Tigecicline Viatris

Patient Information Leaflet: User Information

Tigecycline Viatris, 50 mg, Powder for Solution for Infusion

Tigecycline

Read the Leaflet Carefully Before Receiving the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any questions or concerns, consult your doctor or nurse.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Tigecycline Viatris and what is it used for
• 2. Important information before using Tigecycline Viatris
• 3. How is Tigecycline Viatris administered
• 4. Possible side effects
• 5. How to store Tigecycline Viatris
• 6. Contents of the pack and other information

1. What is Tigecycline Viatris and what is it used for

Tigecycline is an antibiotic belonging to the glycylcycline group, which works by inhibiting the growth of bacteria that cause infections.
This medication has been prescribed by your doctor for you, an adult or a child over 8 years old, to treat one of the following types of severe infections:

• complicated skin and soft tissue infections (tissue under the skin), excluding diabetic foot infections
• complicated intra-abdominal infections

Tigecycline is used only when your doctor believes that other antibiotics are not suitable.

2. Important information before using Tigecycline Viatris

When not to use Tigecycline Viatris

• If you are allergic to tigecycline or any of the other ingredients of this medication (listed in section 6). Patients who are allergic to tetracycline antibiotics (e.g., minocycline, doxycycline, etc.) may also be allergic to tigecycline.

Warnings and precautions

Tell your doctor or nurse before receiving Tigecycline Viatris:

• If your wounds heal poorly or slowly.
• If you had diarrhea before starting treatment. If diarrhea occurs during or after treatment, tell your doctor or nurse immediately. Do not take anti-diarrheal medications without consulting your doctor first.

if you have ever experienced any side effects related to the use of tetracycline antibiotics (e.g., sensitivity to sunlight, tooth discoloration during development, pancreatitis, and changes in some laboratory test results used to monitor blood clotting).

• If you have ever had liver disease. Depending on the condition of your liver, your doctor may reduce the dose to avoid possible side effects.
• If you have had bile duct obstruction (cholestasis).
• If you have blood clotting disorders or are being treated with anticoagulant medications, as this medication may affect blood clotting.

During treatment with Tigecycline Viatris:

• Tell your doctor immediately if you experience any signs of an allergic reaction.
• Tell your doctor immediately if you experience severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas, which can cause severe abdominal pain, nausea, and vomiting).
• For certain severe infections, your doctor may consider administering Tigecycline Viatris with other antibiotics.
• Your doctor will closely monitor you for the development of other bacterial infections. If another bacterial infection occurs, your doctor may prescribe another antibiotic that is typical for that type of infection.
• Although antibiotics like Tigecycline Viatris combat certain bacteria, other types of bacteria and fungi may continue to grow. This phenomenon is called superinfection. Your doctor will closely monitor your condition for possible infections and treat them if necessary.

Children

Do not use Tigecycline Viatris in children under 8 years old due to lack of data on safety and efficacy in this age group and because it may cause permanent tooth damage, such as tooth discoloration during development.

Tigecycline Viatris and other medications

Tell your doctor about all medications you are currently taking or have taken, as well as any medications you plan to take.
Tigecycline Viatris may prolong the duration of certain tests used to monitor blood clotting. It is essential that you inform your doctor if you are taking medications to prevent excessive blood clotting (called anticoagulants). In this case, your doctor will closely monitor your health.
Tigecycline may interfere with the effectiveness of birth control pills. You should discuss with your doctor whether you need to use an additional method of birth control while taking tigecycline.
Tigecycline may enhance the effects of medications used to weaken the immune system (such as tacrolimus or cyclosporine). It is crucial that you tell your doctor if you are taking these medications so that your condition can be closely monitored.

Pregnancy and breastfeeding

Tigecycline Viatris may harm the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medication.
It is not known whether Tigecycline Viatris passes into breast milk. Before breastfeeding, consult your doctor.

Driving and using machines

Tigecycline Viatris may cause side effects such as dizziness. These may impair your ability to drive or operate machinery.

Tigecycline Viatris contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How is Tigecycline Viatris administered

Tigecycline Viatris is administered by your doctor or nurse.
The recommended initial dose for adults is 100 mg, followed by 50 mg every 12 hours.
The medication is administered intravenously (directly into the bloodstream) over 30 to 60 minutes.
The recommended dose for children between 8 and 12 years old is 1.2 mg/kg, administered intravenously every 12 hours, with a maximum dose of 50 mg every 12 hours.
The recommended dose for adolescents between 12 and 18 years old is 50 mg, administered every 12 hours.
Treatment usually lasts from 5 to 14 days, and the duration is determined by your doctor.

Using more than the recommended dose of Tigecycline Viatris

If you are concerned that you have received too much Tigecycline Viatris, tell your doctor or nurse immediately.

Missing a dose of Tigecycline Viatris

If you are concerned that you have missed a dose of Tigecycline Viatris, tell your doctor or nurse immediately.

4. Possible side effects

Like all medications, Tigecycline Viatris can cause side effects, although not everybody gets them.
During treatment with most antibiotics, including Tigecycline Viatris, pseudomembranous colitis may occur. This condition is characterized by severe, persistent, or bloody diarrhea, as well as abdominal pain or fever, which may be a sign of severe intestinal inflammation that can occur during or after treatment.
Very common side effects (may affect more than 1 in 10 people):

• nausea, vomiting, diarrhea.

Common side effects (may affect up to 1 in 10 people):

• abscess (collection of pus), infections
• laboratory test results indicating decreased blood clotting
• dizziness
• vein irritation after injection, including pain, inflammation, swelling, and blood clots
• abdominal pain, dyspepsia (stomach pain and indigestion), loss of appetite
• increased liver enzyme activity, hyperbilirubinemia (increased levels of bile pigments in the blood)
• itching (pruritus), rash
• slow or poor wound healing
• headache
• increased amylase activity (an enzyme found in salivary and pancreatic glands), increased blood urea nitrogen levels
• pneumonia
• low blood sugar
• sepsis (severe infection occurring in the body and bloodstream) or septic shock (a life-threatening condition that can lead to multiple organ failure and death due to sepsis)
• reaction at the injection site (pain, redness, inflammation)
• low protein levels in the blood

Uncommon side effects (may affect up to 1 in 100 people):

• acute pancreatitis (inflammation of the pancreas, which can cause abdominal pain, nausea, and vomiting)
• jaundice (yellowing of the skin), hepatitis
• low platelet count (which can lead to frequent bleeding, bruising, or hematoma)

Rare side effects (may affect up to 1 in 1000 people):

• low fibrinogen levels in the blood (a protein involved in blood clotting)

Side effects with unknown frequency (frequency cannot be estimated from available data):

• anaphylactic/anaphylactoid reactions (ranging from mild to severe, including sudden, generalized allergic reactions that can lead to life-threatening shock [e.g., difficulty breathing, low blood pressure, rapid heartbeat])
• liver failure
• rash that can lead to severe blistering and peeling of the skin (Stevens-Johnson syndrome)

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Tigecycline Viatris

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C.
Do not use the medication after the expiration date stated on the vial label and carton after EXP. The expiration date refers to the last day of the given month.

Storage after preparation

It has been shown that Tigecycline Viatris is chemically and physically stable when mixed with 0.9% sodium chloride injection solution or 5% glucose injection solution. The medication can be stored in the refrigerator at a temperature between 2°C and 8°C for up to 48 hours after immediate transfer of the prepared solution to an intravenous infusion bag.
For microbiological reasons, the medication should be used immediately after preparation.
If the medication is not used immediately, the user is responsible for the storage time and conditions.
After preparation, the Tigecycline Viatris solution should have a yellow to orange color; otherwise, it should be discarded.
Do not dispose of medications in the sewage system or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Tigecycline Viatris contains

The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
The other ingredients are L-arginine, hydrochloric acid, and sodium hydroxide (to adjust the pH to 4.5-5.0).

What Tigecycline Viatris looks like and contents of the pack

Tigecycline Viatris is supplied in a vial as a powder for solution for infusion. Before reconstitution, it appears as an orange or orange-red granular powder. The vials are supplied to the hospital in packs containing 1 vial or 10 vials of the medication. Not all pack sizes may be marketed.
The powder should be mixed with a small amount of solution in the vial. The vial should be gently rotated until the medication is dissolved. The prepared solution should then be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable container for infusion solution used in the hospital (e.g., a glass bottle).

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Importer:

Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain
SAG Manufacturing S.L.U.
Crta. N-I, Km 36, San Agustin de Guadalix
28750 Madrid
Spain
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Höhe
Benzstrasse 1, 61352 Bad Homburg v. d. Höhe
Germany
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia (PV)
Italy
Date of last revision of the leaflet:June 2025

The following information is intended for healthcare professionals only:

Instructions for preparation of the medication for use (see also section 3 of the leaflet "How is Tigecycline Viatris administered")

To obtain a tigecycline solution with a concentration of 10 mg/ml, the powder should be dissolved in 5.3 ml of 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution.
The vial should be gently rotated until the active substance is dissolved. The prepared solution should then be immediately withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable container for infusion solution used in the hospital (e.g., a glass bottle).
To prepare a 100 mg dose, the powder from two vials should be dissolved and added to a 100 ml intravenous infusion bag or another suitable container for infusion solution used in the hospital (e.g., a glass bottle).
Note: There is a 6% overfill of medication in the vial. Therefore, 5 ml of the prepared solution corresponds to 50 mg of the active substance. The prepared solution should have a yellow to orange color; otherwise, it should be discarded. Before administering products for parenteral use, visually inspect for particulate matter and color change (e.g., to green or black).
Tigecycline Viatris should be administered intravenously through a dedicated infusion line or through a Y-connector. If multiple active substances are administered sequentially through the same intravenous infusion line, the line should be flushed with 0.9% (9 mg/ml) sodium chloride injection solution or 5% (50 mg/ml) glucose injection solution before and after administering tigecycline.
Only compatible infusion solutions should be administered through the same intravenous infusion line as tigecycline. Compatible infusion solutions: 0.9% (9 mg/ml) sodium chloride injection solution and 5% (50 mg/ml) glucose injection solution. The product has been shown to be incompatible with Ringer's solution with lactate.
Compatibility of Tigecycline Viatris solution has been demonstrated when administered through a Y-connector after dilution in 0.9% sodium chloride injection solution with the following medications or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, lidocaine hydrochloride, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (with EDTA), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Do not mix tigecycline with other medications for which compatibility data are not available.
It has been shown that Tigecycline Viatris is chemically and physically stable when mixed with 0.9% sodium chloride injection solution or 5% glucose injection solution. The product can be stored in the refrigerator at a temperature between 2°C and 8°C for up to 48 hours after immediate transfer of the prepared solution to an intravenous infusion bag.
For microbiological reasons, the medication should be used immediately after preparation.
If the medication is not used immediately, the user is responsible for the storage time and conditions.
For single use only - any unused solution should be discarded.