Chronic Kidney Disease (CKD) - Nutropin · Doctors prescribe Nutropin AQ therapy for children and...

Notes:

Your healthcare team is your primary source of information about your child’s treatment.

Please see the accompanying full Prescribing Information, including Instructions for Use, and additional Important Safety Information throughout and on pages 16-18.

Models used for illustrative purposes only.

Nutropin, Nutropin AQ, and NuSpin are registered trademarks, Nutropin GPS is a trademark, and NuAccess is a service mark of Genentech, Inc.

© 2019 Genentech USA, Inc., 1 DNA Way, So. San Francisco, CA 94080

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For easily accessible answers, education, and support, visit Nutropin.com or call 1-866-NUTROPIN (1-866-688-7674).

Chronic Kidney Diseaseof patients who have

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A Guide for Caregivers

What is chronic kidney disease?CKD is a loss of kidney function over a period of months or years. If your child’s kidneys are damaged, they can start losing their ability to do their job as well as they should. That can throw your child’s body chemistry out of balance. As CKD progresses, blood pressure control becomes more diffi cult. In addition, it gets harder for the body to make red blood cells, use nutrition from food effectively, build bones, strengthen muscles, and gain height.

How CKD can be managedYour healthcare professional (HCP) may recommend one or more therapies to help address these problems:

• Treatments, such as dialysis, can help fi lter yourchild’s blood

• Certain medicines can help manage your child’sblood chemistry

– Make sure your child takes as directed all themedicines his or her healthcare team prescribes

• Healthy eating can go a long way

– Your healthcare team can help you establishand maintain a proper diet for your child

It’s also vital that you do all you can to counter the effects of CKD. An important part of that is supporting the full growth potential of your child,particularly in the early years of life.

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Understanding

chronic kidney diseaseLearning that your child has chronic kidney disease (CKD)can be stressful, both for your child and for you. You might not know what to expect, either in the near future or down the road.

As a parent, it’s natural to focus on your child’s kidney condition. But it’s also important to keep your child’s overall health in perspective, including the need to help him or her maintain growth. For that, it helps to understand CKD and its complications, some of which may affect your child’s ability to grow.

How CKD happensTo understand what’s going on in your child’s body, it’s important to know what healthy kidneys do—and how CKD affects the way kidneys function.

The two kidneys, located on each side of the middle of the back, serve many purposes in a healthy body, including:

• Filtering blood to get rid of excess fl uid, minerals, andwaste through urine

• Helping maintain blood pressure and the right balanceof chemicals and minerals in the body

• Helping produce critical compounds like activatedvitamin D (important to bone health) and erythropoietin(important to healthy blood)


WELD GLUEWELD GLUE

CKD and growth

How does CKD affect your child’s ability to grow? If your child is getting enough nutrition and taking medications as prescribed, but still is not growing well, a substance made in the body called “growth hormone” may be part of the problem.

What is growth hormone?Growth hormone (GH) is a naturally occurring chemical messenger that helps the body grow.

• GH is a protein made in the pituitary gland, located below the brain

• It plays a role in how food is used by the body

• GH also tells the liver to produce a hormone called insulin-like growth factor, or IGF

• IGF travels to muscles, organs, and bones and tells the bones to grow. It also helps improve muscle metabolism

How CKD affects growthHealthy children reach about one-third of their adult height within their fi rst two years of life. CKD can seriously interfere with growth, making it important to act as soon as a growth problem is noted.

Most young people with CKD produce as much GH as anyone their age. The problem is their kidneys aren’t fi ltering waste from their blood as well as they should. Because so much waste is trapped in their blood, their bodies aren’t able to use growth hormone effectively. That means:

• IGF gets stopped along the way to muscles, organs, and bones

• Nutrients in food aren’t absorbed effectively

• Calcium, the main mineral that makes bones, gets drawn out of the bones, potentially causing bone loss

How GH therapy may helpBecause CKD may keep GH from working effectively in your child’s body, your HCP may prescribe additional GH to help treat growth failure associated with CKD.

• The form of GH used as a medication is the same protein your child makes naturally in his or her own body

• GH therapy may help children get closer to reaching their growth potential

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How GH therapy works

The added GH works the same way as the growth hormone your child’s body makes. Because of CKD, your child’s GH and IGF can’t connect properly. Additional GH may help your child overcome this challenge. With GH therapy, the level of GH in the body increases and this triggers an increase in the level of IGF. Working together, GH and IGF help bones, muscles, and organs grow.

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How will you know if GH therapy is right for your child?

Before starting GH therapy, your HCP may test to see if dietary changes and balancing other blood chemistry levels improve your child’s growth. One of the tests they may perform is a bone age X-ray. This is done to determine the maturity or “age” of your child’s bones, which may be different from your child’s chronological age.

• If the HCP fi nds that your child could benefi t from GH therapy, he or she may recommend starting right away

• Your child’s HCP will calculate how much GH is right for your child


As you discuss GH therapy with your child’s HCP, you may hear about a product called Nutropin AQ® (somatropin) injection, for subcutaneous use.

Nutropin AQ® is human growth hormone that is available by prescription only in a disposable pen called NuSpin®.

Who is Nutropin AQ therapy for?Doctors prescribe Nutropin AQ therapy for children and teenagers who are short or growing slowly because they have chronic kidney disease (CKD) up to the time of kidney transplant.

Your doctor will test to see if growth hormone is right for you.

• Patients who have active cancer. Because growthhormone defi ciency can be an early sign of sometumors in the brain or pituitary gland, the presenceof these types of tumors should be ruled out by yourdoctor before you start Nutropin therapy

• Patients who are allergic to somatropin, the activeingredient in Nutropin therapy, or the inactiveingredients in Nutropin therapy

• Adults or children with certain types of eye diseasecaused by diabetes

• Children and teenagers whose bones have fi nishedgrowing

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Using Nutropin AQ® therapyto treat CKD-related growth issues

Select Important Safety InformationNutropin therapy and your safety:

Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor.

Nutropin therapy is NOT for: • Patients having serious complications after undergoing

open heart surgery, abdominal surgery, serious injuriesinvolving many body systems, or life-threatening breathingproblems. Deaths have been reported in such cases

• Children who have Prader-Willi syndrome(PWS) and are very overweight or have a history of severebreathing problems. Deaths have been reported in childrenwith PWS who are very overweight, have a history ofblocked upper airways, sleep apnea (pauses in breathingduring sleeping), or other severe breathing problems

Your healthcare team is your primary source of information about your child’s treatment.Please see the accompanying full Prescribing Information, including Instructions for Use, and additional Important Safety Information throughout and on pages 16-18.

Remember that GH therapy does not replace good nutrition• Make sure your child keeps eating right and takes

all medicines prescribed by your HCP

If your child begins Nutropin AQ therapy, regular check-ups with your HCP are also important to:• Check for any signs of a kidney-related bone

disease called renal osteodystrophy

• Make sure your child’s bones are growingas they should

• Talk about any safety concerns

• Monitor your child’s weight so his or hermedication doses are correct

• Monitor for complications of CKD

• Assess your child’s nutrition

How Nutropin AQ is given

Because it is a protein, Nutropin AQ must be given by injection. If the medication were taken by mouth, it would be broken down by digestion in the stomach and intestines and would never get to the rest of the body to do its job. Nutropin AQ is injected into the fatty layer under the skin (the subcutaneous tissue).

• Your child’s healthcare team will show you andyour child how to give the injection—or a nursewill provide personal instruction

• Your child’s healthcare team will advise you onwhen to give the injection; timing is importantfor children on dialysis

• Some children are able to give themselves theinjection, once instructed by their healthcare team

• Following your healthcare team’s directions offersthe best chance for success 10

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Select ImportantSafety Information (continued)What should you tell your doctor before starting Nutropin therapy?

• If you take cyclosporine, hormone replacementtherapy, insulin or other diabetes medications,drugs containing steroids, or drugs for seizures.These medications may need to be adjusted duringNutropin therapy



Nutropin AQ NuSpin is a disposable, multidose, dial-a-dose injection device prefi lled with Nutropin AQ for subcutaneous use. NuSpin devices are designed to be simple to use.

• Each device is prefi lled

• No need to mix or attach cartridge

• Dosing wheel can be dialed backward and forward

• Two ways to confi rm an accurate dose: the spinning dose knob and the dose window

• Slide activator for priming and injection

• Each device needs to be primed once at fi rst use only

Dosing options to fi t individual needs• NuSpin 20

• NuSpin 10

• NuSpin 5

With NuSpin, you can dial the dose knob forward and back to get to your correct dose. And there’s no math needed. When a cartridge runs out, NuSpin shows the exact amount needed from the next pen to make a full dose.

Using NuSpin®

Designed to be simple



Designed to be simpleDesigned to be simple

Select ImportantSafety Information (continued)What should you tell your doctor before starting Nutropin therapy?

• If you had cancer as a child. An increased risk of a new tumor, particularly certain brain tumors, has been reported in patients taking Nutropin therapy. If you have pre-existing tumors or growth hormone defi ciency caused by abnormal tissue in the brain, you should be watched closely for the worsening or return of this condition

• If you have diabetes, risk factors for diabetes, or impaired glucose tolerance. If so, your doctor should monitor your blood sugar closely during Nutropin therapy. New cases of type 2 diabetes have been reported in patients taking Nutropin therapy

• If you have pituitary hormone defi ciency(s) (an inability of the pituitary gland to produce suffi cient hormones) or adrenal hormone defi ciency (an inabilityof the adrenal glands to produce suffi cient hormones, primarily cortisol). Your doctor may further monitor your hormone levels or your hormone replacementtherapy closely while you are taking Nutropin therapy

• If you are pregnant, nursing, or plan to become pregnant. It is not known whether Nutropin is excreted in human milk. Nutropin therapy should be used during pregnancy only when clearly needed

Helping your child get the full dose of Nutropin AQ—because every dose is an opportunity taken.

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Turn to

Need help navigating the insurance maze?Assistance getting the medicine you need?Expert answers to help access GH therapy?

• Get personalized one-on-one help A dedicated case manager can assist you with insurance questions and help eligible patients get access to therapy

• Get injection trainingA nurse will personally train you and your child on how to administer Nutropin AQ using the NuSpin®

device. With a little help, you or your child will feel comfortable giving GH therapy. And you can always get your treatment questions answered live by calling the Nurse Hotline at 1-866-NUTROPIN

Genentech Patient FoundationThe Genentech Patient Foundation provides eligible patients their Nutropin AQ free of charge.

The Genentech Patient Foundation provides free Genentech medicine to patients who meet income guidelines and:• Who don’t have insurance• Whose treatment is not covered by insurance

• Who are struggling with high out-of-pocket costs

For further information, please go to www.nutropin.com.

If you need help with the co-pay for your Nutropin AQ, Nutropin GPS can refer you to an independent co-pay assistance foundation.

Supporting you throughout treatment

• Get the Nutropin GPS™ Co-pay CardHelps eligible patients cover the co-pay costs. Speak to your HCP about getting started on the Nutropin Co-pay Card Program or call 1-866-NUTROPIN

In order to be eligible for the Nutropin GPS Co-pay Card, the patient must confi rm that they meet the criteria set forth in the Terms &Conditions for the program. Please visit www.nutropin.com for the full list of Terms &Conditions

• Get started fastNuAccessSM provides access to Nutropin AQ to all eligible patients for a limited time while insurance coverage is being secured



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• Progression of scoliosis (curvature of the spine) that can occur in children who have rapid growth. Nutropin therapy has not been shown to increase the occurrence of this condition

• Increases in laboratory test serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH), or IGF-1

• Abdominal pain. Cases of pancreatitis (infl ammation of the pancreas) have been reported rarely in children and adults receiving Nutropin therapy

Other important information about Nutropin:

• Adults may retain water during Nutropin therapy. This may be brief but may increase with higher doses of Nutropin therapy

• Patients should have their thyroid function tested periodically during Nutropin therapy. Thyroid hormone treatment may need to be started or adjusted

• Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the fi rst injection

• The use of Nutropin therapy has not been studied in patients over 65 years of age. Elderly patients may be more sensitive to Nutropin therapy and may experience more side effects

• Patients with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems during Nutropin therapy

AdditionalImportant Safety Information (continued)

Nutropin therapy and your safety:

Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor.

While taking Nutropin, contact your doctor immediately if you experience:

• Changes in upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, in patients with PWS. These patients should also haveeffective weight control and be monitored by a doctor for signs of respiratory infection

• Changes in vision, a bad headache, or nausea with orwithout vomiting. This may be a sign of increased pressure in the brain

• Any allergic reaction you experience to the injection ofNutropin therapy

• Any allergic reaction you experience to the injection of Nutropin therapy

• A limp or have hip or knee pain

− A fracture in the ball of the hip joint can occur inchildren who have endocrine problems and in children who have rapid growth

− Children with growth failure due to CKD should beexamined periodically for evidence of loss of boneminerals. Hip x-rays should be taken before starting Nutropin therapy in these children

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AdditionalImportant Safety Information (continued)

Your healthcare team is your primary sourceof information about your child’s treatment.


Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

What are common possible side effects of Nutropin therapy?

Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.You may also report side effects to Genentechat (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]).Do not freeze. NuSpin pens must be used within 28 days of initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

Notes:


Please see the accompanying full PrescribingInformation, including Instructions for Use, andadditional Important Safety Information throughout and on pages 16-18.


Nutropin, Nutropin AQ, and NuSpin are registered trademarks, Nutropin GPSis a trademark, and NuAccess is a service mark of Genentech, Inc.


NTR/110415/0128(4) 08/19

1819

For easily accessible answers, education,and support, visit Nutropin.com or call1-866-NUTROPIN (1-866-688-7674).


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A Guide for CaregiversAdditionalImportant Safety Information (continued)



Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

What are common possible side effectsof Nutropin therapy?

Common side effects reported in adults and children takingNutropin therapy include injection site reactions. Additionalcommon side effects in adults include swelling, joint pain,and carpal tunnel syndrome.

You may report side effects to the FDA at(800) FDA-1088 or www.fda.gov/medwatch.You may also report side effects to Genentechat (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]).Do not freeze. NuSpin pens must be used within 28 daysof initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

Notes:


Please see the accompanying full PrescribingInformation, including Instructions for Use, andadditional Important Safety Information throughout and on pages 16-18.


Nutropin, Nutropin AQ, and NuSpin are registered trademarks, Nutropin GPSis a trademark, and NuAccess is a service mark of Genentech, Inc.


NTR/110415/0128(4) 08/19

1819

For easily accessible answers, education,and support, visit Nutropin.com or call1-866-NUTROPIN (1-866-688-7674).


FPO


Notes:




Nutropin, Nutropin AQ, and NuSpin are registered trademarks, Nutropin GPS is a trademark, and NuAccess is a service mark of Genentech, Inc.


NTR/110415/0128(4) 09/19

1819

For easily accessible answers, education, and support, visit Nutropin.com or call 1-866-NUTROPIN (1-866-688-7674).



ROUTINE USE: DOSING AND ADMINISTRATION

STEP 3:Set the dose

STEP 4:Give the injection

Check dose given

InstructIons for use

If the dose knobstops before itreturns to 0.0 ,your Nutropin AQNuSpin 5 is emptyand you have notreceived your fulldose.

The number shownin the dose windowis the amount neededto obtain a full dose.

Your healthcareprofessional willadvise you on theprocedure for usingthe last dose in theNuSpin 5.

Select and prepareyour injection siteas instructed byyour healthcareprofessional.

Position your handso you can easilyslide the Activator.

Push the needle intothe skin.

Slide the Activatortoward the needle.

Hold the Activatordown until the doseknob returns to

0.0 and continueto hold in place for5 seconds.

Withdraw theNutropin AQ NuSpin5 until the needleis removed fromthe skin.

If the dose knobreturns to 0.0 ,you have receivedyour full dose.

If your dose is“between” twonumbers in the dosewindow, the –between those twonumbers indicatesyour dose. Turn thedose knob to – .

The P positionindicates a 0.35 mgdose on yourNuSpin 5.

If you turn the doseknob too far, simplyturn it backto the correct dose.

(Example above showsa dose of 0.05 mg,represented by – ).

Make sure the dosewindow reads 0.0 .

Turn the doseknob until thedose prescribedby your healthcareprofessionalappears in thedose window.

Carefully place the outer cover of the needle package over the needle, unscrew, and dispose of it as instructedby your healthcare professional.

STORAGE AND NEXT USE

REMOVAL AND DISPOSAL OF THE NEEDLE

Replace the cap and store your NuSpin 5 inside the refrigerator at 2–8°C (36–46°F). Protect from light.For the next use, it is already primed. Follow the instructions and skip Step 2.

NEW NuSpin 5 SET UP: STEP-BY-STEP INSTRUCTIONS FOR THE FIRST USE OF EACH NEW NUTROPIN AQ NuSpin 5

STEP 1:Attach the needle

STEP 2:Prime the Nutropin AQ NuSpin

Before you begin,wash your hands.

Twist gently and pullto remove the NuSpin5 cap. Inspect thecartridge beforeuse to ensure thatthe medicine in it isclear. If it is cloudyor hazy, do not inject.

Open a new needleby peeling off thepaper tab from theneedle package.

Attach the needle bycarefully screwingthe needle onto theneedle holder.

Do not overtighten.

Remove bothprotective coversfrom the needle andsave the outer cover.

Turn the dose knob tothe P position in thedose window.

It may take multipleclicks to get to P .

Hold the NuSpin 5with the needlepointing upwards.

Gently tap thecartridge holderto move any airbubbles to theNuSpin 5 tip.


If you do not see fluidat the needle tip,redial to P and slidethe Activator forwardagain.

Repeat until yousee fluid.

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ROUTINE USE: DOSING AND ADMINISTRATION

STEP 3:Set the dose

STEP 4:Give the injection

Check dose given

InstructIons for use

If the dose knobstops before itreturns to 0.0 ,your Nutropin AQNuSpin 10 is emptyand you have notreceived your fulldose.

The number shownin the dose window isthe amount neededto obtain a full dose.

Your healthcareprofessional willadvise you on theprocedure for usingthe last dose in theNuSpin 10.

Select and prepareyour injection siteas instructed byyour healthcareprofessional.

Position your handso you can easilyslide the Activator.

Push the needle intothe skin.


Hold the Activatordown until the doseknob returns to

0.0 and continueto hold in place for5 seconds.

Withdraw theNutropin AQ NuSpin10 until the needle isremoved fromthe skin.

If the dose knobreturns to 0.0 ,you have receivedyour full dose.

Make sure the dosewindow reads 0.0 .

Turn the doseknob until thedose prescribedby your healthcareprofessionalappears in thedose window.

Carefully place the outer cover of the needle package over the needle, unscrew, and dispose of it as instructedby your healthcare professional.

STORAGE AND NEXT USE

REMOVAL AND DISPOSAL OF THE NEEDLE

Replace the cap and store your NuSpin 10 inside the refrigerator at 2–8°C (36–46°F). Protect from light. For the next use,it is already primed. Follow the instructions and skip Step 2.

NEW NuSpin 10 SET UP: STEP-BY-STEP INSTRUCTIONS FOR THE FIRST USE OF EACH NEW NUTROPIN AQ NuSpin 10

STEP 1:Attach the needle

STEP 2:Prime the Nutropin AQ NuSpin

Before you begin,wash your hands.

Twist gently and pullto remove the NuSpin10 cap. Inspect thecartridge beforeuse to ensure thatthe medicine in it isclear. If it is cloudyor hazy, do not inject.

Open a new needleby peeling off thepaper tab from theneedle package.

Attach the needle bycarefully screwingthe needle onto theneedle holder.

Do not overtighten.

Remove bothprotective coversfrom the needle andsave the outer cover.

Turn the dose knob tothe P position in thedose window.

It may take multipleclicks to get to P .

Hold the NuSpin 10with the needlepointing upwards.

Gently tap thecartridge holder tomove any air bubblesto the NuSpin 10 tip.


If you do not see fluidat the needle tip,redial to P and slidethe Activator forwardagain.

Repeat until yousee fluid.

If your dose is“between” twonumbers in the dosewindow, the –between those twonumbers indicatesyour dose. Turn thedose knob to – .

The P positionindicates a 0.7 mgdose on yourNuSpin 10.

If you turn the doseknob too far, simplyturn it backto the correct dose.

(Example above showsa dose of 0.1 mg,represented by – ).

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Chronic Kidney Disease (CKD) - Nutropin · Doctors prescribe Nutropin AQ therapy for children and...

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Transcript of Chronic Kidney Disease (CKD) - Nutropin · Doctors prescribe Nutropin AQ therapy for children and...