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Zorbtive

Generic name: somatropin
Drug class: Growth hormones

Medically reviewed by  A Ras MD. Last updated on june 03,2022.

What is Zorbtive used for?

  • Zorbtive is used to treat short bowel syndrome.
  • Zorbtive may be given to you for other reasons. Talk to your doctor.

Description

  • Zorbtive® (somatropin) for injection is a human growth hormone produced by recombinant DNA technology for subcutaneous use. Zorbtive® has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. Zorbtive® is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the human growth hormone gene. Zorbtive® is secreted directly through the cell membrane into the cell-culture medium for collection and purification.
  • Zorbtive® is a highly purified preparation. Biological potency is determined by measuring the increase in the body weight induced in hypophysectomized rats.
  • Zorbtive® is a sterile, lyophilized powder available in 8.8 mg vials for single-patient use. Each 8.8 mg vial contains 8.8 mg somatropin, 2.05 mg phosphoric acid and 60.19 mg sucrose.

Mechanism of Action

Intestinal mucosa contains receptors for growth hormone and for insulin-like growth factor-1 (IGF-1), which is known to mediate many of the cellular actions of growth hormone. Thus, the actions of somatropin on the gut may be direct or mediated via the local or systemic production of IGF-1.

In human clinical studies the administration of growth hormone has been shown to enhance the transmucosal transport of water, electrolytes, and nutrients.

Before taking Zorbtive, tell your doctor:

  • If you are allergic to Zorbtive; any part of this medicine; 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.

This is not a list of all drugs or health problems that interact with this medicine.

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 Zorbtive 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 Zorbtive?

For all patients taking Zorbtive:

  • Tell all of your health care providers that you take Zorbtive. This includes your doctors, nurses, pharmacists, and dentists.
  • High blood sugar has happened with Zorbtive. 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 Zorbtive.
  • 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 Zorbtive. 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 Zorbtive. 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 Zorbtive. 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 Zorbtive 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:

  • This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. This medicine is not approved for use in children. Talk with the doctor.

How is Zorbtive best taken?

Use Zorbtive 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.
  • If stored in a refrigerator, let Zorbtive come to room temperature before using it. Be sure you know how long to leave it at room temperature before using. Do not heat Zorbtive.
  • 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 Zorbtive.

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 the side effects of Zorbtive that I need to call my doctor about immediately?

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 Zorbtive is used.
  • Ear pain.

What are some other side effects of Zorbtive?

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 Zorbtive?

  • Store at room temperature.
  • After mixing, store in a refrigerator. Check with the doctor or pharmacist if you have questions about how long Zorbtive may be used after mixing.
  • 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 Zorbtive, 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 Zorbtive 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 this medicine. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Label

PRINCIPAL DISPLAY PANEL – 8.8 MG VIAL LABEL

 

  • Zorbtive® 8.8 mg
    (somatropin) for injection

    8.8 mg (approximately 26.4 IU). For subcutaneous injection Reconstituted
    vials should be refrigerated and used within 14 days.
    Storage: room temperature (15-30°C/59-86°F)
  • Lot:
  • Exp:
  • L8840101E
PRINCIPAL DISPLAY PANEL - 8.8 mg Vial Label

PRINCIPAL DISPLAY PANEL – 3.5 ML VIAL LABEL

 

  • NDC 44087-8007-0
  • Bacteriostatic Water for injection, USP
  • Sterile 3.5 mL Multiple Dose Vial
    Rx Only
    Each mL contains: Benzyl Alcohol (as bacteriostat) 0.9% in
    Water for Injection q.s. For use as solvent vehicle or carrier of
    drugs for parenteral use. Pyrogen free.
  • NOT FOR USE
    IN NEWBORNS
  • Store at 15° to 30°C
    (59° to 86°F)
    [see USP Controlled
    Room Temperature].
  • Lot:
  • Exp:
  • L1320108D
PRINCIPAL DISPLAY PANEL - 3.5 mL Vial Label

PRINCIPAL DISPLAY PANEL – KIT CARTON

 

  • NDC 44087-3388-7
  • ZORBTIVE® 8.8 mg
    (somatropin) for injection
  • 8.8 mg
    For subcutaneous injection
    Rx Only
  • 7 vials Zorbtive® (somatropin) for injection
    7 vials Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol)
  • EMD
    SERONO
PRINCIPAL DISPLAY PANEL - Kit Carton

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