Teduglutide, Injection

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KEY POINTS

• This medicine is given by injection (shots) to treat short bowel syndrome in people who use parenteral nutrition.
• You need regular checkups and colon exams while taking this medicine. Keep all appointments.
• This medicine may increase your risk for cancer or for polyps in your intestines or cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: GLP-2 analog

Generic and brand names: teduglutide, injection; Gattex

What is this medicine used for?

This medicine is given by injection (shots) to treat short bowel syndrome in people who use parenteral nutrition (when normal feeding by mouth is not possible or is not enough to provide good nutrition).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• Cancer
• Gallstones, gallbladder disease, or pancreatic disease
• Heart failure or other heart problems
• Kidney disease
• Polyps in your intestine or rectum

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start using this medicine and each time you get a refill.

This medicine is injected just under the skin once a day, at the same time each day. Talk with your healthcare provider for specific instructions. Do not stop taking this medicine without your healthcare provider's approval.

Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under 18.

What if I miss a dose?

If you miss a dose, use it as soon as you remember that same day. Use your next dose the next day at the same time you usually use it. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe nausea, vomiting, constipation.

What should I watch out for?

This medicine may increase your risk for cancer or for polyps in your intestines. Your healthcare provider may check your colon within 6 months before starting this medicine and at the end of 1 year of using this medicine. If no polyp is found, your healthcare provider will check you for polyps as needed and at least every 5 years.

You need to have blood tests and checkups regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Swelling in your feet and ankles or any unexplained swelling; sudden weight gain; fever; chills; any change in bowel movements; severe or constant nausea or vomiting; severe constipation; severe stomach pain or swelling; swelling and blockage of your stoma opening (if you have a stoma); shortness of breath; decrease in urination; dark urine; yellowing of your eyes or skin.

Other: Mild nausea; headache; redness, pain or irritation at the injection site; bloating or gas; runny or stuffy nose; cough; sore throat; trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), and quinidine
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, risperidone (Risperdal), thioridazine, and trifluoperazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Digoxin (Lanoxin)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), frovatriptan (Frova), isometheptene/dichloralphenazone/acetaminophen, rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Theophylline
• Thyroid medicines such as levothyroxine (Levo-T, Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid USP (Armour Thyroid, Nature-Throid)
• Warfarin (Coumadin)

This medicine can affect how other medicines you take are absorbed and used by your body. Talk with your healthcare provider if you take other medicines by mouth.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light. Do not let it freeze. Use the medicine within 3 hours after you mix it. Throw away any unused mixture after you have given the injection. Do not use this medicine after the expiration date.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.