Somatropin belongs to a class of drugs known as growth stimulants. Somatropin is a synthetic version of growth hormone. Growth hormone is made naturally in our bodies by the pituitary gland. This medication is used to manage HIV wasting (a metabolic disorder resulting in severe weight loss seen in people with HIV). It works by stimulating an increase in lean body mass (i.e., muscle mass).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Somatropin is administered by injection only. It is usually injected subcutaneously (under the skin). It is important to rotate the site of injection in order to minimize the risk of fat wasting at the site of injection.

The dose depends on the body weight of the person being treated. The recommended dose is:

• over 55 kg: 6 mg daily at bedtime
• 45-55 kg: 5 mg daily at bedtime
• 35-45 kg: 4 mg daily at bedtime
• less than 35 kg: 0.1 mg per kilogram of body weight daily at bedtime

If you are using this medication at home, your doctor will ensure that you understand exactly how to use this medication. Make sure you ask any and all questions to ensure that you use the medicine exactly as prescribed. Please refer to the appropriate package insert for details on how to mix the medicine and for proper injection procedures. It is important to visit your doctor regularly during therapy to ensure the medication is working safely and effectively.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of the medication, call your doctor for further instructions. Do not take a double dose to make up for a missed one.

Follow the package instructions for storing the medication. Do not use the solution if it is discoloured or contains particles.

This medication should be stored at room temperature (25°C or below). After reconstituting this medication with the diluent provided, it should be injected within 3 hours. Keep this medication out of the reach of children.

Each vial of sterile powder contains 5 mg of somatropin. Nonmedicinal ingredients: phosphoric acid, sodium hydroxide, and sucrose.

Do not use somatropin injection if you:

• are allergic to somatropin or any ingredients of the medication
• have active cancer
• have a brain tumour
• have an acute illness due to complications of surgery, have respiratory (breathing) failure, or have just had a serious accident
• have certain types of eye damage due to diabetes (proliferative or pre-proliferative diabetic retinopathy)
• have diabetes

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• carpal tunnel syndrome
• diarrhea
• joint pain
• muscle pain
• swelling of hands, feet, or lower legs
• trouble sleeping
• unusual tiredness or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain or bloating
• depression of skin at place of injection
• fast or racing heartbeat
• fever
• headache
• limp
• nausea and vomiting
• numbness or tingling in the hands or feet
• pain and swelling at site of injection
• pain in hip or knee
• skin rash or itching
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe or frequent headaches with nausea and vomiting or vision problems
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Cancer: Treatment with growth hormone may be associated with an increased risk of developing certain types of cancer. Discuss any concerns you may have with your doctor.

Diabetes: Somatropin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hypothyroidism (low level of thyroid hormone): If you have uncontrolled hypothyroidism, treatment with somatropin may not work as well as it could. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if somatropin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication in children under the age of 18 years have not been established.

There may be an interaction between somatropin and any of the following:

• corticosteroids (e.g., cortisone, prednisone)

• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, metformin, repaglinide, rosiglitazone)

• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• thyroid medications (e.g., desiccated thyroid, levothyroxine, levothyroxine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.