Somapacitan-beco (Subcutaneous)

Somapacitan-beco injection is used to treat growth hormone deficiency (not being able to produce enough growth hormone). Somapacitan-beco is a synthetic version of human growth hormone. Growth hormone is naturally made by the pituitary gland and is important for promoting growth. Synthetic growth hormone may be used in adults with specific conditions that hinder normal growth.

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

It is very important that your doctor checks your progress at regular visits to ensure 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 notice changes in your moles, birthmarks, or skin color.

Check with your doctor right away if you experience anxiety, blurred vision, chills, cold sweats, coma, confusion, cool or 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 changes in your vision.

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 experience burning, crawling, itching, numbness, prickling, "pins and needles" sensations, 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 (e.g., hypoadrenalism).

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

Check with your doctor right away if you experience bloating, chills, constipation, darkened urine, a fast heartbeat, fever, indigestion, loss of appetite, nausea, pain in the stomach, side, or abdomen (possibly radiating to the back), vomiting, or yellowing of the 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.

In deciding to use a medicine, you and your doctor will consider the risks of taking it compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

There have been no suitable studies on how somapacitan-beco injection affects children. Safety and effectiveness have not been established for this group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of somapacitan-beco injection. However, older patients may be more sensitive to this medicine, which could mean they need a different dose.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together despite possible interactions. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food to avoid interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine is used. Be sure to 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 worsen these conditions.

• Cancer, active or
• Diabetic retinopathy (eye problem caused by diabetes) or
• Severe illness after surgery or major medical emergency (e.g., 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 interfere with how insulin or other diabetes medications work.

• Kidney disease or
• Liver disease, moderate—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

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

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

In the U.S.

• Sogroya

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Somapacitan

Find detailed information on biosimilars for this medication.

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.