Somapacitan-beco Injection

WHY is this medicine prescribed?

Somapacitan-beco injection is used to replace growth hormone (a natural hormone produced by your body) in adults with growth hormone deficiency. Somapacitan-beco injection is also used to replace growth hormone and to increase growth in children 2.5 years of age or older with growth hormone deficiency. Somapacitan-beco is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Somapacitan-beco comes as a solution (liquid) in a prefilled injection pen to inject subcutaneously (under the skin). It is usually injected once a week, on the same day of the week, and at around the same time of day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use somapacitan-beco exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

If somapacitan-beco injection is given to replace growth hormone in adults, your doctor will probably start you on a low dose of somapacitan-beco and may gradually increase your dose, not more than once every 2 to 4 weeks.

You may receive your first dose of somapacitan-beco injection in your doctor's office. After your first dose, your doctor may allow you or a friend or relative to perform the injections at home. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of somapacitan-beco. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Continue to use somapacitan-beco injection even if you feel well. Do not stop using somapacitan-beco injection without talking to your doctor.

You can inject somapacitan-beco anywhere on the front of your thighs (upper leg), on your stomach except around your navel (belly button), upper arms, or buttocks. Choose a different spot each time you inject your medication.

Always look at somapacitan-beco solution before injecting it. Check that the expiration date has not passed and that the liquid is clear to almost clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use a pen if it is expired or if the liquid is cloudy or contains particles.

Do not reuse or share pens and needles. Dispose of used pens and needles in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using somapacitan-beco injection,

• tell your doctor and pharmacist if you are allergic to somapacitan-beco, other growth hormone products, any other medications, or any of the ingredients in somapacitan-beco injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have recently had heart or stomach surgery, an accident or trauma, or serious breathing problems or if you have cancer or diabetic retinopathy (damage to the eyes caused by diabetes). Your doctor may tell you not to use somapacitan-beco injection. Somapacitan-beco should not be used in children whose growth plate has closed and whose bones are no longer growing (usually after puberty) or in children who have breathing problems, sleep apnea (stopping breathing for short periods of time during sleep), or Prader-Willi syndrome (a genetic condition that can cause physical, mental and behavioral problems).

• tell your doctor if you have ever received radiation therapy in the area of the head or brain; or if you have or have ever had diabetes; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); pancreatitis (swelling of the pancreas); papilledema (swelling of the optic nerve caused by increased pressure in the brain); high blood levels of phosphate; or thyroid, parathyroid, or liver problems. Also, tell your doctor if your child has or ever had scoliosis (curving of the spine).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using somapacitan-beco injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you remember the missed dose no longer than 3 days after you were scheduled to inject it, inject the missed dose as soon as you remember it. Then inject your next dose on your regularly scheduled day the following week. If more than 3 days have passed since the day you were scheduled to inject the medication, skip the missed dose and continue your regular dosing schedule on your regularly scheduled day the following week. Do not use a double dose to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Somapacitan-beco injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• skin thickening at injection site
• injection site pain, redness, swelling, or itching
• back or joint pain
• heartburn
• vomiting
• dizziness
• increased weight
• difficulty falling asleep or staying asleep
• runny nose, nasal congestion, fever, or sore throat

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• vision changes, headache, nausea, and vomiting
• sudden changes in behavior
• hives; rash; itching; difficulty breathing or swallowing; sweating; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
• ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite
• fast heartbeat
• shortness of breath
• pale skin
• numbness, burning, tingling, or tingling in the hands, fingers, arms, legs, or feet
• swelling of the hands, feet, ankles, or lower legs
• excessive tiredness, muscle or joint pain, weakness, lightheadedness, darkening of the skin, or weight loss
• hip and knee pain or a limp (in children)

Somapacitan-beco may increase the risk of developing certain types of cancer, including skin cancer. Your doctor will check your skin during treatment for signs of skin cancer. Call your doctor right away if you have any of the following symptoms: changes in moles, birthmarks, or skin color.

Somapacitan-beco may cause an increase in your blood sugar levels. Your doctor will order tests to monitor your blood sugar levels during your treatment with somapacitan-beco injection. Talk to your doctor about the risks of taking this medication.

Somapacitan-beco may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze. Do not leave somapacitan-beco outside of the refrigerator for more than 72 hours (3 days).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• swelling of the hands, feet, ankles, or lower legs
• excessive sweating and body odor
• enlarged hands, feet, lips, nose, and tongue
• joint or muscle weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order an eye exam before and during your treatment with somapacitan-beco. Your doctor will also order certain lab tests to check your body's response to somapacitan-beco.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using somapacitan-beco injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.