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Saizen (Generic Somatropin)

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Why is this medication prescribed?

Somatropin injection is used to replace growth hormone (a natural hormone produced by your body) in adults and children with growth hormone deficiency. Somatropin injection is also used to increase growth in children with certain conditions that affect normal growth and development. Somatropin injection (Serostim) is used to increase body weight and physical endurance in patients with human immunodeficiency virus (HIV) who have HIV-associated wasting syndrome. Somatropin injection (Zorbtive) is used to treat short bowel syndrome in adults who are receiving additional nutrition or fluids from intravenous (IV) therapy. Somatropin is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body, which may result in increased growth, body weight, and improved absorption of nutrients and fluids from the intestines.

How should this medicine be used?

Somatropin injection comes as a solution (liquid) in prefilled dosing pens and cartridges and also as a powder in vials and cartridges to be mixed with liquid to be injected subcutaneously (under the skin). When somatropin injection is given to replace growth hormone in adults, it is usually given once a day. When somatropin injection to replace growth hormone or increase growth in children, it is usually given once daily on 3 to 7 days each week. When somatropin injection (Serostim) is given to increase body weight and physical endurance in patients with HIV-associated wasting syndrome, it is usually given once daily or once every other day. When somatropin injection (Zorbtive) is given to treat short bowel syndrome, it is usually given once daily for 4 weeks. Use somatropin injection at around the same time on each scheduled day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use somatropin injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of somatropin and may gradually increase your dose.

You may receive your first dose of somatropin injection in your doctor’s office or your doctor may allow you or a caregiver to perform the injections at home. Before you use somatropin injection for the first time, you or the person who will be giving the injections should read the manufacturer’s information for the patient that comes with it. These instructions describe how to inject a dose of somatropin. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how or where to inject the medication or how to dispose of used needles and syringes after you inject the medication.

Continue to use somatropin injection even if you feel well. Do not stop using somatropin injection without talking to your doctor.

Always look at somatropin solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy or contains particles.

Do not reuse or share syringes, needles, injection pens, or vials of medication. Dispose of used syringes, needles, injection pens, and vials in a puncture resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using somatropin injection,

  • Tell your doctor and pharmacist if you are allergic to somatropin, any other medications, benzyl alcohol, or any of the ingredients in somatropin injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: corticosteroids such as cortisone acetate, dexamethasone (Hemady), fludrocortisone, hydrocortisone (Alkindi Sprinkle, Cortef), and prednisone (Rayos); insulin and oral medications for diabetes; and medications that contain estrogen (including birth control pills). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with somatropin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • Tell your doctor if you have recently had heart or stomach surgery, an accident or trauma, or serious breathing problems, or if you have sleep apnea (stopping breathing for short periods of time during sleep), cancer, or diabetic retinopathy (damage to the eyes caused by diabetes). Your doctor may tell you not to use somatropin injection.
  • Tell your doctor if you have ever had cancer or if you have ever been treated with radiation therapy to the head or brain; or if you have or have ever had diabetes; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); pancreatitis (swelling of the pancreas); papilledema (swelling of the optic nerve caused by increased pressure in the brain); scoliosis (curving of the spine); high blood levels of phosphate; or thyroid, parathyroid, or liver problems. Somatropin should not be used in children whose growth plate has closed and whose bones are no longer growing (usually after puberty).
  • Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using somatropin injection, call your doctor.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are using somatropin injection.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Call your doctor if you forget to inject a dose of this medication. Your doctor will tell you when to inject the missed dose and when to inject your next scheduled dose. Do not inject a double dose to make up for a missed one.

What side effects can this medication cause?

Somatropin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • Skin thickening at injection site
  • Injection site pain, redness, swelling, or itching
  • Headache
  • Muscle or joint pain
  • Sore throat, cough, fever, or other signs of infection
  • Ear pain
  • Flatulence or large amounts of gas in the intestines or bowels
  • Hair loss

Some side effects can be serious. If you experience any of these symptoms, stop taking and call your doctor immediately or get emergency medical treatment:

  • Vision changes, headache, nausea, and vomiting
  • Hives; rash; itching; difficulty breathing or swallowing; sweating; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
  • Ongoing pain that begins in the stomach area but may spread to the back nausea, vomiting, or loss of appetite
  • Numbness, burning, tingling, or tingling in the hands, fingers, arms, legs, or feet
  • Swelling of the hands, feet, ankles, or lower legs
  • Excessive tiredness, muscle or joint pain, weakness, lightheadedness, darkening of the skin, or weight loss
  • New or persistent knee or hip pain, limping
  • Breathing problems, snoring, or sleep apnea
  • Enlarged breasts

Somatropin may increase the risk of developing certain types of cancer, including brain or skin cancer. Call your doctor right away if you have any of the following symptoms: changes in behavior or vision; headaches; or changes in moles, birthmarks, or skin color.

Somatropin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

  • Swelling of the hands, feet, ankles, or lower legs
  • Excessive sweating and body odor
  • Enlarged hands, feet, lips, nose, and tongue
  • Joint or muscle weakness

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body’s response to somatropin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

  • Accretropin®
  • Genotropin ®
  • Humatrope®
  • Norditropin®
  • Nutropin®
  • Nutropin® AQ® Nuspin®
  • Omnitrope®
  • Saizen®
  • Serostim®
  • Zomacton
  • Zorbtive®
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