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SKYTROFA and the SKYTROFA Auto-Injector

What is SKYTROFA?

SKYTROFA is a prescription medicine used for:

The replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD)
The replacement of growth hormone in adults with growth hormone deficiency (GHD)

What makes once-weekly SKYTROFA different?

SKYTROFA is the only long-acting growth hormone treatment for pGHD that does not require refrigeration for up to 6 months* and is preservative free.

*Store SKYTROFA in the original package to protect from light. Do not freeze. SKYTROFA can be stored at room temperature (not to exceed 86°F [30°C]) for up to 6 months. Alternatively, SKYTROFA can be stored under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If refrigerated, keep at room temperature for 15 minutes before use. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was ﬁrst removed from refrigeration (whichever is earlier).

Who can take SKYTROFA?

Children 1 year and older and weigh at least 26 pounds (11.5kg) who are diagnosed with growth hormone deficiency (GHD). Your child’s doctor will help you determine if SKYTROFA is an appropriate treatment option.

How does the SKYTROFA Auto-Injector work?

To learn more about how the SKYTROFA Auto-Injector works, watch the step-by-step instruction video.

What happens if I forget to charge my child’s auto-injector?

The battery icon on your auto-injector will always let you know when it is time to charge the device. If you forget, it takes only 15 minutes to charge for 1 injection.

After injecting, allow your auto-injector to fully charge before using it again. A full charge will last at least 4 weeks when used for 1 injection each week. To learn more about charging the auto-injector, refer to the Instructions for Use.

What if I have questions about using the auto-injector?

Once your doctor prescribes SKYTROFA, they will also enroll you in the Ascendis Signature Access Program^® (A·S·A·P). Through A·S·A·P, you will receive personalized support with a team member, who will coordinate auto-injector training and provide injection assistance.

For any questions, please call 1-844-442-7236.

Do SKYTROFA cartridges need to be refrigerated?

No, SKYTROFA cartridges do not need to be refrigerated for up to 6 months.* With SKYTROFA, you can conveniently store your child’s medicine at home or when traveling.

What happens if my child misses a dose?

In the case of a missed dose, administer SKYTROFA as soon as possible and not more than 2 days after the missed dose. If more than 2 days have passed from the scheduled day, skip that dose and administer the next does on their regular injection day.

To help avoid missed doses, SKYTROFA can be taken 2 days before or 2 days after the scheduled dosing day. You should always go back to their regular injection day after taking a missed dose.

Ensure there are at least 5 days between doses.

What dosage strengths are available?

SKYTROFA is available in 9 dosage strengths: 3mg, 3.6mg, 4.3mg, 5.2mg, 6.3mg, 7.6mg, 9.1mg, 11mg, and 13.3mg. Your doctor can adjust your child’s treatment as needed and switch to the appropriate cartridge.

How can I get my child started on SKYTROFA?

Talk with your child’s doctor about once-weekly SKYTROFA. Download our discussion guide to bring to your next visit.

For more information about getting started, click here.

Pediatric GHD

What does it mean if my child has GHD?

It means that their pituitary gland does not produce enough growth hormone to stimulate their body to grow. Your child is likely growing at a slower rate than other children, which will be noticeable on their growth chart.

How can GHD affect my child?

Children with GHD may be shorter, look younger than their peers, or have delayed puberty. It can also cause lower strength, energy, or, in some cases, low blood sugar.

How do I know if my child might have GHD?

If you are concerned about your child’s growth, share your concerns as soon as possible with your child’s doctor who will conduct an exam. If pGHD is suspected, you may be referred to a specialist who can conduct further tests.

Use our Find a Doctor tool to find a specialist in your area and download our Doctor Discussion Guide to help guide the conversation with your child’s doctor.

Where can I learn more about pediatric GHD?

Click here to learn more about signs of pGHD, advocacy organizations, traveling with medications, and more.

Insurance coverage

What are the primary types of health insurance available?

Health insurance comes in many forms:

Group-sponsored Health Insurance: Offered through employers or spouse/domestic partner’s employer.
Private Coverage: Directly purchased from insurance carriers.
Exchange Plans: Purchased through state or federal exchanges, with possible subsidies based on income.
Medicare: A federal program for individuals aged 65 and older.
Medicaid and Children’s Health Insurance Program (CHIP): Available for qualifying individuals with disabilities or conditions.

What are the main categories for insurance plans?

Health insurance plans can be classified into 4 primary categories, each with its own set of features:

Health Maintenance Organization (HMO): Limited to in-network providers, requires a primary care physician (PCP), and referrals for specialists.
Exclusive Provider Organization (EPO): Restricts care to in-network providers but doesn’t require a PCP or referrals.
Point of Service (POS): Allows both in-network and out-of-network care, but PCP and referrals are needed.
Preferred Provider Organization (PPO): Provides in-network and out-of-network coverage without requiring a PCP or referrals.

What is the difference between fully insured and self-funded health plans?

With a fully insured plan, the employer pays a fixed monthly premium to an insurance company, covering plan administration and claims. The insurance company bears the loss if claims exceed expectations.

With a self-funded plan, the employer pays a monthly fee to an insurance company for administration and claims adjudication but covers the actual claims costs. The employer benefits if costs stay below expectations and has more flexibility in plan features.

How can I manage rising costs for prescriptions?

Health insurance companies use various strategies to manage specialty medication costs, including prior authorizations and step therapy. Stay informed about new trends, such as co-pay accumulators, and explore financial assistance programs.

Watch the New Rx Trends chapter in this video for more details.

How can I find out what my plan covers?

To understand your coverage, review the Summary of Benefits and Coverage (SBC) provided by the insurance company. It outlines co-pays, deductibles, and out-of-pocket maximums.

For detailed coverage information, you can get the medical policy from the insurance company’s website or call their Member Services department.

What should I consider during open enrollment?

During open enrollment, consider the following factors to make the best decisions for your family’s healthcare needs:

Estimate your annual expenses, including co-pays, coinsurance, deductibles, and out-of-pocket maximums.
Compare total costs of different plans, including in-network and out-of-network expenses.
Check if your prescriptions, especially growth hormone medications, are covered similarly in each plan.
Attend open enrollment events, ask questions, and seek assistance to understand any changes to the plan.

What should I know about prior authorizations and appeals?

Be proactive in the prior authorization and appeals process by documenting all communications between you and your insurance company.

If you face a denial, involve your child’s doctor, focus on medical necessity, and provide evidence to support your appeal. Always advocate for yourself and your family to get the medicine you need!

If you have any additional questions, talk to an A·S·A·P representative at 1-844-442-7236 (available at 8am to 8pm ET, Monday through Friday).

What additional resources are available?

Various advocacy organizations offer support and educational resources. Seek assistance and advocacy to ensure you have access to the best healthcare options.

Click here to explore some of these organizations and more pediatric GHD resources.

IMPORTANT SAFETY INFORMATION & USES

SKYTROFA is a prescription medicine used for:

the replacement of growth hormone in children 1 year old or older who weigh at least 26 pounds (11.5 kilograms) with growth hormone deficiency (GHD)
the replacement of growth hormone in adults with growth hormone deficiency (GHD)

Do not take SKYTROFA if:

you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems
you are allergic to somatropin or any of the ingredients in SKYTROFA
you are a child with closed bone growth plates
you have cancer or other tumors
you have certain types of eye problems caused by diabetes
you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep)

Tell your healthcare provider if you are pregnant or plan to become pregnant, about all of your medical conditions, and about all the medicines you take. SKYTROFA may affect how other medicines work, and other medicines may affect how SKYTROFA works.

What are the possible side effects of SKYTROFA?

SKYTROFA may cause serious side effects, including:

serious allergic reactions. Get medical help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing
high risk of death in people who have critical illnesses caused by heart or stomach surgery, trauma, or serious breathing problems
increased risk of growth of an existing tumor or cancer, or increased risk of a previous tumor or cancer returning in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your healthcare provider will need to monitor for the growth or return of a tumor or cancer. Contact your healthcare provider if you start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or skin color
new or worsening high blood sugar or diabetes. Your blood sugar may need to be monitored during treatment with SKYTROFA
increase in pressure in the skull. Contact your healthcare provider if headaches, eye problems, nausea, or vomiting occur
too much fluid in the body (fluid retention). Contact your healthcare provider if you notice swelling in the hands and feet, pain in the joints or muscles, or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet
decrease in a hormone called cortisol. Your healthcare provider will do blood tests to check your cortisol levels
decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well SKYTROFA works. Your healthcare provider will do blood tests to check your thyroid hormone levels
hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to a lack of blood supply (osteonecrosis). Get medical help right away for children who develop a limp or have hip or knee pain
worsening of curvature of the spine in children (scoliosis)
severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider about any new abdominal pain
loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your healthcare provider about rotating the areas where SKYTROFA is injected
high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
increase in phosphate, alkaline phosphatase, and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this

The most common side effects of SKYTROFA in children include: viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, joint pain and arthritis

The most common side effects of SKYTROFA in adults include: swelling due to fluid build-up and low thyroid hormone

These are not all of the possible side effects of SKYTROFA. Call your doctor for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ascendis Pharma at 1-844-442-7236.

Please click here for SKYTROFA full Prescribing Information.