Pronunciation:

soe-MA-troe-gon - ghla

Brand Names:

• Ngenla

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Somatrogon

Uses of This Medicine:

Somatrogon-ghla injection is used to treat growth failure caused by growth hormone deficiency (inability to produce enough growth hormone). This medicine is a man-made version of the human growth hormone. Growth hormone is naturally produced by the pituitary gland and is necessary to stimulate growth in children.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of somatrogon-ghla injection in children 3 years of age and older. However, safety and efficacy have not been established in children younger than 3 years of age.

Older adults—

No information is available on the relationship of age to the effects of somatrogon-ghla injection in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Albiglutide
• Alclometasone
• Alogliptin
• Amcinonide
• Beclomethasone
• Betamethasone
• Budesonide
• Canagliflozin
• Chlorotrianisene
• Chlorpropamide
• Ciclesonide
• Clobetasol
• Clobetasone
• Clocortolone
• Cortisone
• Dapagliflozin
• Deflazacort
• Desonide
• Desoximetasone
• Dexamethasone
• Diethylstilbestrol
• Diflorasone
• Diflucortolone
• Difluprednate
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Esterified Estrogens
• Estradiol
• Estramustine
• Estropipate
• Ethinyl Estradiol
• Exenatide
• Flucloronide
• Flumethasone
• Flunisolide
• Fluocinolone
• Fluocinonide
• Fluocortin
• Fluocortolone
• Fluorometholone
• Flurandrenolide
• Fluticasone
• Glimepiride
• Glipizide
• Glyburide
• Halcinonide
• Halobetasol
• Hydrocortisone
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Linagliptin
• Liraglutide
• Lixisenatide
• Loteprednol
• Medrysone
• Mestranol
• Metformin
• Methylprednisolone
• Miglitol
• Mometasone
• Nateglinide
• Paramethasone
• Pioglitazone
• Pramlintide
• Prednicarbate
• Prednisolone
• Prednisone
• Quinestrol
• Repaglinide
• Rimexolone
• Rosiglitazone
• Saxagliptin
• Semaglutide
• Sitagliptin
• Tibolone
• Tolazamide
• Tolbutamide
• Triamcinolone
• Voglibose

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, active or
• Closed epiphyses (normal bone growth stopped) in children or
• Diabetic retinopathy (eye condition) or
• Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems (eg, sleep apnea) or
• Severe illness after surgery or major medical emergency (eg, open heart surgery, stomach surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.

• Cancer, history of or
• Hypopituitarism (pituitary gland produces low hormone levels) or
• Hypothyroidism (underactive thyroid gland) or
• Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.

• Diabetes, or a family history of—Use with caution. May prevent insulin or other drugs for diabetes from working properly.

Proper Use of This Medicine:

A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin in the stomach, buttock, upper arms, or thigh area. Somatrogon-ghla injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.

This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Always check the label before use, to make sure you have the correct dose.

This medicine is available in prefilled pens. Read all instructions carefully to be sure you know how to use your device.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

You may use the pen straight from the refrigerator. You may also allow the medicine to warm at room temperature for 30 minutes before use.

Do not inject into bony areas, skin areas that are bruised, red, sore or hard, or has scars or skin conditions.

The medicine should be colorless to slightly light yellow. Do not use the medicine if it is cloudy or dark yellow, or has flakes or particles in it.

To use the prefilled pen:

• Wash your hands with soap and water.
• Place the needle straight on the pen. Prime the pen by removing the air from the needle. Select 0.4 units when turning the dose knob.
• Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
• Press the injection button until it stops. You should see a "0" in the dose window.
• You should see the liquid at the needle tip. If you do not see the liquid, repeat the priming steps but not more than 5 times. If there is still no liquid, do not use the pen.
• Turn the dose selector, be careful not to press the injection button. If the dose is more than 12 milligrams (mg), you will need to split the dose into more than 1 injection.
• Insert the needle into your skin and press the injection button all the way in for at least 10 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
• Use a new needle each time you inject your medicine. Always remove and throw the needle after each injection. Do not use the pen if it is frozen, exposed to heat, dropped, or looks broken or damaged. Do not shake the pen.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):
  • For treatment of growth failure caused by growth hormone deficiency:
    • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.66 milligrams (mg) per kg of body weight injected under the skin once a week on the same day, at any time of the day.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

If you miss a dose, use it as soon as possible within 3 days after the missed dose. However, if it is more than 3 days, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Store opened pen in the refrigerator for up to 28 days. Throw away opened pen after 28 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you and your child's progress at regular visits. Blood and urine tests may be needed to check for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which are life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after receiving this medicine.

Never share pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Using this medicine may increase your or your child's risk of getting cancer. Talk to your doctor if you have concerns about this risk.

This medicine may affect blood sugar levels. Check with your doctor if you notice a change in the results of your or your child's blood or urine sugar tests or if you have any questions.

This medicine may cause an increased pressure in the head. Check with your doctor immediately if headache, nausea, vomiting, blurred vision, or any other change in vision occurs during treatment. Your doctor may want you to have your or your child's eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you or your child have decrease in amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, or weight gain. These may be symptoms of fluid retention (extra water in the body).

Check with your doctor right away if you have darkening of skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of an adrenal gland problem (hypoadrenalism).

Pancreatitis (inflammation of the pancreas) has occurred rarely in some patients receiving somatrogon-ghla. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if your child has hip and knee pain or limp. These may be symptoms of slipped capital femoral epiphysis (hip bone dislocation).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Constipation

depressed mood

dry skin and hair

feeling cold

hair loss

hoarseness or husky voice

muscle cramps and stiffness

slowed heartbeat

weight gain

Incidence not known

Bloating

blurred vision

change in ability to see colors, especially blue or yellow

chest tightness

chills

cough

darkened urine

darkening of the skin

decrease amount in urine

diarrhea

difficulty swallowing

dizziness

dry mouth

fainting

fast heartbeat

flushed, dry skin

headache

hives, itching, skin rash

increased hunger

increased thirst

increased urination

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

loss of consciousness

mental depression

nausea

noisy, rattling breathing

pains in the stomach, side, or abdomen, possibly radiating to the back

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

stomachache

sweating

swelling of the fingers, hands, feet, or lower legs

unexplained weight loss

vomiting

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

cough producing mucus

difficulty in moving

earache

joint pain

muscle pain

redness or swelling in the ear

sore throat

stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.