Somapacitan Injection

What is this medication?

SOMAPACITAN (SOE ma PAS i tan) treats growth hormone deficiency. It works by increasing levels of growth hormones in the body. This increases bone and muscle growth. It belongs to a group of medications known as human growth hormones (hGH).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SOGROYA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Are a child who has stopped growing
• Are a child with Prader-Willi syndrome
• Are a child with scoliosis or a curved spine
• Cancer
• Diabetes
• Eye disease caused by diabetes
• Liver disease
• Low adrenal gland function
• Low thyroid levels
• Lung or breathing disease, such as asthma or COPD
• Recent surgery or trauma
• Sleep apnea
• An unusual or allergic reaction to somapacitan, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2.5 years for selected conditions, precautions do apply.

People over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 3 days late. If it is more than 3 days late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Estrogen hormones
• Medications for diabetes
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work while you are taking this medication.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

Pens should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Bone or joint pain
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Lipodystrophy—hardening or scarring of tissue at injection site
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Swelling of the ankles, hands, or feet, shortness of breath or trouble breathing, sudden weight gain

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Burning or tingling sensation in hands or feet
• Headache
• Muscle pain
• Pain, redness, or irritation at injection site
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Unopened pens: Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Protect from light. Avoid exposure to extreme heat. Keep this medication with the cap on and in the original carton until you are ready to take it. Get rid of any unused medication after the expiration date.

Pens that you are using: Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. The pen may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 3 days and then returned to the refrigerator. Keep this medication with the cap on and in the original carton until you are ready to take it. Do not store your pen with the needle attached. Get rid of any unused medication after it expires or 6 weeks after opening, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.