Uses of Somatropin:

• It is used to help with growth and to treat growth hormone deficiency.
• It is used to treat some patients who have problems growing normally.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Somatropin?

For all patients taking somatropin (rDNA origin):

• If you are allergic to somatropin (rDNA origin); any part of somatropin (rDNA origin); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Breathing problems like sleep apnea; cancer or other tumors like a brain tumor; diabetic eye disease; or illness shortly after open heart surgery, stomach surgery, or accidental injury.

Children:

• If your child has Prader-Willi syndrome and is very overweight, has trouble breathing, or has sleep apnea.
• If your child's bones are no longer growing (closed epiphyses).

This is not a list of all drugs or health problems that interact with somatropin (rDNA origin).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take somatropin (rDNA origin) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Somatropin?

For all patients taking somatropin (rDNA origin):

• Tell all of your health care providers that you take somatropin (rDNA origin). This includes your doctors, nurses, pharmacists, and dentists.
• High blood sugar has happened with somatropin (rDNA origin). This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take somatropin (rDNA origin).
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• If you have cancer or a tumor or have ever had cancer or a tumor, talk with your doctor. The chance of cancer or tumor growth is raised with somatropin (rDNA origin). The chance of new tumors may also be raised in some patients.
• If you have Turner syndrome, talk with your doctor. The chance of ear infections, high blood pressure, and very bad blood vessel problems like stroke and bleeding in the brain may be raised.
• Raised pressure in the head has rarely happened with somatropin (rDNA origin). The risk may be greater in patients with Turner syndrome or Prader-Willi syndrome. Signs most often happen within the first 8 weeks of starting somatropin (rDNA origin). Call your doctor right away if you have change in eyesight, a very bad headache, upset stomach, or throwing up.
• If you are 65 or older, use somatropin (rDNA origin) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Children:

• Very bad and sometimes deadly lung or breathing problems have happened in some children with Prader-Willi syndrome. The chance may be higher in children who have sleep apnea, an infection in the lungs or airway, a block in the airway, and in children who are very overweight. Call the doctor right away if your child has a fever of 100.4°F (38°C) or higher, cough, sore throat, shortness of breath, chest pain or discomfort, new or worse snoring, or breathing that is not normal while asleep.
• If your child has an abnormal curve in the spine (scoliosis), talk with your doctor. This medicine could make it worse in children who are still growing.
• Children who use somatropin (rDNA origin) can rarely have a bone problem in the hip (slipped growth plate). Call the doctor right away if your child has hip or knee pain or a limp.
• Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.

How is this medicine (Somatropin) best taken?

Use somatropin (rDNA origin) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• If stored in a refrigerator, let somatropin (rDNA origin) come to room temperature before using it. Be sure you know how long to leave it at room temperature before using. Do not heat somatropin (rDNA origin).
• Move the site where you give the shot with each shot.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not shake the solution.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Wash your hands before and after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take somatropin (rDNA origin).

Prefilled pen:

• This product may make a clicking sound as you prepare the dose. Do not prepare the dose by counting the clicks. Doing so could lead to using the wrong dose.
• Remove all pen needle covers before injecting a dose (there may be 2). If you are not sure what type of pen needle you have or how to use it, talk with the doctor.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low thyroid levels like constipation; not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• Sweating a lot.
• Depression or other mood changes.
• Change in how you act.
• Change in skin color.
• Burning, numbness, pain, or tingling in the hands, arms, legs, or feet.
• Bone pain.
• Change in color or size of a mole.
• Redness or swelling where the shot is given.
• Skin breakdown where somatropin (rDNA origin) is used.
• Ear pain.

What are some other side effects of Somatropin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Back, muscle, or joint pain.
• Muscle stiffness.
• Trouble sleeping.
• Upset stomach or throwing up.
• Gas.
• Stomach pain or diarrhea.
• Irritation where the shot is given.
• Signs of a common cold.
• Flu-like signs.
• Hair loss.
• Enlarged breasts.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Somatropin?

Saizen:

• Store at room temperature.
• After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long somatropin (rDNA origin) may be used after mixing.

Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Tev-Tropin, Zomacton:

• Store in a refrigerator. Do not freeze.
• Be sure you know how long you can store somatropin (rDNA origin) before you need to throw it away. Check the storage information that comes with this drug. If you have questions, check with your pharmacist.

All products:

• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about somatropin (rDNA origin), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.