Hematopoietic progenitor cells, cord blood (Intravenous route)
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Hematopoietic progenitor cells, cord blood administration can result in serious, including fatal, infusion reactions. Monitor patients and discontinue the infusion for severe reactions. Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), dextran 40, hydroxyethylstarch, or human serum albumin. Graft-vs-host disease (GVHD) is expected and may be fatal. Administration of immunosuppressive therapy may decrease the risk of GVHD. Engraftment syndrome may progress to multiorgan failure and death. Treat engraftment syndrome promptly with corticosteroids. Graft failure may be fatal. Monitor patients for laboratory evidence of hematopoietic recovery. Prior to choosing a specific unit of hematopoietic progenitor cells, cord blood, consider testing for HLA antibodies to identify patients who are alloimmunized .
Uses of This Medicine:
Hematopoietic progenitor cells, cord blood is used for blood cell transplantation procedures in patients with disorders that affect blood production. This medicine is derived from human blood that is collected from the umbilical cord and placenta. The hematopoietic progenitor cells go to the bone marrow where they become red blood cells, white blood cells, or platelets. These cells enter the blood stream and help restore low blood counts in patients with blood disorders.
This medicine is to be given only by or under the immediate supervision of your doctor.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hematopoietic progenitor cells, cord blood in children.
Although appropriate studies on the relationship of age to the effects of hematopoietic progenitor cells, cord blood have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving this medicine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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 antibiotics (eg, amoxicillin, ciprofloxacin, penicillin, Augmentin®, Bactrim®, Septra®), history of—Use with caution. May cause side effects to become worse.
- Allergy to dextran 40 or
- Allergy to dimethyl sulfoxide (DMSO) or
- Allergy to hydroxyethylstarch or
- Allergy to plasma proteins—Should not be used in patients with these conditions.
Proper Use of This Medicine:
A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
You may also receive medicines (eg, antihistamines, corticosteroids) to help prevent adverse reactions to the injection.
Precautions While Using This Medicine:
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a skin rash, hives or itching, sweating, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you get the injection.
This medicine may cause infusion reactions. This can occur while you are receiving the injection or in the first few hours after it has ended. Check with your doctor or nurse right away if you have headaches, dizziness, muscle aches, fever or chills, or a skin reaction, such as a rash or itching.
Tell your doctor right away if you have a fever, rash, diarrhea, unexplained weight gain, or yellow skin or eyes. These may be symptoms of serious conditions called graft-versus-host disease or engraftment syndrome.
Tell your doctor right away if you have swollen glands, a fever, diarrhea, loss of appetite, stomach pain, or weight loss after receiving this medicine. These may be symptoms of a rare, but serious condition, called posttransplant lymphoproliferative disorder (PTLD). It can be life-threatening and requires immediate medical attention.
This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
Side Effects of This Medicine:
- More common
- Blurred vision
- chest pain or discomfort
- difficult or labored breathing
- lightheadedness, dizziness, or fainting
- pounding in the ears
- shortness of breath
- slow, irregular, or fast heartbeat
- tightness in the chest
- unusual tiredness
- Less common
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- raised red swellings on the skin, lips, tongue, or in the throat
- skin rash or itching over the entire body
- Incidence not known
- Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
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 or nurse immediately if any of the following side effects occur:
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:
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.
Last Updated: 11/4/2014