Zorbtive is a form of human growth hormone important for the growth of bones and muscles. It is similar to the growth hormone your body manufactures.

Zorbtive is used to treat Short Bowel Syndrome (SBS) in patients who are on a specialized diet.

When used with along with special diet, Zorbtive helps your bowel take in more water, electrolytes and nutrients and lowers the need for I.V. (intravenous) feedings.

Zorbtive is not cure for Short Bowel Syndrome.

When taking Zorbtive to treat short bowel syndrome, it is very important to follow the diet plan created for you by your doctor or nutrition counselor.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice

You should not use somatropin if you have cancer, eye problems caused by diabetes. You should not use Zorbtive if you have a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma.

Use Zorbtive exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Zorbtive is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Your care provider will show you the best places on your body to inject Zorbtive. Change (rotate) your injection site with each injection. Do not inject Zorbtive into skin that is tender, bruised, red, or hard.

Do not inject the subcutaneous injection (under the skin) into the same place two times in a row.

Do not shake the Zorbtive bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using Zorbtive, you may need frequent blood tests. Your growth progress will need to be tested often. Your eyes may also need to be checked.

Follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Zorbtive is not a cure for short bowel syndrome.

Store unmixed Zorbtive vials and diluent at room temperature. After mixing store under refrigeration for up to 14 days. Avoid freezing.

Throw away any Zorbtive left over after the expiration date on the label has passed.

Usual Adult Dose for Short Bowel Syndrome:

Approximately 0.1 mg/kg subcutaneously once a day

Maximum dose: 8 mg once a day

Duration of therapy: 4 weeks

Comments:
-Administration for more than 4 weeks has not been adequately studied.
-Use in conjunction with optimal management of Short Bowel Syndrome (SBS).
-Optimal management of SBS may include dietary adjustments, enteral feedings, parenteral nutrition, fluid, and micronutrient supplements, as needed.
-Specialized nutritional support may consist of a high carbohydrate, low-fat diet, adjusted for patient requirements and preferences.
-Nutritional supplements may be added at the discretion of the treating physician.
-Changes to concomitant medications should be avoided.
-Patients and physicians should monitor for adverse events.

Use: Treatment of Short Bowel Syndrome in patients receiving specialized nutritional support

You should not use Zorbtive if you are allergic to somatropin or benzyl alcohol, or if you have:

• a serious illness due to lung failure or complications from recent surgery, injury, or medical trauma;

• closed epiphyses;

• active cancer;

• eye problems caused by diabetes (diabetic retinopathy); or

To make sure Zorbtive is safe for you, tell your doctor if you have:

• cancer (especially during childhood);

• diabetes;

• breathing problems, sleep apnea (breathing stops during sleep);

• a pituitary gland disorder;

• abnormal curvature of the spine (scoliosis);

• underactive thyroid;

• a head injury or brain tumor; or

• childhood brain cancer and radiation treatment.

It is not known whether Zorbtive will cause harm to an unborn baby.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Zorbtive contains benzyl alcohol, an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Get emergency medical help if you have signs of an allergic reaction to Zorbtive: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain in your knees or hips, walking with a limp;

• ear pain, swelling, warmth, or drainage;

• numbness or tingling in your wrist, hand, or fingers;

• severe swelling or puffiness in your hands and feet;

• changes in behavior;

• vision problems, unusual headaches;

• changes in the shape or size of a mole;

• pain or swelling in your joints;

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• signs of an adrenal gland problem - extreme weakness, severe dizziness, weight loss, changes in skin color, feeling very weak or tired.

Common Zorbtive side effects may include:

• swelling, rapid weight gain;

• muscle or joint pain;

• headache; or

• pain, itching, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines, and those you start or stop using during your treatment with Zorbtive, especially:

• birth control pills or hormone replacement therapy

• insulin or oral diabetes medicine; or

• steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.