Pronunciation:

soe-ma-PAS-i-tan - beco

Brand Names:

• Sogroya

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Somapacitan

Uses of This Medicine:

Sompacitan-beco injection is used to treat growth hormone deficiency (inability to produce enough growth hormone). Sompacitan-beco 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. Man-made growth hormone may be used in adults who have certain conditions that prevent normal growth.

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 have not been performed on the relationship of age to the effects of somapacitan-beco injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sompacitan-beco injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine, which may require an adjustment in the dose for patients receiving sompacitan-beco injection.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Adrenal gland problem or
• Cancer, history of or
• Hypothyroidism (underactive thyroid gland) or
• Lung or breathing problems—Use with caution. May make these conditions worse.

• Cancer, active or
• Diabetic retinopathy (eye problem caused by diabetes) 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.

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

• Kidney disease or
• Liver disease, moderate—Used with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

This medicine is given as a shot under the skin of your stomach area or thighs. Sompacitan-beco 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. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Use a new needle each time you inject your medicine.

Check the liquid in the prefilled pen. It should be clear to almost clear and colorless to slightly yellow. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.

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 (prefilled pen):
  • For growth hormone deficiency:
    • Adults—At first, 1.5 milligrams (mg) once a week. Your doctor will adjust your dose as needed. However, dose is usually not more than 8 mg once a week.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose, take it as soon as possible within 3 days after the missed dose. If you miss a dose and more than 3 days have passed, skip the missed dose and take your next dose at the regular time.

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.

You might not use all of the medicine in each prefilled pen. If there is still medicine left in the pen (in-use pen), you may store it in the refrigerator and use it within 6 weeks. Store the unused and in-use pens with the cap on and keep it in the original carton.

You may also store the unused and in-use pens at room temperature for up to 3 days and place it back to the refrigerator.

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:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk for cancer, including skin cancer. Call your doctor right away if you have changes in your moles, birthmarks, or color of the skin.

Check with doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hyperglycemia (high blood sugar).

This medicine may increase pressure in your head (intracranial hypertension). Check with your doctor right away if you have confusion, headache, severe nausea, vomiting, or vision changes.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause fluid retention (excess fluid build-up in the body). Call your doctor right away if you have burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings, joint or muscle pain, swelling of the hands, ankles, feet, or lower legs, or weight gain.

Check with your doctor right away if you have darkening of the 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 (eg, hypoadrenalism).

Thyroid problems (eg, hypothyroidism) may occur during treatment with this medicine. Call your doctor right away if you have constipation, depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or husky voice, muscle cramps and stiffness, slow heartbeat, weight gain, or unusual tiredness or weakness.

Check with your doctor right away if you have bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pain in the stomach, side, or abdomen, possibly radiating to the back, vomiting, or yellow eyes or skin. These may be symptoms of pancreatitis (swelling of the pancreas).

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

Bloating

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in ability to see colors, especially blue or yellow

chills

constipation

cough

darkened urine

darkening of the skin

depressed mood

diarrhea

difficulty swallowing

dizziness

dry mouth

dry skin and hair

fainting

fast heartbeat

feeling cold

fever

flushed, dry skin

fruit-like breath odor

hair loss

headache

hives, itching, skin rash

hoarseness or husky voice

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

loss of fat or tissue weakness in the skin area at the injection site

mental depression

muscle cramps and stiffness

nausea

nervousness

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

pale skin

persistent non-healing sore

pink growth

pounding in the ears

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

reddish patch or irritated area

shiny bump

slow or fast heartbeat

stomach pain

sweating

swelling

thickening of the skin

tightness in the chest

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

white, yellow or waxy scar-like area

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

Acid or sour stomach

back pain

belching

difficulty in moving

heartburn

muscle pain or stiffness

pain in the joints

stomach discomfort or upset

trouble sleeping

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.