Every woman who is pregnant in the world needs to know Marianne Cummins.

50 years ago, Teaneck, New Jersey homemaker, was pregnant with her third child. She was 29 years old at the time. In May 1968, she was the first person to get an injection of RhoGAM. This new medicine was developed to prevent the condition known as brain damage and death in America.

“That one injection had a tremendous impact on my family,”Cummins has recently been recalled.

Cummins, as you can see, is Rh-negative. This trait is shared by 15% of the U.S. Population.

However, the fetus within her was Rh-positive as were her two children.

It is worth learning a little bit about Biology 101 to understand the terrifying nature of this incompatibility back in the pre-RhoGAM days. It’s common for some baby’s blood to reach the mother’s circulation during pregnancy. This is usually around delivery. Rh-positive fetal red cells cross into the mother’s circulation. The body responds like it’s fighting an invading viral infection, and makes antibodies that can attack baby’s cells. This is known as the immune system response “Rh sensitization.”

Since antibodies are made slowly, the first child is often unaffected. The second Rh-positive child, although it is unlikely, will be affected. This is because the production of antibodies takes time.

RhoGAM as it still does today, stopped that sensitization.

“I still marvel at RhoGAM’s impact,” John Gorman, MD, a co-creator of the medicine and former director of the blood bank at New York Presbyterian/Columbia University Medical Center, has said.

The FDA approved the drug, and the use of the drug became a standard medical practice for all Rh-negative pregnant women here and in Europe and Canada. This resulted in HDFN’s complete elimination. However, this protocol is not available in many countries that are less wealthy. Even so, many still call it so “dire”According to leading medical professionals, an estimated 14 percent of the affected fetuses die stillborn. A full 50% of live births result in brain injury or death.

In celebration of the FDA’s 50th anniversary, Kedrion Biopharma (which makes RhoGAM) and Columbia University Irving Medical Center (which developed it), hosted a panel discussion in February 2018. The purpose of the discussion was to discuss strategies for getting RhoGAM to other parts of the globe.

“The view ahead should be bright for all women, their partners, and their families around the globe,”Paolo Marcucci is chief executive officer of Kedrion Biopharma.

Additionally, there will be a series events throughout the year that encourage Rh-negative females to donate blood plasma for the ongoing production of RhoGAM. Kedrion Biopharma.

 

Important Safety Information 

RhoGAM should not be used if Rh-positive.

Inform your healthcare provider of all medical conditions.

* If you have known severe allergic reactions or a severe response to human immune globulin.

* If you have experienced a serious reaction to other medicines that contain immune globulin.

* If you have an immunoglobulin A (IgA) deficiency. RhoGAM contains a small amount of IgA, and IgA-deficient people may experience an allergic reaction. If you are unsure, consult your healthcare provider.

* Your recent history of vaccinations. Some vaccines, which contain live viruses, may not work well if you also receive immune globulins such as RhoGAM. The vaccine might not work because of the antibodies in RhoGAM. Tell your healthcare provider that RhoGAM was given to you before you receive a vaccine.

RhoGAM, which is made from human blood, has the potential to transmit infectious agents like viruses, the agent with variant CreutzfeldtJakob disorder (vCJD), as well as unknown infectious agents. If you have questions or concerns, it is best to consult your healthcare provider.

RhoGAM reactions that affect the entire body can be rare. RhoGAM could cause allergic reactions. To detect signs and symptoms of allergic reactions, it is important to be monitored for at most 20 minutes following RhoGAM administration. Itchy rash, hives, tightness in the chest, wheezing and low blood pressure are all signs and symptoms of allergic reactions.

Side effects of RhoGAM include swelling, redness, hardening, and mild pain near the injection site. Some patients may experience a mild fever.

For you to keep and present to other healthcare providers, your healthcare provider should give you a completed Patient ID Card.

Report adverse effects of prescription drugs to FDA. www.fda.gov/Safety/MedWatchCall 1-800-FDA-1088.

Click hereRhoGAM Full Prescribing Details