Tirofiban Altan 50 micrograms/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

TIROFIBAN ALTAN 50 micrograms/ml solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Tirofiban Altan is used to help improve blood flow to the heart and to prevent chest pain and heart attacks. It works by preventing platelets, which are blood cells, from clumping together and forming blood clots.

This medicine may also be used in patients whose arteries are widened with a balloon (percutaneous coronary intervention or PCI). This is a procedure achieved by implanting a small tube (stent) to improve blood flow to the heart.

Tirofiban Altan is intended to be used with aspirin and unfractionated heparin.

2. What you need to know before starting to use Tirofiban Altan

Do not use Tirofiban Altan:

• If you are allergic (hypersensitive) to tirofiban or to any of the other components of this medicine (listed in section 6)
• If you have internal bleeding or a history of internal bleeding within the last 30 days.
• If you have a history of intracranial bleeding, a brain tumor, or abnormal blood vessels in the brain.
• If you have severe uncontrolled high blood pressure (malignant hypertension).
• If you have low platelet count (thrombocytopenia) or blood coagulation disorders.
• If you developed thrombocytopenia while being treated with Tirofiban Altan or another medicine in the same therapeutic group.
• If you have had a stroke within the previous 30 days or any history of hemorrhagic stroke.
• If you have had major trauma or major surgery within the past six weeks.
• If you have severe hepatic impairment.

Your doctor will review your medical history to determine if you are at increased risk of experiencing side effects associated with the use of this medicine.

Warnings and precautions

Talk to your doctor before starting to use Tirofiban Altan, if you have or have had:

• Any medical condition.
• Any allergies.
• Cardiopulmonary resuscitation, biopsy, or lithotripsy within the last 2 weeks.
• Major trauma or major surgery within the last 3 months.
• A stomach or intestinal (duodenal) ulcer within the last 3 months.
• Recent hemorrhagic disorder (within the last year), such as bleeding in the stomach or intestine, or blood in urine or stools.
• Recent spinal intervention.
• History or symptoms of aortic rupture (aortic dissection).
• Uncontrolled high blood pressure.
• Inflammation of the membrane lining the heart (pericarditis).
• Inflammation of blood vessels (active vasculitis).
• Hemorrhagic retinopathy.
• Thrombolytic treatment.
• Liver problems.
• Insertion of a special intravenous catheter below the clavicle within the last 24 hours.
• Heart failure.
• Low blood pressure due to heart failure (cardiogenic shock).
• Liver disorder.
• Low blood count or anemia.

Use of Tirofiban Altan with other medicines

In general, Tirofiban Altan can be used with other medicines. Please tell your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, as they may affect the action of this medicine. It is very important to inform your doctor if you are taking medicines that prevent blood clotting, such as warfarin.

Use of Tirofiban Altan with food, drinks, and alcohol

Food and drinks do not affect this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and use of machines

Due to your medical condition, you will not be able to drive or operate machinery while using Tirofiban Altan.

Tirofiban Altan contains sodium

This medicine contains 916.28 mg of sodium (the main component of table or cooking salt) in each 250 ml bag. This is equivalent to 46% of the maximum recommended daily intake of sodium for an adult.

3. How to use Tirofiban Altan

Tirofiban Altan must be prescribed by qualified physicians experienced in the management of acute coronary syndromes.

Tirofiban Altan is administered intravenously. Your doctor will determine the appropriate dose based on your condition and body weight.

Use in children

Use in children is not recommended.

If you use more Tirofiban Altan than you should

Y our dose of Tirofiban Altan will be carefully monitored and supervised by your doctor and pharmacist.

The most commonly reported adverse effect due to overdose is bleeding. If you experience bleeding, you must inform your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested.

If you forget to use Tirofiban Altan

Your doctor will decide when to administer this medicine.

If you stop using Tirofiban Altan

Your doctor will decide when treatment should be discontinued. However, if you wish to stop treatment earlier, you should discuss alternative options with your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most common adverse effect during treatment with Tirofiban Altan is bleeding, which may occur anywhere in your body. This adverse effect can be serious and, rarely, may be fatal.

If you experience side effects, you may require medical attention. While receiving Tirofiban Altan, if you develop any of the following symptoms, you must contact your doctor immediately:

• Signs of intracranial bleeding such as headache, sensory deficits (visual or hearing), difficulty speaking, numbness, or problems with movement or balance.
• Signs of internal bleeding such as coughing up blood or presence of blood in urine or stools.
• Signs of serious allergic reactions such as difficulty breathing or dizziness.

Listed below are adverse effects that have occurred in patients treated with Tirofiban Altan. These adverse effects are classified in decreasing order of frequency.

Very common adverse effects (may affect more than 1 in 10 people):

Bleeding after surgery

Bleeding under the skin at the injection site, or in the muscle causing swelling

Small red spots on the skin

Occult blood in urine or stools

Feeling dizzy

Headache

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

Blood in urine

Coughing up blood

Nosebleeds

Bleeding from gums or mouth

Bleeding at puncture site

Reduction in blood count (reduction in hematocrit and hemoglobin)

Decrease in platelet count below 90,000/mm³

Fever

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

Bleeding in stomach or intestine

Vomiting blood

Decrease in platelet count below 50,000/mm³

Adverse effects of unknown frequency (cannot be estimated from available data):

Intracranial bleeding

Spinal hematoma

Retroperitoneal bleeding

Accumulation of blood around the heart

Pulmonary hemorrhage

Acute and severe decrease in platelet count below 20,000/mm³

Severe allergic reactions with chest tightness, urticaria, including reactions that may cause difficulty breathing and dizziness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.com. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tirofiban Altan

Your doctor or pharmacist will know how to store and dispose of this medicine. Keep out of the sight and reach of children.

After opening, this medicine should be used immediately.

Do not use this medicine after the expiry date stated on the bag. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use Tirofiban Altan if visible particles are present or if the solution is discolored before use.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tirofiban Altan

The active substance is tirofiban.

1 ml of concentrate for solution for infusion contains 50 micrograms of tirofiban.

Other ingredients are: sodium acetate trihydrate, acetic acid, sodium chloride, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the medicinal product and content of the container

Tirofiban Altan is a clear, colourless solution supplied in 250 ml bags.

Pack size: 1 or 3 bags containing 250 ml of solution for infusion. Only certain pack sizes may be commercially available.

Marketing Authorisation Holder:

ALTAN PHARMACEUTICALS S.A.

C/Cólquide 6 Portal 2 1st Floor – Office F

28230 Las Rozas (Madrid)

Spain

Manufacturer:

ALTAN PHARMACEUTICALS S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

This medicinal product is authorised in EU Member States under the following names:

< Germany > Tirofiban Ibisqus 50 microgram/ml infusion solution
< France > Tirofiban Farmages 50 microgramme/ml solution for infusion
< Italy > Tirofiban Ibigen
< Spain > Tirofiban G.E.S. 50 microgramos/ml solución para perfusión EFG
< United Kingdom > Tirofiban 50 micrograms/ml solution for infusion

Date of the latest revision of this leaflet: September 2020

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”

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This information is intended for healthcare professionals only:

This product is intended exclusively for hospital use and must be administered by physicians experienced in the treatment of acute coronary syndromes.

Tirofiban Altan must be administered with unfractionated heparin and oral antiplatelet therapy, including acetylsalicylic acid (ASA), unless contraindicated.

Posology and method of administration

In patients treated with an early invasive strategy for acute coronary syndrome without ST-segment elevation (ACS-NSTEMI) who are not scheduled to undergo angiography within at least 4 hours and up to 48 hours after diagnosis, Tirofiban Altan is administered intravenously at an initial infusion rate of 0.4 micrograms/kg/min for 30 minutes. At the end of the initial infusion, Tirofiban Altan should be continued at a maintenance infusion rate of 0.1 micrograms/kg/min. Tirofiban Altan should be administered with unfractionated heparin (typically an intravenous bolus of 50–60 units (U)/kg given simultaneously with the initiation of Tirofiban Altan therapy, followed by approximately 1,000 (U) per hour, adjusted according to activated partial thromboplastin time (aPTT), which should be approximately twice the normal value) and oral antiplatelet therapy, including but not limited to ASA, unless contraindicated.

In patients with ACS-NSTEMI undergoing percutaneous coronary intervention (PCI) scheduled within the first 4 hours after diagnosis, or in patients with acute myocardial infarction undergoing primary PCI, Tirofiban Altan should be administered using an initial bolus dose of 25 micrograms/kg administered over a period of 3 minutes, followed by continuous infusion at a rate of 0.15 micrograms/kg/min for 18–24 hours, and up to 48 hours. Tirofiban Altan should be administered with unfractionated heparin and oral antiplatelet therapy, including but not limited to acetylsalicylic acid (ASA), unless contraindicated.

No dose adjustment is required for elderly patients.

Patients with severe renal impairment

In patients with severe renal impairment (creatinine clearance <30 ml/min), the dose of Tirofiban Altan should be reduced by 50%.

Paediatric population

The safety and efficacy of Tirofiban Altan in children has not been established.

No data are available.

Initiation and duration of TirofibanAltan

In patients treated with an early invasive strategy for acute coronary syndrome without ST-segment elevation (ACS-NSTEMI) who are not scheduled to undergo angiography within at least 4 hours and up to 48 hours after diagnosis, the Tirofiban Altan dosing regimen should be initiated after diagnosis at a rate of 0.4 micrograms/kg/min loading dose. The recommended duration of maintenance infusion should be at least 48 hours. The infusion of Tirofiban Altan and unfractionated heparin should be maintained during coronary angiography and continued for at least 12 hours and no more than 24 hours after angioplasty/atherectomy. Once the patient is clinically stable and no coronary intervention is planned by the physician, the infusion should be discontinued. The total duration of treatment should not exceed 108 hours.

If a patient diagnosed with ACS-NSTEMI is treated with an early invasive strategy and undergoes angiography within 4 hours after diagnosis, the bolus dosing regimen of Tirofiban Altan at 25 micrograms/kg should be initiated at the beginning of PCI, followed by continuous infusion for 12 to 24 hours and up to 48 hours. In patients with acute myocardial infarction undergoing primary PCI, the bolus infusion regimen should be initiated as soon as possible after diagnosis.

Concomitant treatment (unfractionated heparin, oral antiplatelet therapy including ASA)

Unfractionated heparin treatment is initiated with an intravenous bolus of 50–60 U/kg, followed by a maintenance infusion of 1,000 units per hour. The heparin dose should be titrated to maintain an activated partial thromboplastin time (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 Altan therapy. This medication should be continued for at least the duration of the Tirofiban Altan infusion.

Most studies investigating the administration of Tirofiban Altan as adjunctive therapy during PCI have used ASA in combination with clopidogrel as oral antiplatelet therapy. The efficacy of Tirofiban Altan in combination with prasugrel or ticagrelor has not been established in randomised, controlled trials.

If angioplasty (PCI) is required, heparin should be discontinued after PCI, and catheters should be removed once coagulation has returned to normal, for example, when the activated clotting time (ACT) is less than 180 seconds (typically 2–6 hours after discontinuation of heparin).

Incompatibilities

Cases of incompatibility with diazepam have been reported. Therefore, Tirofiban Altan and diazepam must not be administered via the same intravenous line.

No incompatibilities have been found between Tirofiban Altan and the following intravenous formulations: atropine sulfate, dobutamine, dopamine, epinephrine hydrochloride, furosemide, heparin, lidocaine, midazolam hydrochloride, morphine sulfate, nitroglycerin, potassium chloride, propranolol hydrochloride, and injectable famotidine.

Instructions for use:

Check the expiry date.

Do not withdraw the solution directly from the container with a syringe.

Instructions for use of containers

Do not use unless the solution is clear and the closure is intact.

Do not add supplementary medication or withdraw solution directly from the bag with a syringe.

PRECAUTION: Do not use plastic containers in series connections, as this may result in air embolism due to residual air being drawn from the primary container before completion of fluid administration from the secondary container.

Preparation for administration

Use according to the dosing table.

The following table is provided as a guide for dose adjustment based on body weight.

	0.4 micrograms/kg/min Loading Dose Regimen Most patients	0.4 micrograms/kg/min Loading Dose Regimen Severe renal impairment	25 micrograms/kg Bolus Dose Regimen Most patients	25 micrograms/kg Bolus Dose Regimen Severe renal impairment
Patient weight (kg)	Loading infusion rate 30 min (ml/h)	Maintenance infusion rate (ml/h)	Loading infusion rate 30 min (ml/h)	Maintenance infusion rate (ml/h)	Bolus (ml)	Maintenance infusion rate (ml/h)	Bolus (ml)	Maintenance infusion rate (ml/h)
30–37	16	4	8	2	17	6	8	3
38–45	20	5	10	3	21	7	10	4
46–54	24	6	12	3	25	9	13	5
55–62	28	7	14	4	29	11	15	5
63–70	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

• Parenteral drugs should always be inspected for the presence of visible particles or discoloration prior to administration, whenever solution and container permit.
• Tirofiban Altan must be administered intravenously only and may be given with unfractionated heparin through the same infusion line.
• It is recommended to administer Tirofiban Altan using a calibrated infusion set with sterile materials.
• Care must be taken to avoid prolonging the initial dose infusion and to prevent calculation errors in the maintenance dose infusion rates based on the patient's body weight.

Special storage precautions

Do not use Tirofiban Altan after the expiry date stated on the label and outer packaging. The expiry date refers to the last day of the month indicated.

Nature and contents of the container

Tirofiban Altan is a clear, colourless solution supplied as follows:

250 ml bags made of colourless, multilayer polyolefin membrane free of PVC, with two polyolefin tubes free of PVC and an administration port.

It is packaged in a pre-printed aluminum overpouch.

Pack sizes: 1 or 3 bags containing 250 ml of infusion solution. Some pack sizes may not be marketed.

Special precautions for disposal and other handling

Disposal of unused medication and of all materials that have been in contact with it must be carried out in accordance with local regulations.