Patient Medication Information: uses, side effects, how to take - Argatroban
What is ARGATROBAN used for:
ARGATROBAN is used to prevent blood clots from forming in patients who have received therapy with heparin (another type of blood thinner used to treat blood clots) and developed blood clots as a result of the heparin therapy.
How does ARGATROBAN work?
ARGATROBAN reduces or stops the activity of thrombin, a component in the blood which is necessary for blood clotting.
What are the ingredients in ARGATROBAN?
Medicinal ingredients: argatroban
Non-medicinal ingredients: D-sorbitol, dehydrated alcohol and water for injection.
ARGATROBAN comes in the following dosage forms:
Concentrate, solution for intravenous injection; 250 mg/2.5 mL vial.
Do not use ARGATROBAN if:
- you are hypersensitive or “allergic” to the active ingredient argatroban or to any ingredient in the formulation (see ‘What are the ingredients in ARGATROBAN:’ section).
- you have active major bleeding or a bleeding disorder.
- you have a rare disease known as hereditary fructose intolerance.
The safety of ARGATROBAN has not been established in children age 18 and younger.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given ARGATROBAN. Talk about any health conditions or problems you may have, including if you:
- have or have had a bleeding disorder, such as hemophilia (a condition where blood takes a long time to clot) or ulcers (a condition in which sores and possibly bleeding occur in the stomach or intestines);
- have high blood pressure;
- have had or about to have surgery;
- are pregnant or nursing;
- have a liver disease or problems.
Other warnings you should know about:
Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They will do blood tests to check your blood.
Pregnancy and breastfeeding:
- Do not use ARGATROBAN if you are pregnant. It may harm your unborn baby.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with ARGATROBAN.
- Do not breastfeed while you are given ARGATROBAN.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ARGATROBAN:
- Medications used to prevent blood clotting such as ASA, clopidogrel, ticlopidine, prasugrel, ticagrelor
- Medications used to thin the blood such as warfarin, heparin, low molecular weight heparins
- Acetaminophen (a drug taken for pain)
How to use ARGATROBAN:
ARGATROBAN must be administered by a healthcare professional experienced in anti-thrombotic therapy.
Concentrate Solution:
ARGATROBAN is supplied as a concentrate. It should be properly diluted prior to administration. It should not be mixed with other drugs prior to dilution in an infusion.
Usual dose: ARGATROBAN is a prescription drug and must be used as directed. It is administered as an intravenous injection, which means the injection is made into a vein. ARGATROBAN must NOT be given by any other route. Overdose: If you think you, or a person you are caring for, have been given too much ARGATROBAN, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose: n/a
What are possible side effects from using ARGATROBAN?
These are not all the possible side effects you may have when given ARGATROBAN. If you experience any side effects not listed here, tell your healthcare professional.
Along with its intended action, any medication, including ARGATROBAN, may cause side effects. Most adverse events are mild and tend to diminish with continuation of therapy.
The most common side effects are:
- bleeding,
- stomach upset (nausea and vomiting),
- diarrhea,
- low blood pressure,
- difficulty breathing,
- increased heartbeat,
- dizziness,
- fever and
- chest pain.
The most serious side effect is unusual bleeding (such as hemorrhage).
The following table contains a list of side effects that may occur with ARGATROBAN.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Stomach pain, nausea or diarrhea | X | ||
| COMMON | |||
| Any unusual bleeding | X | ||
| Difficulty Breathing | X | ||
| Chest pain | X | ||
| Dizziness | X | ||
| Fever | X | ||
| Rapid heartbeat | X | ||
| Pain | X | ||
| Infection | X | ||
| UNKNOWN | |||
| Allergic reaction (symptoms like itching, swelling of the face, lips, tongue and throat, difficulty breathing) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice |
Storage:
Keep out of reach and sight of children.
Store the vials in the original cartons at room temperature (15 – 25oC, 59 – 77oF). Do not freeze. Store in carton until use. PROTECT FROM LIGHT.
Discard prepared solution if haziness, particulate matter, precipitate, discoloration or leakage is found upon inspection.
If you want more information about ARGATROBAN:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html ; the manufacturer’s website www.sandoz.ca or by calling 1-800-361-3062.