First time mom-refusing rhogam
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I am a first time mom and am A-. I had early bleeding (around the 6th week) and went to the ER. I am now fully convinced it was just implantation bleeding but the hospital made it out to be life threatening to my child and were trying to push rhogam on me (I'm 34 weeks today with a very active and healthy, growing baby boy). I initially agreed because I was worried but as they were prepping it I had an out of body experience and something told me don't do it. I've had my doctor (now seeing a different one) and the doctor who does my scans try to push it on me several times. I have declined it at least 10 times now. I have done as much research on it as I possibly can inlcuding watching Candace's episode on it. I have found so much as to why I "should" get the shot and it's always just "bad things MAY happen if you get pregnant again" but there is virtually nothing out there from moms who have refused it. Is there anyone out there who has first hand experience with this?
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https://www.fda.gov/media/190188/download
This is a little long but here is the FDA print out for this shot. Some things to consider below:
CONTRAINDICATIONS
The use of RhoGAM and MICRhoGAM is contraindicated in the following:
• Rh-positive individuals
• Patients with a known history of anaphylactic or severe systemic reactions to the administration
of human immune globulin products.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Severe hypersensitivity reactions may occur with the use of RhoGAM/MICRhoGAM, even in patients who
have tolerated previous administrations.
RhoGAM / MICRhoGAM contain a small quantity of IgA3. There is a potential risk of hypersensitivity in IgA
deficient individuals. Although high doses of intravenous immune globulin containing IgA at levels of 270-
720 μg/mL have been given without incident during treatment of patients with high-titer antibodies to
IgA4, the attending physician must weigh the benefit against the potential risks of hypersensitivity
reactions.
RhoGAM / MICRhoGAM should be administered in a setting where appropriate equipment, medications
such as epinephrine, and personnel trained in the management of hypersensitivity, anaphylaxis, and shock
are available.
5.2 Transmissible Infectious Agents
Because RhoGAM and MICRhoGAM are made from human blood, they may carry a risk of transmitting
infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
All infections thought by a physician possibly to have been transmitted by these products should be
reported by the physician or other healthcare provider in the United States to Kedrion Biopharma Inc. at 1-
855-3KDRION (1-855-353-7466). Outside the United States, the company distributing these products
should be contacted. The physician should discuss the risks and benefits of these products with the patient.
5.3 Interference with Laboratory Tests
After administration of Rho(D) immune globulin, a transitory increase of various passively transferred
antibodies in the patient’s blood may yield positive serological testing results, with the potential for
misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, C and E)
and other blood group antibodies may cause a positive direct or indirect antiglobulin (Coombs’) test.
Recovery of anti-D in plasma or serum after injection of RhoGAM or other Rho(D) Immune Globulin
(Human) products is highly variable among individuals. Anti-D detection in a patient’s plasma is dependent
on assay sensitivity and time of sample collection post-injection. Currently there are no requirements or
practice standards to test for the presence of anti-D in order to determine adequacy or efficacy of dose
following an injection of RhoGAM.
The presence of passively acquired anti-D antibodies in the maternal serum may cause a positive antibody
screening test. This does not preclude further antepartum or postpartum prophylaxis.
A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field
positive Du test result. Assess such an individual for a large fetomaternal hemorrhage and adjust the dose
of Rho(D) immune globulin accordingly. The presence of passively administered anti Rho(D) in maternal or
fetal blood can lead to a positive direct antiglobulin (Coombs’) test. If there is an uncertainty about the
father’s Rh group or immune status, administer Rho(D) immune globulin to the mother.
5.4 Hemolysis
Incompatible blood transfusion
Administration of RhoGAM / MICRhoGAM to patients who are Rh-positive or have received Rh-positive
red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain,
nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and
decreased haptoglobin. Therefore, patients treated for Rh-incompatible transfusion should be monitored
by clinical and laboratory means for signs and symptoms of a hemolytic reaction. Alert patients to, and
monitor them for, the signs and symptoms of intravascular hemolysis, including back pain, shaking chills,
fever, and discolored urine or hematuria. Absence of these signs and/or symptoms of intravascular
hemolysis within 8 hours do not indicate intravascular hemolysis cannot occur subsequently.
6 ADVERSE REACTIONS
The most frequently reported adverse reactions in patients receiving Rho(D) Immune Globulin (Human)
products are injection site reactions, such as swelling, induration, redness and mild pain or warmth.
Possible systemic reactions are skin rash, body aches or a slight elevation in temperature. Severe
systemic reactions include allergic reactions and hemolytic reactions (see Warnings and Precautions
[5.2]).
There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM or
MICRhoGAM administration.
6.1 Clinical Studies Experience
Because clinical studies are conducted under different protocols and widely varying conditions, adverse
reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect
the rates observed in practice.
No clinical studies with RhoGAM and MICRhoGAM have been conducted under the current Good Clinical
Practices (GCP) Guidelines.
6.2 Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or to establish a causal relationship to Rho(D) Immune
Globulin (Human) products.
The following adverse reactions have been reported during post-approval use of RhoGAM/MICRhoGAM:
hypersensitivity reactions, including cases of anaphylactic shock or anaphylactoid reactions, skin rash,
erythema, pruritus, chill, pyrexia, malaise, and back pain. Transient injection-site irritation and pain
have been reported following intramuscular administration.
7 DRUG INTERACTIONS
7.1 Live Virus Vaccines
Immune globulin preparations including Rho(D) Immune Globulin (Human) may impair the efficacy of live
vaccines such as measles, mumps and varicella. Administration of live vaccines should generally be delayed
until 12 weeks after the final dose of immune globulin. If an immune globulin is administered within 14
days after administration of a live vaccine, the immune response to the vaccination may be inhibited.5
Because of the importance of rubella immunity among women of childbearing age, the postpartum
vaccination of rubella-susceptible women with rubella or MMR vaccine should not be delayed because of
the receipt of Rho(D) Immune Globulin (Human) during the last trimester of pregnancy or at delivery.
Vaccination should occur immediately after delivery and if possible, testing should be performed after 3 or
more months to ensure immunity to rubella and if necessary, to measles.517 PATIENT COUNSELING INFORMATION
Please inform patients of the following:
• The risks and benefits of RhoGAM and MicRhoGAM.
• The most common adverse reactions are local reactions including swelling, induration, redness and
mild pain at the site of injection, and a small number of patients have noted a slight elevation in
temperature.
• Allergic reactions to RhoGAM and MICRhoGAM may occur. Patients should be observed for at least
20 minutes after administration. Signs of hypersensitivity reactions include hives, generalized
urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
• RhoGAM and MICRhoGAM may interfere with the response to live virus vaccines (e.g., measles,
mumps, rubella, and varicella). Instruct patients to notify their healthcare professional of this
potential interaction when they are receiving vaccinations.
• RhoGAM and MICRhoGAM are prepared from human plasma and may contain infectious agents that
can cause disease. Numerous tests have been applied in the plasma collection process and specific
viral inactivation steps have been added to the manufacturing process to minimize the risk of
transmission of diseases, but all risk cannot be eliminated.
• Retain the RhoGAM Patient Identification Card…. -
Hi! I am so sorry you are having these experiences. I don’t know much about it either but wanting some more details. So essentially you “qualify” for Rhogam because of your blood type? I didn’t and up needing it so I can’t say much on my personal experience but I’d love to dig in more for you!
Club Candace
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