Rhogam

DRUG DESCRIPTION

RhoGAM (rhod immune globulin human) and MICRhoGAM (rhod immune globulin human) Rho(D) Immune Globulin (Human) are sterile solutions containing IgG anti-D (anti-Rh) for use in preventing Rh immunization. They are manufactured from human plasma containing anti-D. A single dose of RhoGAM (rhod immune globulin human) contains sufficient anti-D (approximately 300 ?g or 1500 IU)* to suppress the immune response to 15 mL (or less) of Rh-positive red blood cells.2,3 A single dose of MICRhoGAM (rhod immune globulin human) contains sufficient anti-D (approximately 50 ?g or 250 IU)* to suppress the immune response to 2.5 mL (or less) of Rh-positive red blood cells. The anti-D dose is measured by comparison to the RhoGAM (rhod immune globulin human) in-house reference standard, the potency of which is established relative to the US/WHO/EP Standard Anti-D Immunoglobulin Rho(D) Immune Globulin (Human) CBER Lot 4: NIBSC Lot 01/572 (285 IU/ampoule).

All donors are carefully screened by history and laboratory testing to reduce the risk of transmitting blood-borne pathogens from infected donors. Fractionation of the plasma is performed by a modification of the cold alcohol procedure that has been shown to significantly lower viral titers.4 Following fractionation, an additional viral-clearance filtration step is incorporated into the manufacturing process. This filtration step removes viruses via a size-exclusion mechanism utilizing a patented Viresolve?? 180 ultrafiltration membrane with defined pore-size distribution of 12-18 nanometers. The ultrafiltration step utilizes tangential flow filtration to permit filtration of IgG while effectively retarding enveloped and non-enveloped viruses above the pore-size distribution cutoff. The filter is inert to the product. Non-enveloped viruses are known to be resistant to chemical and physical inactivation.5,6 Laboratory spiking studies have shown that the cumulative viral removal capability of the RhoGAM (rhod immune globulin human) /MICRhoGAM (rhod immune globulin human) manufacturing process exceeds 13 logs for human immunodeficiency virus (HIV). Clearance of model viruses for hepatitis C virus (HCV), hepatitis B virus (HBV) and parvovirus B19 (a non-enveloped virus) exceeds 11 logs.4 The donor selection process, the fractionation process and the Viresolve ultrafiltration step are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses. Rho(D) Immune Globulin (Human) intended for intramuscular use and prepared by cold alcohol fractionation has not been reported to transmit hepatitis or other infectious diseases.7

The safety of Rho(D) Immune Globulin (Human) has been further shown in an empirical study of viral marker rates in female blood donors in the United States.8 This study revealed that Rh-negative donors, of whom an estimated 55-60% had received Rho(D) Immune Globulin (Human) for pregnancy-related indications, had prevalence and incidence viral marker rates similar to those of Rh-positive female donors who had not received Rho(D) Immune Globulin (Human). However, even after the fractionation and virus-filtration steps, there remains a risk of contracting blood-borne pathogens from a plasma-derived product.

The final product contains approximately 5 ?1% gamma globulin, 2.9 mg/mL sodium chloride, 0.01% polysorbate 80 and 15 mg/mL glycine. Small amounts of IgA, typically less than 15 ?g per dose, are present.9 The pH range is 6.20-6.55. The product contains no preservative and utilizes a latex-free delivery system.

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Rhogam


Rhogam Patient Information Including Side Effects

Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

Generic Name: RHo (D) immune globulin (Pronunciation: ROE D im MYOON GLOB yoo lin)

  • What is Rho(D) IG (Rhogam)?
  • What are the possible side effects of Rho(D) IG?
  • What is the most important information I should know about Rho(D) IG?
  • What should I discuss with my healthcare provider before I receive Rho(D) IG?
  • How is Rho(D) IG given?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while receiving Rho(D) IG?
  • What other drugs will affect Rho(D) IG?
  • Where can I get more information?

What is Rho(D) IG (Rhogam)?

Rho(D) immune globulin (Rho(D) IG) 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 (loss of red blood cells), kidney failure, or shock.

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

Rho(D) IG may also be used for other purposes not listed in this medication guide.

What are the possible side effects of Rho(D) IG?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, or shaking;
  • urinating less than normal;
  • a change in color of your urine;
  • sudden weight gain, swelling in your hands, feet, or ankles;
  • back pain; or
  • shortness of breath.

Less serious side effects may include:

  • muscle aches or pains;
  • headache;
  • feeling tired or light-headed;
  • nausea, vomiting; or
  • pain or tenderness where the injection is given.

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 is the most important information I should know about Rho(D) IG?

While you are being treated with this medication, call your doctor right away if you have fever, chills, shaking, back pain, a change in the color of your urine or how much you urinate, sudden weight gain, or swelling in your hands, ankles, or feet.

Do not receive live-virus vaccines such as measles, mumps, rubella, or chicken pox (also called MMR or Varivax) for at least 3 months after treatment with Rho(D) IG. These vaccines may not work properly during Rho(D) IG treatment and shortly afterward.

Rho(D) IG is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although Rho(D) IG is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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.

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