INTRODUCTION

FONDASTAR 2.5MG INJECTION contains fondaparinux which belongs to the group of medicines called Anti-thrombotic agents. It is used to treat deep vein thrombosis and pulmonary embolism in adults, prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopedic surgery or abdominal surgery and treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart) and to treat blood clots in blood vessels that are near the surface of the skin of the legs (superficial vein thrombosis).

Deep vein thrombosis occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs. Deep vein thrombosis can cause leg pain or swelling and can occur with no symptoms. Pulmonary embolism (PE) is a blood clot that develops in a blood vessel in the body (often in the leg) and then travels to a lung artery where it suddenly blocks blood flow to the artery of the lungs.

FONDASTAR 2.5MG INJECTION is not recommended for use in patients having bacterial heart infection, very severe kidney disease or are bleeding excessively. Before receiving FONDASTAR 2.5MG INJECTION, inform your doctor if you have the risk of uncontrolled bleeding (hemorrhage) including stomach ulcer, bleeding disorders, recent bleeding into the brain (intracranial bleeding), recent surgery on the brain, spine or eye or severe liver disease.

FONDASTAR 2.5MG INJECTION is not recommended to use among pregnant or breastfeeding women. Consult your doctor before receiving it. FONDASTAR 2.5MG INJECTION should be used with caution in elderly patients above 75 years of and is not recommended for use in children below 17 years of age.

The most common side effects of receiving FONDASTAR 2.5MG INJECTION are bleeding from an operation site, an existing stomach ulcer, nosebleed and bruising. Consult your doctor if any of the symptoms worsen.

USES OF FONDASTAR 2.5MG INJECTION

Treats:

• Deep vein thrombosis
• Pulmonary embolism in adults
• Some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart)
• Blood clots in blood vessels that are near the surface of the skin of the legs (superficial vein thrombosis)

Prevents formation of blood clots:

• In the blood vessels of the legs or lungs after orthopedic surgery or abdominal surgery
• During and shortly after a period of restricted mobility due to acute illness

HOW FONDASTAR 2.5MG INJECTION WORKS

FONDASTAR 2.5MG INJECTION acts by stopping a clotting factor Xa (“ten-A”) from working in the blood and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.

DIRECTIONS FOR USE

FONDASTAR 2.5MG INJECTION given to you by your doctor or nurse as an injection under the skin (subcutaneously) into a skin fold of the lower abdominal area or in the vein (intravenously). Your doctor will decide the correct dose and duration of FONDASTAR 2.5MG INJECTION for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF FONDASTAR 2.5MG INJECTION

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Ask for your doctor’s advice if diarrhea doesn’t improve.

Nausea:

Stick to simple meals while receiving FONDASTAR 2.5MG INJECTION. Avoid eating rich or spicy food. Do not take any medication on your own. Ask for your doctor’s advice if nausea doesn’t improve.

Headache:

Try to take rest and don’t involve yourself in exertive activities. Rest in a quiet and dark room. Apply a pain-relieving balm on your forehead. Ask for your doctor’s advice if headache doesn’t improve

Vomiting:

Drink clear or ice-cold drinks. Eat light, bland foods and avoid fried, oily or sweet foods. Avoid carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve.

Stomach pain:

Try to rest and relax. Try to have smaller and frequent meals. Keep a heat pad on your stomach. Take your physicians advice.

Drowsiness:

Take adequate sleep. Do not involve in rigorous activities. Do not interfere with your sleep cycle. Talk to your doctor if the drowsiness doesn’t improve.

Itchy skin:

Hot water makes your skin irritated, so avoid taking hot showers. Do not scratch the affected area. Use sunscreen and protective clothing when outdoors. To soothe and hydrate the irritated skin, apply moisturizers. Contact your doctor if itching worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before receiving FONDASTAR 2.5MG INJECTION, inform your doctor if you are receiving any of the following medicine:

• heparin or heparin-like medicines (used to prevent blood clotting)

Overdosage:

FONDASTAR 2.5MG INJECTION will be administered only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if there are any unusual symptoms

SYNOPSIS

MORE INFORMATION

• Keep FONDASTAR 2.5MG INJECTION out of reach of children
• Store FONDASTAR 2.5MG INJECTION below 25°C

FAQs ABOUT FONDASTAR 2.5MG INJECTION

What precautions should I need to follow while receiving FONDASTAR 2.5MG INJECTION?

Patients receiving FONDASTAR 2.5MG INJECTION must inform their doctor about their existing disease conditions like liver disease, kidney disease or uncontrolled bleeding (hemorrhage) including stomach ulcer, bleeding disorders, recent bleeding into the brain (intracranial bleeding), recent surgery on the brain, spine or eye. Consult your doctor if you experience any unusual symptoms after receiving FONDASTAR 2.5MG INJECTION.

Can FONDASTAR 2.5MG INJECTION be used on infants?

No. FONDASTAR 2.5MG INJECTION is generally used in adults and is not recommended for use in children and adolescents below the age of 17 years. Your doctor will select the correct dose or suitable alternate therapy for your child.

Can I take FONDASTAR 2.5MG INJECTION intramuscularly?

No. FONDASTAR 2.5MG INJECTION should be given under the skin (subcutaneously) into a skin fold of the lower abdominal area or in a vein (intravenously) in some specific conditions. Consult your doctor before receiving [GBNKEYWROD].

Can [GBNKEYWROD] cause anemia?

Yes. [GBNKEYWROD] causes anemia. However, it does not affect every individual. Consult your doctor immediately if you experience any unusual symptoms that occur after receiving [GBNKEYWROD].

Is [GBNKEYWROD] suitable for patients with kidney disease?

FONDASTAR 2.5MG INJECTION is not recommended for use in patients having very severe kidney diseases. In the case of kidney disease patients, the dose is required to be adjusted accordingly. Consult your doctor before receiving [GBNKEYWROD]. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

What are the common side effects of FONDASTAR 2.5MG INJECTION?

The common side effects of FONDASTAR 2.5MG INJECTION are bleeding from an operation site or an existing stomach ulcer, nosebleed, bruising and anemia. Consult your doctor if any of the symptoms worsen.

REFERENCES

1. Kerstin Hogg and Jeffrey I. Weitz. Blood Coagulation and Anticoagulant, Fibrinolytic and Antiplatelet Drugs. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018 Page – 585-603.

2. David Bergqvist. Review of fondaparinux sodium injection for the prevention of venous thromboembolism in patients undergoing surgery. Journal of Vascular health and risk management. NIH National Library of Medicine, National Centre for Biotechnology Information. Pubmed Central. December 2006 [Accessed on 16th May]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1994024/

3. Enokiya T, Hasegawa M, Morikawa Y, Muraki Y, Sudo A, Okuda M. Postoperative Anaemia Is a Risk Factor for Bleeding-Related Event in Thromboprophylaxis Using Fondaparinux Sodium Injection after Total Knee or Hip Arthroplasty. NIH National Library of Medicine, National Centre for Biotechnology Information. Pubmed.gov. [Accessed on 16th May]. https://pubmed.ncbi.nlm.nih.gov/32009116/

4. Mylan products limited. Electronic Medicines Compendium (EMC). [Revised in June 2021]. [Accessed on 16th May]. https://www.medicines.org.uk/emc/files/pil.3340.pdf

5. Mylan products limited. Electronic Medicines Compendium (EMC). [Revised in June 2021]. [Accessed on 16th May]. https://www.medicines.org.uk/emc/files/pil.3335.pdf

USEFUL DIAGNOSTIC TESTS

• Activated Partial Thromboplastin Time
• Platelet Count
• Prothrombin Time