Rhogam shot side effects

Rhogam

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/3/2019

RhoGAM (rhod immune globulin human) is a sterilized solution made from human blood used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RhoGAM may also be used in the treatment of immune thrombocytopenic purpura (ITP). Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). An Rh negative person can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. RhoGAM is available in generic form. Common side effects of RhoGAM include:

  • injection site reactions (pain discomfort, or tenderness),
  • fever,
  • joint or muscle pain,
  • headache,
  • dizziness,
  • weakness,
  • tiredness,
  • itching,
  • skin rash,
  • nausea,
  • diarrhea,
  • vomiting,
  • stomach pain,
  • or an allergic reaction to tiny amounts of proteins in the injection.

Tell your doctor if you have a serious side effect of RhoGAM including:

  • chills,
  • shaking,
  • back pain,
  • dark colored urine,
  • rapid breathing,
  • shortness of breath,
  • urinating less than usual or not at all,
  • swelling,
  • rapid weight gain,
  • pale skin,
  • easy bruising or bleeding,
  • rapid heart rate,
  • trouble concentrating, or
  • feeling light-headed.

A single 300 mcg dose RhoGAM is usual for the indications associated with pregnancy. There may be other drugs that can interact with RhoGAM. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. RhoGAM is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breastfeeding.

Our RhoGAM (rhod immune globulin human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Frequently Asked Questions

APPROVED USES

RhoGAM® Ultra-Filtered PLUS (300 μg), is a prescription medicine given by intramuscular injection that is used to prevent Rh immunization, a condition in which an individual with Rh-negative blood develops antibodies after exposure to Rh-positive blood. MICRhoGAM® Ultra-Filtered PLUS (50 μg) is a lower dose of Rho(D) immune globulin that is used in certain clinical situations.

If the father or baby is not conclusively shown to be Rh-negative, RhoGAM should be given to a Rh-negative mother in the following clinical situations to prevent Rh immunization:

  • After delivery of an Rh-positive baby
  • Routine prevention of Rh immunization at 26 to 28 weeks of pregnancy
  • Maternal or fetal bleeding during pregnancy from certain conditions
  • Actual or threatened pregnancy loss at any stage. MICRhoGAM should be used in Rh-negative women who experience pregnancy loss at or up to 12 weeks of pregnancy
  • Ectopic pregnancy (pregnancy in which the fertilized egg implants outside the uterus)

IMPORTANT SAFETY INFORMATION

RhoGAM or MICRhoGAM should NOT be used if you are Rh-positive or if you have had a severe allergic reaction to human immune globulin.

Be sure to tell your healthcare provider about all your medical conditions, including:

  • If you have ever had a severe allergic reaction or a severe response to human immune globulin.
  • If you have an immunoglobulin A (IgA) deficiency. RhoGAM and MICRhoGAM contain a small quantity of IgA and there is a potential risk of an allergic reaction in IgA-deficient individuals. Ask your healthcare provider if you are not sure.
  • Your recent history of vaccinations. Certain types of vaccines (ones containing a live virus) may not work as well for you if you are also receiving immune globulin products like RhoGAM or MICRhoGAM. The antibodies in RhoGAM and MICRhoGAM may prevent the vaccine from working. Before you get a vaccine, tell your healthcare provider that you have received RhoGAM or MICRhoGAM.

Allergic reactions to RhoGAM or MICRhoGAM may occur. You should be observed for at least 20 minutes after administration. Signs and symptoms of an allergic reaction include itchy rash (hives/urticaria), tightness of the chest, wheezing, low blood pressure and anaphylaxis (which may also include throat or tongue swelling, shortness of breath, vomiting, hives and/or lightheadedness).

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.

The most common side effects of RhoGAM and MICRhoGAM are swelling, hardening, redness, and mild pain at the site of the injection. A small number of patients have noted a slight fever.

Your healthcare provider should provide you with a completed Patient Identification Card for you to retain and present to other healthcare providers.

You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or
call 1-800-FDA-1088.

Click here for the RhoGAM and MicRhoGAM Full Prescribing Information.
This site is intended for residents of the US only.

RhoGAM

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Name: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

Medically reviewed by Drugs.com on Feb 4, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Interactions
  • Pregnancy
  • More

What is RhoGAM?

RhoGAM is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (low red blood cells), kidney failure, or shock.

RhoGAM is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. This medicine may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RhoGAM may also be used for purposes not listed in this medication guide.

Important Information

You should not receive RhoGAM if you have immune globulin A (IgA) deficiency with antibody to IgA, or if you have hemolytic anemia (a lack of red blood cells).

RHo(D) immune globulin can cause an abnormal breakdown of red blood cells. This effect can lead to life-threatening blood clots or organ failure.

Call your doctor right away if you have any of the following symptoms: fever, chills, back pain, unusual weakness, red or pink urine, pale skin, feeling short of breath, little or no urinating, rapid weight gain, sudden numbness or weakness, slurred speech, problems with vision or balance, coughing up blood, or swelling or warmth in your leg.

Before taking this medicine

You should not receive this medicine if you have ever had an allergic reaction to an immune globulin, or if you have:

  • immune globulin A (IgA) deficiency with antibody to IgA; or

  • hemolytic anemia (a lack of red blood cells).

To make sure RhoGAM is safe for you, tell your doctor if you have:

  • a history of anemia;

  • heart disease or a history of coronary artery disease (hardened arteries);

  • a bleeding disorder (such as hemophilia);

  • high triglycerides (a type of fat in the blood);

  • kidney disease; or

  • diabetes.

RhoGAM is often used during and after pregnancy. This medicine is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RhoGAM is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RhoGAM given?

RhoGAM is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely after you receive immune globulin. Your urine may also need to be tested every 2 to 4 hours for at least 8 hours.

For treatment during pregnancy, RhoGAM is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medicine is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with RhoGAM.

RhoGAM can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RhoGAM.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RhoGAM?

Do not receive a “live” vaccine for at least 3 months after treatment with RhoGAM. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

RhoGAM side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills, shaking, back pain, unusual weakness, red or pink urine;

  • pale or yellowed skin, dark colored urine;

  • rapid breathing, rapid heart rate, confusion, feeling short of breath;

  • signs of kidney failure–little or no urinating, swelling, rapid weight gain; or

  • signs of a blood clot–sudden numbness or weakness, slurred speech, problems with vision or balance, chest pain, coughing up blood, swelling with redness and warmth in one or both legs.

Common side effects may include:

  • nausea, diarrhea, vomiting, stomach pain;

  • headache, dizziness;

  • drowsiness, weakness, general ill feeling;

  • joint or muscle pain;

  • flushing (warmth, redness, or tingly feeling);

  • mild itching or skin rash;

  • increased sweating; or

  • pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RhoGAM?

Other drugs may interact with RHo (D) immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 5.01.

Medical Disclaimer

More about RhoGAM (rho (d) immune globulin)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Interactions
  • En Español
  • Drug class: immune globulins

Consumer resources

  • Rhogam (Advanced Reading)

Other brands: Rhophylac, WinRho SDF, BayRHo-D, HyperRHO S/D Full Dose, … +4 more

Professional resources

  • Rho(D) Immune Globulin (AHFS Monograph)

Related treatment guides

  • Idiopathic Thrombocytopenic Purpura
  • Rh-Isoimmunization

RhoGAM is a brand name of the medicine Rho(D) immune globulin, which is used to treat blood problems in certain people.

The medicine is often used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion of Rh-positive blood.

It’s also given during pregnancy when a mother has Rh-negative blood, and the baby has Rh-positive blood.

Having Rh-negative blood means that you don’t have a specific protein (known as the Rh factor) on the surface of your red blood cells. You have Rh-positive blood if you do have the protein.

RhoGAM is also used to treat immune thrombocytopenic purpura (a blood disorder characterized by a very low number of platelets) in people with Rh-positive blood.

The medicine is an immunoglobulin. It’s a sterilized solution made from human blood.

The U.S. Food and Drug Administration (FDA) initially approved RhoGAM in 1968. It’s manufactured by Kedrion Biopharma, Inc.

RhoGAM Warnings

RhoGAM may raise your risk of blood clots.

The risk of blood clots is higher if you’re an older adult or confined to a bed or chair, or if you take estrogen products, use a catheter, or have any condition that raises your risk of blood clots, thick blood, or heart problems.

Tell your doctor if you have a history of blood clots before taking RhoGAM.

Also, let your doctor know immediately if you experience any of the following symptoms:

  • Pain, tenderness, redness, warmth, or swelling in your legs or arms
  • Chest pain or discomfort
  • Shortness of breath
  • Numbness or weakness on one side of the body
  • Fast heartbeat
  • Coughing up blood

You should know that receiving live vaccines may reduce the effectiveness of RhoGAM.

Avoid any vaccinations while taking this medicine, and for three months afterward.

RhoGAM is made from human plasma, so there’s an extremely low chance that you could develop a viral infection or a condition called Creutzfeldt-Jakob disease (CJD) after taking it.

Talk to your doctor about this risk.

Before taking RhoGAM, let your doctor know if you:

  • Have a blood disorder, such as anemia, IgA deficiency, or bleeding problems
  • Have had your spleen removed
  • Have heart or kidney problems
  • Have diabetes
  • Have allergies to medications or blood products

RhoGAM may cause false results on certain lab tests. Tell all your healthcare providers and lab personnel that you’re taking this medicine before having any tests performed.

Your doctor will order tests to check your body’s response to the medicine. Be sure to keep all appointments with your doctor’s office and laboratory.

Pregnancy and RhoGAM

If you’re pregnant, discuss the benefits and risks of taking RhoGAM.

It’s not known whether the medicine can harm an unborn baby, but the benefits may outweigh the risks for some pregnant women.

Studies suggest that RhoGAM poses minimal risks to a breastfeeding baby.

Still, talk to your doctor before breastfeeding while taking this medicine.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have a history of kidney problems, anemia, blood clotting problems, heart or blood vessel problems (such as atherosclerosis), lung or breathing problems, or have had a stroke.
  • Check with your doctor right away if you or your child have back pain, shaking chills, a fever, dark urine, a decreased amount of urine, a sudden weight gain, swelling of the hands or feet, or shortness of breath after receiving this vaccine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).
  • This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.
  • This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.
  • This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.
  • This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

What Happens When You Get a RhoGam Shot

Ariel Skelley/Getty Images

Early in your pregnancy, one of the battery of tests you’ll take is a blood test to determine whether you are Rh positive or Rh negative. Rh, or Rhesus, is a protein that rides along on the surface of the red blood cells of about 85 percent of people. If the protein is found on your red blood cells, you are Rh positive, if it’s not there, you’re negative. Pretty much the only time in your life this presence or absence of the Rhesus protein will matter is when you’re pregnant with your second or subsequent child.

  • RELATED: Your Prenatal Test Checklist

Let’s break down how our bodies work: Your body’s immune system “reads” the surfaces of your cells for foreign or unfamiliar proteins, and if a cell is determined to have unfamiliar proteins, your body reacts by producing antibodies for that particular protein. Think of antibodies as little warrior cells who go off to do battle against invading forces. Anytime you are exposed to an antigen, your body produces antibodies specific to that antigen, so if it attacks again, your immune system is ready to fight it off.

This is why your Rh factor isn’t an issue during first pregnancies. It isn’t until second and subsequent pregnancies, when antibodies are already built up, that Rh incompatibility can cause problems.

If you are Rh-negative and your baby’s blood is Rh-positive and makes contact with yours during your first pregnancy, your body begins to produce antibodies because it doesn’t recognize the Rh protein present in your baby’s blood.

Remember: Since you and your baby don’t share circulation, there are only a few points during pregnancy that fetal blood can come into contact with maternal blood. Tami Prince, M.D., of Women’s Health and Wellness Center of Georgia, says cross-contamination can occur “during early pregnancy bleeding, procedures such as an amniocentesis or CVS (chorionic villus sampling), direct abdominal trauma, ectopic pregnancy, miscarriage, or blood transfusion with mismatched blood typing.”

“It is critical that an Rh-negative woman be treated with Rh immunoglobulin if bleeding occurs in order to prevent antibody formation,” Dr. Prince says. If not, and your baby during a subsequent pregnancy is Rh positive, there will be an immune response and your antibodies can cross the placenta and attack your baby’s red blood cells. This can cause your baby to develop anemia, and in severe cases, result in miscarriage.

Luckily, there’s an injection women can receive during pregnancy to counteract Rh incompatibility: the RhoGam injection.

What is the RhoGam shot?

RhoGam is an injection made up of antibodies called immunoglobulin, that help protect a fetus from its mother’s antibodies. According to the product website, “RhoGAM prevents the Rh-negative mother from making antibodies during her pregnancy. As long as the Rh-negative mother receives RhoGAM appropriately during every pregnancy, her babies are at very low risk of developing .”

Sheila Chhutani, M.D., of Gyn/OB Associates in Dallas, Texas, tells Parents.com, “RhoGam is immunoglobulin, or manufactured antibodies, that will attach to the rhesus protein in the mother’s blood, not allowing her body to process or ‘see’ that protein to start manufacturing her own antibodies. The RhoGam does not cross the placenta and will not harm the baby.”

Dr. Chhutani adds, “The injection is typically given at 28 weeks gestation because it will last for about 12 weeks. At delivery, if the newborn is RH positive, the mother will receive another dose of RhoGam.” This last injection is given just in case there was any cross-contamination of blood from baby to mother during delivery. One last dose of immunoglobulin will prevent the mother’s body from producing antibodies that may place future pregnancies at risk.”

  • RELATED: All About Rh Disease

RhoGam Side-effects

Side-effects are usually mild and don’t affect the baby or breastfeeding after delivery. Common RhoGam side-effects include swelling and/or redness at the injection site, itching at the injection site, and mild fever. Less common side-effects can include allergic reaction, headache, joint or muscle pain, and fatigue. If any of these are experienced, you should talk to your doctor.

  • By Kristi Pahr

Now for some real-life complexities. RhoGAM is useless if a woman is already sensitized. Any pregnancy event with the potential for fetal-maternal blood mixing can sensitize the mother. That includes certain placental abnormalities, tubal pregnancy, miscarriage and invasive procedures such as abortion or amniocentesis. The chances of mixing and sensitization are lower earlier in pregnancy, but there’s still a risk.

Most experts recommend a RhoGAM shot at 28 weeks to head-off sensitization, as well as after birth. RhoGAM doesn’t hurt the fetus because there are different kinds of antibodies and the ones in RhoGAM are a type that won’t cross the placenta, so never reach the fetus. Once a woman has had this shot, she should make sure everyone involved in her health care knows. Otherwise, when she has blood tests, they might wrongly assume that she has become sensitized.

RhoGAM shots aren’t necessary if the fetus has Rh-negative blood, but that usually isn’t known until birth. An amniocentesis at 18 weeks can tell you, but also carries a small risk of sensitization. “When they do an amnio, the doctor should know she’s Rh-negative and try not to go through the placenta,” says Dr. Amos Grunebaum, director of Maternal-Fetal Medicine at St. Luke’s-Roosevelt Hospital Center in New York, and a vice president of OnHealth.com. “They should go to a doctor who will only stick once, and with the smallest possible needle,” he says.

In your case, whether your baby has Rh-negative or Rh-positive blood depends on your genes. You can be Rh-positive two ways. You might be what’s called homozygous, meaning you carry two positive Rh-factor genes, one from each of your parents. If so, your baby will have Rh-positive blood. Or you might be what’s called heterozygous, meaning you carry one negative and one positive gene. In that case, your baby has a 50/50 chance of having Rh-positive blood.

If you happen to know that one of your parents is Rh-negative, then you know you have one negative gene and that you’re heterozygous. If both your parents are Rh-positive, you can’t assume anything, because, like you, they might be either heterozygous or homozygous, and you have no way of knowing which genes you got.

Some people worry that RhoGAM is a blood product. “Nobody has ever gotten AIDS or hepatitis from it,” Dr. Grunebaum says. You may hear that sometimes even with RhoGAM a woman becomes sensitized. That can happen, and it’s unfortunate, but it’s no reason to avoid the shot. Or you may hear that some Rh-negative women have given birth to multiple Rh-positive babies, without benefit of RhoGAM, and everyone was fine. That can happen, too, but it’s no reason to take chances. The benefits of RhoGAM seem to far outweigh the risks, but you’ll want to discuss this when you find that knowledgeable, communicative doctor.

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