Rubella (German measles)

About Rubella

Rubella is a viral illness transmitted via direct or droplet exposure to nasopharyngeal fluids and is characterized by rash, low-grade fever, swollen lymph nodes, and malaise.

Because rubella symptoms can be mild, up to half of infections present as subclinical. While symptoms may be mild for some, adults may experience recurring episodes of arthralgia or arthritis, which are more common among women.

Rubella Is a Serious Disease

Rubella can be especially challenging for women in their first trimester of pregnancy; it can cause miscarriages and increases the potential for a group of birth defects called congenital rubella syndrome (CRS). Common symptoms of CRS include cataracts, hearing loss, mental retardation, and congenital heart defects. In addition, infants with CRS often exhibit slowed growth in utero and after birth. During the first 3 months of gestation, the risk for congenital infections and defects is highest, and the risk for any defects diminishes beginning in the second trimester.

The Centers for Disease Control and Prevention (CDC) can provide more information on rubella.

Postexposure Prophylaxis for Rubella2

Some studies suggest that the use of GamaSTAN in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN may benefit those women who will not consider a therapeutic abortion.

INDICATIONS AND USAGE

GAMASTAN (immune globulin [human]) is indicated for prophylaxis following exposure to hepatitis A infection, prevention or modification of measles in susceptible persons exposed fewer than 6 days previously, modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion.

Limitations of Use

GAMASTAN is not indicated for routine prophylaxis or treatment of viral hepapitis type B, rubella, poliomyelitis, mumps, or varicella.

IMPORTANT SAFETY INFORMATION

Thrombosis may occur with immune globulin products, including GAMASTAN. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

For patients at risk of thrombosis, do not exceed the recommended dose of GAMASTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

GAMASTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Administer GAMASTAN cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

Inject intramuscularly only. Do not administer GAMASTAN intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]). Do not inject into a blood vessel.

GAMASTAN is made from human blood; it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reaction reported for GAMASTAN S/D during post-approval use was fatigue.

Antibodies in GAMASTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GAMASTAN administration.

Please see full Prescribing Information for GAMASTAN.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


References:

  1. McLean HQ, Fiebelkorn AP, Temte JL, Wallace GS; Advisory Committee on Immunization Practices (ACIP). Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62(RR-04):1-34.
  2. GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.