Applies to teduglutide: subcutaneous powder for solution.

Serious side effects of Teduglutide

Along with its needed effects, teduglutide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking teduglutide:

More common

• Decrease in the amount of urine
• excess air or gas in the stomach or bowels
• fast heartbeat
• fever
• full or bloated feeling
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• noisy, rattling breathing
• pressure in the stomach
• redness of the skin
• stomach pain
• swelling of the abdominal or stomach area
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• weight gain

Less common

• Indigestion
• severe nausea or vomiting

Incidence not known

• Blurred vision
• chest pain or discomfort
• dilated neck veins
• extreme tiredness or weakness
• inability to speak
• irregular breathing
• irregular heartbeat
• loss of consciousness
• no blood pressure or pulse
• seizures
• severe or sudden headache
• slurred speech
• stopping of the heart
• temporary blindness
• weakness in the arm or leg on one side of the body, sudden and severe

Other side effects of Teduglutide

Some side effects of teduglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain
• changes in appetite
• chills
• cough
• ear congestion
• headache
• loss of voice
• nausea
• runny or stuffy nose
• sneezing
• sore throat
• trouble sleeping
• unusual tiredness or weakness
• vomiting

For Healthcare Professionals

Applies to teduglutide: subcutaneous kit.

General

The most commonly reported side effects included antibody formation, abdominal distention, abdominal pain, and gastrointestinal stoma complications (in patients with a stoma).^[Ref]

Gastrointestinal

Very common (10% or more): Abdominal distention (up to 45%), abdominal pain (up to 45%), gastrointestinal (GI) stoma complications (up to 42%), nausea (up to 26%), vomiting (up to 14%)

Common (1% to 10%): Colonic polyp, colonic stenosis, colorectal polyp, diarrhea, flatulence, intestinal obstruction, pancreatic duct stenosis, pancreatitis, small intestinal stenosis, upper abdominal pain

Uncommon (0.1% to 1%): Duodenal polyp

Frequency not reported: Abdominal wall hematoma, acute pancreatitis, chronic pancreatitis, gastric polyp, pancreatic disease, pancreatic pseudocyst^[Ref]

GI stoma complication (swelling of the stoma and associated complications) is considered a sign of efficacy rather than an adverse event.^[Ref]

Respiratory

Very common (10% or more): Respiratory tract infections (up to 28%), upper respiratory tract reaction (up to 21%), nasopharyngitis (up to 13%)

Common (1% to 10%): Cough, dyspnea

Frequency not reported: Laryngitis, lower respiratory tract infection, pharyngitis, rhinitis, sinusitis, viral upper respiratory infection^[Ref]

Local

Very common (10% or more): Injection site reactions (up to 26%), injection site hematoma (up to 11%)

Common (1% to 10%): Injection site erythema

Frequency not reported: Injection site discoloration, injection site hemorrhage, injection site pain, injection site rash, injection site swelling^[Ref]

Immunologic

Very common (10% or more): Antibody formation (up to 54%)

Common (1% to 10%): Catheter related infection, catheter sepsis, influenza, influenza-like illness^[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%)

Uncommon (0.1% to 1%): Syncope^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 13%)^[Ref]

Metabolic

Very common (10% or more): Fluid overload (up to 12%)

Common (1% to 10%): Decreased appetite

Frequency not reported: Fluid imbalance, fluid retention^[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia, sleep disturbance^[Ref]

Cardiovascular

Common (1% to 10%): Congestive heart failure, peripheral edema

Frequency not reported: Edema, flushing, generalized edema, hematoma, jugular vein distention, post-procedural hematoma^[Ref]

Hepatic

Common (1% to 10%): Acute cholecystitis, cholecystitis

Frequency not reported: Biliary disease, cholelithiasis^[Ref]

Other

Common (1% to 10%): Fatigue, pyrexia^[Ref]

Dermatologic

Common (1% to 10%): Skin hemorrhage

Frequency not reported: Allergic dermatitis, blood blister, drug eruption, erythema, pruritus, macular rash, rash, umbilical hematoma^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia

Frequency not reported: Hypersomnia^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Oncologic

Frequency not reported: Acceleration of neoplastic growth, metastatic adenocarcinoma, lung cancers (squamous and non-small cell)^[Ref]

Ocular

Frequency not reported: Eyelid edema^[Ref]

Hematologic

Frequency not reported: Increased c-reactive protein^[Ref]