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Somatropin (rDNA origin)

Pronunciation

Generic Name: Somatropin (rDNA origin) (SOE ma TROE pin)
Brand Name: Humatrope, Omnitrope

Uses of Somatropin:

  • It is used 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 have an allergy to human growth hormone or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Brain tumor, cancer, diabetic eye disease, illness shortly after open heart or belly surgery, many injuries from a crash, lung disease, or sleep apnea.

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.

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 this medicine 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 this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • 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.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take somatropin.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid drinking alcohol while taking this medicine.
  • Follow the diet and workout plan that your doctor told you about.
  • If you have a history of cancer or tumors, talk with your doctor. The chance of new tumors may 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.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking somatropin with your other drugs.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using somatropin while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your 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.
  • Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn. Talk with the doctor to see if this product has benzyl alcohol in it.

How is this medicine (Somatropin) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • 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.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • 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.

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.

See also: Dosage Information (in more detail)

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:

For all patients taking somatropin (rDNA origin):

  • 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 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 hard stools (constipation); not able to handle cold; memory problems; mood changes; or a burning, numbness, or tingling feeling that is not normal.
  • 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.
  • Mood changes.
  • Low mood (depression).
  • Change in eyesight.
  • Very bad headache.
  • Chest pain.
  • Numbness or tingling in the hands or feet.
  • Swelling in the arms or legs.
  • Bone pain.
  • Very bad muscle or joint pain.
  • Change in color or size of a mole.
  • Blood in the urine.
  • Redness or swelling where the shot is given.
  • Skin breakdown where this medicine is used.
  • Thinning of the skin.
  • 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 this medicine. Call your doctor right away if you have change in eyesight, a very bad headache, upset stomach, or throwing up.

Children:

  • Children who use somatropin 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.

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.
  • Muscle or joint pain.
  • Muscle stiffness.
  • Not able to sleep.
  • Upset stomach or throwing up.
  • Gas.
  • Belly pain.
  • Irritation where the shot is given.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

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 this medicine may be used after mixing.

All other products:

  • Store in a refrigerator. Do not freeze.

All products:

  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

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.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about somatropin, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about somatropin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using somatropin.

Review Date: September 6, 2017

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