Revestive

Applies to teduglutide: subcutaneous kit

Oncologic

Uncommon (0.1% to 1%): Colorectal polyps
Rare (less than 0.1%): Malignancy[Ref]

Cardiovascular

Very common (10% or more): Fluid overload (up to 11.7%)
Common (1% to 10%): Flushing
Uncommon (0.1% to 1%): Syncope
Rare (less than 0.1%): Congestive heart failure
Postmarketing reports: Cardiac arrest, cardiac failure[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal stoma complication (up to 41.9%), abdominal pain (up to 37.7%), nausea (up to 27%), abdominal distension (up to 19.5%), vomiting (up to 14%)
Common (1% to 10%): Pancreatic disease, intestinal obstruction/stenosis, flatulence[Ref]

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

Hepatic

Common (1% to 10%): Gallbladder and biliary tract disease (cholecystitis, cholangitis, cholelithiasis, cholestasis), increased c-reactive protein[Ref]

Dermatologic

Common (1% to 10%): Skin hemorrhage, allergic dermatitis[Ref]

Hypersensitivity

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

Immunologic

Very common (10% or more): Antibody formation (up to 48%)
Common (1% to 10%): Influenza

Nervous system

Very common (10% or more): Headache (up to 17%)
Common (1% to 10%): Paresthesia
Postmarketing reports: Cerebral hemorrhage[Ref]

Psychiatric

Common (1% to 10%): Anxiety, sleep disturbance/disorder
Very rare (less than 0.01%): Mental status deterioration[Ref]

Respiratory

Very common (10% or more): Respiratory tract infection (up to 28%)
Common (1% to 10%): Dyspnea, cough[Ref]

Metabolic

Common (1% to 10%): Appetite disorder

Musculoskeletal

Common (1% to 10%): Arthralgia

Other

Very common (10% or more): Injection site reaction (up to 21.8%), peripheral edema (up to 10%)
Common (1% to 10%): Chest pain, night sweats

Renal

Common (1% to 10%): Renal colic, costovertebral angle tenderness

Some side effects of teduglutide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

0.05 mg/kg administered by subcutaneous injection once a day.

Use: Treatment of patients with Short Bowel Syndrome who are dependent on parenteral support.