Zorbtive

Generic Name: somatropin (rdna origin - nonrefrigerated) (SOE-ma-TROE-pin)
Brand Name: Zorbtive

Zorbtive is used for:

Treating short bowel syndrome (SBS). It is used along with a specialized diet. It may also be used for other conditions as determined by your doctor.

Zorbtive is a growth hormone. It works by increasing the flow of water, electrolytes, and nutrients into the bowels.

Do NOT use Zorbtive if:

  • you are allergic to any ingredient in Zorbtive or in the diluent
  • you have active or recurring cancer or a brain tumor
  • you have severe breathing problems (eg, respiratory failure) or a serious illness caused by complications from a surgery or injury

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Zorbtive:

Some medical conditions may interact with Zorbtive. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including benzyl alcohol)
  • if you have a history of lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, pancreas problems, liver or kidney problems, or endocrine problems (eg, pituitary or adrenal gland problems)
  • if you have a history of diabetes, high blood sugar levels, a certain type of eye problem caused by diabetes (diabetic retinopathy), or if a member of your family has had diabetes
  • if you have a history of leukemia, other types of cancer (eg, skin cancer), or any unusual growths or tumors (especially in the brain)
  • if you have curvature of the spine (scoliosis), carpal tunnel syndrome, or Prader-Willi syndrome
  • if you are very overweight or have had a recent major surgery or injury

Some MEDICINES MAY INTERACT with Zorbtive. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogens because they may decrease Zorbtive's effectiveness
  • Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Zorbtive
  • Corticosteroids (eg, cortisone, prednisone) or insulin or other medicines for diabetes because their effectiveness may be decreased by Zorbtive

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zorbtive may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zorbtive:

Use Zorbtive as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Zorbtive. Talk to your pharmacist if you have questions about this information.
  • Zorbtive is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Zorbtive. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Gently swirl Zorbtive to mix it. Do not shake Zorbtive. If the liquid is foamy, let it sit for a few minutes until the bubbles disappear.
  • Zorbtive should be clear and colorless. Do not use Zorbtive if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
  • Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin. Do not inject Zorbtive into skin that is sore, red, infected, or damaged. Do not inject in the areas near your navel or waistline.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Zorbtive, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use more than 1 dose in a day. Contact your doctor if you miss more than 3 doses.

Ask your health care provider any questions you may have about how to use Zorbtive.

Important safety information:

  • Follow the diet plan given to you by your health care provider.
  • Do not drink alcohol while you are using Zorbtive. It may irritate your stomach and worsen your condition. Discuss any questions with your doctor.
  • Check with your doctor about what liquids are okay for you to drink while you are using Zorbtive.
  • If you experience nausea, vomiting, stomach pain, or gas, check with your doctor for ways to lessen these effects.
  • Do NOT use more than the recommended dose or change your dose without checking with your doctor.
  • An increased risk of a second cancer has been seen in patients that had certain types of cancer as a child and received Zorbtive to treat the lack of growth hormone. Discuss any questions or concerns with your doctor.
  • Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Zorbtive. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop severe stomach or back pain.
  • Zorbtive may cause mild swelling (particularly in the hands or feet), or muscle or joint pain, swelling, or stiffness. These effects may go away on their own. If they persist or become bothersome, check with your doctor for ways to lessen these effects. Do not take any pain medicine unless your doctor tells you to.
  • Zorbtive may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood sugar levels and eye exams, may be performed while you use Zorbtive. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Zorbtive with caution in the ELDERLY; they may be more sensitive to its effects. Safety and effectiveness of Zorbtive in patients older than 65 years old have not been confirmed.
  • Zorbtive may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • Zorbtive should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zorbtive while you are pregnant. It is not known if Zorbtive is found in breast milk. If you are or will be breast-feeding while you use Zorbtive, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zorbtive:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Gas; mild swelling (eg, of the hands or feet); mild nausea, stomach pain, or vomiting; mild pain, swelling, redness, itching, or bruising at the injection site; muscle or joint pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast enlargement; burning, numbness, or tingling; change in appearance or size of a mole; chest pain; fast heartbeat; fever, chills, or persistent cough or sore throat; new growth on the skin; severe or persistent headache or dizziness; severe or persistent muscle or joint pain, swelling, or stiffness; severe or persistent nausea or vomiting; severe or persistent swelling of the head, face, hands, ankles, or feet; severe stomach or back pain; shortness of breath; snoring or irregular breathing during sleep; symptoms of dehydration (eg, very dry mouth or eyes, sluggishness, weakness); symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; unusual sweating; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include swelling of the hands, ankles, or feet; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).

Proper storage of Zorbtive:

Store new (unopened) vials at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from heat, moisture, and light. Do not store in the bathroom. Do not use Zorbtive past the expiration date on the product label.

If you mix Zorbtive with bacteriostatic water for injection, the mixed medicine may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed vials after 14 days, even if they still contain medicine.

If you mix Zorbtive with sterile water for injection, use it right away. Throw away any medicine left in the vial. Do not save medicine mixed with sterile water for injection for use at a later time.

Contact your pharmacist if you have any questions about the proper storage of Zorbtive. Keep Zorbtive out of the reach of children and away from pets.

General information:

  • If you have any questions about Zorbtive, please talk with your doctor, pharmacist, or other health care provider.
  • Zorbtive is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Zorbtive or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 Zorbtive. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zorbtive. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Zorbtive.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 this medicine. 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 your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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