What is Gattex?

Gattex is used to treat short bowel syndrome (SBS) in adults and children at least 1 year old who depend on intravenous (parenteral) feeding to receive nutrition.

Gattex’s mechanism of action involves boosting levels of a peptide called human glucagon-like peptide-2 (GLP-2), which is needed for the proper functioning and growth of cells in the stomach and intestines. GLP-2 is found in low concentrations in people with SBS and Gattex is a man-made form of GLP-2.

Gattex first gained FDA approval on December 21, 2012. Approval of Gattex was extended on May 17, 2019, to include children aged 1 year and older with SBS. A Gattex generic has not yet been approved but there is speculation that one may be introduced soon.

Warnings

You should not use Gattex if you are allergic to teduglutide, or if you have cancer of the stomach, intestines, liver, gallbladder, or pancreas.

Before using Gattex, tell your doctor if you have heart disease, kidney disease, intestinal polyps, a blockage in your stomach or intestines, a colostomy or ileostomy, or a history of gallbladder or pancreas problems.

Teduglutide can make it easier for your body to absorb any medicines you take by mouth. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.

Gattex may increase your risk of colon polyps (in your large intestine). You will need a colonoscopy before and during treatment with Gattex. Teduglutide may also increase your risk of certain types of cancer. Talk with your doctor about the risks and benefits of this medicine.

Call your doctor at once if you have severe constipation, stomach cramps, fever, chills, nausea, vomiting, dark urine, or yellowing of your skin or eyes.

While using Gattex, you may need frequent blood tests (every 6 months), and then a colonoscopy after 1 year of treatment. If you use this medication long-term, you may need a colonoscopy every 5 years.

Before taking this medicine

Gattex can cause any abnormal cells in your body to grow faster. Some abnormal cells could become cancerous, increasing your risk of cancer of the liver, gallbladder, pancreas, or intestines. Ask your doctor about your specific risk.

Gattex may also increase your risk of polyps in your colon (large intestine). You will need a colonoscopy before and during treatment with teduglutide.

Talk with your doctor about the risks and benefits of this medicine.

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

• cancer;
• polyps in your intestines or rectum;
• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• heart problems, high blood pressure;
• kidney disease; or
• problems with your gallbladder or pancreas.

Short bowel syndrome can increase your risk of malnutrition during pregnancy. This could lead to premature delivery, low birth weight, birth defects, or other complications in both mother and baby. Follow your doctor’s instructions about using this medicine if you are pregnant.

You should not breastfeed while using this medicine.

How is Gattex given?

Use Gattex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Use the medicine at the same time each day.

Gattex is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself or how to give an injection to a child using teduglutide. Do not inject into a vein or muscle.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all the instructions.

Gattex must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Mixed medicine must be used within 3 hours.

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

You may need blood tests every 6 months while using Gattex. Your stools may need to be checked for blood every 12 months. You may also need a colonoscopy after 1 year of treatment, and then once every 5 years if you use Gattex long-term.

Do not change your dose or dosing schedule without your doctor’s advice.

Store unmixed powder at room temperature. Do not freeze and do not shake the vial. Throw away any Gattex not used before the expiration date on the medicine label.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult and Child Dose of Gattex for Short Bowel Syndrome (SBS):

Gattex 0.05 mg/kg via subcutaneous injection 1 time a day.

Comments:
-Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
-IV and IM administration should be avoided.
-Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Use: Treatment of patients with short bowel syndrome who are dependent on parenteral support

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line

What should I avoid while using Gattex?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Gattex side effects

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

Call your doctor at once if you have:

• severe constipation or stomach cramps, nausea, vomiting;
• swelling in your hands and feet, rapid weight gain, feeling short of breath;
• a change in your stools (bowel movements);
• severe pain in your upper stomach spreading to your back;
• fever, chills; or
• dark urine or yellowing of your skin or eyes.

Common Gattex side effects may include:

• an allergic reaction;
• stomach pain or swelling;
• nausea, vomiting;
• cold or flu symptoms;
• swelling in your hands or feet; or
• pain, swelling, redness, or other irritation 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 the FDA

What other drugs will affect Gattex?

Teduglutide can make it easier for your body to absorb any medicines you take by mouth, which could increase your blood levels of those medicines or cause unwanted effects. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Gattex storage

If you have Gattex at home for self-administration, store the Gattex powder at room temperature up to 77°F (25°C).

Do not freeze Gattex. Use the Gattex powder by the expiration date on the “Use By” sticker on the kit.

Use Gattex within 3 hours after mixing it. Throw away any unused Gattex that has been mixed, even if there is medicine left in the vial. Do not store any Gattex you have mixed.

Keep out of the reach of children.

Gattex ingredients

Active ingredient: teduglutide

Inactive ingredients: dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.

What is misoprostol?

Misoprostol reduces stomach acid and helps protect the stomach lining from damage that can be caused by taking aspirin or a nonsteroidal anti-inflammatory drug (NSAID).

Misoprostol is a synthetic prostaglandin that works by “replacing” prostaglandins whose production is blocked by aspirin or NSAIDs. It is used to prevent stomach ulcers from developing during treatment with aspirin or an NSAID. Examples of NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, and meloxicam.

Misoprostol is used in a hospital setting to induce cervical ripening, labor induction in women with premature rupture of membranes, and treatment of serious post-partum hemorrhage, These uses are outside of the approved indications.

Misoprostol is also in combination with mifepristone or methotrexate to end an early pregnancy (medical abortion) or alone for early pregnancy loss (miscarriage).

• Although FDA regulations allow certified healthcare professionals and pharmacies to dispense mifepristone and misoprostol for medical abortion both in healthcare facilities and by telehealth and mail, certain state laws may not allow this. For example, Louisiana has passed a bill that classifies mifepristone and misoprostol as dangerous controlled substances which, once signed, would mean anyone possessing these abortion pills without a prescription could face jail time and fines. Most abortions are already illegal in Louisiana.

When used for non-pregnancy-related conditions, misoprostol should not be used during pregnancy, and if you can become pregnant, you will need to have a negative pregnancy test before starting this treatment.

Misoprostol was FDA approved on December 27, 1988, under the brand Cytotec. Generic misoprostol is available.

Misoprostol side effects

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

Misoprostol may cause serious side effects. Call your doctor at once if you have:

• severe ongoing stomach discomfort or diarrhea; or
• dehydration–dizziness, confusion, feeling very thirsty, less urination.

Common misoprostol side effects may include:

• diarrhea and stomach pain.

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 .

Warnings

Misoprostol can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use misoprostol to prevent stomach ulcers if you are pregnant.

If you are able to become pregnant, you will need to have a negative pregnancy test before starting this treatment. You will also need to use effective birth control to prevent pregnancy during treatment.

Before taking this medicine

You should not use this medicine if you are allergic to misoprostol or other prostaglandins.

To make sure misoprostol is safe for you, tell your doctor if you have ever had:

• inflammatory bowel disease (IBD) or other intestinal problems;
• heart disease; or
• if you are dehydrated.

May cause birth defects. Do not use if you are pregnant, unless misoprostol is beeing used for pregnancy related conditions. You must use effective birth control while using misoprostol and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

You will need to have a negative pregnancy test before starting this treatment.

Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take misoprostol?

Take misoprostol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Do not share misoprostol with another person, even if they have the same symptoms you have.

Misoprostol is usually taken four times a day with meals. The last dose of the day should be at bedtime. Follow your doctor’s instructions.

You may have nausea, stomach cramps, or diarrhea while taking this medicine, especially during the first few weeks after you start taking misoprostol. These symptoms usually last for about a week.

Call your doctor if you have severe nausea, stomach pain, or diarrhea lasting longer than 8 days.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Duodenal Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Usual Adult Dose for Gastric Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Labor Induction or Cervical Ripening:

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours
-Some patients may require doses of 50 mcg every 6 hours

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks’ gestation.
-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Postpartum Bleeding:

ACOG Recommendations:
800 to 1000 mcg rectally once

Use: Management of postpartum hemorrhage

International Federation of Gynecology Obstetrics (FIGO) Recommendations:
600 mcg orally OR 800 mcg sublingually once immediately after delivery

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Prior to administration of treatment, abdominal palpitation is recommended to confirm that there are no additional babies in utero.
-The dose is not based upon the patient’s weight.
-The addition of this drug to oxytocin was not shown to provide additional benefit, but may increase the risk of adverse events.

Use: Prevention of postpartum hemorrhage in settings where oxytocin is not available

Usual Adult Dose for Abortion:

ACOG Recommendations
First Trimester of Pregnancy:
-Early Pregnancy Loss: 800 mcg intravaginally once; a second dose may be given if there is no response to the first dose no sooner than 3 hours after the first dose, and usually within 7 days
-Incomplete Abortion: 600 mcg orally once
-Missed Abortion: 800 mcg intravaginally OR 600 mcg sublingually once; the dose may be repeated every 3 hours for 2 additional doses

FDA-approved use for termination of an early pregnancy

The usual dosage for a medical abortion is 200 mg of mifepristone on Day 1, followed 24 to 48 hours later by 800 mcg misoprostol taken buccally (see below).

• The pregnancy must not be over 70 days (10 weeks) gestation. This means 70 days or less have passed since the first day of the woman’s last menstrual period (10 weeks or less).
• The mifepristone tablet is swallowed whole.
• The misoprostol tablets are taken buccally which means between your top lip and gum (in your cheek pouch).
  • Place 2 misoprostol tablets in each cheek pouch for 30 minutes and then swallow anything left over with a drink of water or another liquid.
• The medicines may not work as well if you take misoprostol sooner than 24 hours after mifepristone or later than 48 hours after mifepristone.

Comments:
-Pain medications should be provided.
-Patients that are Rh(D) negative and unsensitized: Rh(D)-immune globulin should be given within 72 hours of administration of the initial dose.
-Follow-up treatment should be made within 7 to 14 days to ensure complete expulsion has occurred.
-If treatment fails, surgical options may need to be considered.

Use: Treatment of early pregnancy loss, incomplete abortion, missed abortion, or termination of an early pregnancy.

What happens if I miss a dose?

Take the missed dose of misoprostol as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking misoprostol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can increase your risk of diarrhea while you are taking misoprostol.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.