くすりのしおり

Self-injection
Published: 8/2021

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
REVESTIVE 3.8 mg for S.C. Injection
 Active ingredient:
Teduglutide(genetical recombination)
 Dosage form:
white powder for injection
 Print on wrapping:

Effects of this medicine

This medicine is an analogue of a glucagon-like peptide-2 (GLP-2), one of the gut peptide hormones, and improves ability of the remaining small intestine to absorb nutrients and fluid by binding to GLP-2 receptors and prompting cell growth in the intestinal mucosa to increase the intestinal mucosal surface area.
It is usually used to treat short bowel syndrome.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have: malignant tumor or renal disorder, a history of malignant tumor in the gastrointestine, hepatobiliary system or pancreas within 5 years or a history of cardiovascular diseases such as cardiac failure or hypertension.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, inject subcutaneously 0.05 mg of the active ingredient per kg of the body weight at a time, once a day. If you have moderate or severe renal dysfunction, use half of the dose. Strictly follow the instructions.
  • You may self-inject this medicine if you or your family receive appropriate instructions in the medical institution for the self-injection at home.
  • Receive an explanation about the self-injection method of this medicine from your doctor or pharmacist before initiating the self-injection. As well, be sure to read the attached "Instruction Manual" or "Self-Injection Guide Book" provided by the medical institution separately.
  • If any symptoms suspected as adverse reactions to this medicine appear at the time of self-injection or if you feel you are not able to continue self-injections, consult with your doctor immediately.
  • Do not reuse needles or syringes if you self-inject this medicine. You receive instruction in the medical institution about how to discard them safely. Discard the used needles or syringes with the containers provided by the medical institution.
  • Dissolve this medicine in the attached 0.5 mL of solution every time before using this medicine.
  • After adding the attached full amount of solution to the vial containing this medicine, hold the vial between your hands and roll it gently. Then, slowly turn the vial upside down once and turn it back (do not shake the vial).
  • Do not use the injection solution if there is cloudiness, particles or precipitation.
  • You can obtain 0.38 mL of injection solution per vial.
  • Use the injection solution immediately after preparation. Use the injection solution within 3 hours after preparation as this medicine contains no preservative. Discard the unused medicine.
  • Do not freeze the injection solution.
  • Inject this medicine subcutaneously into the abdomen, thighs or upper arms.
    Injection site should be changed every time you inject this medicine.
    Avoid injecting into the sensitive area of skin or abnormal site of skin (wound site, rash, redness, induration, etc.).
    Do not reuse this medicine as this should be used only once.
  • If you miss a dose, inject the missed dose as soon as possible. Do not inject this medicine twice a day. You should never inject two doses at one time.
  • If you accidentally inject more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop injecting this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • For adults, colonoscopy or other imaging tests, etc. may be performed within 6 months before initiating this medicine. If colonic polyp is observed, polypectomy will be considered before initiating this medicine. Colonoscopy or other imaging tests, etc. may be performed from 1 to 2 years after initiating this medicine. For patients with high risk of colonic polyp, colonoscopy may be further performed within 5 years or so. This medicine should be discontinued if colorectal cancer is diagnosed.
  • For children aged 1 year or over, occult blood test may be performed before initiating this medicine. Colonoscopy or other imaging tests, etc. may be performed if there is fecal occult blood of uncertain cause. If colonic polyp is observed, polypectomy will be considered before initiating this medicine. If there is fecal occult blood of uncertain cause in the occult blood test before initiating this medicine, occult blood test will be performed once a year during using this medicine.
    For children under the age of 1, occult blood test or colonoscopy, etc. may be performed before initiating this medicine if necessary.
    For all children, colonoscopy or other imaging tests, etc. may be performed to determine the presence of colonic polyp at 1 year after initiating this medicine, each five years thereafter and when gastrointestinal bleeding of uncertain cause is observed.
  • Physical examination, blood test and imaging test may be performed before, during and after using this medicine, because polyp or hyperplastic change may be observed in the stomach, small intestine, hepatobiliary system or pancreas.
  • Liver function test (bilirubin, ALP, etc.) or imaging tests may be regularly performed before and during using this medicine, because cholecystitis, cholangitis or cholelithiasis may occur.
  • Pancreatic function test (lipase, amylase, etc.) or imaging tests may be regularly performed before and during using this medicine, because pancreatic diseases, such as chronic pancreatitis, acute pancreatitis, pancreatic ductal stenosis or pancreatic infection may occur.
  • This medicine may cause congestive heart failure, as it may increase fluid absorbed from the gastrointestinal tract and result in excess of the body fluid. As well, patient with short bowel syndrome should be careful for dehydration. Consult with your doctor if acute weight gain, edema in the face or lower limbs or dyspnea occurs. The excess of body fluid had been reported a lot from the initiation of this medicine to 4 weeks in the clinical trial of this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include abdominal pain, abdominal bloating, nausea, vomiting, injection site reactions (erythema, swelling, pain, etc.) and gastrointestinal stoma complications (enlargement of stoma size and nipple stoma size, etc.). If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • bloody stool, melena [intestinal polyp]
  • abdominal pain, abdominal bloating, loss of appetite, nausea/vomiting [intestinal obstruction, gastrointestinal stoma blockage]
  • pain in the right flank, epigastric pain, fever, nausea/vomiting, yellowing of the skin and the white of eyes [gallbladder disease, biliary tract disease]
  • severe abdominal pain, back pain, nausea/vomiting, fever [pancreatic disease]
  • shortness of breath, weight gain, facial/limbs edema, fatigability [body fluid retention]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store below 25 degrees Celsius and avoid freezing.
    (Store it in the refrigerator depending on the temperature.)
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.