Tirofiban Aurobindo

Package leaflet: Information for the user

Tirofiban Aurobindo 50 micrograms/ml solution for infusion

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Tirofiban Aurobindo is and what it is used for
2. What you need to know before taking Tirofiban Aurobindo
3. How to take Tirofiban Aurobindo
4. Possible side effects
5. How to store Tirofiban Aurobindo
6. Contents of the pack and other information

1. What Tirofiban Aurobindo is and what it is used for

Tirofiban Aurobindo is used to help improve blood flow to the heart and to help prevent chest pain and heart attacks. It works by preventing platelets, which are blood cells, from forming clots. This medicine may also be used in patients whose heart blood vessels are being widened by a balloon (coronary angioplasty or PCI). This is a procedure to improve blood flow to the heart, sometimes involving the placement of a small tube (stent).
Tirofiban Aurobindo must be used in combination with aspirin and unfractionated heparin.

2. What you need to know before taking Tirofiban Aurobindo

Do not take Tirofiban Aurobindo

• if you are allergic (hypersensitive) to tirofiban or to any of the other ingredients of this medicine (listed in section 6 “What Tirofiban Aurobindo contains”);
• if you have internal bleeding or have had internal bleeding within the last 30 days;
• if you have a history of cerebral haemorrhage, brain tumour, or cerebral blood vessel abnormalities;
• if you suffer from severe uncontrolled hypertension (malignant hypertension);
• if you have low platelet count (thrombocytopenia) or blood clotting disorders;
• if you have developed thrombocytopenia after previous treatment with Tirofiban Aurobindo or another medicine in the same drug class;
• if you have had a stroke within the last 30 days or a previous stroke with haemorrhage;
• if you have sustained severe injuries or undergone major surgery within the last 6 weeks;
• if you have severe liver disease.

Your doctor will evaluate your medical history to determine whether you are at increased risk of
adverse effects associated with the use of this medicine.
Warnings and precautions
Talk to your doctor before taking Tirofiban Aurobindo if you have had or currently have:

• any medical condition;
• any allergy;
• cardiopulmonary resuscitation (CPR), a biopsy, or a procedure to break up kidney stones within the last 2 weeks;
• severe injuries or major surgery within the last 3 months;
• a stomach or intestinal (duodenal) ulcer within the last 3 months;
• a recent bleeding disorder (within the last year), such as gastrointestinal bleeding, or blood in urine or stools;
• a recent spinal procedure;
• history or symptoms of aortic rupture (aortic dissection);
• uncontrolled high blood pressure (hypertension);
• inflammation of the lining surrounding the heart (pericarditis);
• inflammation of blood vessels (vasculitis);
• blood vessel problems in the back of the eye (retina);
• treatment with medicines that help prevent or dissolve blood clots;
• kidney problems;
• a special intravenous catheter inserted under the clavicle within the last 24 hours;
• heart failure;
• very low blood pressure due to heart failure (cardiogenic shock);
• liver disease;
• low blood cell count or anaemia.

Other medicines and Tirofiban Aurobindo
In general, Tirofiban Aurobindo can be used with other medicines. Inform your doctor if you are
taking, have recently taken, or might take any other medicines, including those without a prescription,
as some of them may affect the action of other medicines.
It is particularly important that you inform your doctor if you are taking other medicines that
prevent blood clot formation, such as warfarin.
Tirofiban Aurobindo with food and drink
Food and drink do not affect this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor before taking this medicine.
Driving and using machines
Due to your medical condition, you will not be able to drive or operate machinery while receiving
Tirofiban Aurobindo.
Tirofiban Aurobindo contains sodium
Tirofiban Aurobindo infusion solution contains approximately 921 mg of sodium per 250 ml bag.
This corresponds to 46% of the maximum daily recommended dietary intake for an adult.

3. How to take Tirofiban Aurobindo

Tirofiban Aurobindo must be prescribed by a qualified doctor experienced in the treatment of heart attacks.
Tirofiban Aurobindo will be, or has been, administered to you intravenously. The doctor will decide the appropriate dose, which will depend on your condition and body weight.
Use in children
Use in children is not recommended.
If you use more Tirofiban Aurobindo than you should
Your dose of Tirofiban Aurobindo will be carefully monitored and controlled by the doctor and pharmacist.
The most common symptom of overdose is bleeding. If you experience bleeding, inform healthcare personnel immediately.
If you forget to use Tirofiban Aurobindo
The doctor will decide when to administer the dose.
If you stop using Tirofiban Aurobindo
The doctor will decide when treatment should end. However, if you wish to discontinue therapy earlier, discuss the possibility of alternative options with your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common side effect of Tirofiban Aurobindo is bleeding, which may occur in any part of the body. This may become severe and, rarely, may be fatal.
If you experience any side effects, medical intervention may be required. During treatment with Tirofiban Aurobindo, contact your doctor immediately if you develop any of the following symptoms:

• signs of intracranial bleeding such as headache, sensory disturbances (visual or auditory), difficulty speaking, numbness, or problems with movement or balance;
• signs of internal bleeding, such as coughing up blood or blood in the urine or stools;
• signs of severe allergic reactions, such as difficulty breathing and dizziness.

Below is a list of side effects observed in some people treated with Tirofiban Aurobindo. The side effects are listed in decreasing order of frequency.

Very common (may affect more than 1 in 10 people):
Bleeding following surgical procedures
Bleeding under the skin at the site of injection or into a muscle, causing swelling
Small red spots on the skin (petechiae)
Occult blood in urine or stools
Nausea
Headache.

Common (may affect up to 1 in 10 people):
Blood in the urine
Coughing up blood
Nosebleeds
Bleeding from gums or mouth
Bleeding from the blood vessel injection site
Reduction in red blood cells (decreased haematocrit and haemoglobin)
Reduction in platelet count below 90,000/mm³
Fever.

Uncommon (may affect up to 1 in 100 people):
Bleeding in the stomach or intestine
Vomiting blood
Reduction in platelet count below 50,000/mm³.

Not known (frequency cannot be estimated from available data):
Bleeding within the skull
Spinal haematoma
Bleeding in internal abdominal organs
Blood accumulation around the heart (pericardial haemorrhage)
Bleeding in the lungs
Acute and/or severe reduction in platelet count below 20,000/mm³
Severe allergic reactions with chest tightness, urticaria, including reactions causing difficulty breathing and dizziness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tirofiban Aurobindo

Your doctor and pharmacist know how to store and dispose of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bag after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
After opening: the product should be used immediately.
Do not use this medicine if you notice visible particles or discoloration of the solution before use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tirofiban Aurobindo contains
The active substance is tirofiban hydrochloride monohydrate.
1 ml of Tirofiban Aurobindo contains 56 micrograms of tirofiban hydrochloride monohydrate, equivalent
to 50 micrograms of tirofiban.
The other components are: sodium chloride, sodium citrate, anhydrous citric acid, water for injectable
preparations, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).

Description of the appearance of Tirofiban Aurobindo and package contents
Tirofiban Aurobindo is a clear, colourless solution, available in 300 ml bags.
Packaging: 1 or 3 infusion bags containing 250 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Arrow Génériques
26 avenue Tony Garnier,
Lyon, 69007
France

This medicinal product is authorised in the European Economic Area countries under the
following names:
France: Tirofiban Arrow 50 microgrammes/mL, solution for infusion
Italy: Tirofiban Aurobindo
Netherlands: Tirofiban Eugia 0.05 mg/ml, oplossing voor infusie
Portugal: Tirofibano Generis

The following information is intended exclusively for healthcare professionals:

This product is for hospital use only, administered by specialist physicians experienced in the management of
acute coronary syndromes.
Tirofiban Aurobindo must be administered with unfractionated heparin and oral antiplatelet therapy,
including acetylsalicylic acid (ASA).
Dosage and method of administration
In patients treated with an early invasive strategy for acute coronary syndromes without ST-segment elevation (NSTE-ACS), but for whom angiography is not planned within at least 4 hours and up to 48 hours after diagnosis, Tirofiban Aurobindo is administered intravenously at an initial infusion rate of 0.4 micrograms/kg/min for 30 minutes. After completion of the initial infusion, Tirofiban Aurobindo should be continued at a maintenance infusion rate of 0.1 micrograms/kg/min. Tirofiban Aurobindo should be administered with unfractionated heparin (typically an intravenous bolus of 50–60 units (U)/kg given concomitantly with the start of Tirofiban Aurobindo therapy, followed by approximately 1,000 U per hour, titrated based on 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 patients with NSTE-ACS undergoing coronary angioplasty within 4 hours of diagnosis or in patients with acute myocardial infarction scheduled for primary angioplasty, Tirofiban Aurobindo should be administered using an initial bolus of 25 micrograms/kg given over 3 minutes, followed by continuous infusion at a rate of 0.15 micrograms/kg/min for a period of 12–24 hours and up to 48 hours. Tirofiban Aurobindo should be administered with unfractionated heparin (dose as described above) and oral antiplatelet therapy, including but not limited to ASA, unless contraindicated.
Dose adjustment is not required in elderly patients.
Patients with severe renal impairment
In severe renal impairment (creatinine clearance <30 ml/min), the dose of Tirofiban Aurobindo should be reduced by 50%.
Paediatric population
The safety and efficacy of Tirofiban Aurobindo in children has not been established.
No data are available.
Initiation and duration of Tirofiban Aurobindo therapy
In patients treated with an early invasive strategy for NSTE-ACS, but for whom angiography is not planned within at least 4 hours and up to 48 hours after diagnosis, the loading dose of Tirofiban Aurobindo of 0.4 micrograms/kg/min should be initiated immediately after diagnosis. The recommended duration of the maintenance infusion should be at least 48 hours. The infusion of Tirofiban Aurobindo and unfractionated heparin may continue during coronary angiography and should be maintained for at least 12 hours and no longer than 24 hours after angioplasty/atherectomy. The infusion should be discontinued once the patient is clinically stable and no further coronary intervention procedures are planned by the treating physician. The total duration of treatment should not exceed 108 hours.
If a patient diagnosed with NSTE-ACS undergoes an invasive procedure and undergoes angiography within 4 hours of diagnosis, the bolus regimen of Tirofiban Aurobindo of 25 micrograms/kg should be initiated at the beginning of percutaneous coronary intervention (PCI), and the infusion continued for 12–24 hours and up to 48 hours. In patients with acute myocardial infarction undergoing primary PCI, the bolus should be initiated as soon as possible after diagnosis.
Concomitant therapy (unfractionated heparin, oral antiplatelet therapy, including ASA)
Unfractionated heparin treatment should be initiated with an intravenous bolus of 50–60 U/kg, followed by a maintenance infusion of 1,000 U per hour. The heparin dose should be 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, prior to initiation of Tirofiban Aurobindo therapy. This treatment should continue for at least the entire duration of Tirofiban Aurobindo infusion. Most studies evaluating Tirofiban Aurobindo administration as adjunct to PCI used ASA in combination with clopidogrel as oral antiplatelet therapy. The efficacy of combining Tirofiban Aurobindo with prasugrel or ticagrelor has not been established in randomized controlled clinical trials.
If angioplasty (PCI) is performed, heparin should be discontinued at the end of the procedure and the introducer sheath removed once coagulation has returned to normal, e.g., when activated clotting time (ACT) is less than 180 seconds (usually 2–6 hours after discontinuation of heparin).
Incompatibilities
Incompatibility has been observed with diazepam. Therefore, Tirofiban Aurobindo and diazepam must not be administered through the same intravenous line.
No incompatibilities have been observed between Tirofiban Aurobindo and the following intravenous medications: atropine sulfate, dobutamine, dopamine, epinephrine HCl, furosemide, heparin, lidocaine, midazolam HCl, morphine sulfate, nitroglycerin, potassium chloride, propranolol HCl, and injectable famotidine.
Instructions for use
Check the expiry date.
Do not withdraw solution directly from the container using a syringe.
To open: tear the protective film (250 ml infusion solution) at the notch and remove the inner container. Check for small leaks by firmly pressing the inner bag. If leaks are detected, discard the solution as sterility may be compromised.
Instructions for use of containers
Do not use if the solution is not clear or if the seal is not intact.
Do not add supplementary medications or withdraw solution directly from the bag using a syringe.
WARNING: do not use plastic containers in series connections. This may result in gas embolism due to residual air being drawn from the primary container before fluid administration from the secondary container is complete.
Preparation for administration

1. Identify the infusion port.
2. Remove the cover from the infusion port. The membrane beneath the cover is sterile – disinfection of the membrane is not required!
3. Close the roller clamp. Insert the spike until the plastic collar of the port meets the shoulder of the spike. Use a non-vented set or close the air inlet.
4. Hang the bag on the infusion stand. Squeeze the drip chamber to fill it with fluid. Start the infusion set. Connect and adjust the flow rate.

Use according to the dosage table provided above. The following table is provided as a guide for dose adjustment based on body weight.

• Wherever solution and container permit, parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
• Tirofiban Aurobindo must be administered only by intravenous route and may be co-administered with unfractionated heparin through the same infusion line.
• It is recommended that Tirofiban Aurobindo be administered using a calibrated infusion set, employing sterile materials.
• Care should be taken to ensure that the infusion time of the initial dose is not prolonged and that calculation errors in the weight-based infusion rate for the maintenance dose are avoided.

Special precautions for storage
Do not use Tirofiban Aurobindo after the expiry date stated on the bag after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicinal product from light.
Nature and contents of the container
Tirofiban Aurobindo is a clear, colourless solution, available in 300 ml bags.
Packaging: 1 or 3 infusion bags containing 250 ml of solution.
It is possible that not all pack sizes are marketed.
Special precautions for disposal and handling
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.