about the product
Solution for subcutaneous administration.
A clear, colorless to slightly yellowish solution.
A clear, colorless to slightly yellowish solution.
Drug website
tirzetta.comOriginal product
This product is a fully original Promomed product
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Specifications
Name
Tirzetta®
Dosage form
SOLUTION FOR SUBCUTANEOUS ADMINISTRATION
Nosological classification
Drugs for the treatment of diabetes mellitus
INN
TIRZEPATIDE
Dosages
2.5 mg; 5 mg; 7.5 mg; 10 mg; 12.5 mg; 15 mg
ATC code
A10BX16
Active substance
Tirzepatide
Pharmacotherapeutic group
Endocrinological preparations
use
The drug is injected subcutaneously into the abdomen, thigh or shoulder area. The drug can be administered at any time of the day, regardless of food intake. The injection area should be changed with each injection. If you are also receiving insulin injections, Tirzetta® should be injected into another area. Recommended dose
- The initial dose of Tirzetta® is 2.5 mg once a week for 4 weeks. After 4 weeks, the attending physician will increase the dose of the drug to 5 mg once a week.
- If necessary, an increase in the dose is possible after 4 weeks, but not more than 2.5 mg. Thus, taking into account the increase, the dose should not exceed 7.5 mg once a week.
- Further, it is possible to increase the dose, but not more than 2.5 mg to the current dose every 4 weeks to doses of 10 mg, 12.5 mg or 15 mg once a week. On a case-by-case basis, your doctor will advise you to stay on a certain dose for at least 4 weeks before switching to a higher dose.
Help
Package leaflet
Tirzepatide acts similarly to natural hormones – physiological regulators of carbohydrate metabolism (insulin, glucose levels), as well as appetite and food intake. Tirzepatide is a long-acting glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (interacts with the receptor (target), causing a specific biological response).
Tirzetta® is used as an additional therapy when following a low-calorie diet and increasing physical activity to reduce body weight and control weight in adults over 18 years of age with an initial body mass index (BMI):
• ≥ 30 kg/m2 (obese);
or
• ≥ 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one overweight-related concomitant disease (for example, hypertension (high blood pressure), dyslipidemia (violation of the normal ratio of fats in the blood), obstructive sleep apnea (suspension of breathing during sleep), cardiovascular diseases, prediabetes, or type 2 diabetes).
In case of suspected overdose with Tirzetta®, consult your doctor. If possible, show the doctor the package of the drug. You will be prescribed supportive treatment according to your symptoms. Undesirable reactions from the gastrointestinal tract may occur, including nausea.
Some adverse reactions can be serious and life-threatening.
Tell your doctor immediately if you experience any of the following adverse reactions:
Infrequently (may occur in no more than 1 person out of 100):
-
acute, unbearable abdominal pain, nausea, vomiting, fever (acute pancreatitis).
-
severe allergic reaction, which is accompanied by symptoms such as difficulty breathing, decreased blood pressure, a feeling of lack of air, a feeling of pressure and chest pain, rash, itching, swelling of the lips, tongue, face, sudden weakness or other signs of a sharp deterioration in well-being (anaphylactic reaction);
rapidly developing and increasing swelling of the skin, face, neck, larynx, mucous membranes, difficulty breathing and swallowing (angioedema (angioedema)).
It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, and prescribe additional therapy).
For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the leaflet.
Do not use the drug Tirzetta®.:
• if you are allergic to tirzepatide or any other components of the drug;
• if you or your relatives have previously been diagnosed with medullary thyroid cancer;
• if you are diagnosed with multiple endocrine neoplasia (MEN) type 2, this is a group of pathological conditions characterized by the presence of neoplasms affecting two or more organs of the endocrine system;
• if you have type 1 diabetes mellitus (DM1);
• if you have diabetic ketoacidosis (an acute complication of diabetes mellitus).
Tell your doctor that you are taking, have recently taken, or may start taking any other medications. Your doctor needs to know about the medications you are taking in order to take into account possible adverse reactions that may develop due to the interaction of various medications with Tirzetta®, and possibly adjust the doses of the medications you are taking.
In particular, tell your doctor if you are taking any of the following medications:
Registration certificate holder:
Russian Federation, PROMOMED RUS LLC, Address: 13 Mira Avenue, building 1, office 13, Moscow, 129090
Phone: +7 (495) 640-25-28
Email: reception@promomed.pro
Manufacturer: Biochemist JSC, Russian Federation Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Notification of adverse reactions:
Russian Federation Federal Service for Healthcare Supervision
Address: 109012, Moscow, Slavyanskaya square, 4, building 1
Phone number: +7 800 550 99 03
Email: pharm@roszdravnadzor.gov.ru
Website on the Internet information and telecommunication network: www.roszdravnadzor.gov.ru
If you are pregnant or breastfeeding, think you are pregnant, or are planning to become pregnant, consult your doctor before using the drug. Use reliable methods of contraception during treatment with Tirzetta®. Do not use Tirzetta® if you are breastfeeding.
Store at a temperature of 2 to 8 °C. Store in the original packaging (pack) to protect from light. Do not freeze.
Tirzepatide has no or negligible effect on the ability to drive vehicles or work with mechanisms. When combined with sulfonylureas or insulin, it is recommended to take precautions to prevent hypoglycemia when driving a vehicle and working with mechanisms.
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