Aggrastat 250 mcg/ml Concentrate for Solution for Infusion

Patient Leaflet Updated 10-Jan-2024 | ADVANZ Pharma

Aggrastat 250 mcg/ml concentrate for solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aggrastat (250 micrograms/ml) concentrate for 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 Aggrastat is and what it is used for
2. What you need to know before you use Aggrastat
3. How to use Aggrastat
4. Possible side effects
5. How to store Aggrastat
6. Contents of the pack and other information

1. What Aggrastat is and what it is used for

Aggrastat 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.

Aggrastat is intended for use with aspirin and unfractionated heparin.

2. What you need to know before you use Aggrastat
Do not use Aggrastat
  • if you are allergic (hypersensitive) to tirofiban or any of the other ingredients of Aggrastat (listed in Section 6 “What Aggrastat 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 Aggrastat 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 before using Aggrastat, 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 Aggrastat

In general, Aggrastat 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.

Aggrastat 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 for advice before using this medicine.

Driving and using machines

Due to your disease state, you will not be able to drive or operate machinery while Aggrastat is being used.

Aggrastat contains sodium

This medicinal product contains approximately 189 mg of sodium per 50 ml vial which should be taken into consideration by patients on a controlled sodium diet.

3. How to use Aggrastat

Aggrastat 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, Aggrastat 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 Aggrastat than you should

Your dose of Aggrastat 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 Aggrastat

Your doctor will decide when to administer the dose.

If you stop using Aggrastat

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 Aggrastat 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 Aggrastat, 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 Aggrastat. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store Aggrastat

Your physician and pharmacist will 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 which is stated on the label and outer carton after EXP.

The expiry date refers to the last day of that month.

Do not freeze. Keep container in outer carton to protect from light.

Do not use this medicine if you notice there are visible particles or discolouration of the solution before use.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Aggrastat contains

The active substance is tirofiban hydrochloride monohydrate.

1 ml of Aggrastat contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms tirofiban.

The other ingredients are Sodium chloride, sodium citrate dihydrate, citric acid anhydrous, water for injection, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

What Aggrastat looks like and contents of pack

Aggrastat is a clear, colourless concentrated solution available in a 50 ml Type I glass vial.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Focus Pharmaceuticals Limited
Dashwood House
69 Old Broad Street
London
EC2M 1QS
United Kingdom

Product Manufacturer
Orion Corporation
Orion Pharma Espoo site
Orionintie 1
FI 02200 Espoo
Finland

This leaflet was last revised in: 10/2023.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.

Company Contact Details
ADVANZ Pharma
Address

Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK

Medical Information Direct Line

+44 (0)208 588 9131

WWW

www.advanzpharma.com

Telephone

+44 (0)208 588 9131

Medical Information e-mail
Customer Care direct line

+44 (0)208 588 9273