begin Acthar, it might take you longer to go through
the injection steps, so allow yourself at least 15 minutes. But once you
get used to giving the injections, you may find it takes less time.
Injection
(right thigh)
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
14
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
Contact all of your doctors to let them know you have started Acthar therapy.
This is a great time to review your medication lists as well as all vitamins, herbs,
and supplements that you may be taking.
My doctor who prescribed Acthar is:
Next appointment:
My primary care doctor is:
Next appointment:
My specialist is:
Next appointment:
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
16
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
It’s easier to follow your treatment plan when you consider the possible benefits
of therapy but also think about potential obstacles and how to solve them. Write
some down below to help you stay motivated throughout treatment and help
you overcome challenges if they come up.
Benefits
Example: Hopefully feel better
Concerns
Example: Difficult to find time
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
18
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tips for building a routine:
Write down when and where you plan to take Acthar
Schedule your injections/set an alarm
Link Acthar to part of an existing plan or routine
Use visual cues to remind yourself
Have a partner or friend present for moral support
When you first begin Acthar, it might take you longer to go through the steps,
so allow yourself at least 15 minutes. Once you get used to giving the injections,
you may find it takes less time.
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
20
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Tip:
For people with proteinuria, a well-planned diet
can replace lost protein and ensure you get
enough calories to meet your body’s energy needs.
Eating according to your doctor’s or dietician’s
recommendations may help manage some of
your symptoms and condition.
Only your doctor or dietician can advise you on
which foods to eat more of and which to avoid.
Saturday
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
22
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
If you ever start to feel overwhelmed, anxious, or stressed:
Close your eyes and take a slow deep breath in, hold it for 5 seconds, and
slowly exhale
Repeat 4 more times
When you feel more relaxed, go back to what you were doing. Or, if you have
some free time—go do something that you enjoy to help clear your mind
Some things I can do to help clear my mind*:
✔
✔
✔
✔
*Simple things like listening to music or going for a walk can be very helpful.
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
24
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
Remind yourself that each dose of Acthar is an important step in your
treatment and helps bring you closer to your treatment goal
Remember that you’re choosing to follow your doctor’s recommendation
to take this medication in order to help lower protein levels in your urine
It may take time before you notice changes in how you feel or in your proteinuria levels.
That does not mean Acthar is not working. Even if you feel better, it is important to take
Acthar the way it was prescribed. Do not stop taking it unless you consult your doctor.
Stopping early may cause your symptoms to return and you may not get the full benefit
from treatment.
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
26
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
Some people feel comfortable discussing their health while others feel it is a
private topic. It’s important to find a balance that feels comfortable to you and
to tell people about your condition only if and when you’re ready.
If you have any concerns about how to handle social situations, write them in
the blanks below. Discuss them with your ActharPACT nurse coach, your
doctor, or a supportive family member or friend.
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
28
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Tip:
Remember that most people who are dealing with significant
health concerns go through ups and downs. It can be a very
stressful and emotional experience.
If you find yourself in a rough patch, it can help to remind
yourself that it’s likely to pass. You can also lean on your
support team or find some additional support.
Your medical team, organizations like the National Kidney Foundation
and NephCure, or your local hospital can help connect you with other
patients, a support group, or additional resources.
Saturday
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
30
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
Are you planning a work trip or vacation? A few things you can do to plan:
Stay on your regular injection schedule
Plan how many doses you will need during travel. Bring an extra dose
in case of itinerary changes
Carry a list of your updated medications, doctors, and emergency
contact numbers
Remember that Acthar is to be refrigerated at all times, at 36–46°F (2–8°C)
Make sure to pack all of your supplies together in your carry-on to ensure
you always have your medications with you
Check with TSA before you fly to make sure that you are carrying Acthar on
the plane according to TSA regulations. Visit the TSA website at tsa.gov or call
TSA Cares at 1-855-787-2227.
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
32
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
It can help to give yourself a little mental vacation to remind yourself that you
have other interests and things you enjoy, especially if your health has been
taking up a lot of your energy.
Activities can include:
Visiting a local park or shopping mall
Attending a theater production or
musical performance
Going to the library
Weekly telephone “check-in” calls
with a friend
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
34
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Saturday
Tip:
When dealing with a medical condition, you may need to make certain lifestyle
adjustments and redefine what a “normal life” means. It’s easy to focus on the
downsides of health problems because they can be so obvious. While it can be
more challenging to find the positive aspects of your experience, many people
can point to something positive coming out of a medical issue.
Positive aspects of your experience may be:
Making more time to take care of yourself and your health
Enjoying new hobbies or books
Spending more time with friends and family
A chance to reevaluate priorities and what’s truly
important to you
Monday
Tuesday
Wednesday
Comments
My doctor’s
instructions
Month:
Sunday
Symptom
Start
date
End
date
Notes:
36
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
T
ay
Thursday
Friday
Tip:
Stay organized. Many people find it helpful to keep all
of their medical information in one place, like in a binder
or an accordion file. That way, there are separate sections
for insurance paperwork, bills, receipts related to medical
expenses, etc. Getting your information together may
lower some of the stress of your medical care.
Saturday
Notes from my office visit
38
Please see Important Safety Information on pages 40–41,
and the accompanying full Prescribing Information.
Notes from my office visit
Important Safety Information
Acthar is injected beneath the skin or into the muscle.
Who should NOT take Acthar?
You should not take Acthar if you have:
A skin condition called scleroderma
High blood pressure
Bone density loss or osteoporosis
Allergies to pig-derived proteins
Any infections, including fungal, bacterial, or viral
Been recently given a vaccine or are about to take one
Eye problems, such as ocular herpes simplex
Suspected congenital infections (in children under
2 years of age)
Had recent surgery
Stomach ulcers or a history of ulcers
Heart problems
A condition where your adrenal glands produce
either too much of certain hormones (as with Cushing’s
syndrome), or not enough (adrenal insufficiency)
Tell your doctor if you have any of these conditions or any other health problems. Also, share with your doctor what
medicines you are taking. Don’t forget to mention nonprescription medicines, vitamins, and herbal supplements.
What is the most important information I should know about Acthar?
Never inject Acthar directly into a vein, and always take Acthar as prescribed by your doctor
Never stop treatment suddenly unless your doctor tells you to
Try not to miss any scheduled doctor’s appointments, as it is important for the doctor to monitor
you while taking Acthar
Acthar can cause side effects similar to those with steroid treatments. While taking Acthar, tell your doctor
right away if you have any of the symptoms listed here:
Increased risk of infections. You may be more likely to get new infections. Also, old infections may become
active. Before and during treatment, tell your doctor if you see any signs of an infection. Contact your doctor at
the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may
be flu or any open cuts or sores
Adrenal gland changes. When taking Acthar long term, your adrenal gland may produce too much of a
hormone called cortisol, which may cause symptoms of Cushing’s syndrome, such as upper body fat, rounded
“moon” face, bruising easily, or muscle weakness
Sometimes when you stop taking Acthar long term, your body may not produce enough cortisol on its own.
This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the
adrenal gland recovers.
Increased blood pressure, body salt, and fluid levels. Your doctor may check your blood pressure while you are
being treated with Acthar. He or she may recommend some changes to your diet, such as eating less salt and
taking certain supplements
Unpredictable response to vaccines. Talk to your doctor about which vaccines are safe to use when you are
taking Acthar
Masking other conditions. Acthar may hide symptoms of other diseases. This can make it more difficult for your
doctor to make a diagnosis if something else is going on
Stomach or intestinal problems. Acthar may put you at increased risk for bleeding from the stomach, or getting
stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive
tiredness, increased thirst, difficulty breathing, or increased heart rate
40
Please see the accompanying full Prescribing Information.
Changes in mood or behavior. Taking Acthar can make you feel irritable or depressed. You may also have mood
swings or trouble sleeping
Worsening of other medical conditions. If you have other conditions, such as diabetes or muscle weakness,
you may find they get worse
Eye problems. It’s possible that you may develop certain eye conditions, such as cataracts, glaucoma,
or optic nerve damage
Allergic reactions. Your body may develop antibodies or become sensitive when Acthar is used long term. Signs
of allergic reaction in children are:
– Skin rash
– Swelling of the face, tongue, lips, or throat
– Trouble breathing
Problems with growth and physical development. Using Acthar long term can affect growth and physical
development in children. This can be reversed when Acthar is no longer needed
Bone density loss. Acthar may cause osteoporosis at any age
Potential harm to unborn baby. Tell your doctor if you are pregnant or plan on becoming pregnant
What are the most common side effects of Acthar?
The most common side effects of Acthar are similar to those of steroids. They include:
Fluid retention
Changes in blood sugar
Increased blood pressure
Behavior and mood changes
Changes in appetite and weight
Specific side effects in children under 2 years of age include:
Increased risk of infections
Increased blood pressure
Irritability
Symptoms of Cushing’s syndrome
Cardiac hypertrophy (thickening of the heart muscle)
Weight gain
The above side effects may also be seen in adults and children over 2 years of age.
These are not all the possible side effects of Acthar.
Tell your doctor about any side effect that bothers you, or that does not go away. Call your
doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA.
Call 1-800-FDA-1088 or visit fda.gov/medwatch. You may also report side effects by calling
1-800-778-7898.
Please see the accompanying full Prescribing Information.
Resources
The distributor of Acthar offers different support services
listed below at no cost to you.
My phone numbers
Nephrologist (kidney doctor)
Name:
ActharPACT (Patient & Acthar Coaching Team)
1-888-419-8482 • ActharPACT.com
Provides a trained registered nurse to support you when
you begin taking Acthar and throughout your treatment.
This program also gives you access to an interactive
website for people using Acthar and allows you to
schedule personalized communications with helpful tips.
Phone:
Primary care doctor
Name:
Phone:
Nurse
Name:
A.S.A.P. (Acthar Support & Access Program)
1-888-435-2284 • Acthar.com
Works with you to get the insurance coverage and
financial assistance you need for Acthar.
Phone:
Specialty pharmacy
Name:
Phone:
Acthar H.I.T.S. (Home Injection Training Services)
Acthar HITS nurse
1-888-435-2284 • Acthar.com
Name:
Helps arrange for a nurse to come to your home to show
you or your caregiver how to do your first injection.
Phone:
Acthar Website
Name:
ActharExcessProtein.com
Presents comprehensive information about Acthar,
including Important Safety Information and information
about administering Acthar.
ActharPACT nurse phone coach
Phone: 1-888-419-8482
Other
Name:
Phone:
Other
Name:
Phone:
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Other brands are trademarks of a Mallinckrodt company or their respective owners.
© 2015 Mallinckrodt. PM-01-03-1405(1) 9/15 Printed in USA