Ngenla 60 mg/1.2 mL (50 mg/mL) subcutaneous pen injector

Generic name:
Somatrogon - subcutaneous injection

Pronunciation
(soe-MA-troe-gon)

Brand name(s)
Ngenla

This medication is used to treat growth failure due to a lack of growth hormone. Growth hormone is normally produced in the brain by a certain gland (pituitary gland) and has various effects on development in the body. A lack of growth hormone in children results in slowed growth and short height for the child's age. Somatrogon works by providing more growth hormone, which may help the long bones (such as the arms and legs) grow longer.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using somatrogon and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once weekly. The injection is given in the stomach (abdomen), thighs, buttocks, or upper arms. The dosage is based on your medical condition, weight, and response to treatment.

For a more comfortable injection, take the medication out of the refrigerator for up to 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not leave the device out of the refrigerator for longer than 2 hours. If there is medication remaining in the device after use, be sure to put it back in the refrigerator. Do not shake the medication.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is bruised, red, sore, or hard, or into bony areas, scars, or other skin conditions. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

This medication is injected with a device (prefilled pen) made to help you use it properly. Do not share your device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Pain, redness, itching, swelling, or thickening of the skin at the injection site may occur. Headache, fever, nausea, vomiting, joint/muscle pain, or cold-like symptoms (such as cough, runny/stuffy nose, sore throat) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• development of a limp
• hip/knee pain
• increased thirst/frequent urination
• severe stomach/abdominal pain
• swelling hands/ankles/feet
• numbness/tingling of arms/legs
• symptoms of thyroid problems (such as cold intolerance, unexplained increased weight)

Somatrogon may increase your risk of getting a new tumor or cancer. Children who have had brain/head radiation treatment for cancer should be monitored for new tumors/cancers. Tell your doctor right away if you or a caregiver notice symptoms such as unusual changes in behavior, vision problems/changes, severe headache, changes in skin color, or change in the appearance or size of a mole. Talk with your doctor for details and to discuss the risks and benefits of this medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before using somatrogon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• adrenal gland problems
• recent major surgery/injury
• diabetes
• a certain eye condition (diabetic retinopathy)
• kidney disease
• cancer (especially of the head/neck)
• thyroid problems
• a certain back problem (scoliosis)
• a certain genetic condition (Prader-Willi syndrome)

If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as pregnancy tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as growth factor blood tests, thyroid function, blood sugar, cortisol level, eye exam) may be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, use it as soon as you remember. If it is more than 3 days after the missed dose, skip the missed dose. Use your next dose on the regular scheduled day. Do not double the dose to catch up. If you decide to change the regular scheduled day, make sure to wait at least 3 days between the last dose and the new dosing day.

Store the pen device in the refrigerator away from light. After first use, write the date on the pen label and use the medication within 28 days. Discard the pen after 28 days, even if it contains unused medication. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.