Dalteparin

What is Dalteparin?

• Dalteparin (Fragmin) is a low molecular weight heparin (LMWH) used for prophylaxis or treatment of deep vein thrombosis and pulmonary embolism to reduce the risk of a stroke or heart attack.

Fragmin

Heparin General Structure V.1

What are the uses of this medicine?

Dalteparin (Fragmin) is used as:

• Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction.
• Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness.
• Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the Fragmin therapy begins with the initial VTE treatment and continues for six months.
• Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older.

How does this medicine work?

• The sodium salt of a low molecular weight, synthetic heparin.
• As an anticoagulant/antithrombotic agent, dalteparin binds to antithrombin and enhances the inhibition of Factor Xa.
• Compared to unfractionated heparins, the use of dalteparin is associated with lower incidences of osteoporosis and heparin-induced thrombocytopenia.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Patients with active major bleeding.
• Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis.
• Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions).
• Patients undergoing Epidural/Neuraxial anesthesia, do not administer Fragmin
• As a treatment for unstable angina and non-Q-wave MI.
• For prolonged VTE prophylaxis.
• Patients with prior hypersensitivity to heparin or pork products.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• anagrelide (Agrylin)
• apixaban (Eliquis)
• aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others), indomethacin (Indocin, Tivorbex), ketoprofen, and naproxen (Aleve, Anaprox, others)
• cilostazol
• clopidogrel (Plavix)
• dabigatran (Pradaxa)
• dipyridamole (Persantine, in Aggrenox)
• edoxaban (Savaysa)
• heparin
• prasugrel (Effient)
• rivaroxaban (Xarelto)
• ticagrelor (Brilinta)
• ticlopidine
• warfarin (Coumadin, Jantoven)

Is this medicine FDA approved?

• Dalteparin (dal' te par' in) (average 5,000 daltons) was approved in the United States in 1994 and is available in liquid solution in single or multidose vials under the brand name Fragmin.

How should this medicine be used?

Recommended dosage: For Unstable angina and non-Q-wave MI:

• 120 IU/kg subcutaneous every 12 hours (with aspirin).

For DVT prophylaxis in abdominal surgery: Postoperative start :

• 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 IU subcutaneous once daily,

Preoperative start(day of surgery):

• 2,500 IU subcutaneous 2 hours before surgery followed by 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 IU subcutaneous once daily.

Preoperative start(Evening Before Surgery):

• 5,000 IU subcutaneous followed by 5,000 IU subcutaneous 4 to 8 hours after surgery.

For DVT prophylaxis in medical patients:

• 5,000 IU subcutaneous once daily.

For Extended treatment of VTE in adult patients with cancer:

• Month 1: 200 IU/kg subcutaneous once daily
• Months 2 – 6: 150 IU/kg subcutaneous once daily

For Treatment of VTE in pediatric patients:

• 4 Weeks to less than 2 Years: 150 IU/kg twice daily
• 2 Years to less than 8 Years: 125 IU/kg twice daily
• 8 Years to less than 17 Years: 100 IU/kg twice daily

Administration:

• Dalteparin comes as a solution in vials and prefilled syringes to inject subcutaneously.
• When used for adults, it is usually given once a day, but may be given twice a day for certain conditions.
• When used for children, it is usually given twice a day.
• The length of your treatment depends on the condition that you have and how well your body responds to the medication.
• If you are using dalteparin to prevent complications from angina and heart attacks it is usually given for 5 to 8 days.
• If you are using dalteparin to prevent DVT after surgery, it is usually given on the day of surgery, and for 5 to 10 days after surgery.
• If you are using dalteparin to prevent DVT in people who are on bedrest, it is usually given for 12 to 14 days.
• If you have cancer and dalteparin is used to treat and prevent DVT, you may need to use the medication for up to 6 months.
• Dalteparin may be given to you by a nurse or other healthcare provider, or you may be told to inject the medication at home. If you will be using dalteparin at home, a healthcare provider will show you how to inject the medication.
• Inject the medication at about the same times every day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2,500 IU/ 0.2 mL, 5,000 IU/ 0.2 mL, 7,500 IU/ 0.3 mL, 12,500 IU/ 0.5 mL, 15,000 IU/ 0.6 mL, and 18,000 IU/ 0.72 mL single-dose prefilled syringes
• Injection: 10,000 IU/mL single-dose graduated syringes
• Injection: 95,000 IU/ 3.8 mL (25,000 IU/mL) multiple-dose vials
• Injection: 10,000 IU/ 4 mL (2,500 IU/mL) single-dose vials

This medicine is available in fallowing brand namesː

• Fragmin

What side effects can this medication cause?

The most common side effects of this medicine include:

• bleeding (including hemorrhage), thrombocytopenia (Type I), hematoma at the injection site, pain at the injection site, transient elevation of transaminases

Less common, but serious side effects may include:

• Risk of Hemorrhage including Spinal/Epidural Hematomas
• Thrombocytopenia
• Benzyl Alcohol Preservative Risk to Premature Infants

What special precautions should I follow?

• Epidural or spinal [[]]hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.
• Use Fragmin with extreme caution in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacterial endocarditis, congenital or acquired bleeding disorders, active ulceration and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal or ophthalmological surgery.
• Fragmin may enhance the risk of bleeding in patients with thrombocytopenia or platelet defects; severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding. Bleeding can occur at any site during therapy with Fragmin.
• Heparin-induced thrombocytopenia can occur with the administration of Fragmin. Monitor thrombocytopenia of any degree closely.
• Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low-birth weight infants treated with medications that contain the preservative benzyl alcohol. Use preservative-free Fragmin in neonates and infants.
• Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with Fragmin.
• Limited published data indicate that dalteparin is present in human milk in small amounts). No adverse effects on the breastfed infant have been reported. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fragmin and any potential adverse effects on the breastfed child from Fragmin or from the underlying maternal condition.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• hemorrhagic complications

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• These may generally be stopped by slow intravenous injection of [[]]protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa IU of Fragmin given.
• Take particular care to avoid overdosage with protamine sulfate.
• Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions.
• Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available.

Can this medicine be used in pregnancy?

• Available data from published literature and postmarketing reports have not reported a clear association with Fragmin and adverse developmental outcomes.
• Because animal reproduction studies are not always predictive of human response, Fragmin should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of Fragmin for the treatment of symptomatic venous thromboembolism (VTE) in patients have been established in pediatric patients aged 1 month and older.
• Cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered ,
• Use preservative-free Fragmin in neonates and infants.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DALTEPARIN SODIUM

Inactive ingredients:

• WATER
• SODIUM CHLORIDE

Who manufactures and distributes this medicine?

• Fragmin is a registered trademark of Pfizer Health AB.

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F).
• The needle shield of the prefilled syringe may contain natural rubber latex.

• Dailymed label info on Dalteparin
• FDA Dalteparin

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