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TIROFIBAN 50 MICROGRAMS/ML SOLUTION FOR INFUSION

Active substance(s): TIROFIBAN / TIROFIBAN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tirofiban 50 micrograms/ml solution for infusion.
Tirofiban
Read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Tirofiban is and what it is used for
2. What you need to know before you use Tirofiban.
3. How to use Tirofiban
4. Possible side effects
5. How to store Tirofiban
6. Contents of the pack and other information

1. What Tirofiban is and what it is used for
Tirofiban is used to help assist the blood flow to your heart and to help prevent chest pain and
heart attacks. It works by preventing platelets, cells found in the blood, from forming blood
clots.
This medicine may also be used in patients whose heart vessels are dilated with a balloon
(percutaneous coronary intervention or PCI). This is a procedure, possibly with implantation of
a small tube (stent), to improve the blood flow to the heart.
Tirofiban is intended for use with aspirin and unfractionated heparin.

2. What you need to know before you use Tirofiban
Do not use Tirofiban
If you are allergic to tirofiban or any of the other ingredients of this medicine (listed in
section 6“What contains”).
If you are bleeding internally or have a history of bleeding internally within the last 30
days.
If you have a history of bleeding in the brain, brain tumor or abnormal blood vessels in
the brain.
If you have severe uncontrolled high blood pressure (malignant hypertension).
If you have a low blood platelet count (thrombocytopenia) or problems with blood
clotting.
If you developed thrombocytopenia if you had received treatment with Tirofiban or
another medicine in the same group of drugs previously.
If you have a history of stroke within the last 30 days or any history of stroke with
bleeding.
If you have been seriously injured or had a major operation within the last 6 weeks.
If you have severe liver disease.

Your doctor will review your medical history to see if you are at an increased risk of any side
effects associated with being given this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Tirofiban, if you have or have had:
any medical problems
any allergies
cardiopulmonary resuscitation (CPR), a biopsy, or a procedure to break up kidney stones
within the last 2 weeks
been seriously injured or had a major operation within the last 3 months
an ulcer in the stomach or intestine (duodenum) within the last 3 months
a recent bleeding disorder (within 1 year) such as bleeding in the stomach or intestine, or
blood in your urine or stool
recent spinal procedure
a history or symptoms of splitting of the aorta (aortic dissection)
uncontrolled high blood pressure (hypertension)
an inflammation of the lining around your heart (pericarditis)
an inflammation of the blood vessels (vasculitis)
problems with the blood vessels in the back of your eye (retina)
treatment with medications that help to prevent or dissolve blood clots
kidney problems
a special intravenous line inserted under your collar bone within the last 24 hours
heart failure
very low blood pressure due to a failing heart (cardiogenic shock)
a liver disorder
low blood count or anemia
Other medicines and Tirofiban
In general, Tirofiban can be used with other medicines. Please tell your doctor if you are taking
or have recently taken or might take any other medicines, including medicines obtained without
a prescription, as some drugs may affect each other's action. It is especially important to tell
your doctor if you are taking other medicines that help prevent your blood from clotting such as
warfarin.
Tirofiban with food and drink
Food and drink have no effect on this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Due to your disease state, you will not be able to drive or operate machinery while Tirofiban is
being used.
Tirofiban contains sodium
This medicinal product contains approximately 39.8 mmol (916.28 mg) sodium per 250 ml bag.
To be taken into consideration by patients on a controlled sodium diet.

3. How to use Tirofiban
Always use this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Tirofiban should be prescribed by a qualified doctor who is experienced in the management of
heart attacks.
You have been given, or are about to be given, Tirofiban into a vein. Your doctor will decide on
the appropriate dose, depending on your condition and your weight.
Use in Children
The use in children is not recommended.
If you use more Tirofiban than you should
Your dose of Tirofiban is carefully monitored and checked by your doctor and pharmacist.
The most frequently reported symptom of overdose is bleeding. If you notice bleeding, you
should notify your health care professional immediately.
If you forget to use Tirofiban
Your doctor will decide when to administer the dose.
If you stop using Tirofiban
Your doctor will decide when treatment should be stopped. However, if you wish to stop your
treatment earlier, you should discuss other options with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effect of treatment with Tirofiban is bleeding which could occur
anywhere in the body. This can become serious and may, rarely, be fatal.
If side effects occur, they may need medical attention. While using Tirofiban, if you develop
any of the following symptoms, you should contact your doctor immediately:
- Signs of bleeding in the skull such as pain in the head, sensory impairments (visual or
hearing), difficulties in speech, numbness or problems with movement or balance
- Signs of internal bleeding such as coughing up blood or blood in your urine or stool
- Signs of serious allergic reactions such as difficulties in breathing and dizziness
Below is a list of side effects that have occurred in some people following treatment with
Tirofiban. The side effects are listed in decreasing order of frequency.
Very common (may affect more than 1 in 10 people):
Bleeding after surgery
Bleeding under the skin at the site of an injection, or into a muscle, causing swelling
Small red bruises on the skin
Invisible blood in urine or stool
Feeling sick
Headache

Common (may affect up to 1 in 10 people):
Blood in urine
Coughing up of blood
Nose bleeds
Bleeding in the gums and mouth
Bleeding from vessel puncture site
Reduction in red blood cells (reduced haematocrit and haemoglobin)
Decreases in platelet count below 90,000/mm3
Fever
Uncommon (may affect up to 1 in 100 people):
Bleeding in the stomach or intestines
Vomiting of blood
Decreases in platelet count below 50,000/mm3
Not known (frequency cannot be estimated from the available data):
Bleeding in the skull
Haematoma in the spinal region
Bleeding in the abdomen of the internal organs
Accumulation of blood around the heart
Bleeding in the lung
Acute and/or severe decreases in platelet counts below <20,000/mm3
Severe allergic reactions with tightness of chest, hives or nettle rash, including reactions that
cause difficulty in breathing and dizziness
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national
reporting system listed in Appendix V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Tirofiban
Keep this medicine out of the sight and reach of children.
After opening, the product should be used immediately.
Do not use Tirofiban after the expiry date which is stated on the bag. The expiry date refers to
the last day of that month.
Do not use Tirofiban if there are visible particles or discolouration of the solution before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Tirofiban contains
The active substance is tirofiban.
1 ml of solution for infusion contains 50 micrograms of tirofiban.

The other ingredients are: sodium acetate trihydrate, acetic acid, sodium chloride, sodium
hydroxide (for pH adjustment) and water for injection.
What Tirofiban looks like and contents of the pack
Tirofiban is a clear, colourless solution available in 250 ml bags.
Pack sizes: 1 or 3 bags with 250 ml solution for infusion. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
G.E.S. GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
C/Cólquide 6 Portal 2 1ª Planta – Oficina F
28230 Las Rozas (Madrid)
Spain
Manufacturer
BIOMENDI, S.A.U.
Polígono Industrial de Bernedo, s/n
01118 Bernedo (Álava)
Spain

This medicinal product is authorised in the Member States of the EEA under the
following names:
< Germany >
< France >
< Italy >
< Spain >
< United Kingdom >

Tirofiban Ibisqus 50 mikrogramm/ml Infusionslösung
Tirofiban Farmages 50 microgramme/ml solution pour perfusion
Tirofiban Ibisqus
Tirofiban G.E.S. 50 microgramos/ml solución para perfusión EFG
Tirofiban 50 micrograms/ml solution for infusion

This leaflet was last revised in November 2013
-----------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
This product is for hospital use only, by specialist physicians experienced in the management of
acute coronary syndromes.
Tirofiban 50 micrograms/ml solution for infusion should be administered with unfractionated
heparin and oral antiplatelet therapy, including acetylsalicylic acid (ASA).
Posology and method of administration
In patients who are managed with an early invasive strategy for Non-ST-Segment Elevation
Acute Coronary Syndrome (NSTE-ACS) but not planned to undergo angiography for at least 4
hours and up to 48 hours after diagnosis, Tirofiban is given intravenously at an initial infusion
rate of 0.4 microgram/kg/min for 30 minutes. At the end of the initial infusion, Tirofiban should
be continued at a maintenance infusion rate of 0.1 microgram/kg/min. Tirofiban should be given
with unfractionated heparin (usually an intravenous bolus of 50-60 Units (U)/kg simultaneously
with the start of Tirofiban therapy, then approx. 1000 (U) per hour, titrated on the basis of the
activated partial thromboplastin time (APTT), which should be about twice the normal value)
and oral antiplatelet therapy, including but not limited to ASA, unless contraindicated.
In NSTE-ACS patients planned to undergo PCI within the first 4 hours of diagnosis or in
patients with acute myocardial infarction intended for primary PCI should be administrated

utilizing an initial bolus of 25 microgram/kg given over a 3 minute period, followed by a
continuous infusion at a rate of 0.15 microgram/kg/min for 12-24, and up to 48 hours. Tirofiban
should be administered with unfractionated heparin (dosage as above) and oral antiplatelet
therapy, including but not limited to ASA, unless contra-indicated.
No dosage adjustment is necessary for the elderly.
Patients with severe kidney failure
In severe kidney failure (creatinine clearance < 30 ml/min) the dosage of Tirofiban should be
reduced by 50%.
Paediatric population
The safety and efficacy of Tirofiban in children have not been established.
No data are available.
Start and duration of Tirofiban
In patients who are managed with an early invasive strategy for NSTE-ACS but not planned to
undergo angiography for at least 4 hours and up to 48 hours after diagnosis, the Tirofiban
0.4 microgram/kg/min loading dose regimen should be initiated upon diagnosis. The
recommended duration of the maintenance infusion should be at least 48 hours. Infusion of
Tirofiban and unfractionated heparin may be continued during coronary angiography and should
be maintained for at least 12 hours and not more than 24 hours after angioplasty/atherectomy.
Once a patient is clinically stable and no coronary intervention is planned by the treating
physician, the infusion should be discontinued. The entire duration of treatment should not
exceed 108 hours.
If the patient diagnosed with NSTE-ACS and managed with an invasive strategy undergoes
angiography within 4 hours after the diagnosis, the Tirofiban 25 microgram/kg dose bolus
regimen should be initiated at the start of PCI with the infusion continued for 12-24 hours and
up to 48 hours. In patients with acute myocardial infarction intended for primary PCI, the bolus
infusion regimen should be initiated as soon as possible after diagnosis.
Concurrent therapy (unfractionated heparin, oral antiplatelet therapy including ASA)
Treatment with unfractionated heparin is initiated with an intravenous bolus of 50-60 /Kg and
then continued with a maintenance infusion of 1000 units per hour. The heparin dosage is
titrated to maintain an APTT of approximately twice the normal value.
Unless contraindicated, all patients should receive oral antiplatelet agents, including but not
limited to ASA, before the start of Tirofiban. This medication should be continued at least for
the duration of the infusion of Tirofiban.
Most studies investigating the administration of Tirofiban as an adjunct to PCI have used ASA
in combination with clopidogrel as oral antiplatelet therapy. The efficacy of the combination of
Tirofiban with either prasugrel or ticagrelor has not been established in randomised controlled
trials
If angioplasty (PCI) is required, heparin should be stopped after PCI, and the sheaths should be
withdrawn once coagulation has returned to normal, e.g. when the activated clotting time (ACT)
is less than 180 seconds (usually 2-6 hours after discontinuation of heparin).
Incompatibilities
Incompatibility has been found with diazepam. Therefore, Tirofiban and diazepam should not
be administered in the same intravenous line.
No incompatibilities have been found with Tirofiban and the following intravenous
formulations: atropine sulfate, dobutamine, dopamine, epinephrine HCl, furosemide, heparin,

lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, propranolol
HCl, and famotidine injection.
Instructions for use
Do not withdraw solution directly from the container with a syringe.
Directions for Use of Containers
Do not use unless solution is clear and bag is intact.
Do not add supplementary medication or withdraw solution directly from the bag with a
syringe.
CAUTION: Do not use plastic containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary container before administration of
the fluid from the secondary container is completed.
Use according to the dosage table.
The following table is provided as a guide to dosage adjustment by weight.
Patient
Weight
(kg)

0.4 microgram/kg/min
Loading Dose Regimen

0.4 microgram/kg/min
Loading Dose Regimen

25 microgram/kg
Dose Bolus Regimen

Most Patients

Severe Kidney
Failure
30 min
Maintenan
Loading ce Infusion
Infusion
Rate
Rate
(ml/hr)
(ml/hr)
8
2

Most Patients

Maintenan
ce Infusion
Rate(ml/hr
)

30-37

30 min
Loading
Infusion
Rate(ml
/hr)
16

38-45

20

5

10

46-54

24

6

55-62

28

63-70

Severe Kidney
Failure
Bolus
Mainte
(ml)
nance
Infusio
n Rate
(ml/hr)
8
3

17

Mainte
nance
Infusio
n Rate
(ml/hr)
6

3

21

7

10

4

12

3

25

9

13

5

7

14

4

29

11

15

5

32

8

16

4

33

12

17

6

71-79

36

9

18

5

38

14

19

7

80-87

40

10

20

5

42

15

21

8

88-95

44

11

22

6

46

16

23

8

96-104

48

12

24

6

50

18

25

9

105-112

52

13

26

7

54

20

27

10

113-120

56

14

28

7

58

21

29

10

121-128

60

15

30

8

62

22

31

11

129-137

64

16

32

8

67

24

33

12

138-145

68

17

34

9

71

25

35

13

146-153

72

18

36

9

75

27

37

13

4

Bolus
(ml)

25 microgram/kg
Dose Bolus Regimen






Where the solution and container permit, parenteral drugs should be inspected for visible
particles or discolouration before use.
Tirofiban should only be given intravenously and may be administered with
unfractionated heparin through the same infusion tube.
It is recommended that Tirofiban be administered with a calibrated infusion set using
sterile equipment.



Care should be taken to ensure that no prolongation of the infusion of the initial dose
occurs and that miscalculation of the infusion rates for the maintenance dose on the basis
of the patient’s weight is avoided.

Special precautions for storage
Do not use Tirofiban after the expiry date which is stated on the bag after . The expiry
date refers to the last day of that month.
Nature and contents of container
Tirofiban is a clear, colourless solution available as follows:
250 ml bag, colourless, multilayer PVC-free polyolefine film with 2 tubes of PVC-free
polyolefin and an administration port.
It is packed in a preprinted foil overpouch.
Pack size: 1 or 3 bags with 250 ml solution for infusion. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local
requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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