Description
Dalteparin is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. This medicine is also used together with aspirin to prevent blood clots from forming in blood vessels of patients with unstable angina or heart attack. Dalteparin is also used for several days after abdominal surgery, hip replacement surgery, or while you are unable to walk. It is during this time that blood clots are most likely to form. Dalteparin is also used to treat symptomatic blood clots (eg, pulmonary embolism or deep vein thrombosis) in children and as extended treatment of symptomatic blood clots in adults with cancer.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dalteparin to treat symptomatic blood clots in children younger than 1 month of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dalteparin in the elderly. However, elderly patients may require an adjustment in the dose, especially those who are at risk of bleeding or those who have kidney disease.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Defibrotide
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amtolmetin Guacil
- Anagrelide
- Anistreplase
- Antithrombin, Recombinant
- Apixaban
- Argatroban
- Aspirin
- Bemiparin
- Betrixaban
- Bivalirudin
- Bromfenac
- Bufexamac
- Caplacizumab-yhdp
- Celecoxib
- Choline Salicylate
- Citalopram
- Clonixin
- Clopidogrel
- Collagenase, Clostridium histolyticum
- Curcumin
- Dabigatran Etexilate
- Danaparoid
- Desvenlafaxine
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Dipyridamole
- Dipyrone
- Drotrecogin Alfa
- Droxicam
- Edoxaban
- Enoxaparin
- Eptifibatide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to pork or heparin or
- Bleeding, active or
- Regional anesthesia or
- Thrombocytopenia (low platelet count in the blood), heparin-induced, or history of—Should not be used in patients with these conditions.
- Bleeding problems or
- Catheter insertion in your spine or
- Eye problems caused by diabetes or high blood pressure or
- Heart infection or
- Hypertension (high blood pressure), severe and uncontrolled or
- Kidney disease or
- Liver disease or
- Stomach or intestinal ulcer or bleeding, active or recent or
- Stroke or
- Surgery (eg, surgery of the eye, brain, or spine), recent or history of or
- Thrombocytopenia—Use with caution. The risk of bleeding may be increased.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin (usually in the stomach, buttocks, or thighs). You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
If the medicine in the vial (glass container) or prefilled syringe has changed color, or if you see particles in it, do not use it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (solution):
- For prevention of blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
- Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 120 international units (IU) per kilogram (kg) of body weight injected under the skin (but not more than 10,000 IU) given every 12 hours for 5 to 8 days. Unless your doctor recommends otherwise, aspirin should be given 75 to 165 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis after abdominal surgery:
- Adults—2,500 or 5,000 international units (IU) injected under the skin once a day, or 2,500 IU injected under the skin followed by 2,500 IU injected under the skin given 12 hours later and then 5,000 IU injected under the skin once a day for 5 to 10 days.
- Children—Use and dose must be determined by your doctor.
- For prevention of deep venous thrombosis after hip replacement surgery:
- Adults—
- If started the evening before surgery: 5,000 international units (IU) injected under the skin 10 to 14 hours before surgery followed by 5,000 IU injected under the skin 4 to 8 hours after surgery, then 5,000 IU injected under the skin once a day.
- If started on the day of surgery: 2,500 IU injected under the skin within 2 hours before surgery followed by 2,500 IU injected under the skin 4 to 8 hours after surgery, then 5,000 IU injected under the skin once a day.
- If started after surgery: 2,500 IU injected under the skin given 4 to 8 hours after surgery, then 5,000 IU injected under the skin once a day, given 5 to 10 days after surgery.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For prevention of deep venous thrombosis in medical patients with acute illness:
- Adults—5,000 international units (IU) injected under the skin once a day for 12 to 14 days.
- Children—Use and dose must be determined by your doctor.
- For symptomatic deep venous thrombosis and pulmonary embolism in children:
- Children 8 to 16 years of age—Dose is based on body weight and must be determined by your doctor. At first, 100 internation units (IU) per kilogram (kg) of body weight injected under the skin 2 times a day. Your doctor will adjust your dose as needed.
- Children 2 to 7 years of age—Dose is based on body weight and must be determined by your doctor. At first, 125 IU per kg of body weight injected under the skin 2 times a day. Your doctor will adjust your dose as needed.
- Children 4 weeks to 1 year of age—Dose is based on body weight and must be determined by your doctor. At first, 100 IU per kg of body weight injected under the skin 2 times a day. Your doctor will adjust your dose as needed.
- Children younger than 4 weeks of age—Use and dose must be determined by your doctor.
- For symptomatic deep venous thrombosis and pulmonary embolism in patients with cancer:
- Adults—Dose is based on body weight and must be determined by your doctor. On the first 30 days, 200 international units (IU) per kilogram (kg) of total body weight injected under the skin (but not more than 18,000 IU) once a day. On months 2 to 6, 150 IU per kg of body weight injected under the skin once a day.
- Children—Use and dose must be determined by your doctor.
- For prevention of blood clots after unstable angina (chest pain) or non–Q-wave myocardial infarction (a type of heart attack):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If you were given a bottle of medicine to use with your syringes, you must use the medicine within 14 days after the first shot. Throw away any unused medicine after 14 days.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.
This medicine may increase your risk of bleeding or bruising. This risk is higher if you have poorly controlled high blood pressure, a heart infection, stomach ulcers, or other bleeding problems. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.
This medicine may increase your risk of serious bleeding or nerve problems in your spine. This risk is higher if you have a catheter in your back for pain medicine or anesthetics, or have an injection into your spine (sometimes called an "epidural" or "spinal"). Other factors include traumatic or repeated epidural or spinal punctures in the past, spinal deformity, previous spinal surgery, or use of other medications that increase the risk of bleeding. Check with your doctor right away if you develop weakness or numbness in your legs or feet, or loss of urine or bowel control.
Call your doctor right away if you start having pains in the chest, groin, or legs, especially the calves, difficulty with breathing, severe, sudden headache, slurred speech, sudden, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes. These may be symptoms of thromboembolism.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.
This medicine contains benzyl alcohol which may cause serious unwanted effects to newborn or premature infants. Talk to your doctor if you have concerns about this.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bruise
- deep, dark purple bruise, pain, or swelling at the injection site
- nosebleed
Less common
- Bleeding of the gums
- constipation
- coughing up blood
- difficulty with breathing or swallowing
- dizziness
- headache
- increased menstrual flow or vaginal bleeding
- paralysis
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- severe stomach pain
- unexplained pain, swelling, or discomfort, especially in the chest, abdomen or stomach, joints, or muscles
- unusual bleeding or bruising
- vomiting of blood or material that looks like coffee grounds
- weakness
Rare
- Back pain
- bleeding from mucous membranes
- bluish or black discoloration, flushing, or redness of the skin
- burning, pricking, tickling, or tingling sensation
- cough
- feeling faint
- fever
- leg weakness
- numbness
- problems with bowel or bladder function
- skin rash (which may consist of pinpoint, purple-red spots), hives, or itching
- sloughing of the skin at the injection site
- swelling of the eyelids, face, or lips
- tightness in the chest
Incidence not known
- Blue-green to black skin discoloration
- decrease in height
- pain in the ribs, arms, or legs
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Hair loss or thinning of hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20063314
