Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. WARNING: THROMBOSIS See full Prescribing Information for complete BOXED WARNING • Thrombosis may occur with immune globulin products, including CUTAQUIG. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. • For patients at risk of thrombosis, administer CUTAQUIG at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. IMPORTANT SAFETY INFORMATION
Transcript
Please see Full Important Safety Information on pages 29 and 30 and Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use, at the end of this document.
IMPORTANT SAFETY INFORMATION
For adults with prim
ary immun
odef
cienc
y (PI
) Cutaquig Infusion Guid
e
who are startin
g cuta
quig
1
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use.
WARNING: THROMBOSISSee full Prescribing Information for complete BOXED WARNING• Thrombosis may occur with immune globulin products, including CUTAQUIG. Risk factors may include advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• For patients at risk of thrombosis, administer CUTAQUIG at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 2
INDICATION AND USAGECUTAQUIG (Immune Globulin Subcutaneous [Human] - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults. There are many forms of PI. Certain types of PI are associated with low immunoglobulin G (IgG), which are proteins that help fight infection. CUTAQUIG is a liquid medicine for infusion that contains immunoglobulin G (IgG), which are proteins that help fight infection. It is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI. CUTAQUIG is given under the skin (subcutaneous). Most of the time, infusions under the skin are given at home by self-infusion or by a caregiver. Only use CUTAQUIG by yourself after you have been instructed on use by a healthcare provider (HCP).
Cutaquig is a 16.5% immune globulin (SCIg) solution for subcutaneous administration1
Cutaquig is FDA approved to treat adults with primary immunodeficiency (PI).1
After you’ve been fully trained by your healthcare provider, you can begin self-administering cutaquig.1
Keep track of your infusions In addition to this infusion guide, you have received an infusion journal to record details of each infusion, so that your healthcare provider can monitor your progress. It’s important that you fill out every section and keep an accurate record of each time you administer cutaquig.1 Please remember to bring your journal to any appointments with your healthcare provider.
During your first few infusions, it is recommended that you ask your infusion nurse or trainer to help you complete your journal.
The following information is intended to help you understand how your cutaquig infusion volume per site and infusion rate are determined. Please speak with your healthcare provider about your infusion preferences so that they can provide supplies that are best for you.
Rate and Volume1:For the first 6 infusions, your healthcare provider might prescribe a rate and volume that are lower than your later infusions. This is particularly true if you have not previously been on SCIg therapy.
Speak with your healthcare provider about the rate and volume per site that work best for you as you gain experience with the product.
Infusion parameters*
Infusion number
1st-6th 7th and above
Volume (mL/site)
≤25 mL/hr Gradually increase to maximum of 40 mL/hr
Rate per site (mL/hr)
≤20 mL/hr ≤25 mL/hr
Rate all sites combined (mL/hr)
30 mL/hr
Gradually increase to 50 mL, then to 80 mL; if well tolerated, use
a maximum of 100 mL
Infusion Volumes and Infusion Rates1
*As tolerated
Talk with your healthcare provider about infusion volumes and rates
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 3
Pre-infusion guidelines
• Use cutaquig only after you have been properly instructed and trained by your healthcare provider. Follow the administration guidance step by step and use sterile technique when administering cutaquig. Use gloves if you have been told to do so when preparing your infusion.
• Cutaquig is a clear and colorless solution that may turn slightly pale yellow during storage. Be sure to visually inspect each vial of cutaquig. Do not use the solution if it appears cloudy or contains small particles. Do not use if the caps are missing.
• Use sterile technique when preparing and administering cutaquig. Your healthcare provider should demonstrate the practices and procedures to prevent contamination from bacteria and viruses.
• Check the labeling for the expiration date and do not use beyond this date.
• Do not mix cutaquig with other products.
• Do not mix cutaquig with water.
• Do not shake the solution.
• Dispose of all materials, including any unused cutaquig, in an appropriate container.
• Do not freeze. Do not use frozen product.
• You can store cutaquig in a refrigerator at 36°F to 46°F (+2°C to +8°C) for up to 24 months from the date of manufacture. Within its shelf-life, the product may be stored at room temperature up to 77°F (up to +25°C) for up to 6 months without being refrigerated again during this period, and must be discarded if not used after this.
• Keep cutaquig in the outer carton to protect it from exposure to light.
• If you have any questions or concerns, contact your healthcare provider.
Always keep in mind the following points before you start administering cutaquig1:
What is the most important information I need to know about CUTAQUIG?CUTAQUIG can cause the following serious reactions:• Severe allergic reactions causing difficulty in breathing or skin rashes• Blood clots in the heart, brain, lungs, or elsewhere in the body• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting• Decreased kidney function or kidney failure• Dark colored urine, swelling, fatigue, or difficulty breathingCUTAQUIG is made from human blood. The risk of transmission of infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent cannot be completely eliminated.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 4
Step 1: Prepare the necessary number of cutaquig vials1
Always keep in mind the following important points before you start administering cutaquig:
Prepare your cutaquig vials prior to infusion:
• If stored in the refrigerator, place the vials at room temperature (77°F) at least 90 minutes prior to infusion.
• Do not return product to the refrigerator after placing it at room temperature—or if product has reached room temperature and the infusion has been deferred.
• Do not heat the vials or put them into the microwave.
• Do not shake the vials to avoid foaming.
• Do not draw up product into a syringe prior to the time of your infusion.
Needle, vented spike adapter, or needleless transfer device (for drawing up product from the vial)
Subcutaneous needle set, rate tubing and, if required, a Y connector
Other supplies, including sterile wipes, gauze or transparent dressing, tape, bandages, gloves, and sharps container
Your cutaquig infusion journal and a pen
Make sure you have sterile, unopened supplies for each infusion.
Here are items that you’ll need:
Infusion pump and compatible syringes
Step 2: Gather your infusion equipment1
IMPORTANT SAFETY INFORMATION (continued)What should I avoid while taking CUTAQUIG?• CUTAQUIG can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your
HCP that you take CUTAQUIG.• Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 5
Step 3: Wash your hands thoroughly1
It is important to wash your hands before starting your infusion. Wash them thoroughly and let them air dry, or you should wear gloves if you have been told to do so during your training.
Step 4: Check your vials1
Allow products to reach room temperature (77°F).
Inspect each vial carefully:
Check that the labeled dose is correct and according to your prescription.
Check that the expiration date has not passed.
Check the appearance of the solution (it should be clear and colorless to pale yellow).
Do not use the solution if it is cloudy or contains particles.
Make sure the protective cap is not broken or missing.
IMPORTANT SAFETY INFORMATION (continued)CUTAQUIG can cause serious side effects. If any of the following problems occur after starting CUTAQUIG, contact your HCP or call emergency services. If any of the following problems occur during CUTAQUIG infusion, stop the infusion immediately and contact your HCP or call emergency services: • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction.• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.• Fever over 100°F. This could be a sign of an infection.Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 6
Step 5: Open your vial1
Remove the protective cap, then disinfect the rubber stopper by using a sterile wipe and allowing it to dry. When using more than one vial, use a separate sterile wipe for each vial.
6a Remove the syringe and the vented spike adapter from their sterile packaging.
Do not touch the exposed area of the syringe and the vented spike adapter.
When a needleless transfer device is used—like a vented spike adapter—follow the instructions from the device manufacturer, along with the training from your healthcare provider.
Syringe
Step 6: Prepare and fill your syringe1
Vented Spike
Adapter
6b Attach the vented spike adapter to the syringe with a screw action.
IMPORTANT SAFETY INFORMATION (continued)What are the possible or reasonably likely side effects of CUTAQUIG?The most common side effects that may occur with CUTAQUIG are:• Infusion site reactions• Headache
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 7
6c Insert the vented spike adapter into the center of the vial and slowly turn the vial upside down.
Adjust the placement of the vented spike adapter so that the tip is and always remains in the solution; then slowly draw up the desired volume of cutaquig solution.
Step 6: Prepare and fill your syringe1 (continued)
6d Withdraw the vented spike adapter and syringe from the vial. Using the same syringe, repeat this procedure if you need multiple vials for the calculated dose.
6e When finished, remove the vented spike adapter and dispose of it into your sharps container.
IMPORTANT SAFETY INFORMATION (continued)One or more of the following possible side effects may occur at the site of infusion; these may go away within a few hours and are less likely after the first few infusions:• Mild or moderate pain • Redness • Itching
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 8
�
�
�
1
2
3
When using an infusion pump, follow the manufacturer’s preparation instructions.1
Before proceeding, always remember the 3 items needed for every infusion1 (refer to illustrations): 1 Filled syringe from Step 6 2 Rate tubinga 3 Needle set tubing
Once you have all 3 items, you may proceed with priming the tubing.1
Prime the tubing by attaching one end of the rate tubing to the syringe and the other end to the needle set tubing. Gently push the plunger of the syringe to fill the tubing with cutaquig,1 and make sure to stop filling the tubing before the solution gets within 2 inches of the needle set. Inserting a needle that has cutaquig on the tip can cause redness and irritation.2
aRate tubing is not needed if you are using a programmable pump.
Step 7: Prepare your pump
Cutaquig can be infused into the following areas: upper arm, abdomen, upper leg/hip area, and/or thigh (as shown in image 1).1
The number and location of the infusion sites varies and is determined by the total volume of the dose ordered.1
• The infusion sites should be at least 2 inches apart (as shown in image 2).1
• If infusing in the abdomen, ensure infusion sites are at least 2 inches from the navel.2
• Do not use more than 6 infusion sites at the same time.1
• Rotate sites between infusions.1
• Avoid inserting the needle into scars, tattoos, stretch marks, or any skin that has signs of an infection (such as injured, inflamed, or red areas of skin).1
1 2
Step 8: Prepare your infusion site
IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSISSee full Prescribing Information for complete BOXED WARNING• Thrombosis may occur with immune globulin products, including CUTAQUIG. Risk factors may include advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• For patients at risk of thrombosis, administer CUTAQUIG at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 9
Step 9: Begin your infusion (insert needles)1
9a Clean the skin at the selected infusion site with a sterile wipe, starting at the center and working outward in a circular motion. Allow each site to air dry (5-10 seconds) before proceeding.
9b Carefully remove the needle cover, holding the plastic needle set in your dominant hand. Using your other hand, pinch the skin around the infusion site between your thumb and forefinger.
9c In one swift motion, insert the needle into the skin at a 90-degree angle.
90˚
What is the most important information I need to know about CUTAQUIG?CUTAQUIG can cause the following serious reactions:• Severe allergic reactions causing difficulty in breathing or skin rashes• Blood clots in the heart, brain, lungs, or elsewhere in the body• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting• Decreased kidney function or kidney failure• Dark colored urine, swelling, fatigue, or difficulty breathingCUTAQUIG is made from human blood. The risk of transmission of infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent cannot be completely eliminated.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 10
9d To assure needle placement, wings should be secured flat against the skin with a transparent dressing.
Step 9: Begin your infusion (insert needles)1 (continued)
9e Check needle placement by pulling back on the syringe plunger. There should not be any blood in the tubing.
Note: If blood return is seen, remove the needle, connect a new needle set to the rate tubing, prep the infusion site, and insert the new needle at a different location.
9f Load the syringe into the infusion pump and initiate infusion, following the manufacturer’s instructions.
What should I avoid while taking CUTAQUIG?• CUTAQUIG can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your
HCP that you take CUTAQUIG.• Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 11
Step 10: Complete your infusion
Be sure to turn off the infusion pump before following the instructions below.
After your infusion is completed, follow these instructions1:
• While holding the needle set in place, gently remove the dressing and pull the needle(s) straight out and immediately place them in the sharps container
• Press a small piece of gauze on the needle site and apply tape or adhesive bandage
• Discard all used disposable supplies, as well as any unused product and the empty vial(s), as recommended by your healthcare provider and according to local requirements
• Clean up and securely store your pump and any unopened supplies until the next infusion
Next, we will walk through how to record your infusion to share with your healthcare provider on your next visit.
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
8g/48mL
8g/48mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx onlyNDC 0069-1965-01
NDC 0069-1965-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20XX XX MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
On each vial of cutaquig, you’ll find a peel-off portion of the label with the batch-number details. Stick this label in your cutaquig infusion journal. Record all details of the infusion, as indicated in the journal.
In the event that you encounter any problems, such as side effects during or after the infusion, record them in your infusion journal and contact your healthcare provider and specialty pharmacy. Even if you are not experiencing any side effects, always remember to bring your infusion journal with you to every appointment with your healthcare provider.
Step 11: Record your infusion1
CUTAQUIG can cause serious side effects. If any of the following problems occur after starting CUTAQUIG, contact your HCP or call emergency services. If any of the following problems occur during CUTAQUIG infusion, stop the infusion immediately and contact your HCP or call emergency services: • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction.• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 12
How to complete your cutaquig infusion journal
During your first few infusions, it is recommended that you ask your infusion nurse or trainer to help you complete your journal.
For ease of portability, each infusion journal will cover up to 1 month of your cutaquig infusions.
It’s important that you fill out every section and keep an accurate record of each time you administer cutaquig.1 This journal will help you and your healthcare provider monitor your progress.
Please remember to bring this and any other relevant journal to any appointments with your healthcare provider.
Cutaquig infusion record
Please record the date of your weekly infusions into the appropriate month after starting cutaquig. This provides a quick-glance for you and your healthcare provider to preview the number of infusions you’ve completed over the last month, and when those infusions occurred. The additional pages to follow will provide you and your healthcare provider with an easy way to track the progress that you have made with your cutaquig treatment, so necessary adjustments can be made. The following entries have been completed as an example.
Needed to call my healthcare provider about (optional):
Needed to order the following supplies (optional):
Since my last infusion, I:
Started a new medication:
Was sick for Was sick with:day(s)
Saw my healthcare provider:
Please see Full Important Safety Information on pages 2 and 3 and Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use, in pocket.
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
8g/48mL
8g/48mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1965-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
2g/12mL
2g/12mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1476-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
July 29, 2019
10 g 9 mm4:00 pm
3
5:30 pm
60 mL
Dosage questionsSharps container
No
None
3
None
No
CUTAQUIG can cause serious side effects. If any of the following problems occur after starting CUTAQUIG, contact your HCP or call emergency services. If any of the following problems occur during CUTAQUIG infusion, stop the infusion immediately and contact your HCP or call emergency services: (continued)• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.• Fever over 100°F. This could be a sign of an infection.Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine.
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use. 13
Cutaquig infusion journal sample entry
76
Infusion Date:
Infusion Start Time: Infusion Finish Time:
Dose (grams): Needle Length:
# of Needles: Infusion Total Volume:
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Lot Number (affix vial label here):
Infusion Sites:
Infusion journal entry
Within 3 days of this infusion, I:
Had side effects:
At infusion site Other, not at the infusion site
Had symptoms that were:
Mild Moderate Severe Resolved within ___ hours
During this infusion, I:
Took these medications:
Had these side effects:
Needed to call my healthcare provider about (optional):
Needed to order the following supplies (optional):
Since my last infusion, I:
Started a new medication:
Was sick for Was sick with:day(s)
Saw my healthcare provider:
Please see Full Important Safety Information on pages 2 and 3 and Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use, in pocket.
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
8g/48mL
8g/48mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1965-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
2g/12mL
2g/12mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1476-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
July 29, 2019
10 g 9 mm4:00 pm
3
5:30 pm
60 mL
Dosage questionsSharps container
No
None
3
None
No
The following is an example of your infusion worksheet.
Each journal entry has two pages. The first page records the start and end time of the infusion, along with the details of the supplies used as part of the infusion.
Note: Infusion time will vary based on a variety of factors, such as your total infusion volume, rate tubing and number of needles.
76
Infusion Date:
Infusion Start Time: Infusion Finish Time:
Dose (grams): Needle Length:
# of Needles: Infusion Total Volume:
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Affix vial label here
Lot Number (affix vial label here):
Infusion Sites:
Infusion journal entry
Within 3 days of this infusion, I:
Had side effects:
At infusion site Other, not at the infusion site
Had symptoms that were:
Mild Moderate Severe Resolved within ___ hours
During this infusion, I:
Took these medications:
Had these side effects:
Needed to call my healthcare provider about (optional):
Needed to order the following supplies (optional):
Since my last infusion, I:
Started a new medication:
Was sick for Was sick with:day(s)
Saw my healthcare provider:
Please see Full Important Safety Information on pages 2 and 3 and Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use, in pocket.
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
8g/48mL
8g/48mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1965-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
For subcutaneous use only. See package insert for dosage and adm
inistration.
8 g48 m
L
2g/12mL
2g/12mL
Mat-N
o./C
AN
/Datam
atrix: 2013716-01 (co
de is a sam
ple)
Versio
n/R
evision
ind
ex: 05
Date:
2019-07-12
Prod
uct co
de:
810 (Pfizer) (A
)Pro
du
ct nam
e: C
utaq
uig
Co
un
try:U
SAFillin
g Size/C
on
centratio
n:
48 ml
Form
at: 96 x 32 m
m (2x 16 x 32 m
m)
Co
lou
rs: Pan
ton
e 320Pan
ton
e Co
ol G
ray 11B
lack, Black 5%
Barco
de (G
S1-Co
de 128):
(01)10300691965013
Desig
n:
Bo
rng
räber
2013716-01
NDC 0069-1965-01
Distributed by: Pfizer Labs
Division of Pfizer Inc, NY, N
Y 10017
Mfd. by: O
ctapharma
Pharmazeutika Produktionsges.m
.b.H.O
berlaaer Strasse 235, 1100 Vienna,Austria, U
.S. Lic # 1646
Lot
EXP
Lot
EXP
Lot
EXP
If stored at +2°C to +8°C (36°F to 46°F)
Rx only
NDC 0069-1965-01
NDC 0069-1476-01
Imm
une Globulin Subcutaneous
(Human) - hipp 16.5%
(01)10300691965013
variable data will be printed in black color
on the final printed packaging material
font size 6pt
A123A1234
20XX MAR 31
A123A1234
20XX MAR 31
A123A1234
20X X MAR 31
96 mm
12 mm
16 mm
16 mm
32 mm
July 29, 2019
10 g 9 mm4:00 pm
3
5:30 pm
60 mL
Dosage questionsSharps container
No
None
3
None
No
The following is an example of your infusion worksheet.
The second page provides a record of symptoms during, before, and after the infusion. It is important to record any reactions and to discuss them with your healthcare provider on your next visit.
What are the possible or reasonably likely side effects of CUTAQUIG?The most common side effects that may occur with CUTAQUIG are:
One or more of the following possible side effects may occur at the site of infusion; these may go away within a few hours and are less likely after the first few infusions:• Mild or moderate pain • Redness • Itching
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.You are encouraged to report negative side effects of prescription drugs to Pfizer, Inc. at 1-800-438-1985 or to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.
14Please click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use.
Indication, Usage, and Important Safety Information
INDICATION AND USAGECUTAQUIG (Immune Globulin Subcutaneous [Human] - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults. There are many forms of PI. Certain types of PI are associated with low immunoglobulin G (IgG), which are proteins that help fight infection. CUTAQUIG is a liquid medicine for infusion that contains immunoglobulin G (IgG), which are proteins that help fight infection. It is made from human plasma that is donated by healthy people and contains antibodies that replace the missing antibodies in patients with PI. CUTAQUIG is given under the skin (subcutaneous). Most of the time, infusions under the skin are given at home by self-infusion or by a caregiver. Only use CUTAQUIG by yourself after you have been instructed on use by a healthcare provider (HCP).
IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSISSee full Prescribing Information for complete BOXED WARNING• Thrombosis may occur with immune globulin products, including CUTAQUIG. Risk factors may include advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• For patients at risk of thrombosis, administer CUTAQUIG at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
What is the most important information I need to know about CUTAQUIG?CUTAQUIG can cause the following serious reactions:• Severe allergic reactions causing difficulty in breathing or skin rashes• Blood clots in the heart, brain, lungs, or elsewhere in the body• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting• Decreased kidney function or kidney failure• Dark colored urine, swelling, fatigue, or difficulty breathingCUTAQUIG is made from human blood. The risk of transmission of infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent cannot be completely eliminated.
What should I avoid while taking CUTAQUIG?• CUTAQUIG can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your
HCP that you take CUTAQUIG.• Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.
CUTAQUIG can cause serious side effects. If any of the following problems occur after starting CUTAQUIG, contact your HCP or call emergency services. If any of the following problems occur during CUTAQUIG infusion, stop the infusion immediately and contact your HCP or call emergency services: • Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting, or dizziness. These could be signs of a serious allergic reaction.• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.• Chest pain or trouble breathing, or blue lips or extremities. These could be signs of a serious heart or lung problem.• Fever over 100°F. This could be a sign of an infection.Ask your HCP whether you should have rescue medications available, such as antihistamines or epinephrine.
What are the possible or reasonably likely side effects of CUTAQUIG?The most common side effects that may occur with CUTAQUIG are:
One or more of the following possible side effects may occur at the site of infusion; these may go away within a few hours and are less likely after the first few infusions:• Mild or moderate pain • Redness • Itching
These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.You are encouraged to report negative side effects of prescription drugs to Pfizer, Inc. at 1-800-438-1985 or to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.
IMPORTANT SAFETY INFORMATIONCUTAQUIG is made from human blood. The risk of transmission of infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent cannot be completely eliminated.
References: 1. Cutaquig® [package insert]. Lachen, Switzerland: Octapharma AG; August 2019. 2. Greer M. Reducing SCIG Side Effects. http://www.igliving. com/magazine/articles/IGL_2015-08_AR_Clinical-Brief-Reducing-SCIG-Side-Effects.pdf. Accessed July 11, 2019.
immunoglobulin (SCIg) solution for adults with primary
immunodeficiency.1
Please see Important Safety Information on page 14 and click here for Full Prescribing Information, including complete BOXED WARNING and Patient Information and Instructions for Use.You are encouraged to report negative side effects of prescription drugs to Pfizer, Inc. at 1-800-438-1985 or to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088.CUTAQUIG is a registered trademark of Octapharma AG.
CUTAQUIG is manufactured by Octapharma and distributed by Pfizer Inc.
