Immunotherapy Guidelines The information provided here is not intended as a substitute for medical advice from your physician. The reader should regularly consult a physician in matters relating to his or her health and particularly with respect to any symptoms that may require diagnosis or medical attention. The information herein is a general guideline and may better prepare you to discuss this therapy with your physician. Aspirin Therapy Possible Side Effects You have been instructed to start low dose aspirin (78-81 mg/day). This is often sold as baby aspirin. The possible side effects of full dose aspirin are not often seen with baby aspirin. These side effects are nausea, heartburn, upset stomach, decreased appetite and microscopic amounts of blood in stools. The above mentioned side effects were mainly experienced in patients taking a normal adult dose or high dose of aspirin therapy. You are on a low dose aspirin regimen, so you will have minimal side effects, if any. On very rare occasions, allergic reactions have been observed following aspirin ingestion. If you have any history of aspirin sensitivity, please inform your nurse and your doctor. Aspirin Intolerance Aspirin intolerance manifested by exacerbation of bronchospasm and rhinitis may occur in patients with a history of nasal polyps, asthma, allergic skin reactions or rhinitis. If you have a past history of any of the above, please notify your physician before starting aspirin. The use of aspirin during pregnancy, especially chronic or intermittent high doses, may affect maternal and newborn blood clotting mechanisms, leading to an increased risk of bleeding. High dose aspirin may be related to increased perinatal mortality intrauterine growth retardation, and congenital defects. Aspirin at low doses (81 mg/day does not carry these risks. Since higher doses than 81 mg/day may have side effects, make sure that any medication that is prescribed for you during your pregnancy contains no additional aspirin. When you start to take low dose aspirin, moderation in taking the following foods is recommended: curry powder, paprika, licorice, prunes, raisins, gherkins, tea and other than the occasional use of non-absorbable antacids (Maalox, Rolaids). In addition, phenobarbital decreases aspirin efficacy. Aspirin is excreted into breast milk in low concentration ranging from 1.1 to 10 mcg/ml. Adverse effects of platelet function in the nursing infants have not been reported, but are a potential risk. If you choose to breast feed your baby you will not be taking low dose aspirin at that time. Heparin Therapy Hypersensitivity Purified commercial preparations of heparin are nontoxic, and side effects from the drug are infrequent. Because heparin is obtained from animal tissue, you should be cautious when you start the injections, especially if you have any history of allergy. Hypersensitivity reactions include chills, fever, skin eruptions, and in rare cases asthma, - rhinitis, excessive eye tearing, headache, nausea, vomiting, and anaphylactic shock. Before a therapeutic dose is given, a trial dose of 1000 IU of heparin injection may be advisable as a skin test. We use sodium heparin which can be extracted from either beef or pork. Please inform us if you have an allergy to either. Bleeding Heparin in blood thinning doses can cause mild reduction of platelet count and bleeding. Regular platelet and hematocrit monitoring during heparinization is recommended. The usual dosage for heparin administered during pregnancy will not cause this problem. If your physician recommends higher dosages, then blood clotting tests will be ordered at regular intervals. Side Effects Heparin is a type of anticoagulant which can cause blood in the urine, blood in the stool, nose bleeding and easy bruising. If any of these symptoms occur, contact our office immediately. Almost all patients experience some bruising at the site where the heparin is injected. If bruising occurs at other sites on your body, you must contact us. Osteoporosis Long term heparin therapy during pregnancy has been associated with osteoporosis (thinning of the bones) and spontaneous fractures in patients who have received 15,000 units or more of heparin daily for over 6 months (Ailo, 1975). One study found bone demineralization to be dose related, with more severe changes occurring after long-term therapy (>25 weeks) and in patients who had also received heparin in a previous pregnancy (De Swiet, 1983). Previous studies of 117 patients on long term heparin treatment showed none developed fracture in patients receiving less than 10,000 IU daily for as long as 15 years (Griffith et al, 1965). Even though our protocol uses low dose heparinization, we recommend supplementing calcium in your diet, i.e. milk or milk products and the addition of calcium supplements, if necessary, to minimize this possible side effect. A natural preventative of osteoporosis is some sun exposure and exercise, e.g., water aerobics during pregnancy. If you have hypersensitivity to the drug, active bleeding, hemophilia, purpura (tissue hemorrhage), thrombocytopenia (low platelet count), bacterial active tuberculosis, ulcerative lesions of the gastrointestinal tract, diverticulitis, ulcerative colitis or severe hypertension, Heparin therapy is contraindicated. Caution should be used when taking Heparin if you have mild hypertension, liver or kidney disease, or diabetes. This will be discussed with you by your physician. Preferred anti-coagulant Heparin has not been related to congenital defects, nor does it cross the placenta. It has been reported that heparin use during pregnancy has been associated with a 13 to 22% unfavorable pregnancy outcome including premature and still birth. Please note that this incidence was in patients who had severe maternal disease necessitating high dose anticoagulant therapy. Heparin is probably the preferred anticoagulant during pregnancy, but is not risk free. Your physician will share with you all the up-to-date data he has on heparin therapy and pregnancy outcome and on any complications that other women like yourself have experienced during pregnancy. The only statistically significant fact that has surfaced to date is that mothers on heparin deliver their babies at an average of 37 weeks instead of 40 weeks. Breastfeeding Heparin is not excreted in breast milk. It is safe to breast feed your baby while on heparin. Happily, heparin therapy is stopped at 34 weeks of pregnancy. The heparin may be administered subcutaneously or via a small ambulatory infusion pump, depending on your physician's orders. Guidelines for subcutaneous delivery follow, and should you have a pump, the instructions will be included in your patient training manual. Guidelines For Subcutaneous Heparin Injections Supplies 1 cc. tuberculin syringe or insulin syringe with 27-30 gauge needle (1 /2''-5/8" long) Alcohol wipes or Isopropyl Alcohol 70% (Rubbing Alcohol) Cotton balls Band aid (optional) Sodium Heparin (concentration that we recommend is 20,000 units/ml) Technique for Preparing the Injection Wash hands Collect all equipment needed for injection and prepare it in a clean area. Wipe off top of heparin vial with alcohol. Remove cap from needle and pull back on the plunger of the syringe to where it is equal to the amount you will be injecting. The syringe is now filled with only air. Insert the needle of the syringe into the center of the rubber stopper or the heparin vial. Push down on the plunger of the syringe and inject the air into the heparin vial. This is to help produce a suction when drawing up the heparin. While supporting both the heparin vial and syringe invert them so that the syringe is below the heparin vial. Be sure not to remove the syringe from the vial. Draw back the amount of heparin needed to inject. Look for air bubbles If any air bubbles are in the syringe flick them to the top and push on the plunger to release them. Once you have removed all air bubbles and have obtained the exact amount of heparin needed for injection remove the syringe from the heparin vial. Cap the needle until you are ready for the injection. Administration of Subcutaneous Heparin Wipe the area with alcohol. Do not rub! Remove cap from needle. Gently pick up a well defined fold of skin. Hold the syringe in a dart fashion and insert the needle directly into the skin at a 45-90 degree angle just into the subcutaneous "fatty layer" Move hand or finger in position to direct plunger. Do not remove needle once it is inserted and do not pull back on the plunger (this prevents damage to the small blood vessels which could lead to bleeding and bruising). Push down on plunger slowly as far as it will go. When all the heparin has been injected, slowly withdraw the needle at the same angle at which it entered, and also releasing the skin roll as you withdraw. Apply light pressure to the area with a cotton ball for a few minutes. Do not rub the area. Rubbing the area increases the chances for bruising and bleeding. Apply band aid only if necessary. The site may be irritated by the removal of the band aid, thus causing increased bruising. Remove needle from syringe and discard instruments separately. IMPORTANT POINTS TO REMEMBER Preferred site of injection is the abdominal area. Injections must be given 2 inches away from umbilicus. SEE DIAGRAM. If you need another area to give your heparin, you may use your thighs or buttocks, but this is only if there is no other place in your abdominal area. Rotate your sites of injections. Never inject in the same place as a previous injection or in a bruised area. Some bruising at the site of injection is normal (less than quarter size). If increased bruising occurs, you may use ice before you clean the area for injection and/or after you have given yourself the injection. Notify your doctors before any medical or surgical procedure that you are taking heparin. Carry an identification card in your wallet stating that you are on heparin. Contact your doctor if any of the following symptoms occur: Nose bleeds. Blood in the urine or stool. Excessive bleeding lasting greater than 15 minutes and not controlled by direct pressure. Unusual bruising not at the site of injection. Possible Side Effects Bleeding Local irritation—redness, mild pain and itching at site of injection Nausea and vomiting, chills and fever (rare) Immunoglobulin G Infusion In addition to conventional anticoagulation treatment with ASA and heparin or immunosupression with prednisone, a small percentage of patients may need additional treatment. These patients are at risk to develop intrauterine growth retardation, low amniotic fluid volume (oligohydramnios) toxemia, or severe side effects from steroids, or preexisting maternal disease. For these patients, immunoglobulin G infusion treatment is recommended. Immunoglobulin G is a purified immunoglobulin G from human origin. Your physician will choose the appropriate dosing regimen. The most frequently recommended protocols involve giving IVIG intravenously either once monthly for three consecutive months or for 3 consecutive days monthly. Monitoring your immune status during your pregnancy may lead your physician to recommend additional treatments. Immunoglobulin G is contraindicated in patients who have had a known anaphylactic or severe systemic response to human immune globulin. Patients with IgA deficiencies should not receive immunoglobulin G infusion. Side Effects Side effects to immunoglobulin G infusion tend to be related to the rate of infusion. Possible side effects include malaise, a feeling of faintness, fever, chills, headache, nausea and vomiting. Shortness of breath (dyspnea), chest tightness, hip joint pain, and back pain also have been reported. If you are found to be a candidate to receive immunoglobulin G infusion treatment, your physician may order the medication to be administered in your home following the first treatment being given at a medical facility. The information on this page has been taken from a brochure produced by Homedco Home Infusion Services for patients receiving immunotherapy. BUT, Is it safe? Adverse effects of intravenous immunoglobulin. Drug Safety, 1993 Oct, 9(4):254-62. Abstract: The range of diseases in which intravenous immunoglobulin (IVIG) is effective has expanded significantly since its initial use in primary antibody deficiency. There are at present at least 17 preparations of IVIG in use worldwide with similar profiles of adverse effects. Infusion-related effects range in severity. Mild adverse reactions (headache, flushing, low backache, nausea, wheezing) are often associated with a fast infusion rate, and respond rapidly on slowing the infusion. Very rare episodes of life-threatening anaphylaxis may occur, particularly in those IgA-deficient patients with anti-IgA antibodies; such patients should receive an IgA-depleted preparation of IVIG. There are concerns with any blood product about safety in regard to viral transmission. The 4 outbreaks of non-A non-B hepatitis (probably hepatitis C) in the 1980s were associated with the use of particular batches of IVIG. The more recent exclusion of all anti-hepatitis C virus positive individuals from the donor pool, and the introduction of specific antiviral steps in the manufacture of IVIGs, should prevent further outbreaks. The human immunodeficiency virus (HIV) is effectively inactivated during the manufacturing process itself and HIV transmission has not been reported with IVIG. Rarely, haematological (Coombs' test positive haemolysis), neurological (aseptic meningitis) or renal (transient rises in serum creatinine) adverse effects may be seen when high doses of IVIG are used for immunomodulatory purposes. Haemolysis, due to passive transmission of blood group antibodies (anti-A, anti-D), may be prevented by selecting IVIG batches that give a negative cross-match between the recipient's red cells and IVIG. 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